Gliclid

Gliclid may be available in the countries listed below.

Ingredient matches for Gliclid

Gliclazide

Gliclazide is reported as an ingredient of Gliclid in the following countries:

• Bangladesh

International Drug Name Search

Cataflam-V

Cataflam-V may be available in the countries listed below.

Ingredient matches for Cataflam-V

Diclofenac

Diclofenac is reported as an ingredient of Cataflam-V in the following countries:

• Hungary

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Coltramyl

Coltramyl may be available in the countries listed below.

Ingredient matches for Coltramyl

Thiocolchicoside

Thiocolchicoside is reported as an ingredient of Coltramyl in the following countries:

• France


• Malta


• Oman


• Peru


• Tunisia


• Vietnam

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Bisoprolol Labesfal

Bisoprolol Labesfal may be available in the countries listed below.

Ingredient matches for Bisoprolol Labesfal

Bisoprolol

Bisoprolol is reported as an ingredient of Bisoprolol Labesfal in the following countries:

• Portugal

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Ciprofloxacin Arrow

Ciprofloxacin Arrow may be available in the countries listed below.

Ingredient matches for Ciprofloxacin Arrow

Ciprofloxacin

Ciprofloxacin is reported as an ingredient of Ciprofloxacin Arrow in the following countries:

• Slovakia

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacin Arrow in the following countries:

• Denmark


• Sweden

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Cliovelle

Cliovelle may be available in the countries listed below.

Ingredient matches for Cliovelle

Estradiol

Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Cliovelle in the following countries:

• Germany


• Poland


• Sweden

Norethisterone

Norethisterone 17ß-acetate (a derivative of Norethisterone) is reported as an ingredient of Cliovelle in the following countries:

• Germany


• Poland


• Sweden

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Orphenadrine Hydrochloride 50mg / 5ml Oral Solution

Orphenadrine 50mg/5ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What is Orphenadrine Oral Solution and what is it used for


• 2. Before you take Orphenadrine Oral Solution


• 3. How to take Orphenadrine Oral Solution


• 4. Possible side effects


• 5. How to store Orphenadrine Oral Solution


• 6. Further information

What is Orphenadrine Oral Solution and what is it used for

The name of your medicine is Orphenadrine 50mg/5ml Oral Solution (called orphenadrine in this leaflet). It contains orphenadrine hydrochloride. This belongs to a group of medicines called anticholinergics.

Orphenadrine can be used for the symptoms of Parkinsonism (usually slow movement, muscle stiffness and shaking fingers). These symptoms can be caused by Parkinson’s Disease, but there are other causes as well.

Before you take Orphenadrine Oral Solution

Do not take Orphenadrine Oral Solution and tell your doctor if:

• You are allergic (hypersensitive) to orphenadrine or any of the ingredients in this liquid (see section 6: Further information)


• You have an enlarged prostate gland, particularly if you are an elderly man


• You have problems with your movement and speech


• You have porphyria. This is a red blood cell problem that is passed through families


• You have difficulty passing water (urine)


• You have stomach problems including a paralysed bowel. The signs include swollen and tender stomach (abdomen), feeling and being sick but with no wind


• You have glaucoma (increased pressure in the eye)


• You are at risk of getting a very high temperature. This can happen if you have malaria.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking orphenadrine.

Take special care with Orphenadrine Oral Solution

Before you take orphenadrine tell your doctor if:

• You have unusual fast heart beats, high blood pressure or heart problems


• You have kidney or liver problems


• You are an older person


• You suffer from involuntary movements of the face or body (tardive dyskinesia).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking orphenadrine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because orphenadrine can affect the way some other medicines work.

Also some medicines can affect the way orphenadrine works.

Tell your doctor if you are taking any of these medicines

• Painkillers such as dextropropoxyphene


• Anti-histamines - used for allergies


• Disopyramide - used for irregular heartbeats


• Medicines used for depression


• Medicines used for mental problems called ‘psychoses’ (such as chlorpromazine and thioridazine)


• Medicines used for Parkinson’s disease (such as amantadine – which can also be used to treat viral infections)


• Medicines used for stomach pain – "antispasmodics" (such as atropine sulphate, dicycloverine hydrochloride and propantheline bromide).

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

Driving and using machines

While taking this medicine you may feel light-headed, your eyesight can become blurry or you could get an unusual feeling of excitement (elation). If this happens, you should not drive a car or use any tools or machines.

Important information about what is in Orphenadrine Oral Solution

This medicine contains:

• Methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine


• Liquid maltitol and liquid sorbitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine


• Ethanol (alcohol). This product contains small amounts of alcohol, less than 100mg per dose.

How to take Orphenadrine Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

• This medicine contains 50mg of orphenadrine hydrochloride in each 5ml


• Take this medicine by mouth.

Adults

The usual doses for adults are given below:

Parkinsonism

• A total daily dose of 100mg to 400mg each day


• This total daily dose can be split into two or three smaller doses to be taken through the day


• At the start of treatment you may be asked to take 150mg each day


• This total daily dose may be increased by 50mg every two to three days
  
  The increases should be continued until your symptoms are under control.

Parkinsonism that happens after having encephalitis (brain infection) or where the cause is unknown

• 250mg to 300mg each day


• This can be split into two or three smaller doses to be taken through the day.

Parkinsonism that happens when your arteries harden

• 100mg to 150mg each day


• This can be split into two or three smaller doses to be taken through the day.

Parkinsonism that is caused by other medicines

• 150mg to 300mg each day


• This can be split into two or three smaller doses to be taken through the day.

Children

This medicine is not usually given to children.

Elderly

If you are an older person you may be more sensitive to the medicine. The chances of you getting side effects are increased.

If you take more Orphenadrine Oral Solution than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken. The following effects may happen: excitement, confusion, being delirious, unusually fast heart beats, pupils become larger, difficulty in passing urine, fits and coma.

If you forget to take Orphenadrine Oral Solution

Do not take a double dose (two doses at the same time) to make up for forgotten doses. Skip the missed dose, then go on as before.

If you stop taking Orphenadrine Oral Solution

Keep taking orphenadrine until your doctor tells you to stop. Do not stop taking your medicine suddenly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, orphenadrine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, STOP taking the medicine and see a doctor immediately:

• any kind of skin rash, flaking skin, boils or sore lips and mouth


• sudden wheezing, fluttering or tightness of the chest or collapse

This may mean that you are having an allergic reaction to orphenadrine.

If you get any of the following side effects, see your doctor as soon as possible:

Common (affect more than 1 in 100 people)

• Blurred vision and dizziness.

Uncommon (affect more than 1 in 1000 people)

• Fast heart beats


• Difficulty in managing your movements


• Difficulty in passing urine


• Hallucinations


• Feeling confused


• Fits.

Tell your doctor if you get any of these side effects:

Common (affect more than 1 in 100 people)

• Dry mouth


• Feeling sick (nausea) and stomach upset


• Feeling restless.

Uncommon (affect more than 1 in 1000 people)

• Constipation


• Greater sensitivity to things around you or feeling nervous


• Feeling light-headed and an unusual feeling of excitement (elation)


• Difficulty sleeping or feeling tired.

Rare (affect more than 1 in 10,000 people)

• Forgetting things more than usual.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Orphenadrine Oral Solution

• Keep out of the reach and sight of children.


• Do not store above 25°C and keep out of direct sunlight.


• Do not use after the expiry date (month, year) which is stated on the label and carton (exp: month, year)


• The expiry date refers to the last day of that month


• Do not use Orphenadrine Oral Solution if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist


• Medicines should not be disposed of via wastewater or household waste.
  
  Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Orphenadrine Oral Solution contains

• The active ingredient is orphenadrine hydrochloride.


• The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), liquid maltitol (E965), sorbitol solution (E420), saccharin sodium, blackcurrant flavour (containing propylene glycol and ethanol), aniseed flavour, citric acid (E330), sodium citrate (E331) and purified water.

What Orphenadrine Oral Solution looks like and contents of the pack

An almost colourless liquid with an odour of blackcurrant.

It comes in a brown glass bottle holding 150ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

This leaflet was last revised in November 2009.

P0486

Children's Motrin Cold

Ingredient matches for Children's Motrin Cold

Ibuprofen

Ibuprofen is reported as an ingredient of Children's Motrin Cold in the following countries:

• United States

Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Children's Motrin Cold in the following countries:

• United States

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Prosfin

Prosfin may be available in the countries listed below.

Ingredient matches for Prosfin

Finasteride

Finasteride is reported as an ingredient of Prosfin in the following countries:

• Bangladesh

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Klinset

Klinset may be available in the countries listed below.

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Loratadine

Loratadine is reported as an ingredient of Klinset in the following countries:

• Indonesia

International Drug Name Search

Atracurium-DeltaSelect

Atracurium-DeltaSelect may be available in the countries listed below.

Ingredient matches for Atracurium-DeltaSelect

Atracurium Besilate

Atracurium Besilate is reported as an ingredient of Atracurium-DeltaSelect in the following countries:

• Germany


• Serbia

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Ceprazol

Ceprazol may be available in the countries listed below.

Ingredient matches for Ceprazol

Albendazole

Albendazole is reported as an ingredient of Ceprazol in the following countries:

• Chile


• Peru

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Chloortalidon A

Chloortalidon A may be available in the countries listed below.

Ingredient matches for Chloortalidon A

Chlortalidone

Chlortalidone is reported as an ingredient of Chloortalidon A in the following countries:

• Netherlands

International Drug Name Search

Ciclizina

Ciclizina may be available in the countries listed below.

Ingredient matches for Ciclizina

Cyclizine

Ciclizina (DCIT) is known as Cyclizine in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Captopril Alter

Captopril Alter may be available in the countries listed below.

Ingredient matches for Captopril Alter

Captopril

Captopril is reported as an ingredient of Captopril Alter in the following countries:

• Spain

International Drug Name Search

Niferex

In the US, Niferex (iron polysaccharide systemic) is a member of the drug class iron products and is used to treat Iron Deficiency Anemia.

US matches:

• Niferex


• Niferex Elixir


• Niferex-150

Ingredient matches for Niferex

Ferrous Glycine Sulfate

Ferrous Glycine Sulfate is reported as an ingredient of Niferex in the following countries:

• Denmark


• Italy


• Norway


• Sweden

Polyferose

Polyferose is reported as an ingredient of Niferex in the following countries:

• China


• Hong Kong


• United States

International Drug Name Search

Cinfatos

Cinfatos may be available in the countries listed below.

Ingredient matches for Cinfatos

Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Cinfatos in the following countries:

• Dominican Republic


• El Salvador


• Guatemala


• Panama


• Spain

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Panadol Junior

Panadol Junior may be available in the countries listed below.

Ingredient matches for Panadol Junior

Paracetamol

Paracetamol is reported as an ingredient of Panadol Junior in the following countries:

• Czech Republic


• Netherlands


• Switzerland

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Roxazin

Roxazin may be available in the countries listed below.

Ingredient matches for Roxazin

Piroxicam

Piroxicam is reported as an ingredient of Roxazin in the following countries:

• Portugal

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Deosect

Deosect may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Deosect

Cypermethrin

Cypermethrin is reported as an ingredient of Deosect in the following countries:

• United Kingdom

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Udder Wash Concentrate175

Dosage Form: FOR ANIMAL USE ONLY

FOR COMMERCIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

CAUTION

CAUTION

Harmful if swallowed, eye irritant.

FIRST:

Avoid contact with skin and eyes. Contact can cause severe irritation. Get medical attention. If ingested, drink

large amounts of water or milk. DO NOT induce vomiting. Get immediate attention. Avoid repeated contact with

skin and hands. Use rubber gloves to avoid skin irritation. If contact occurs, wash thoroughly with clean water.

EMERGENCY: CHEMTREC 800-424-9300

UDDER WASH #175 is a concentrated product containing a minimum of 1.75% titratable iodine.

UDDER WASH #175 diluted at one once per five gallons of water produces an efficient washing

solution of minimum of 25 parts per million (ppm).

Utter Wash Concntrate #175


Iodine Utter Wash


An aid in Reducing the Spread of Organisms


Which May Causes Mastitis


ACTIVE INGREDIENTS:


Iodine...........................................1.75%


INACTIVE INGREDIENTS..............98.25%


Wausau Chemical Corporation


2001 North River Drive


Wausau, WI 54403-0953 U.S.A.

UDDER WASH CONCENTRATE 175  iodine  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 64892-005 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 1.75 L  in 100 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64892-005-16 18.9 L In 1 DRUM None 2 64892-005-17 56.78 L In 1 DRUM None 3 64892-005-18 113.6 L In 1 DRUM None 4 64892-005-21 208.2 L In 1 DRUM None 5 64892-005-88 1040 L In 1 CONTAINER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/14/2000

Labeler - Wausau Chemical (006136220)

Establishment
Name	Address	ID/FEI	Operations
Wausau Chemical		006136220	manufacture

Revised: 09/2000Wausau Chemical

Diltiazem RPG

Diltiazem RPG may be available in the countries listed below.

Ingredient matches for Diltiazem RPG

Diltiazem

Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Diltiazem RPG in the following countries:

• France

International Drug Name Search

Clindamicina Normon

Clindamicina Normon may be available in the countries listed below.

Ingredient matches for Clindamicina Normon

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clindamicina Normon in the following countries:

• Spain

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Tigal

Tigal may be available in the countries listed below.

Ingredient matches for Tigal

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Tigal in the following countries:

• Turkey

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Nervus

Nervus may be available in the countries listed below.

Ingredient matches for Nervus

Alprazolam

Alprazolam is reported as an ingredient of Nervus in the following countries:

• Dominican Republic

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Cimetidin AbZ

Cimetidin AbZ may be available in the countries listed below.

Ingredient matches for Cimetidin AbZ

Cimetidine

Cimetidine is reported as an ingredient of Cimetidin AbZ in the following countries:

• Germany

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Precose

acarbose

Dosage Form: tablets
Precose

(acarbose tablets)

Precose Description

Precose® (acarbose tablets) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically known as O-4,6-dideoxy- 4 - [[(1S,4R,5S,6S) - 4,5,6 - trihydroxy - 3 - (hydroxymethyl) - 2 - cyclohexen - 1 - yl]amino] - α - D - glucopyranosyl - (1 → 4)-O-α-D-glucopyranosyl-(1 → 4)-D-glucose. It is a white to off-white powder with a molecular weight of 645.6. Acarbose is soluble in water and has a pKa of 5.1. Its empirical formula is C25H43NO18 and its chemical structure is as follows:

Precose is available as 25 mg, 50 mg and 100 mg tablets for oral use. The inactive ingredients are starch, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide.

Precose - Clinical Pharmacology

Acarbose is a complex oligosaccharide that delays the digestion of ingested carbohydrates,

thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, Precose reduces levels of glycosylated hemoglobin in patients with type 2 diabetes mellitus. Systemic non-enzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time.

Mechanism of Action:

In contrast to sulfonylureas, Precose does not enhance insulin secretion. The antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia.

Because its mechanism of action is different, the effect of Precose to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, Precose diminishes the insulinotropic and weight-increasing effects of sulfonylureas.

Acarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.

Pharmacokinetics:

Absorption

In a study of 6 healthy men, less than 2% of an oral dose of acarbose was absorbed as active drug, while approximately 35% of total radioactivity from a 14C-labeled oral dose was absorbed. An average of 51% of an oral dose was excreted in the feces as unabsorbed drug-related radioactivity within 96 hours of ingestion. Because acarbose acts locally within the gastrointestinal tract, this low systemic bioavailability of parent compound is therapeutically desired. Following oral dosing of healthy volunteers with 14C-labeled acarbose, peak plasma concentrations of radioactivity were attained 14–24 hours after dosing, while peak plasma concentrations of active drug were attained at approximately 1 hour. The delayed absorption of acarbose-related radioactivity reflects the absorption of metabolites that may be formed by either intestinal bacteria or intestinal enzymatic hydrolysis.

Metabolism

Acarbose is metabolized exclusively within the gastrointestinal tract, principally by intestinal bacteria, but also by digestive enzymes. A fraction of these metabolites (approximately 34% of the dose) was absorbed and subsequently excreted in the urine. At least 13 metabolites have been separated chromatographically from urine specimens. The major metabolites have been identified as 4-methylpyrogallol derivatives (that is, sulfate, methyl, and glucuronide conjugates). One metabolite (formed by cleavage of a glucose molecule from acarbose) also has alpha-glucosidase inhibitory activity. This metabolite, together with the parent compound, recovered from the urine, accounts for less than 2% of the total administered dose.

Excretion

The fraction of acarbose that is absorbed as intact drug is almost completely excreted by the kidneys. When acarbose was given intravenously, 89% of the dose was recovered in the urine as active drug within 48 hours. In contrast, less than 2% of an oral dose was recovered in the urine as active (that is, parent compound and active metabolite) drug. This is consistent with the low bioavailability of the parent drug. The plasma elimination half-life of acarbose activity is approximately 2 hours in healthy volunteers. Consequently, drug accumulation does not occur with three times a day (t.i.d.) oral dosing.

Special Populations

The mean steady-state area under the curve (AUC) and maximum concentrations of acarbose were approximately 1.5 times higher in elderly compared to young volunteers; however, these differences were not statistically significant. Patients with severe renal impairment (Clcr < 25 mL/min/1.73m2) attained about 5 times higher peak plasma concentrations of acarbose and 6 times larger AUCs than volunteers with normal renal function. No studies of acarbose pharmacokinetic parameters according to race have been performed. In U.S. controlled clinical studies of Precose in patients with type 2 diabetes mellitus, reductions in glycosylated hemoglobin levels were similar in Caucasians (n=478) and African-Americans (n=167), with a trend toward a better response in Latinos (n=132).

Drug-Drug Interactions

Studies in healthy volunteers have shown that Precose has no effect on either the pharmacokinetics or pharmacodynamics of nifedipine, propranolol, or ranitidine. Precose did not interfere with the absorption or disposition of the sulfonylurea glyburide in diabetic patients. Precose may affect digoxin bioavailability and may require dose adjustment of digoxin by 16% (90% confidence interval: 8-23%), decrease mean Cmax of digoxin by 26% (90% confidence interval: 16–34%) and decreases mean trough concentrations of digoxin by 9% (90% confidence limit: 19% decrease to 2% increase). (See PRECAUTIONS, Drug Interactions.)

The amount of metformin absorbed while taking Precose was bioequivalent to the amount absorbed when taking placebo, as indicated by the plasma AUC values. However, the peak plasma level of metformin was reduced by approximately 20% when taking Precose  due to a slight delay in the absorption of metformin. There is little if any clinically significant interaction between Precose and metformin.

Clinical Trials

Clinical Experience from Dose Finding Studies in Type 2 Diabetes Mellitus Patients on Dietary Treatment Only: Results from six controlled, fixed-dose, monotherapy studies of Precose in the treatment of type 2 diabetes mellitus, involving 769 Precose-treated patients, were combined and a weighted average of the difference from placebo in the mean change from baseline in glycosylated hemoglobin (HbA1c) was calculated for each dose level as presented below:

Table 1 Mean Placebo-Subtracted Change in HbA1c in Fixed-Dose Monotherapy Studies

Dose of Precose*	N	Change in HbA1c %	p-Value
* Precose was statistically significantly different from placebo at all doses. Although there were no statistically significant differences among the mean results for doses ranging from 50 to 300 mg t.i.d., some patients may derive benefit by increasing the dosage from 50 to 100 mg t.i.d. † Although studies utilized a maximum dose of 200 or 300 mg t.i.d., the maximum recommended dose for patients < 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d.
25 mg t.i.d.	110	-0.44	0.0307
50 mg t.i.d.	131	-0.77	0.0001
100 mg t.i.d.	244	-0.74	0.0001
200 mg t.i.d.†	231	-0.86	0.0001
300 mg t.i.d.†	53	-1.00	0.0001

Results from these six fixed-dose, monotherapy studies were also combined to derive a weighted average of the difference from placebo in mean change from baseline for one-hour postprandial plasma glucose levels as shown in the following figure:

* Precose was statistically significantly different from placebo at all doses with respect to effect on one-hour postprandial plasma glucose.

** The 300 mg t.i.d. Precose regimen was superior to lower doses, but there were no statistically significant differences from 50 to 200 mg t.i.d.

Clinical Experience in Type 2 Diabetes Mellitus Patients on Monotherapy, or in Combination with Sulfonylureas, Metformin or Insulin: Precose was studied as monotherapy and as combination therapy to sulfonylurea, metformin, or insulin treatment. The treatment effects on HbA1c levels and one-hour postprandial glucose levels are summarized for four placebo-controlled, double-blind, randomized studies conducted in the United States in Tables 2 and 3, respectively. The placebo-subtracted treatment differences, which are summarized below, were statistically significant for both variables in all of these studies.

Study 1 (n=109) involved patients on background treatment with diet only. The mean effect of the addition of Precose to diet therapy was a change in HbA1c of -0.78%, and an improvement of one-hour postprandial glucose of -74.4 mg/dL.

In Study 2 (n=137), the mean effect of the addition of Precose to maximum sulfonylurea therapy was a change in HbA1c of -0.54%, and an improvement of one-hour postprandial glucose of -33.5 mg/dL.

In Study 3 (n=147), the mean effect of the addition of Precose to maximum metformin therapy was a change in HbA1c of -0.65%, and an improvement of one-hour postprandial glucose of -34.3 mg/dL.

Study 4 (n=145) demonstrated that Precose added to patients on background treatment with insulin resulted in a mean change in HbA1c of -0.69%, and an improvement of one-hour postprandial glucose of -36.0 mg/dL.

A one year study of Precose as monotherapy or in combination with sulfonylurea, metformin or insulin treatment was conducted in Canada in which 316 patients were included in the primary efficacy analysis (Figure 2). In the diet, sulfonylurea and metformin groups, the mean decrease in HbA1c produced by the addition of Precose was statistically significant at six months, and this effect was persistent at one year. In the Precose-treated patients on insulin, there was a statistically significant reduction in HbA1c at six months, and a trend for a reduction at one year.

Table 2: Effect of Precose on HbA1c

		HbA1c (%)*
Study	Treatment	Mean Baseline	Mean change from baseline†	Treatment Difference	p-Value
* HbA1c Normal Range: 4-6% † After four months treatment in Study 1, and six months in Studies 2, 3, and 4 ‡ SFU, sulfonylurea, maximum dose § Although studies utilized a maximum dose of up to 300 mg t.i.d., the maximum recommended dose for patients = 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d ¶ Metformin dosed at 2000 mg/day or 2500 mg/day # Results are adjusted to a common baseline of 8.33% Þ Mean dose of insulin 61 U/day
1	Placebo Plus Diet	8.67	+0.33	—	—
	Precose 100 mg t.i.d. Plus Diet	8.69	-0.45	-0.78	0.0001
2	Placebo Plus SFU‡	9.56	+0.24	—	—
	Precose 50-300§ mg t.i.d. Plus SFU‡	9.64	-0.30	-0.54	0.0096
3	Placebo Plus Metformin¶	8.17	+0.08 #	—	—
	Precose 50-100 mg t.i.d. Plus Metformin¶	8.46	-0.57 g	-0.65	0.0001
4	Placebo Plus InsulinÞ	8.69	+0.11	—	—
	Precose 50-100 mg t.i.d. Plus InsulinÞ	8.77	-0.58	-0.69	0.0001

* After four months treatment in Study 1, and six months in Studies 2, 3, and 4 † SFU, sulfonylurea, maximum dose ‡ Although studies utilized a maximum dose of up to 300 mg t.i.d., the maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d. §   Metformin dosed at 2000 mg/day or 2500 mg/day ¶ Results are adjusted to a common baseline of 273 mg/dL # Mean dose of insulin 61 U/day
		One-Hour Postprandial Glucose (mg/dL)
Study	Treatment	Mean	Mean change	Treatment	p-Value
		Baseline	from baseline*	Difference
1	Placebo Plus Diet	297.1	+31.8	—	—
	Precose 100 mg t.i.d.	299.1	-42.6	-74.4	0.0001
	Plus Diet
2	Placebo Plus SFU†	308.6	+6.2	—	—
	Precose 50-300‡  mg t.i.d.	311.1	-27.3	-33.5	0.0017
	Plus SFU†
3	Placebo Plus Metformin§	263.9	+3.3¶	—	—
	Precose 50-100 mg t.i.d.	283.0	-31.0¶	-34.3	0.0001
	Plus Metformin§
4	Placebo Plus Insulin#	279.2	+8.0	—	—
	Precose 50-100 mg t.i.d.	277.8	-28.0	-36.0	0.0178
	Plus Insulin#

Figure 2: Effects of Precose (■) and Placebo (●) on mean change in HbA1c levels from baseline throughout a one-year study in patients with type 2 diabetes mellitus when used in combination with: (A) diet alone; (B) sulfonylurea; (C) metformin; or (D) insulin. Treatment differences at 6 and 12 months were tested: * p < 0.01; # p = 0.077.

Indications and Usage for Precose

Precose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Contraindications

Precose is contraindicated in patients with known hypersensitivity to the drug. Precose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. Precose is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, Precose is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

Precautions

General

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Precose or any other anti-diabetic drug.

Hypoglycemia

Because of its mechanism of action, Precose when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylurea agents or insulin may cause hypoglycemia. Because Precose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the potential for hypoglycemia. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when Precose was added to metformin therapy. Oral glucose (dextrose), whose absorption is not inhibited by Precose, should be used instead of sucrose (cane sugar) in the treatment of mild to moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by Precose, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.

Elevated Serum Transaminase Levels

In long-term studies (up to 12 months, and including Precose doses up to 300 mg t.i.d.) conducted in the United States, treatment-emergent elevations of serum transaminases (AST and/or ALT) above the upper limit of normal (ULN), greater than 1.8 times the ULN, and greater than 3 times the ULN occurred in 14%, 6%, and 3%, respectively, of Precose-treated patients as compared to 7%, 2%, and 1%, respectively, of placebo-treated patients. Although these differences between treatments were statistically significant, these elevations were asymptomatic, reversible, more common in females, and, in general, were not associated with other evidence of liver dysfunction. In addition, these serum transaminase elevations appeared to be dose related. In US studies including Precose doses up to the maximum approved dose of 100 mg t.i.d., treatment-emergent elevations of AST and/or ALT at any level of severity were similar between Precose-treated patients and placebo-treated patients (p ≥ 0.496).

In approximately 3 million patient-years of international postmarketing experience with Precose, 62 cases of serum transaminase elevations > 500 IU/L (29 of which were associated with jaundice) have been reported. Forty-one of these 62 patients received treatment with 100 mg t.i.d. or greater and 33 of 45 patients for whom weight was reported weighed < 60 kg. In the 59 cases where follow-up was recorded, hepatic abnormalities improved or resolved upon discontinuation of Precose in 55 and were unchanged in two. Cases of fulminant hepatitis with fatal outcome have been reported; the relationship to acarbose is unclear.

Loss of Control of Blood Glucose

When diabetic patients are exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.

Information for Patients

Patients should be told to take Precose orally three times a day at the start (with the first bite) of each main meal. It is important that patients continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine and/or blood glucose.

Precose itself does not cause hypoglycemia even when administered to patients in the fasted state. Sulfonylurea drugs and insulin, however, can lower blood sugar levels enough to cause symptoms or sometimes life-threatening hypoglycemia. Because Precose given in combination with a sulfonylurea or insulin will cause a further lowering of blood sugar, it may increase the hypoglycemic potential of these agents. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when Precose was added to metformin therapy. The risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be well understood by patients and responsible family members. Because Precose prevents the breakdown of table sugar, patients should have a readily available source of glucose (dextrose, D-glucose) to treat symptoms of low blood sugar when taking Precose in combination with a sulfonylurea or insulin.

If side effects occur with Precose, they usually develop during the first few weeks of therapy. They are most commonly mild-to-moderate gastrointestinal effects, such as flatulence, diarrhea, or abdominal discomfort, and generally diminish in frequency and intensity with time.

Laboratory Tests:

Therapeutic response to Precose should be monitored by periodic blood glucose tests. Measurement of glycosylated hemoglobin levels is recommended for the monitoring of long-term glycemic control.

Precose, particularly at doses in excess of 50 mg t.i.d., may give rise to elevations of serum transaminases and, in rare instances, hyperbilirubinemia. It is recommended that serum transaminase levels be checked every 3 months during the first year of treatment with Precose and periodically thereafter. If elevated transaminases are observed, a reduction in dosage or withdrawal of therapy may be indicated, particularly if the elevations persist.

Renal Impairment:

Plasma concentrations of Precose in renally impaired volunteers were proportionally increased relative to the degree of renal dysfunction. Long-term clinical trials in diabetic patients with significant renal dysfunction (serum creatinine > 2.0 mg/dL) have not been conducted. Therefore, treatment of these patients with Precose is not recommended.

Drug Interactions

Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Precose, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving Precose in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia.

Patients Receiving Sulfonylureas or Insulin:  Sulfonylurea agents or insulin may cause hypoglycemia. Precose given in combination with a sulfonylurea or insulin may cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving Precose therapy in combination with sulfonylureas and/or insulin.

Intestinal adsorbents (for example, charcoal) and digestive enzyme preparations containing carbohydrate-splitting enzymes (for example, amylase, pancreatin) may reduce the effect of Precose and should not be taken concomitantly.

Precose has been shown to change the bioavailability of digoxin when they are coadministered, which may require digoxin dose adjustment. (See CLINICAL PHARMACOLOGY, Drug-Drug Interactions .

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Eight carcinogenicity studies were conducted with acarbose. Six studies were performed in rats (two strains, Sprague-Dawley and Wistar) and two studies were performed in hamsters.

In the first rat study, Sprague-Dawley rats received acarbose in feed at high doses (up to approximately 500 mg/kg body weight) for 104 weeks. Acarbose treatment resulted in a significant increase in the incidence of renal tumors (adenomas and adenocarcinomas) and benign Leydig cell tumors. This study was repeated with a similar outcome. Further studies were performed to separate direct carcinogenic effects of acarbose from indirect effects resulting from the carbohydrate malnutrition induced by the large doses of acarbose employed in the studies. In one study using Sprague-Dawley rats, acarbose was mixed with feed but carbohydrate deprivation was prevented by the addition of glucose to the diet. In a 26-month study of Sprague-Dawley rats, acarbose was administered by daily postprandial gavage so as to avoid the pharmacologic effects of the drug. In both of these studies, the increased incidence of renal tumors found in the original studies did not occur. Acarbose was also given in food and by postprandial gavage in two separate studies in Wistar rats. No increased incidence of renal tumors was found in either of these Wistar rat studies. In two feeding studies of hamsters, with and without glucose supplementation, there was also no evidence of carcinogenicity.

Acarbose did not induce any DNA damage in vitro in the CHO chromosomal aberration assay, bacterial mutagenesis (Ames) assay, or a DNA binding assay. In vivo, no DNA damage was detected in the dominant lethal test in male mice, or the mouse micronucleus test.

Fertility studies conducted in rats after oral administration produced no untoward effect on fertility or on the overall capability to reproduce.

Pregnancy

Teratogenic Effects: Pregnancy Category B

The safety of Precose in pregnant women has not been established. Reproduction studies have been performed in rats at doses up to 480 mg/kg (corresponding to 9 times the exposure in humans, based on drug blood levels) and have revealed no evidence of impaired fertility or harm to the fetus due to acarbose. In rabbits, reduced maternal body weight gain, probably the result of the pharmacodynamic activity of high doses of acarbose in the intestines, may have been responsible for a slight increase in the number of embryonic losses. However, rabbits given 160 mg/kg acarbose (corresponding to 10 times the dose in man, based on body surface area) showed no evidence of embryotoxicity and there was no evidence of teratogenicity at a dose 32 times the dose in man (based on body surface area). There are, however, no adequate and well-controlled studies of Precose in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.

Nursing Mothers:

A small amount of radioactivity has been found in the milk of lactating rats after administration of radiolabeled acarbose. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Precose should not be administered to a nursing woman.

Pediatric Use:

Safety and effectiveness of Precose in pediatric patients have not been established.

Geriatric Use:

Of the total number of subjects in clinical studies of Precose in the United States, 27% were 65 and over, while 4% were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. The mean steady-state area under the curve (AUC) and maximum concentrations of acarbose were approximately 1.5 times higher in elderly compared to young volunteers; however, these differences were not statistically significant.

Adverse Reactions

Digestive Tract

Gastrointestinal symptoms are the most common reactions to Precose. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31%, and 74% respectively in 1255 patients treated with Precose 50–300 mg t.i.d., whereas the corresponding incidences were 9%, 12%, and 29% in 999 placebo-treated patients.

In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with Precose are a manifestation of the mechanism of action of Precose and are related to the presence of undigested carbohydrate in the lower GI tract.

If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced

Elevated Serum Transaminase Levels

See PRECAUTIONS.

Other Abnormal Laboratory Findings

Small reductions in hematocrit occurred more often in Precose-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with Precose therapy but are thought to be either spurious or of no clinical significance.

Postmarketing Adverse Event Reports

Additional adverse events reported from worldwide postmarketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoides intestinalis (see PRECAUTIONS).

Overdosage

Unlike sulfonylureas or insulin, an overdose of Precose will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharides) for the next 4–6 hours.

Precose Dosage and Administration

There is no fixed dosage regimen for the management of diabetes mellitus with Precose or any other pharmacologic agent. Dosage of Precose must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t.i.d. Precose should be taken three times daily at the start (with the first bite) of each main meal. Precose should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

During treatment initiation and dose titration (see below), one-hour postprandial plasma glucose may be used to determine the therapeutic response to Precose and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of Precose, either as monotherapy or in combination with sulfonylureas, insulin or metformin.

Initial Dosage

The recommended starting dosage of Precose is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d.

Maintenance Dosage

Once a 25 mg t.i.d. dosage regimen is reached, dosage of Precose should be adjusted at 4–8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d. However, since patients with low body weight may be at increased risk for elevated serum transaminases, only patients with body weight > 60 kg should be considered for dose titration above 50 mg t.i.d. (see PRECAUTIONS).  If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg t.i.d., consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage:

The maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d. The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Patients Receiving Sulfonylureas or Insulin:

Sulfonylurea agents or insulin may cause hypoglycemia. Precose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

How is Precose Supplied

Precose is available as 25 mg, 50 mg or 100 mg round, unscored tablets. Each tablet strength is white to yellow-tinged in color. The 25 mg tablet is coded with the word “Precose” on one side and “25” on the other side. The 50 mg tablet is coded with the word “Precose” and “50” on the same side. The 100 mg tablet is coded with the word “Precose” and “100” on the same side. Precose is available in bottles of 100 and 50 mg strength in unit dose packages of 100.

	Strength	NDC	Tablet Identification
Bottles of 100:	25 mg	50419-863-51

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Betim 10 mg Tablets

Betim 10 mg Tablets

Timolol maleate

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet.You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If you experience any side effect and this becomes serious, tell your doctor or pharmacist.

In this leaflet:

• 1. What Betim is and what it is used for


• 2. Before you take Betim


• 3. How to take Betim


• 4. Possible side effects


• 5. How to store Betim


• 6. Further information

What Betim Is And What It Is Used For

Betim 10 mg Tablets are used to treat high blood pressure (hypertension) and chest pain (angina).

The tablets are also used to prevent a heart attack in those people who have already had one and in reducing the number of migraine attacks for those who suffer from migraine.

Betim Tablets belong to a group of medicines called beta-blockers which slow the heart rate and lower blood pressure, reducing the workload on the heart.

Before You Take Betim

Do not take Betim if you:

• Are allergic (hypersensitive) to timolol maleate or any of the other ingredients of Betim (these are listed in section 6, “Further Information”).


• Have a history of wheezing or asthma.


• Have chronic (long-term) breathing difficulties.


• Have a certain type of chest pain called Prinzmetal’s angina.


• Have uncontrolled heart failure.


• Have been told that you have a slower than normal heart beat or a severe heart condition called cardiogenic shock.


• Have any problems with your blood circulation.


• Are taking medicines known as monoamine oxidase inhibitors that are used for depression.


• Have a condition affecting your adrenal glands called phaeochromocytoma.


• Have a condition that causes acidity of the blood called metabolic acidosis.


• Have low blood pressure.

Take special care with Betim

Tell your doctor before you start treatment if you have or have had in the past one of the following problems or if you develop any of these during treatment:

• Any heart problems at all, including an abnormally slow heart rate.


• Liver or kidney problems.


• Diabetes. Betim may mask some of the usual signs that your blood sugar level is too low.
  
  If you are on medication for diabetes, Betim could also increase the effectiveness of insulin or oral anti-diabetic drugs so your dose of these may need to be changed.


• The skin condition psoriasis.


• Poor circulation in your legs or arms.


• Any allergies (e.g. to pollen), as Betim may intensify your allergic reaction.

It is important to discuss these with your doctor because you may need to stop your treatment or have your dose changed.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is very important because you should not use some other medicines while you are taking Betim. Also, certain other medicines can be used only if special precautions are taken.

In particular, tell your doctor or pharmacist if you are taking:

• Any medicines for high blood pressure (e.g. clonidine or hydralazine).


• Other medicines for heart problems (e.g. verapamil, disopyramide, lignocaine, tocainide, diltiazem, quinidine, amiodarone, nifedipine, digitalis glycosides (e.g. digoxin), or any of the medicines known as class I antiarrhythmic agents).


• Other beta-blockers.


• Medicines known as tricyclic antidepressants used for treating depression, or medicines known as phenothiazines used for treating other mental problems.


• Medicines known as barbiturates used to treat sleeping disorders.


• Medicines for treating diabetes (e.g. insulin and oral anti-diabetic drugs).


• An anti-ulcer drug called cimetidine.


• An antibiotic called rifampicin.


• Medicines to improve circulation.


• Medicines for breathing difficulties (e.g. salbutamol or isoprenaline).


• Medicines for migraine known as ergot preparations.


• Medicines known as prostaglandin synthetase inhibitors (e.g. ibuprofen, aspirin, indomethacin).

If you are going to have surgery

If you are going to have an operation in hospital or going to the dentist, tell the doctor at the hospital or the dentist that you are taking Betim Tablets. Your doctor may decide to stop Betim gradually before you have an anaesthetic such as ether, cyclopropane, trichloroethylene. You should not be given a local anaesthetic combined with adrenaline while you are taking Betim.

Taking Betim with food and drink

You should avoid excessive alcohol consumption while taking Betim.

Pregnancy and breast-feeding

You should not take Betim if you are pregnant.

Therefore, tell your doctor before you start treatment if you are pregnant, think that you may be pregnant or intend to become pregnant.

Consult with your doctor immediately if you think that you have become pregnant during treatment with Betim.

Tell your doctor before you start treatment with Betim if you are breast-feeding or planning to breastfeed.

Driving and using machines

This medicine may cause tiredness or dizziness as a side effect.

Therefore you should be careful if you are going to drive or operate machinery.

How To Take Betim

Your doctor will work out the right number of tablets for you.Always take Betim exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

Swallow the tablet(s) with a glass of water.

The usual dose for adults is:

• Half a tablet to three tablets twice a day for chest pains.


• One to six tablets a day for high blood pressure.


• Half a tablet to one tablet twice a day after a heart attack.


• One to two tablets a day to prevent migraine attacks.

If you are elderly the doctor will probably start with the lowest adult dose and then adjust your dose carefully, depending on how you respond to treatment.

Betim Tablets are not suitable for children.

Your doctor may change the number of tablets you take. This will depend on how well you respond to the treatment. Do not alter the number of tablets you are taking without checking with your doctor.

If you take more Betim than you should

If you or anybody else accidentally take more than the recommended dose of these tablets, call your doctor immediately or go to your nearest hospital casualty department.

If you forget to take Betim

If you forget to take your tablet(s), take the next dose as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Betim

Do not stop taking the tablets without first consulting your doctor.

If it is right for you to stop taking the medicine then your doctor will probably reduce the dose gradually since it is important not to stop suddenly.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Betim can cause side effects, although not everybody gets them.

Tell your doctor if you have any of the following problems:

• Breathing difficulties or a worsening of asthma.


• Slow heart beat or the heart slows so much that you faint, heart failure or other heart problems.


• Cold or bluish hands and feet, low blood pressure, “pins and needles”, tingling in the hands or feet, a worsening of any problems with blood circulation in your legs or impotence (male erection problems).


• Nausea (feeling sick), vomiting (being sick), diarrhoea or abdominal pain.


• Dizziness or light headedness, vertigo or feeling faint, headaches, trouble with sleeping or nightmares.


• Depression, hallucinations, drowsiness, disorientation, confusion or other mental problems.


• Skin rashes, painful joints, visual disturbances or dry eyes.


• Unusual tiredness or weakness.


• Decreased urination or total inability to urinate.

Blood tests may show increased levels of antibodies.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Betim

Keep Betim Tablets out of the reach and sight of children.

Do not use Betim after the expiry date which is stated on the bottle label and outer carton after the text “EXP”. The expiry date refers to the last day of that month.

Medicines must not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

Further Information

What Betim contains

Active substance:
Timolol (as maleate). Each tablet contains 10 mg of timolol maleate.

Other ingredients:
Microcrystalline cellulose, starch and magnesium stearate.

What Betim looks like and contents of the pack

Betim Tablets are white, flat circular tablets. Each tablet is engraved with

on one side and a breakmark on the other.

Betim 10 mg tablets are available in packs of 30 tablets.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

UK

Manufacturer

Labiana Pharmaceuticals S.L.U.

Casanova 27-31

08757- Corbera de Llobregat (Barcelona)

Spain

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in December 2009

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