PATIENT INFORMATION LEAFLET

Propranolol Tablets B.P.

In this leaflet:

1. What Propranolol Tablets are and what they are used for

2. Before you take Propranolol Tablets

3. How to take Propranolol Tablets

4. Possible side effects

5. How to store Propranolol Tablets

The name of this medicine is Propranolol Tablets BP.

Propranolol Tablets BP are produced in three different strengths: 10 mg, 40 mg or 80 mg of the active substance Propranolol Hydrochloride.

These tablets also contain the following inactive ingredients: Lactose, talc stearic acid, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E171) & carmine (E120). In addition to these, the 40 mg and 80 mg tablets also contain microcrystalline cellulose.

Marketing Authorisation Holder

Strides Pharma Limited, Themistokli Dervi 3, Julia House, CY-1066 Nicosia,Cyprus

1. What Propranolol Tablets are and what they are used for

Propranolol Tablets BP are produced in three different strengths: 10 mg, 40 mg or 80 mg of the active substance Propranolol Hydrochloride.

Propranolol Tablets BP 10 mg and 80 mg are produced in packs 20, 50 and 500 tablets.

Propranolol Tablets BP 40 mg are produced in packs of 20, 50 and 1000 tablets.

Propranolol is one of a group of drugs called beta blockers. It has effects on the heart and circulation and on other parts of the body.

Propranolol can be used for many conditions including hypertension (high blood pressure), angina (chest pains), some arrhythmias (disorders of heart rhythm), protection of the heart after a myocardial infarction (heart attack), prevention of migraine, essential tremor, anxiety, certain thyroid conditions (such as thyrotoxicosis, which is caused by an overactive thyroid gland), hypertrophic cardiomyopathy (thickened heart muscle), phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) and bleeding in the oesophagus caused by high blood pressure in the liver.

2. Before you take Propranolol Tablets

Do not take Propranolol if:

•    You have ever had asthma or wheezing.

•    You have previously had an allergic reaction to it, or to any of the other ingredients listed above.

•    You suffer with heart failure, which is not under control.

•    You suffer from conditions such as heart block, very slow or very high irregular heartbeats, very low blood pressure or very poor circulation.

•    You have been fasting for a long time.

•    You have phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) which is not being treated.

•    You have metabolic acidosis or a particular type of chest pain called Prinzmetal’s angina.

If you have one of these conditions, make sure your doctor knows about it before

you take this medicine.

Take special care with Propranolol Tablets

Consult your doctor before taking these tablets if:

•    You get allergic reactions to such things as insect stings.

•    You have diabetes. Propranolol may change your normal response to low blood sugar, which usually involves an increase in heart rate.

•    You have thyrotoxicosis. Propranolol may hide the symptoms of this condition.

•    You have kidney or liver problems (including cirrhosis of the liver), because you may need to have some check ups during your course of treatment.

•    You have any other health problems such as circulation disorders, heart problems, breathlessness or swollen ankles.

•    You are taking any other medicines.

•    You are pregnant or breast -feeding.

•    You have been told by your doctor that you have an intolerance to some sugars.

Taking Propranolol Tablets with food and drink

If you frequently drink a lot of alcohol, this may reduce the effect of your

medicine.

Taking Propranolol with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Propranolol can interfere with the action of some other drugs and some drugs can have an effect on your medicine. The drugs which can cause some problems when taken together with your medicine are verapamil, diltiazem, nifedipine (used to treat hypertension or angina), drugs for irregular heart beats (e.g. disopyramide and quinidine), digoxin (for heart failure), adrenaline (a heart stimulant), ibuprofen and indomethacin (for pain and inflammation), ergotamine and dihydroergotamine (for migraine), chlorpromazine (for certain psychiatric disorders), cimetidine (for stomach problems), hydralazine (for high blood pressure), propafenone (an anti-arrhythmic), rifampicin (a bactericidal antibiotic), theophylline (for respiratory disease), warfarin (for blood thinning), thioridazine (an antipyschotic) and dihydropyridine calcium channel blockers such as nisoldipine, nicardipine, isradipine and lacidipiine.

If you are taking clonidine (for high blood pressure or migraine) and Propranolol together, you must not stop taking clonidine unless your doctor tells you to do so. If it becomes necessary for you to stop taking the clonidine, your doctor will give you careful instructions on how to do it.

Please note that these statements may also apply to products used some time ago or at some time in the future.

If you go into hospital for an operation, tell the anaesthetist or the medical staff that you are taking Propranolol.

Driving and using machines

Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel dizzy or tired when taking Propranolol. If this happens to you, see your doctor.

3. How to take Propranolol Tablets

Propranolol tablets should be swallowed with a drink of water. Your doctor will have decided how may Propranolol tablets you need to take each day depending on your condition. Always follow your doctor’s instructions about when and how to take your tablets. Ask your doctor or pharmacist if you are not sure. The following table shows the usual total daily dosage for an adult.

Hypertension (high blood pressure)	160 mg to 320 mg
Angina (chest pains)	120 mg to 240 mg
Arrthythmias (disorders of the heart rhythm)*	30 mg to 160 mg
Protection of the heart after a heart attack	160 mg

Prevention of migraine* and essential tremor	80 mg to 160 mg
Anxiety	40 mg to 120 mg
Certain thyroid conditions (such as thyrotoxicosis)*	30 mg to 160 mg
Hypertrophic cardiomyopathy (thickened heart muscle)	30 mg to 160 mg
Phaeochromocytoma*	30 mg to 60 mg
Bleeding from the oesophagus caused by high blood pressure in the liver	80 mg to 160 mg

*Under some circumstances, Propranolol can be used to treat children with these conditions. The dosage will be adjusted by the doctor according to the child’s age or weight.

If you take more Propranolol Tablets than you should:

If you accidentally take an overdose of your medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified.

If you forget to take Propranolol Tablets:

If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take two doses at the same time.

If you want to stop taking Propranolol Tablets:

Do not stop taking your medicine without talking to your doctor first. In some cases, it may be necessary to stop taking the medicines gradually.

4. Possible side effects

As with all medicines, undesirable events can sometimes be experienced with Propranolol. Occasionally, a few people can suffer from cold hands and feet, tiredness, slow heart beat, nausea, diarrhoea, disturbed sleep, thinning of the hair, mood changes, confusion, psychoses or hallucinations, bruising more easily or purplish marks on the skin, tingling of the hands, dry eyes, disturbances of vision, muscle weakness, skin rashes, worsening of psoriasis or dizziness (particularly when standing up), low blood sugar (hypoglycaemia) in children who do not have diabetes. Other possible events which may occur in susceptible people are numbness and spasm in the fingers (Raynaud’s phenomenon), heart block (which can cause dizziness or fainting), worsening of heart failure (breathlessness and/or swollen ankles), worsening of breathing difficulties (in people with asthma or breathing problems) or worsening of the circulation (in people with poor circulation).

Do not be alarmed by this list of possible side effects. You may not get any of them. If you notice any other undesirable effects, or if you think your medicine is causing any problems, tell your doctor or pharmacist.

5. How to store Propranolol Tablets

Keep your medicine in a safe place where children cannot see it or reach it.

Do not store your medicine above 25°C

Store in the original container

Do not use after the expiry date on the label

Return any unused tablets to your pharmacist for safe disposal. Only keep them if the doctor tells you to.

Propranolol Tablets BP 10 mg - PL 41061/0012 Propranolol Tablets BP 40 mg - PL 41061/0013 Propranolol Tablets BP 80 mg - PL 41061/0014

Leaflet revised: October 2012