PACKAGE LEAFLET: INFORMATION FOR THE USER

PROPRANOLOL 80MG TABLETS

(Propranolol hydrochloride)

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 effect not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Propranolol Tablets. They contain the

active ingredient called Propranolol Hydrochloride.

Propranolol Hydrochloride belongs to a group of medicines called

beta-blockers.

Propranolol Tablets are used for:

•    hypertension (high blood pressure)

•    angina (chest pain)

•    some arrhythmias (Irregular heart beat)

•    protection of heart after myocardial infarction (heart attack)

•    prevention of migraine

•    tremor without underlying cause (essential tremor)

•    anxiety

•    certain thyroid conditions (such as thyrotoxicosis which is caused by an overactive thyroid gland)

•    heart disease characterised by thickening of the internal heart muscle and a Blockage inside the heart (hypertrophic obstructive cardiomyopathy)

•    phaeochromocytoma (high blood pressure due to a tumour usually near the kidney)

•    bleeding in the oesophagus (gullet) caused by high blood pressure in the liver

Do not take Propranolol Tablets if you:

•    are allergic (hypersensitive) to Propranolol or any of the other ingredients of Propranolol Tablets. See section 6.

•    have a problem common in the elderly, related to poor control of the working of the heart (sick sinus syndrome)

•    have a severe form of angina pectoris (chest pain), not caused by exertion (Prinzmetal's angina)

•    have conditions with severe disturbance of blood circulation in the arms and legs.

•    suffer from failure of the heart to maintain adequate circulation of blood (cardiogenic shock)

•    have or have had a history of asthma or breathing difficulties

•    suffer from increased acid levels in the blood (metabolic acidosis)

•    have low blood pressure (hypotension)

•    have prolonged fasting

•    have serious defect in the heart's electrical message pathways resulting in decreased function of the heart (2nd or 3rd degree heart block)

•    have slow heart rate (bradycardia)

•    suffer from uncontrolled heart failure

•    suffer from untreated tumour of the adrenal gland (phaeochromocytoma)

Take special care with Propranolol Tablets if you:

•    suffer from kidney disorders

•    suffer from liver disorders

•    suffer from lung disorders

•    are a diabetic

•    have heart problems

•    have myasthenia gravis is a chronic disease characterised by fluctuating levels of muscle weakness.

•    have history of hypersensitivity

•    have high pressure in the vein taking blood from the gut to the liver (portal hypertension)

•    have slowed conduction of electrical messages between the chambers of the heart (1st degree heart block)

This medicine may mask the symptoms of low blood sugar such as increased heart rate, tremor and nausea. People with diabetes should carefully monitor their blood sugar.

This medicine may mask the symptoms of the condition caused by an excess of thyroid hormone (thyrotoxicosis).

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Propranolol Tablets.

Examples of medicines that can affect Propranolol Tablets are:

•    Verapamil, Diltiazem, Nifedipine, Nisoldipine, Nicardipine, Isradipine, Lacidipine (which are used to treat high blood pressure and chest pain)

•    Hydralazine (for high blood pressure)

•    Disopyramide, Lignocaine, Quinidine or Propafenone (for irregular heartbeats),

•    Digoxin (for heart failure),

•    Adrenaline (a heart stimulant),

•    Ibuprofen and Indomethacin (for pain and inflammation),

•    Ergotamine and Dihydroergotamine (for migraine),

•    Chlorpromazine and Thioridazine (for certain psychiatric disorders),

•    Cimetidine (for stomach problems),

•    Rifampicin (for the treatment of tuberculosis),

•    Theophylline (for asthma) and

•    Warfarin (to thin the blood).

•    Antidepressants

•    Barbiturates are a type of depressant drug that causes relaxation and sleepiness

•    Anaesthetics

If you are taking Propranolol Tablets with Clonidine (used to treat high blood pressure), do not stop taking Clonidine without seeking advice from your doctor

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

Pregnancy and Breast-feeding

Please consult your doctor or pharmacist if you are pregnant or planning to become pregnant or breast-feeding.

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 Tablets. If this happens to you, ask your doctor for advice.

Important information about some of the ingredients of Propranolol Tablets

This medicinal product contains

• Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. HOW TO TAKE PROPRANOLOL TABLETS

These tablets should be swallowed. Your doctor will have decided how many Propranolol tablets you need to take each day depending on your condition. Follow your doctor’s instructions about when and how to take your tablets. Ask your doctor or pharmacist if you are not sure.

Usual total daily dosage:

Adult:

Hypertension (high blood pressure): 160mg to 320mg

Angina (chest pain): 120mg to 240mg

Some arrhythmias (Irregular heart beat): 30mg to 160mg

Protection of heart after myocardial infarction (heart attack): 160mg

Prevention of migraine: 80mg to 160mg

Essential tremor: 80mg to 160mg

Anxiety: 40mg to 120mg

Certain thyroid conditions (such as thyrotoxicosis): 30mg to 160mg

Hypertrophic obstructive cardiomyopathy (heart disease characterised by thickening of the internal heart muscle and a Blockage inside the heart): 30mg to 160mg Bleeding in the oesophagus caused by high blood pressure in the liver: 80mg to 160mg

Elderly:

The optimum dose is individually determined according to clinical response.

Children:

Under some circumstances, Propranolol Tablets 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 or someone you know accidentally takes more tablets than the stated dose (an overdose), you should contact a doctor immediately or go to the nearest A&E department.

If you forget to take Propranolol Tablets If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Propranolol Tablets

Do not stop taking Propranolol Tablets without talking to your

doctor, even if you feel better.

Your doctors will probably decrease the dose gradually.

4. POSSIBLE SIDE EFFECTS

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

Very serious side effects - If any of the following happens, stop taking Propranolol Tablets and tell your doctor immediately or go to the nearest hospital emergency department:

• Rare allergic (Hypersensitive) reactions such as difficulty of breathing, swelling of your face, throat or tongue, skin rash,

itching, nettle rash, blisters, blood spots, swelling of the skin with wheals (small swellings on the skin) and, less often, blistering skin diseases which may appear like a burn, or as a red/purple rash, or a scaly skin.

Other side effects

•    cold hands and feet

•    tiredness

•    slow heartbeat

•    low blood pressure

•    nausea, diarrhoea

•    disturbed sleep

•    thinning of the hair

•    mood changes, confusion, psychosis (mental problems) or hallucinations (unusual behaviour)

•    a feeling of dizziness or “spinning”

•    bruising more easily or purplish marks on the skin

•    tingling or numbness in the hands or feet

•    disturbances of vision, dry eyes

•    muscle weakness

•    stomach disturbances

•    Skin rashes

•    worsening of psoriasis (a skin disease usually in the form of thick, red, scaly patches) or dizziness particularly

when standing up

•    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) in people with heart failure

•    reduction in blood platelets, which increases risk of bleeding or bruising

•    worsening of breathing difficulties in people with asthma or breathing problems or worsening of the circulation in people with poor circulation.

•    hypoglycaemia (low blood sugar)

•    hypoglycaemic seizure (generalized convulsion due to low blood sugar)

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

5. HOW TO STORE PROPRANOLOL TABLETS

Keep out of the reach and sight of children.

Do not store the tablets above 25°C. Keep them in the original pack. Keep the container tightly closed. Do not take these tablets after the expiry date shown on the pack. The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION

What Propranolol Tablets contain

The active substance is Propranolol Hydrochloride. These tablets are produced in three different strengths and either contains 10mg, 40mg or 80mg of Propranolol Hydrochloride. The other ingredients are Lactose, Talc, Stearic Acid, Magnesium Stearate, Hypromellose, Macrogol, Titanium Dioxide (E 171), and Carmine (E 120). In addition to these, the 40mg and 80mg tablets also contain Microcrystalline Cellulose.

What Propranolol Tablets look like and contents of the pack Propranolol 80mg Tablets: are pink, film-coated, bi-convex tablets embossed ‘P80’ on one face.

Securitainers: 20, 28, 50, 56 and 500 Tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Fourtts (UK) Pharmacare Ltd, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ,

Item code

This leaflet was last revised in: July 2011