BETA-PROGRANE 160 mg AND HALF BETA-PROGRANE 80 mg SUSTAINED RELEASE CAPSULES (Propranolol Hydrochloride BP)

PATIENT INFORMATION LEAFLET

Please read this entire leaflet carefully before you start taking this medicine.

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

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

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

•    If you notice any side effects, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What this medicine is and what it is used for

2.    Before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

The name of this medicine is Beta-Prograne 160 mg Sustained Release Capsules and Half Beta-Prograne 80 mg Sustained Release Capsules (referred to as Beta-Prograne and Half Beta-Prograne Capsules throughout this leaflet).

OWHAT THIS MEDICINE IS AND WHAT IT IS USED FOR

Beta-Prograne and Half Beta-Prograne Capsules belong to a group of medicines called beta-blockers, which help slow the heart beat and relax the blood vessels. This reduces blood pressure and the heart's demand for oxygen.

Your doctor may have given you propranolol (the active substance) before but under a different brand name. The effect of Beta-Prograne or Half Beta-Prograne Capsules (propranolol hydrochloride) will be the same.

This medicine is used to treat the following conditions:

• High blood pressure • Pains in the chest (angina)

• Shaking of the hands, head and face (essential tremor)

• Management of anxiety

• Overactive or enlarged thyroid (thyrotoxicosis or graves' disease)

• Recurrent migraine attacks

• Bleeding in the stomach and intestines caused by high blood pressure in the belly region and lower throat.

BEFORE you take

Do not take Beta-Prograne and Half Beta-Prograne Capsules if:

• you have a history of breathing difficulties, wheezing or asthma. Ask your doctor or pharmacist if you should take this medicine

• you have heart problems

• you sometimes suffer from low blood sugar levels e.g.

due to not having eaten for a long period of time • you have more acid than normal in your blood (metabolic acidosis)

• you have chest pains when at rest (Prinzmetal's angina)

• you have an untreated tumour in your kidneys • you have a very slow heart rate • you have low blood pressure

• you are sensitive to propranolol or any of the other ingredients

• you have circulation problems.

Take special care with Beta-Prograne and Half Beta-Prograne Capsules if:

• your heart has difficulty pumping blood around your body (low cardiac reserve)

• your heart beat slows to less than 50-55 beats per minute whilst resting

• you have diabetes as this medicine may delay your response to low blood sugar treatment • you have a poor flow of blood to your heart (ischaemic heart disease)

• you have an irregular heart beat (first degree heart block) • you have circulatory problems which are not severe such as your toes and fingers go numb and pale (Raynaud's syndrome) or you sometimes limp (intermittent claudication) as these disorders may become worse during treatment

• you have any liver problems (such as cirrhosis)

• you have kidney problems

• you have a history of severe allergic reaction which can cause difficulty in breathing or dizziness (anaphylactic reaction)

•    you are allergic to sulphur dioxide (rare)

•    you are stopping treatment as this must be done gradually (see section 3). You should be monitored by your doctor when stopping treatment, especially if you have ischaemic heart disease

•    you are elderly as you may need to start on a lower dose

•    you have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may mask the symptoms of thyrotoxicosis.

If any of the conditions listed under 'Do not take' or 'Take special care' apply to you, please contact your doctor or pharmacist.

Taking other medicines

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

Some medicines may affect the way Beta-Prograne and Half Beta-Prograne Capsules work, in particular, the following:

•    Cimetidine, for stomach ulcers and indigestion

•    Hydralazine, for high blood pressure

•    Alcohol (see heading below 'alcohol').

With some medicines, side effects can occur when taken together with Beta-Prograne and Half Beta-Prograne Capsules. These include:

•    Adrenaline, for emergency treatment of allergic reaction (anaphylaxis) or the heart stops (cardiac arrest) or other sympathomimetic agents

•    Amphetamines, for tiredness, phenylephrine*, used in eye drop solutions and phenylpropanolamine*, for the relief of cold symptoms (*widely used in medicines purchased over the counter). Other sympathomimetic amines drugs such as salbutamol (for asthma)

•    Medicines for heart failure such as digoxin (digitalis glycosides)

•    Ergotamine, for migraines

•    Indometacin, for arthritis and other prostaglandin inhibiting drugs, such as aspirin and ibuprofen

•    Medicines for irregular heart beat, such as disopyramide, quinidine and amiodarone

•    Lidocaine, used as a local anaesthetic or for an irregular heartbeat

•    Medicines for depression, such as moclobemide, (MAO inhibitors)

•    Nifedipine, for high blood pressure and chest pains (angina)

•    Prenylamine, used to treat angina

•    Medicines for depression, such as amitriptyline (tricyclic antidepressants)

•    Medicines for sleeping difficulties, such as amobarbital (barbiturates)

•    Other medicines for high blood pressure

•    Chlorpromazine for anxiety, feeling sick (nausea), being sick (vomiting) or mental disorders and other phenothiazines, such as trifluoperzine

•    Rizatriptan, used to treat migraine headaches.

Special care should be taken with the following medicines:

•    Clonidine, for high blood pressure and migraine. If Beta-Prograne or Half Beta-Prograne Capsules are used instead of clonidine or both medicines are used together, you must take advice from your doctor

•    Verapamil or diltiazem, medicines for high blood pressure or chest pains (angina)

•    Medicines for the treatment of diabetes, such as insulin and metformin.

The dose of Beta-Prograne may need to be adjusted if you take the following:

•    Propafenone, for irregular heart beat

•    Rifampicin, antibiotic used for various infections, in particular tuberculosis

•    Theophylline, for asthma

•    Warfarin, for thinning the blood

•    Thioridazine, for mental illness

•    Calcium channel blockers for high blood pressure or chest pain, such as nisoldipine, nicardipine, isradipine and lacidipine.

Having an anaesthetic or a blood test

You must tell the medical staff that you are taking Beta-Prograne or Half Beta-Prograne Capsules if you are going to have surgery under anaesthetic or a blood test.

•    Anaesthetics - Anaesthetics may interfere with this medicine

•    Blood test - This medicine may interfere with the results obtained.

Alcohol

It is recommended that you do not drink alcohol whilst being treated with Beta-Prograne or Half Beta-Prograne Capsules. Pregnancy and breast-feeding

If you are pregnant, thinking of becoming pregnant or breast-feeding, consult your doctor before taking Beta-Prograne and Half Beta-Prograne Capsules. You should not take this medicine unless told to do so by your doctor.

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Driving or using machinery

Beta-Prograne and Half Beta-Prograne Capsules are unlikely to affect your ability to drive or operate machinery. Occasionally you may feel a bit dizzy or more tired than normal. If this happens, do not drive or operate machinery and consult your doctor or pharmacist.

Important Information about the ingredients

These capsules contain the ingredient E220 sulphur dioxide, which on rare occasions, may cause severe allergic reactions and difficulty in breathing or wheezing.

These capsules contain sugar-starch neutral microgranules. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

s HOW TO TAKE

You should always take this medicine as prescribed by your doctor. Do not take more than the doctor told you to. Read and follow the instructions on the pharmacist's label.

•    These capsules are to be taken orally

•    Each capsule should be taken at a regular time each day (morning or evening), unless instructed differently.

Warning for diabetics

Diabetics should not go for long periods without food whilst taking Beta-Prograne or Half Beta-Prograne Capsules. Ask your doctor for advice if you have missed several meals for any reason.

One of the actions of this medicine is to slow the heart. This could mask an increase in the heart rate which may be a warning sign of low blood sugar levels (hypoglycaemia). In addition, it may delay the recovery of blood glucose to normal levels after taking insulin.

Normal starting doses

The doses stated below are guidelines only. You should always take this medicine as prescribed by your doctor.

High blood pressure (hypertension)

The normal starting dose is one Beta-prograne 160 mg capsule daily.

Migraine

Anxiety

Chest pains (angina)

Shaking of the hands, head and face (essential tremor) Overactive or enlarged thyroid (thyroxicosis or graves' disease)

High blood pressure in the belly region and lower throat

(portal hypertension)

The normal starting dose is one Half Beta-prograne 80 mg capsule daily.

Elderly patients

The normal starting dose is one Half Beta-prograne 80 mg capsule daily.

Children

Beta-Prograne 160 mg Capsules and Half Beta-Prograne 80 mg Capsules should not be given to children.

If you forget to take your Beta-Prograne or Half Beta-Prograne Capsules

Continue with the normal dose as soon as you remember. Do not take a double dose.

If you have taken more Beta-Prograne or Half Beta-Prograne Capsules than recommended

You should immediately call your doctor or go to the nearest hospital casualty department. Take with you any remaining medicine, the original carton and the label so that the medicine can be identified.

Do not stop taking Beta-Prograne or Half Beta-Prograne Capsules without your doctor's advice.

It could be dangerous. Continue to take this medicine for as long as the doctor has told you to. Your doctor will gradually reduce your dose over a period of 7 - 14 days before you stop taking this medicine.

^ POSSIBLE SIDE EFFECTS

Beta-Prograne and Half Beta-Prograne Capsules are usually well tolerated. However like all medicines they can cause side effects in some patients, particularly when treatment is first started.

Contact your doctor immediately if you have the following symptoms:

•    Slow heart beat and low blood pressure causing dizziness, light-headedness, fainting or blurred vision. These may be symptoms of intolerance to the medicine

•    Difficulty in breathing. This is more likely if you have asthma or a history of asthmatic problems.

Common side effects (affects less than 1 in 10 people):

•    Cold hands and feet

•    Weakness

•    Tiredness

•    Difficulty in sleeping (insomnia)

•    Nightmares

•    Slow heart beat

•    Poor blood circulation which makes the toes and fingers numb and pale.

Uncommon side effects (affects less than 1 in 100 people):

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Diarrhoea.

Rare side effects (affects less than 1 in 1,000 people):

•    Slow or irregular heart rate

•    Light-headedness, fainting or dizziness especially when going from sitting or lying position to standing up

•    Worsening of pain and/or cramping in the lower leg

•    Worsening of heart failure, which can cause shortness of breath or ankle swelling

•    Tingling or numbness in the hands or feet

•    Confusion

•    Dizziness

•    Skin rash

•    Dry eyes

•    Visual disturbances

•    Seeing or hearing things that are not real (hallucinations or psychosis)

•    Mood changes

•    Memory loss

•    Dry flaky skin

•    Worsening of a common skin condition known as psoriasis

•    Hair loss

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

•    Skin rash resulting from bleeding into the skin.

Very rare side effects (affects less than 1 in 10,000 people):

•    Low levels of sugar in the blood (hypoglycaemia). This can happen in people with or without diabetes. This includes infants, children, elderly people, people on artificial kidneys (haemodialysis) or people taking medicines for diabetes. It may also happen if you are fasting or in people with long-term liver disease

•    Increase in ANA (Antinuclear Antibodies - detected through blood test)

•    Severe muscle weakness or worsening of the condition (myasthenia gravis).

Other side effects (frequency not known):

•    Headaches

•    Inability to achieve or maintain an erection (impotence)

•    Masked symptoms of overactive or enlarged thyroid (thyrotoxicosis or grave's disease)

•    Masked symptoms of lack of glucose in the bloodstream (hypoglycaemia).

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

HOW TO STORE

Keep out of reach and sight of children.

Store below 25°C.

Store in the original package.

Protect from light and moisture.

Do not use Beta-Prograne and Half Beta-Prograne Capsules after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

^ FURTHER INFORMATION

What Beta-Prograne and Half Beta-Prograne Capsules contain:

•    Active substance: 80 mg or 160 mg propranolol hydrochloride BP

•    Other ingredients: neutral microgranules, povidone, ethylcellulose, talc, gelatine, titanium dioxide (E171) and sulphur dioxide (E220).

(See 'Important information about the ingredients' section 2, page 2).

What Beta-Prograne and Half Beta-Prograne Capsules look like and the contents of the pack:

•    Beta-Prograne 160 mg Sustained Release Capsules: gastro-resistant, opaque white gelatine capsules (Product Licence Number 11311/0001)

•    Half Beta-Prograne 80 mg Sustained Release Capsules: gastro-resistant, transparent gelatine capsules with a white cap (Product Licence Number 11311/0017)

Beta-Prograne Capsules are available in blister packs of 28 and 100 capsules and Half Beta-Prograne Capsules are available in blister packs of 28 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road,

Eaton Socon, St. Neots,

Cambridgeshire,

PE19 8ET. UK.

Date of last revision: October 2012.

i r q i    40649-V

TEVA UK LIMITED    01704014