PATIENT INFORMATION LEAFLET

BEDRANOL® (PROPRANOLOL HYDROCHLORIDE) SR CAPSULES 160 mg

(Propranolol Hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

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

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

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Bedranol SR Capsules are and what they are used for

2.    What you need to know before you take Bedranol SR Capsules

3.    How to take Bedranol SR Capsules

4.    Possible side effects

5.    How to store Bedranol SR Capsules

6.    Contents of the pack and other information

1. What Bedranol SR Capsules are and what they are used for

The name of your medicine is Bedranol (Propranolol Hydrochloride) SR Capsules 160 mg.

The active ingredient, propranolol hydrochloride, belongs to a group of medicines known as beta-blockers which are used to control blood pressure and reduce the demands on the heart.

Bedranol SR Capsules are prescribed for treating high blood pressure and angina (chest pains from heart disease), anxiety, prevention of migraines, specific thyroid problems, bleeding from the stomach and oesophagus (gullet) in liver disease, and certain forms of tremor.

2. What you need to know before you take Bedranol® SR Capsules

DO NOT take this medicine before telling your doctor if any of the following applies to you:

•    An allergy to propranolol hydrochloride, propranolol, or any of the other ingredients in this medicine (see section 6 'Further Information').

•    You are or might be pregnant, or you are breast-feeding

•    History of wheezing or asthma

•    Low blood pressure (hypotension)

•    Metabolic acidosis (your blood had a low pH - you will know if you have this)

•    You have not eaten for a long time or you are prone to hypoglycaemia (low levels of glucose in your blood)

•    Severe blood vessel disease

•    Thyroid problems, or are being treated with thyroxine

•    The balance of acidity and salts in the blood is disturbed due to fasting or uncontrolled diabetes

•    Very poor circulation

•    Sick sinus syndrome (abnormal function of the sinoatrial node in your heart)

•    Untreated phaeochromocytoma (a rare tumour of the adrenal gland which causes high blood pressure)

•    Missed heart beats (heart block) or heart failure

•    Very slow heart beat (bradycardia)

•    Prinzmetal's angina/variant angina (a type of chest pain experienced at rest)

Do not take this medicine if you allergic to propranol hydrochloride or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Bedranol SR Capsules.

•    This product may make you more sensitive to allergens (e.g. dust, pollen and pet hair).

This may lead to an anaphylactic reaction (severe reaction to allergens).

•    If you need to stop taking this medicine - this should be gradual; talk to your doctor especially if you have heart disease.

•    If you have heart problems and severe blood vessel disease, heart block or problems with your circulation.

•    If you have kidney or liver disease.

•    If you are going to have an operation, or any procedure needing anaesthetic, please check with the doctor or dentist beforehand. It may be necessary to withdraw Bedranol SR Capsules 24 hours

•    Adrenaline injections may cause unwanted effects in patients taking this medicine, make sure that anyone treating you is made aware of your treatment.

•    The results of blood tests, especially those for checking liver function, may be affected by Bedranol therapy. If you do have any blood taken for testing, let your doctor know you are taking Bedranol SR Capsules.

•    If you suffer from diabetes, this medicine may hide the signs of hypoglycaemia (low blood sugar) and slow your recovery from it.

•    Even if you are not diabetic this medicine may cause hypoglycaemia (low blood sugar, seizures or coma).

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

Other medicines and Bedranol SR Capsules

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. It is especially important for:

•    Gonidine (to treat high blood pressure and migraine);

•    Disopyramide, quinidine, propafenone and other similar drugs such as amiodarone used to treat abnormal heart rates;

•    Calcium channel blockers such as verapamil, diltiazem, nisoldipine, isradipine, lacidipine or nifedipine (to treat high blood pressure, angina and abnormal heart rhythms);

•    Digitoxin or digoxin (for heart failure);

•    Lidocaine (to treat abnormal heart rhythms);

•    Ergotamine, dihydroergotamine or related medicines (for migraine);

•    Anti-inflammatory pain relievers (e.g. ibuprofen or indomethacin) for arthritis and similar conditions;

•    Chlorpromazine or thioridazine (for certain psychiatric disorders);

•    Rifampicin (an antibiotic);

•    Thyroxine (for certain thyroid disorders);

•    Gmetidine (to treat stomach ulcers);

•    Corticosteroids (e.g. hormone replacement);

•    The contraceptive pill;

•    Insulin

•    Adrenaline (a heart stimulant);

•    Muscle relaxants (used to treat multiple sclerosis);

•    Parasympathomimetics (e.g.pyridostigmine used to treat myasthenia gravis);

•    Rizatriptan (used to treat migraines);

•    Moxisylyte (to treat poor circulation);

•    Medicines known as Alpha-blockers or Angiotensin-II Antagonists used to treat high blood pressure (e.g. prazosin or telmisartan);

•    Xamoterol (a heart stimulant);

•    Tropisetron (for nausea and vomiting);

•    Aldesleukin (to treat some cancers)

•    Alprostadil (for sexual problems).

•    Fluvoxamine (for depression)

•    Theophylline (for asthma)

•    Warfarin (to thin the blood)

Operations

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Bedranol SR Capsules. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Bedranol SR Capsules.

Interaction with food and drink

Alcohol may enhance the effect of propranolol. You should not drink alcohol when taking this medicine Pregnancy and breast-feeding

Bedranol SR Capsules should not be used in pregnancy and breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

Do not drive or operate machines if you feel dizzy or tired while taking Bedranol SR Capsules.

Bedranol SR Capsules contains sucrose

Bedranol SR Capsules contain sucrose and you should not take this medicine if you have a hereditary intolerance to some sugars.

3. How to take Bedranol SR Capsules

You should always follow your doctor's instructions as to how and when to take your medicine.

Your pharmacist may be able to advise if you are not sure. Exactly how many capsules, and how often you must take them, will be written on the label. Please read it carefully.

Place the capsule on your tongue and swallow it whole with a little liquid.

Adults

High blood pressure: The initial dose is 160 mg daily, taken in the morning or evening.

If necessary, your doctor may prescribe a dose of 320 mg daily, taken in the morning or evening.

Angina, prevention of migraines, thyroid problems, tremors: The usual dose is 80 mg daily, taken in the morning or evening. Your doctor may increase the dose later to a maximum of 240 mg daily.

Situational and generalised anxiety: Some times the doctor will prescribe one Bedranol SR capsule 160 mg, however treatment of this condition usually begins with a lower dose capsule.

Portal hypertension (bleeding from the stomach and oesophagus (gullet) in liver disease): The doctor will often

begin treatment on a lower dose capsule, however, it might be decided by your doctor that you should take one or two Bedranol SR Capsules 160 mg.

Older people

If you are already established on 160 mg propranolol hydrochloride daily, 160mg daily may be given. However, if you are new to propranolol hydrochloride treatment you may need smaller starting doses and it might be preferable to take an alternative preparation.

Patients with kidney or liver problems A reduced initial dose, or an alternative preparation, may be given.

Chita

Bedranol SR Capsules are not recommended for children.

If you take more Bedranol SR Capsules than you should

If you take more than the recommended dose, contact your doctor. If you or someone else has taken several, or a large overdose of capsules, low blood pressure and slowing of the heartbeat may occur: contact your doctor or hospital accident and emergency department straight away.

If you forget to take Bedranol* SR Capsules

Take it as soon as you remember. If your next dose is due within 12 hours, take a single dose now and skip the next. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bedranol SR Capsules:

Consult your doctor if you want to discontinue treatment with this medicine as your original symptoms may recur when you stop taking the capsules. Bedranol SR Capsules should be discontinued gradually over a period of days.

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

4. Possible side effects

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

Stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:

Rare may affect up to 1 in 1,000 people

• Reduced numbers of platelets in your blood which may make you bruise more easily.

The following side effects may occur with this medicine:

Common may affect up to 1 in 10 people

•    You may notice that your pulse rate becomes slower while you are taking the capsules. This is normal, but if you are concerned please tell your doctor about it.

•    Cold hands and feet.

•    Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud's disease).

•    Disturbed sleep or nightmares.

•    Feeling tired.

Uncommon may affect up to 1 in 100 people

•    Diarrhoea.

•    Feeling sick (nausea).

•    Being sick (vomiting).

Rare may affect up to 1 in 1,000 people

•    Heart block (which may cause an abnormal heart beat, dizziness, tiredness or fainting).

•    Dizziness, particularly on standing up.

•    Thinning of your hair.

•    Mood changes.

•    Feeling confused.

•    Memory loss.

•    Changes in personality (psychoses).

•    Hallucinations.

•    Tingling of your hands.

•    Disturbances of vision.

•    Dry eyes.

•    Skin rash.

•    Purplish marks on your skin.

Very rare may affect up to 1 in 10,000 people

•    Severe muscle weakness (myasthenia gravis).

•    Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Bedranol SR has had any effect on your blood.

Not known frequency cannot be estimated from the available data

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

•    Seizure linked to hypoglycaemia

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely, affecting less than 1 in 1,000 people.

•    Psoriasis (a skin condition).

•    Being short of breath or having swollen ankles (if you have heart failure).

•    Asthma or breathing problems.

•    Poor circulation.

Do not be concerned by this list of side effects. You may not get any of them. 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.

5. How to store Bedranol SR Capsules

Keep this medicine out of the sight and reach of children.

D o not take Bedranol* SR Capsules after the expiry date shown on the label. The expiry date refers to the last day of that month.

These capsules should be stored in a cool, dry place, protected from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Bedranol SR Capsules contains

Each capsule contains 160mg of the active ingredient propranolol hydrochloride in a slow release formulation. The other ingredients are: sucrose, maize starch, shellac and talc. The capsule shells contain gelatin and the colours erythrosine (E127) and titanium dioxide (E171) and the capsule ink contains shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide.

What Bedranol SR Capsules look like and content of the pack

Bedranol SR Capsules are a sustained release capsule. They are available in packs of 28, 30, 56, 60 and 100.

Marketing Authorisation Holder and Manufacturer:

The marketing authorisation holder and manufacturer is: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

This leaflet was revised on 05/2016.

Larger text version of the leaflet can be made available upon request.

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