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PATIENT LEAFLET: INFORMATION FOR THE USER PROPRANOLOL 10 MG TABLETS PROPRANOLOL 40 MG TABLETS PROPRANOLOL 80 MG TABLETS PROPRANOLOL 160 MG TABLETS

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, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take Propranolol Tablets

3.    How to take Propranolol Tablets

4.    Possible side effects

5.    How to store Propranolol Tablets

6.    Contents of the pack and other information

1. WHATPROPRANOLOLTABLETSAREAND _WHATTHEYARE USED FOR_

Propranolol belongs to a group of medicines called beta blockers. It is used to:

•    treat pain in the chest (due to poor blood flow to the heart muscle)

•    treat high blood pressure

•    help prevent additional heart attacks

•    treat tremors

•    control irregular or fast heart beats

•    control fast heart rate and other symptoms caused by an overactive thyroid gland

•    treat high blood pressure caused by a tumour near a kidney (phaeochromocytoma)

•    reduce severe headaches (migraine)

•    prevent stomach bleeding in patients with high blood pressure in their liver or swollen blood vessels in their gullet

•    Under some conditions, propranolol can be used to treat children with arrythmias (disorders of the heart rhythm). The dosage will be adjusted by the doctor according to the child’s age or weight.

2. WHATYOU NEED TO KNOWBEFORE YOU TAKE PROPRANOLOL TABLETS

Do not take Propranolol if you:

•    are allergic to Propranolol hydrochloride or any of the other ingredients of this medicine (see section 6).

•    have untreated/uncontrolled heart failure

•    shock caused by heart problems

•    severe heart defects (second or third degree heart blocks)

•    suffer with heart conduction or rhythm problems

•    have a slow heart rate

•    have low or very low blood pressure

•    increased acidity of the blood (metabolic acidosis)

•    are on a strict fasting diet

•    suffer from asthma or any other breathing difficulties

•    suffer from untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney)

•    suffer from severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)

•    suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal’s angina)

If you think that one of these situations applies to you, or if

you are in any doubt, talk to your doctor before you start using

Propranolol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Propranolol if

you:

•    have a history of allergic reactions

•    suffer from muscle weakness (myasthenia gravis)

•    have a weak heart or first degree heart block

•    have kidney disease

•    have liver disease

•    may mask symptoms of hyperthyroidism (increased appetite, weight loss, sweating)

•    have diabetes. Your medicine may lower blood sugar levels (hypoglycaemia) leading to slow heart rate.

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

•    suffer from Raynaud’s disease (cold sensations in fingers and toes) or intermittent claudication (narrowing of arteries in the legs causing pain on walking)

If you have any queries or you are unsure, please ask your doctor or pharmacist.

Other Medicines and Propranolol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These medicines include the following:

•    barbiturates (to treat severe insomnia).

•    MAO inhibitors (to treat depression).

•    propafenone (used to treat life-threatening heart conduction or rhythm problems)

•    fingolimod (to treat multiple sclerosis)

•    verapamil, bepridil and diltiazem (to treat heart diseases)

•    disopyramide, quinidine and amiodarone, lidocaine or flecanide (to treat irregular heartbeat and arrythmias)

•    indometacin (to treat pain)

•    cimetidine (to treat stomach ulcers)

•    adrenaline (epinephrine, used in anaphylactic shock)

•    fluvoxamine (used to treat depression)

•    clonidine, moxonidine and methyldopa (used to treat high blood pressure)

•    chlorpromazine (for mental illness)

•    medicines to treat diabetes including insulin

•    medicines to treat migraine, like rizatriptan and ergotamin

•    rifampicin (to treat infection)

•    theophylline (treating asthma and reversible airways obstruction)

•    smoking tobacco

Pregnancy, breast-feeding and fertility

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Propranolol is not recommended during pregnancy or breastfeeding.

Driving and using machines

Because of the side effects, i.e. tiredness and dizziness, it is conceivable that the ability to drive and use machines might be affected.

Propranolol Tablets contain Lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Propranolol Tablets with food, drink and alcohol

You are advised to avoid alcohol whilst taking this medicine.

Anaesthetics or tests

If you are going to have an anaesthetic or any blood or urine tests, please tell your doctor or dentist that you are taking Propranolol tablets. If you see another doctor or go into hospital, let them know what medicines you are taking.

3. HOW TO TAKE PROPRANOLOL TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take with water before meals.

Do not stop taking this medicine unless your doctor tells you to stop.

Adults:

•    Angina: initially 40 mg two or three times a day, maximum recommended dose 120-240 mg a day.

•    High blood pressure- initially 40 mg two or three times daily, which may be increased by 80 mg per day, up to 160320 mg a day is recommended.

•    Heart attack (post myocardial infarction) - initially 40 mg two to three times daily, later dose may be increased to 80 mg twice daily.

•    Tremor - 40 mg two to three times daily.    g

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Propranolol Tablets INSERT    ^{340 mm}

SAME SIZE ARTWORK 340 x 150 mm Front

•    Irregular heart rhythms - 10 mg to 40 mg two or three times a day.

•    Over active thyroid gland - your dose may be decided based on clinical response.

•    Phaeochromocytoma

-    Before an operation-60 mg a day for 3 days

-    Non operable treatment dose- 30 mg a day

•    Migraine - initially 40 mg two or three times a day, upto 80160 mg a day.

•    Liver disease due to high blood pressure - initially 40 mg twice a day, maximum recommended dose 160 mg twice a day

Children and Adolescents:

Arrhythmias: Under some conditions, propranolol can be used to treat children with arrhythmias (disorders of heart rhythm). The dosage will be adjusted by the doctor according to the child’s age or weight.

Elderly: Your dose may be decided based on clinical response Liver or kidney failure:

Your dose may be decided based on clinical response.

The score line is not intended for breaking the tablet.

If you forget to take Propranolol Tablets

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

If you take more Propranolol Tablets than you should

If you have accidentally taken more than the prescribed dose, contact your doctor or the nearest hospital casualty department or tell your doctor or pharmacist at once. Overdose causes an excessively slow heart rate, too low blood pressure, heart failure and breathing difficulty with symptoms such as fatigue, hallucinations, fine tremor, confusion, nausea, vomiting, body spasms, fainting or coma, low blood sugar.

If you stop taking Propranolol Tablets

If you stop taking the Propranolol Tablets suddenly you may experience unpleasant side effects including sweating, shaking, worsening of angina, irregular heart beat, heart attack or death. Withdrawal should be gradual.

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

_4. POSSIBLE SIDE EFFECTS_

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

Stop treatment and contact a doctor at once if you have the following symptoms:

•    intolerance to Propranolol tablets such as slow heart rate and low blood pressure causing dizziness, light headedness, fainting or blurred vision.

•    allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Common (may affect up to 1 in 10 people)

•    tiredness, cold extremities, difficulty in sleeping (these symptoms usually disappear)

•    slow or irregular heartbeat, severely restricted blood flow to the fingers and toes (Raynaud’s syndrome)

•    nightmares, shortness of breath Uncommon (may affect up to 1 in 100 people)

•    feeling or being sick, diarrhoea (these symptoms usually disappear), vomiting

Rare (may affect up to 1 in 1000 people)

•    your medicine may alter the number and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want to give you a blood test

•    worsening of heart failure, low blood pressure/fainting on standing, dizziness

•    skin rash, worsening of psoriasis, hair loss, dry flaky skin

•    seeing, hearing or feeling things that seem real, but do not happen (hallucinations), mood changes, pins and needles, severe mental disorder (psychoses), memory loss

•    bronchospasm/difficulty breathing in patients with asthma or history of breathing problems

•    dry eyes, visual disturbances

•    being unable to think with clarity

•    abnormal skin sensations (as tingling or tickling or itching or burning)

•    swelling of the blood vessels below the skin, which may be

painful and accompanied by redness Very Rare (may affect up to 1 in 10,000 people)

•    muscle weakness

•    sweating

Not known (frequency cannot be estimated from the available data):

•    a pain in the head

•    an acute blood disorder

•    difficulty in breathing

•    signs of hyperthyroidism may be hidden

•    changes in blood fats, changes in kidney function

•    changes in blood sugar levels

•    fits (seizures) linked to low blood sugar levels

•    worsening of chest pain, depression

•    constipation, dry mouth, eye infections

•    changes in sex drive or impotence e.g. failure to achieve erection

•    joint pain

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PROPRANOLOL TABLETS

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

•    Do not use this medicine after the expiry date which is stated on the label (EXP.). The expiry date refers to the last day of that month.

•    This medicinal product does not require any special storage conditions.

•    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 Propranolol Tablet contains

•    The active substance is Propranolol Hydrochloride.

•    The other ingredients are Lactose, Maize Starch, Povidone, Sodium Starch Glycollate, Magnesium Stearate, Hydroxypropyl Methyl Cellulose, Polyethylene Glycol 400, Titanium Dioxide (E171) and Opaspray M-1-1300B pink.

What Propranolol Tablets look like and contents of pack:

•    Propranolol 10 mg Tablets are pink biconvex film coated tablets embossed with ‘1’ on one side and break line on the other side

•    Propranolol 40 mg Tablets are pink biconvex film coated tablets embossed with ‘2’ on one side and break line on the other side

•    Propranolol 80 mg Tablets are pink biconvex film coated tablets embossed with ‘3’ on one side and break line on the other side

•    Propranolol 160 mg Tablets are pink biconvex film coated tablets embossed with ‘4’ on one side and break line on the other side

•    Propranolol Tablets are available in packs of 28 and 56 tablets for all strengths. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom.

Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

PROPRANOLOL 10 MG TABLETS; PL 17907/0326 PROPRANOLOL 40 MG TABLETS; PL 17907/0327 PROPRANOLOL 80 MG TABLETS; PL 17907/0328 PROPRANOLOL 160 MG TABLETS; PL 17907/0329 This leaflet was last revised in October 2016 To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V6 08-10-16 D0

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340 mm