Medine.co.uk

Propranolol Tablets Bp 160mg

Document: leaflet MAH GENERIC_PL 00142-0142 change

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, please 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.


Index


0 What Propranolol tablets are and what they are used for 0 Before you take 0 How to take 0 Possible side effects 0 How to store 0 Further information

j What Propranolol tablets are and what they are used for

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

•    treat high blood pressure, an enlarged heart muscle or tremors

•    treat angina pectoris (pain in the chest caused by blockages in the arteries leading to the heart) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)

•    help prevent additional heart attacks

•    control irregular or fast heart beats

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

•    to reduce migraine attacks

•    calm people who are anxious or worried

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


Take special care with Propranolol tablets and tell your doctor if you:

•    have a history of allergic reactions

•    suffer with muscle weakness (myasthenia gravis)

•    have a heart weakness or first degree heart block

•    have kidney or liver disease

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

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

•    suffer with or have a history of psoriasis

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

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2l Before you take

Do not take Propranolol tablets and tell your doctor

if you:

•    are allergic (hypersensitive) to Propranolol tablets or any of the other ingredients (see section 6)

•    have untreated/uncontrolled heart failure or are in shock

caused by heart problems

•    suffer with heart conduction or rhythm problems

•    have a slow heart rate

•    have low blood pressure

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

•    suffer from diabetes mellitus (low blood sugar levels may be hidden by this medicine) and increased acidity of the blood (metabolic acidosis)

•    are on a strict fasting diet

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

•    suffer from asthma or any other breathing difficulties

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


Taking other medicines

Before taking Propranolol tablets, tell your doctor if you are taking or have taken recently any of the following medicines

or are taking any non-prescribed medicines:

•    verapamil and diltiazem (to treat heart diseases)

•    disopyramide, quinidine and amiodarone (to treat irregular heartbeat (arrhythmia)

•    ergotamine derivates (to treat migraine)

•    adrenaline (epinephrine, used in anaphylactic shock)

•    medicines to treat diabetes including insulin

•    lidocaine, propafenine or flecanide (to treat irregular heartbeat (arrhythmia) or as a local anasethetic)

•    indometacin (Non-Steroidal Anti-Inflammatory Drug (NSAID))

•    digitalis glycosides such as digoxin (to treat heart conditions)

•    chlorpromazine (for mental illness)

•    cimetidine (to treat stomach ulcers)

•    other drugs treating high blood pressure (alpha blockers, clonidine, moxonidine, methyldopa or hydralazine)

•    monoamine-oxidase inhibitors, imipramine or fluvoxamine (to treat depression)

•    warfarin (to prevent clotting)

•    rizatriptan (to treat migraine)

•    rifampicin (to treat infection)

•    barbiturates (to treat severe insomnia)

•    theophylline (treating asthma and reversible airways obstruction)

•    diuretics (to clear excess water from the body)



Pregnancy and breastfeeding

Propranolol tablets are not recommended during pregnancy or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.


Driving and using machines

Propranolol tablets may cause visual disturbances, hallucinations, fatigue, mental confusion, dizziness or tiredness. Make sure you are not affected before you drive or operate machinery.


Sugar intolerance

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


Alcohol intake

You are advised to avoid alcohol whilst taking this medicine.


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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.

3l How to take

Always take Propranolol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Take with water before meals.

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

Adults & children over 12 years:

•    Angina, migraine or tremor - initially 40mg two or three times a day, then 120-240mg a day for angina or 80-160mg a day for migraine or tremor.

•    High blood pressure - initially 80mg twice a day, then 160-320mg a day.

•    Irregular/fast heart beats, over active thyroid gland or enlarged heart muscle - 10-40mg three or four times a day.

•    Heart attack (start treatment 5-21 days after attack) - 40mg four times a day for 2-3 days, then 80mg twice a day.

•    Phaeochromocytoma

-    before an operation - 60mg a day for 3 days.

-    treatment dose - 30mg a day.

•    Anxiety - 40mg before anxious situations. For long-term anxiety 40mg two or three times a day, treatment is reviewed after 6-12 months.

•    Liver disease due to high blood pressure - initially 40mg twice a day, increasing to 80mg twice a day depending on response. Maximum dose 160mg twice a day.

Children and Adolescents: All other indications - Doses are decided using body weight.

Elderly: your dose may be reduced.

If you take more than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Overdose causes an excessively slowed heart beat with symptoms such as dizziness, sickness, confusion, hallucinations, body spasms, breathlessness on exertion, fainting or coma. Overdose could result in heart attack.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking Propranolol

If you stop taking 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, Propranolol tablets can have side effects, although not everybody gets them.

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

•    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 (less than 1 in 10 users):

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

•    slow or irregular heartbeat, Raynaud's syndrome

•    nightmares

Uncommon (less than 1 in 100 users):

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

Rare (less than 1 in 1000 users):

•    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, worsening of Intermittent claudication

•    skin rash, worsening of psoriasis, hair loss, dry flaky skin, red/itchy skin

•    hallucinations, mood changes, pins and needles, psychoses, memory loss

•    patients with asthma or a history of breathing problems may experience difficulty in breathing

•    dry eyes, visual disturbances

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

•    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 angina, headache, depression, confusion

•    constipation, dry mouth, conjunctivitis

•    changes in sex drive or potency

•    joint pain

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

J| How to store

Keep Propranolol tablets out of the reach and sight of children.

Do not store the tablets above 25°C.

Do not take the tablets after the expiry date which is stated on the carton. The expiry date is also stated on the back of the strip after 'Exp! 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.

a Further information

What Propranolol tablets contain

•    the active substance (the ingredient that makes the tablets work) is propranolol hydrochloride. Each tablet contains either 10mg, 40mg, 80mg or 160mg of the active substance.

•    the other ingredients are lactose, magnesium stearate, maize starch, stearic acid, hypromellose (E464).

•    the coating contains polysorbate, carmoisine (E122), titanium dioxide (E171), iron oxide red (E172), hypromellose (E464).

What Propranolol tablets look like and

contents of the pack

The tablets are pink, circular, film-coated tablets.

Pack sizes are 28 and 56 tablets.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK

Actavis, Barnstaple, EX32 8NS, UK


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This leaflet was last revised in April 2014

148x210 Leaflet Reel Fed Profile (BST)