PROPRANOLOL 40 MG TABLETS - patient leaflet, side effects, dosage

- 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 for

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. WHAT PROPRANOLOL TABLETS ARE AND WHAT THEY ARE USED FOR

Propranolol belongs to a group of medicines called beta-blockers. It can be used to treat many conditions including:

• symptoms of chest pain (angina pectoris)
• high blood pressure (hypertension)
• shaking (tremors)
• stress (anxiety)
• problems affecting the beat of your heart (arrhythmias, tachycardia)
• thickened heart muscle – also called ‘hypertrophic cardiomyopathy’
• high blood pressure caused by a tumour on the adrenal gland. This is called ‚phaeochromocytoma‘
• an overactive thyroid gland – also called ‘thyrotoxicosis’
• protection against further heart attacks – if you have already had one
• severe headaches (migraine)
• bleeding in the food pipe (oesophagus). This happens when the blood pressure is high in your liver

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPRANOLOL TABLETS

Do not take Propranolol Tablets if you:

• are allergic to propranolol or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include a rash, itching or shortness of breath
• 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)
• have a history of asthma, wheezing or any other breathing difficulties
• suffer from untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney).

Warnings and precautions

Talk to your doctor or pharmacist before taking Propranolol Tablets 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 hypothyroidism (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)
• smoke
• are elderly.

Operations and tests

Tell your doctor, dentist or nurse you are taking Propranolol Tablets if you:

• are going to have an operation or an anaesthetic
• are going to have any blood or urine tests

Other medicines and Propranolol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• medicines to treat heart diseases such as verapamil, diltiazem, nifedipine, nisoldipine, nicardipine, isradipine, lacidipine and dihydropyridine
• medicines to treat irregular heartbeat (arrhythmia), such as disopyramide, quinidine, amiodarone, flecainide, propafenone
• ergotamine derivatives or rizatriptan (to treat migraines)
• adrenaline (epinephrine) (used in anaphylactic shock)
• medicines to treat diabetes, such as insulin
• lidocaine (to treat irregular heartbeat (arrhythmia) or as a local anaesthetic)
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin
• medicines to treat heart conditions (digitalis glycosides) such as digoxin
• chlorpromazine and thioridazine (for mental illness)
• cimetidine (to treat stomach ulcers)
• other medicines to treat high blood pressure such as alpha blockers, clonidine, moxonidine, methyldopa or hydralazine
• levodopa (used in Parkinson’s di­sease)
• monoamine-oxidase inhibitors, imipramine or fluvoxamine (to treat depression)
• warfarin (to prevent clotting)
• rifampicin (to treat infection)
• barbiturates (to treat severe insomnia)
• theophylline (to treat asthma and reversible airways obstruction)
• medicines to clear excess water from the body (diuretics)
• anaesthetics
• medicines to treat high blood pressure or difficulty passing urine such as prazosin
• smoking tobacco.

Propranolol Tablets and alcohol

Avoid alcohol whilst taking Propranolol Tablets. This is because alcohol can change the way Propranolol Tablets work.

Pregnancy and breast-feeding

Propranolol Tablets are not recommended during pregnancy or breast-feeding. If you 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.

Driving and using machines

Propranolol Tablets may cause visual disturbances, hallucinations, fatigue, mental confusion, dizziness or tiredness. If you are affected, do not drive or use any tools or machines and tell your doctor.

Propranolol Tablets contain lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. how to take propranolol tablets

Always take this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure. Take this medicine by mouth with water, preferably before meals.

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

The recommended doses are:

Adults and children over 12 years of age:

Angina, migraine and tremors : Initially 40 mg two or three times daily, increasing to 80–160 mg daily for migraine and tremors and 120–240 mg daily for angina.

Hypertension : Initially 80 mg twice daily, increasing to 160–320 mg/daily.

Irregular or fast heartbeat, thickened heart muscle and over-active thyroid gland : 10–40 mg three or four times daily.

Anxiety : 40 mg daily for short-term anxious situations. For long-term anxiety 40 mg two or three times daily. Treatment should be reviewed after six to twelve months.

Heart attack : Start between 5–21 days after an attack with 40 mg four times daily for two or three days, then 80 mg twice a day.

Phaeochromocytoma : Before an operation; 60 mg daily for three days, otherwise 30 mg daily.

Increased blood pressure in the liver : Initially 40 mg twice daily, increasing to 80 mg twice daily or, if necessary, a maximum of 160 mg twice daily.

Children under 12 years of age:

Your doctor will decide on the amount of Propranolol to give to your child based on their weight and what condition they are taking the medicine for.

Elderly:

Your doctor will decide how much Propranolol to give you.

Patients with kidney or liver problems:

A reduced initial dose may be given.

If you take more Propranolol Tablets than you should Propranolol is severely toxic if used in overdose. If you have accidentally taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention.

The symptoms of overdose can include an excessively slowed heart beat, fainting, dizziness, breathlessness on exertion, confusion, hallucinations, body spasms, coma and heart attack.

If you forget to take Propranolol Tablets

Take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Propranolol Tablets

Keep taking this medicine until your doctor tells you to stop. You may have to stop taking this medicine gradually. Your doctor will help you do this.

Stopping this medicine suddenly can cause symptoms such as a faster heart beat, sweating, shaking, palpitations, worsening of angina, heart attack or death.

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 cause side effects, although not everybody gets them.

If you get any of the following side effects, see your doctor or go to the nearest hospital emergency department straight away:

• any kind of skin rash, flaking skin, boils, swelling of the face, lips, tongue or throat, sudden wheezing, fluttering or tightness of the chest or collapse. This may mean you are having an allergic reaction to propranolol
• difficulty in breathing, especially if you have a history of asthma, wheezing or other lung diseases.

If you get any of the following side effects, stop taking Propranolol and tell your doctor as soon as possible:

• slowing of the heart beat or worsening of heart failure (signs include breathlessness and swollen ankles)
• low blood pressure (hypotension) which can make you feel dizzy or light-headed when standing quickly
• feeling dizzy or faint, and worsening of breathing (called ‚heart block‘)
• poor blood circulation making the fingers and toes cold, numb and pale (Raynaud’s phe­nomenon), this can lead to cramp-like pains in the lower leg
• bleeding or bruising more easily or purplish marks on the skin, sore throat, fever, frequent infections. These symptoms may indicate changes in the levels of your blood cells.
• low blood sugar (hypoglycaemia) in children or elderly who do not have diabetes (signs include weakness, headache, feeling hungry, visual disturbances, mood changes and fits (seizures))

Tell your doctor or pharmacist if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

• nightmares or difficulty sleeping
• tiredness and/or weakness (these symptoms usually disappear), cold extremities

Uncommon (may affect up to 1 in 100 people)

• feeling sick (nausea), being sick (vomiting) or diarrhoea

Rare (may affect up to 1 in 1,000 people)

• hallucinations, mood changes, pins and needles, psychoses, memory loss, confusion
• patients with asthma or a history of breathing problems may experience difficulty in breathing
• dry eyes, visual disturbances

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

• development or worsening of myasthenia gravis (disorder characterised by muscle weakness, difficulty chewing or swallowing, slurred speech)

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
• worsening of angina, headache, depression
• constipation, dry mouth, conjunctivitis (inflammation of the front surface of the eye causing red, sore, itching or weeping eyes)
• changes in sex drive or potency
• 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store propranolol tablets

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container, and keep the container tightly closed.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

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 protect the environment.

6. contents of the pack and other information

What Propranolol Tablets contain

The active substance is propranolol hydrochloride. Each tablet contains either 10 mg, 40 mg or 80 mg of the active substance.

The other ingredients are: lactose monohydrate, gelatine, stearic acid, magnesium stearate, ethylcellulose, hypromellose, diethyl phthalate, Opaspray K-1–5506 (titanium dioxide, hypromellose and carmine E120), beeswax yellow.

What Propranolol Tablets look like and contents of the pack

The 10 mg tablets are pink, round film-coated tablets, engraved MP64 on one side.

The 40 mg tablets are pink, round film-coated tablets engraved MP65 on one side.

The 80 mg tablets are pink, round film-coated tablets, engraved MP66 on one side.

All three strengths of Propranolol Tablets come in containers of 50, 100, 250, 500 and 1000 tablets and blister packs of 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited

41–43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

• 310 Old Brompton Road,