Propranolol 80mg Tablets

Document: leaflet MAH GENERIC_PL 20416-0383 change

Patient Information Leaflet PROPRANOLOL 10mg, 40mg and 80mg TABLETS

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 further questions, ask your doctor or your pharmacist.

• This medicine has been prescribed only for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects listed below become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2. Before you take Propranolol Tablets

3. How to take Propranolol Tablets

4. Possible side effects

5. How to store Propranolol Tablets

6. Further information

1. WHAT PROPRANOLOL TABLETS ARE AND WHAT THEY ARE USED FOR

Propranolol Tablets contains propranolol hydrochloride. This belongs to a group of medicines called beta-blockers.

Propranolol Tablets can be used for:

• high blood pressure

• symptoms of chest pain (angina)

• protection against further heart attacks - if you have already had one

• thickened heart muscle - also called ‘hypertrophic cardiomyopathy’

• problems affecting the beat of your heart (arrhythmias, tachycardia).

It can also be used for:

• severe headaches (migraine)

• shaking (tremors)

• stress (anxiety)

• an overactive thyroid gland - also called ‘thyrotoxicosis’

• bleeding in the food pipe (oesophagus).This happens when the blood pressure is high in your liver

• high blood pressure caused by a tumour on the adrenal gland. This is called 'phaeochromocytoma'.

2. BEFORE YOU TAKE PROPRANOLOL TABLETS

Do not take Propranolol Tablets if:

• you are allergic (hypersensitive) to propranolol or any of the other ingredients in these tablets (see section 6: Further information)

An allergic reaction can include a rash, itching or shortness of breath

• you have ever had asthma or wheezing

• you are in shock caused by heart problems

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

• you suffer from heart conduction or rhythm problems

• you have a slow heart rate

• Y ou have untreated/uncontrolled heart failure

• you have low blood pressure

• you have not been eating (fasting) for a long period of time or if your blood has become too acidic (metabolic acidosis)

• you suffer from diabetes mellitus (low blood sugar levels may be hidden by this medicine)

• you have high blood pressure caused by a tumour of the gland situated on the top of your kidneys (phaeochromocytoma) which has not been treated

• you have chest pain that happens when you are resting rather than during exercise (called 'prinzmetals angina').

Do not take Propranolol Tablets if any of the above apply to you. If you are not sure, talk to your doctor before taking Propranolol Tablets.

Take special care with Propranolol Tablets:

Before you take Propranolol Tablets tell your doctor if:

• You have problems with your liver (e.g. cirrhosis or portal hypertension) or kidneys. You may need to have some check-ups during your treatment

• you suffer with muscle weakness ( myasthenia gravis)

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

• You have poor blood circulation or controlled heart failure

• You have first-degree heart block or heart disease

• You are an elderly patient

• You have sharp chest pain which is not caused by exercise (unstable angina)

• You have diabetes. Your medicine may change how you respond to having low blood sugar (hypoglycemia). You may feel your heart beating faster

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

• You have ever suffered from a skin disease called psoriasis

• You have ever had an allergic reaction, for example to insect stings.

Taking other medicines:

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

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• Clonidine (for high blood pressure or migraine). If you are taking clonidine and Propranolol together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it

• Drugs treating high blood pressure ( moxonidine, methyldopa, hydralazine)

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

• rizatriptan ( to treat migraine)

• barbiturates (to treat severe insomnia)

• diuretics (e.g furosemide) to clear excess water from the body

• Verapamil, diltiazem, nifedipine, nisoldipine, nicardipine, isradipine or lacidipine (calcium channel blockers) for high blood pressure or chest pain

• Disopyramide, lidocaine, quinidine, flecainide, amiodarone or propafenone (for an uneven heart beat)

• Digoxin (for heart problems)

• Warfarin (to thin the blood)

• Adrenaline (epinephrine), amedicine that stimulates the heart

• Ibuprofen or indometacin (for pain and inflammation)

• Ergotamine or dihydroergotamiine (for migraine)

• Medicines for mental illness (eg. chlorpromazine, thioridazine)

• Cimetidine (for stomach problems)

• Rifampicin (for tuberculosis)

• Theophylline (for asthma)

• Anaesthetic drugs

• Levodopa used for treatment of Parkinson's disease

• Insulin and other drugs used for Diabetes.

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

• you are going to have any blood or urine tests

Taking Propranolol Tablets with food and drink:

Do not drink alcohol while taking Propranolol Tablets. This is because alcohol can change the way the Propranolol works.

Pregnancy and Breast-feeding:

Propranolol tablets are not recommended during pregnancy or breast feeding. Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

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.

Important information about what is in Propranolol Tablets:

This medicine contains Lactose. If you have been told by your physician that you have an intolerance to some sugars, contact your physician before taking this medicine.

3. HOW TO TAKE PROPRANOLOL TABLETS Taking this medicine:

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

• Take this medicine by mouth

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

Adults:

The usual daily doses for the following conditions are:

• High blood pressure:

80mg twice daily. This may be increased by your doctor to 160 - 320mg daily.

• Angina (chest pain):

40mg two or three times daily. This may be adjusted by your doctor to 120 - 240mg per day.

• Anxiety:

40mg daily. A dose of 40mg two or three times a day may be given for longer term treatment. Your doctor will review your treatment after 6 to 12months.

• Migraine and Involuntary Muscle Movements:

40mg two or three times daily. This may then be increased to 80 - 160mg per day.

• Long-term Prevention of Recurrent Heart Attack:

40mg four times daily for two or three days, then 80mg twice daily.

• Hearth Rhythm Problems; Overactive Thyroid Gland:

10 - 40mg three or four times daily.

Children (under 12 years):

Your doctor will decide on the amount of propranolol to give your child based on their weight. The Elderly:

As for adults, above. However, in patients with kidney problems, a reduced starting dose may be given.

If you take more Propranolol Tablets than you should:

Talk to your doctor or go to a hospital straight away.

If you forget to take Propranolol Tablets:

Do not take a double dose to make up for forgotten doses. Take your next dose as soon as you remember. Then go on as before.

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.

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 can cause 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.

The following side effects may happen with this medicine:

Common (affects less than 1 in 10 people)

• Cold hands and feet

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

• Slower pulse rate-this is normal, but if you are concerned then please tell your doctor

• Feeling tired

• Disturbed sleep or nightmares

• Headache.

Uncommon (affects less than 1 in 100 people)

• Diarrhoea

• Feeling sick (nausea)

• Being sick (vomiting).

Rare (affects less than 1 in 1000 people)

• Mood changes

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

• Pain and cramping in the legs (intermittent claudication)

• Dizziness, particularly on standing up

• Thinning of your hair

• Feeling confused

• Memory loss

• Changes in personality (psychoses)

• Hallucinations

• Tingling in hands

• Disturbance of vision

• Dryness of eyes

• Skin rash dry flaky skin, red/ itchy skin

• 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.

• Purplish marks on your skin

• Besides these, there may be worsening of the following:

A skin condition called psoriasis

- Being short of breath or having swollen ankles (heart failure)

- Poor circulation

- Asthma or breathing problems

Very Rare (affects less than 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 your blood

samples quite often to check whether propranolol has had any effect on your blood.

• Low levels of sugar in the blood. This may happen in people with or without diabetes. This includes elderly people,children, infants, 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

Other side effects include

• Changes in sex drive or potency

• Constipation, dry mouth, conjunctivitis

• Joint pain

• Signs of hyperthyroidism may be hidden

• Worsening of angina, headache, depression, confusion

• Changes in blood fats, changes in kidney function

• Seizures linked to low levels of sugar in the blood

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 PROPRANOLOL TABLETS

Keep out of the reach and sight of children

• Do not store above 25°C. Store in the original container in order to protect from light and heat

• Do not use after the expiry date (month, year) stated on the label and carton

• If it is out of date or you no longer want it, take it back to the pharmacy

• Do not use Propranolol Tablets if you notice anything wrong with the medicine Talk to your pharmacist.

6. FURTHER INFORMATION What Propranolol Tablet contains:

Each tablet contains 10mg, 40mg or 80mg of Propranolol hydrochloride as the active substance. The other ingredients are maize starch, lactose, povidone, colloidal silicon dioxide and magnesium stearate. The coating contains methyl cellulose, ethyl cellulose, diethyl pthalate, methanol, titaniumdioxide (E171), carmine (E120) and hypromellose.

What Propranolol Tablet looks like and contents of the pack:

Propranolol 10mg Tablets are pink, film-coated tablets, embossed 'P/10' on one face and 'a' on the other.

Propranolol 40mg Tablets are pink, film-coated tablets, embossed 'P/40' on one face and 'a' on the other.

Propranolol 80mg Tablets are pink, film-coated tablets, embossed 'P/80' on one face and 'a' on the other.

The 10mg and 40mg strengths are available in container pack of 28 tablets and the 80mg strength is available in container pack of 56 tablets.

Marketing Authorisation Holder and Manufacturer:

Crescent Pharma Limited, Units 3 & 4 Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK

This leaflet was last revised in November 2014.

10727/LF/1, 10728/LF/1, 10729/LF/1