Document: leaflet MAH GENERIC_PL 20395-0035 change

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Artw rk . / Creative Desians	Artwork No.		220415/16			Colours Used
	Customer		Relon Chem		■	Balck
	Description		Propranolol lOmg, 80mg Pil
	Market		UK
_r	Language		English		■	Keyline (not to print)
	Size		148 x 310 mm (Finished)
■jP	Min. Font Size		9 pt
	Page No.		1 of 1
5*	Version No.		2
	Date		05-06-15
	Softwa re		Illustrator 1 0
Packaging Development		Quality Assurance (QA)		Quality Control (QC)		Production

Propranolol lOmg and 80mg Tablets

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, ask your doctor or pharmacist or nurse.

•    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 or nurse. 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.    HowtostorePropranololTablets

6.    Contents of the pack and other information

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

Propranolol is one of a group of drugs called beta-blockers. Beta-blockers slow the heart and circulation and can affect other parts ofthe body e.g liver.

Propranolol can be used for many conditions including

•    Hypertension (high blood pressure), angina (chest pains), some arrhythmias (disorders of heart rhythm), protection ofthe heart after a myocardial infarction (heart attack).

•    Hypertrophic cardiomyopathy (thickening heart muscle).

•    Prevention of migraine, essential tremor and anxiety.

•    Thyrotoxicosis a thyroid condition caused by an overactive thyroid gland.

•    Phaeochromocytoma (high blood pressure due to a tumour usually near the kidney).

•    Bleeding in the oesophagus caused by high blood pressure in the liver.

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

Do not take Propranolol Tablets:

•    If you have a history of wheezing or asthma.

•    Ifyou are allergic (hypersensitive) to propranolol or any ofthe other ingredients in Propranolol Tablets (listed in section 6).

•    If you suffer with heart failure which is not under control.

•    Ifyou sufferfrom conditions such as heart block, very slow or irregular heartbeats, very low blood pressure or very poor circulation.

•    Ifyou have phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) which is not being treated.

•    If you have been fasting for a long time.

•    Ifyou have metabolic acidosis (diabetics).

•    Ifyou have Prinzmental's angina (a certain type of chest pain).

Warnings and precautions

Talk to your doctor or pharmacist before taking

these tablets:

•    If you have an allergy as these tablets may increase your sensitivity.

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•    Ifyou have diabetes as propranolol may change your normal response to low sugar which usually involves an increase in heart rate.

•    Ifyou have thyrotoxicosis as propranolol may hide the symptoms ofthis condition.

•    Ifyou have liver or kidney problems (including cirrhosis ofthe liver) because you may need to have some check ups during your course of treatment.

•    Ifyou have circulatory disorders such as Raynaud's syndrome.

•    Ifyou have heart problems.

•    Ifyou have had psoriasis previously.

Other medicines and Propranolol Tablets Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines. In particular:

•    Verapamil, diltiazem, nifedipine used to treat hypertension or angina.

•    Digoxin for heart failure.

•    Gonidine for high blood pressure or migraine.

•    Monoamine oxidase inhibitors for depression.

•    Disopyramide, quinidine and am/odarone used to treat irregular heart beats.

•    Insulin and other oral diabetic drugs.

•    Anaesthetic: if you are going into hospital for an operation, tell the anaesthetist or medical staff that you are taking propranolol.

•    Adrenaline a heart stimulant.

•    Chiorpromazine for certain psychiatric disorders.

•    Cimetidine for stomach problems.

•    Hydroiazine for high blood pressure.

If you are taking clonidine and propranolol together, you must not stop taking clonidine unless your doctor tells you to do so. If it becomes necessary for you to stop taking clonidine, your doctor will give you careful instructions on how to do it.

Propranolol Tablets with food, drink and alcohol

Propranolol tablets should be swallowed with a drink ofwater.

If you frequently drink a lot of alcohol, this may reduce the effect of your medicine.

Pregnancy and Breastfeeding:

Before taking these tablets tell your doctor if you are, you think you might be or are planning to become pregnant. You should not use Propranolol Tablets ifyou are breast-feeding or are planning to breast-feed your baby.

Driving and using machines:

Propranolol Tablets may make you feel dizzy or tired. If affected do not drive or operate machinery.

Propranolol Tablets contain lactose:

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

3. How to take Propranolol Tablets

Always take Propranolol Tablets exactly as your doctor has told you. You should checkwith your doctor or pharmacist if you are not sure. Propranolol Tablets should be swallowed with a drink ofwater.

*Under some circumstances, propranolol can be used to treat children with these conditions. The dosage will be adjusted by the doctor according to the child's age or weight.

If you take more Propranolol Tablets than you should:

If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

If you forget to take Propranolol Tablets:

If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take two doses at the same time.

If you stop taking Propranolol Tablets:

Do not stop taking Propranolol Tablets without first discussing it with your doctor. In some cases it may be necessary to stop taking the medicine gradually.

If you have any further questions on the use of Propranolol Tablets askyour doctor or pharmacist.

4. Possible side Effects

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

If you experience sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing. Then go to the hospital immediately.

Common: (between linlOtolinlOO patients)

•    Stomach upsets

•    Disturbed sleep, tiredness and muscle weakness.

These may occur at the beginning of the treatment but should go. Ifthese signs do notget better after a few days then contact a doctor.

Rare: (between I in lOOOto I in 10,000)

Contact your doctor or pharmacist if any ofthe following side effects are noticed:-

•    Numbness and spasm in the fingers (Raynaud's phenomenon)

•    Heart blockwhich may cause dizziness or fainting

•    Worsening of heart failure (breathlessness and/or swollen ankles)

•    Worsening of breathing difficulties in people with asthma or breathing problems

•    Worsening of circulation in people with poor circulation

•    Increased bruising, nosebleeds, sore throats or infections due to changes in the number and types of blood cells which can be measured by a blood test at your doctor's

•    Hallucinations, psychoses, confusion, mood changes

•    Fits linked to reduction in blood glucose levels

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

Occasionally people suffer with:

•    Headache, disturbances ofvision, dizziness, impotence, nightmares

•    Cold hands and feet, tingling of the hands

•    Skin rashes or dry eyes

•    Reduction in blood glucose levels

•    Nausea, vomiting and diarrhoea.

Reporting of side effects

Ifyou get any side effects, talkto 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 reportingside effects you can help provide more information on the safety ofthis medicine.

5. How to store Propranolol Tablets

Keep out of the sight and reach of children.

Do not use Propranolol Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day ofthe month.

Do not store the tablets above 25°C.

Store in the original container.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Propranolol Tablets contain

The active substance is Propranolol hydrochloride.

The other ingredients are lactose, talc,

Stearic acid, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (EI7l)and carmine (EI20).

In addition to these ingredients the 80mg tablets also contain microcrystalline cellulose.

What Propranolol Tablets look like and contents of the pack

The lOmg tablets are pink, film-coated biconvex tablets embossed '10'on one face.

The 80mg tablets are pink, film-coated biconvex tablets with breakline on one face embossed '80' on the other.

Propranolol lOmg Tablets are available in pots of 20, 50, 500 and 1000 tablets and blister packs of 28 tablets.

Propranolol 80mg Tablets are available in pots of 20, 50 and 500 tablets and blister packs of 56 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited

Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.

Date Leaflet revised in: June 2015.

[POM]

PL 20395/0033 PL 20395/0035