PACKAGE LEAFLET: INFORMATION FOR THE USER

Angilol® 10 mg, 40 mg, 80 mg & 160 mg Tablets

(Propranolol hydrochloride)

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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.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

This leaflet contains

1.    What Angilol tablets are and what they are used for

2.    What you need to know before you take Angilol tablets

3.    How to take Angilol tablets

4.    Possible side effects

5.    How to store Angilol tablets

6.    Contents of the pack and other information

1. What Angilol tablets are and what they are used for

Angilol tablets belong to a group of medicines called

beta-blockers. It can be used to treat many conditions

including:

•    symptoms of chest pain (angina)

•    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

If you are not sure why you have been prescribed Angilol

tablets, then please ask your doctor.

2. What you need to know before you take Angilol tablets

Do not take Angilol tablets and tell your doctor if you:

•    are allergic (hypersensitive) to propranolol or any of the other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath.

•    have a history of asthma, wheezing or any other breathing difficulties

•    have any of the following heart problems:

-    heart failure which is not under control (signs include breathlessness and swollen ankles)

-    second or third degree heart block (a condition which may be treated with a pacemaker)

-    very slow or very uneven heart beats

-    low blood pressure (hypotension) which can make you feel dizzy or light-headed

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

-    chest pain that happens when you are resting rather than during exercise (Prinzmetal’s angina)

-    have a sudden and rapid fall in blood pressure (cardiogenic shock)

-    a problem (common in the elderly) related to poor control of the working of the heart (sick sinus syndrome)

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

•    have high blood pressure caused by a tumour of the adrenal gland which has not been treated, this is called phaeochromocytoma.

•    have or sometimes get low blood sugar (hypoglycaemia). This can happen if you are not eating well, have long-term liver disease or have diabetes.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Angilol tablets.

Take special care with Angilol tablets

Tell your doctor before you take this medicine if you:

•    have or have had heart problems (including heart failure, first degree heart block, heart attack, uneven heart beats or angina), as your doctor may do some tests on your heart before giving you this medicine

•    suffer from blood circulation problems (such as Raynaud’s disease)

•    have a skin problem called psoriasis

•    have a history of allergic reactions or need anti-allergic treatment e.g. following a wasp or bee sting

•    have a thyroid problem, as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by this medicine

•    have liver problems (such as cirrhosis) or kidney problems as you may be given a lower dose of this medicine

•    have diabetes, as symptoms of low blood sugar levels (hypoglycaemia) may be hidden by this medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Angilol tablets.

Operations and tests

Tell your doctor, dentist or nurse you are taking Angilol tablets if you:

•    are going to have an operation or an anaesthetic

•    are going to have any blood or urine tests.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Angilol tablets can affect the way some medicines work. Also some medicines can affect the way Angilol tablets works.

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

•    medicines to treat irregular or uneven heart-beat, such as disopyramide, amiodarone, propafenone and lidocaine

•    medicines to treat high blood pressure or chest pain, such as verapamil

•    calcium channel antagonists used to treat heart conditions such as dihydropyridine, diltiazem, nifedipine, nisoldipine, nicardipine, isradipine and lacidipine

•    hydralazine used to treat high blood pressure

•    digoxin used to treat heart failure

•    clonidine, used to treat high blood pressure or migraine. Do not stop taking clonidine unless your doctor tells you to. If you have to stop taking clonidine, your doctor will tell you how to do it.

•    medicines for stimulating the heart, such as adrenaline

•    medicines used to treat diabetes, such as insulin, metformin or gliclazide

•    medicines for pain and swelling, such as ibuprofen or indomethacin

•    medicines used to treat anxiety, depression or mental health problems such as amitriptyline, fluvoxamine, chlorpromazine and thioridazine

•    theophylline used for asthma

•    medicines to thin the blood and prevent clotting, such as warfarin

•    quinidine used to treat malaria

•    cimetidine, used for too much stomach acid

•    rifampicin, used for tuberculosis

•    ergotamine, dihydroergotamine or rizatriptan, used to treat migraines

•    barbiturates (sedatives like phenobarbitone)

•    anaesthetics

AVOID ALCOHOL whilst taking Angilol tablets. This is because alcohol can change the way your medicine works.

Pregnancy and breast-feeding

If you are pregnant or plan to become pregnant speak to your doctor before taking Angilol tablets. Its effect in pregnancy is not known but some beta-blockers can affect the growth of the unborn baby.

Do not breast-feed your baby unless you have spoken to your doctor first as propranolol can pass into your breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy or tired while taking Angilol tablets. If this happens, do not drive or use any tools or machines and tell your doctor.

Important information about some of the ingredients in Angilol tablets

This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking this medicine.

3. How to take Angilol tablets

Taking Angilol tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine should be swallowed with a drink of water.

Adults and children over 12 years of age:

The recommended dose ranges from 30 mg - 320 mg daily depending on what condition you are taking the medicine for.

Use in 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. Older people may be started on a lower dose.

Patients with kidney or liver problems:

A reduced initial dose may be given.

If you take more Angilol tablets than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Angilol tablets

Take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Angilol 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, this medicine 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 Angilol tablets

•    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 Angilol tablets 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) may occur in diabetic and non-diabetic patients including the newborn, toddlers and children, elderly patients, patients on artificial kidneys (haemodialysis) or patients on medication for diabetes. It may also occur in patients who are fasting or have been fasting recently or who have long-term liver disease. 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 (affects less than 1 in 10 people)

•    nightmares or difficulty sleeping

•    feeling tired or weak

Uncommon (affects less than 1 in 100 people)

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

Rare (affects less than 1 in 1,000 people)

•    strange sounds and visions (hallucinations), loss of touch with reality (psychoses), mood changes, feeling confused, memory loss, tingling or numbness in the hands and feet

•    dry eyes, changes in eyesight

•    hair loss, skin rashes or worsening of the skin problem ‘psoriasis’

Very rare (affects less than 1 in 10,000 people, including isolated reports)

•    muscle weakness and a disease of the muscles (called ‘myasthenia gravis’) getting worse

•    there may be changes to some of the cells or other parts of your blood. It is possible that your doctor may occasionally take blood samples to check whether Angilol has had any effect on your blood.

Side effects with an unknown frequency occurrence

•    seizure linked to low levels of sugar in the blood

•    depression

•    sexual dysfunction

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/yellowacrd. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Angilol tablets

Keep this medicine out of the sight and reach of children. Your medicine could harm them.

Store below 25°C. Store in the original package or container, and keep the container tightly closed, in order to protect from light and moisture.

Do not use the tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

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

The other ingredients are; lactose monohydrate, gelatin, stearic acid, magnesium stearate, ethylcellulose, hypromellose, diethylphthalate, colours (titanium dioxide E171, carmine E120), beeswax.

What Angilol tablets look like and contents of the pack

The 10 mg tablets are pink, round, film-coated tablets engraved ANGILOL 10 on one side. The diameter of each film-coated tablet is approximately 6.5 mm.

The 40 mg tablets are pink, round, film-coated tablet engraved ANGILOL 40 on one side. The diameter of each film-coated tablet is approximately 8.5 mm.

The 80 mg tablets are pink, round, film-coated tablet engraved ANGILOL 80 on one side. The diameter of each film-coated tablet is approximately 9.5 mm.

The 160 mg tablets are pink, round, film-coated tablet engraved ANGILOL 160 on one side. The diameter of each film-coated tablet is approximately 11 mm.

Angilol tablets are available in containers of 50, 100, 250, 500 and 1,000 tablets, and in blister packs of 28 and 56 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

11 Boumpoulinas, 3rd Floor,

1060 Nicosia, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

Chatfield Road, off York Road,

London SW11 3SE.

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was revised in 10/2016.

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