ANGILOL 10 MG FILM-COATED TABLETS, PROPRANOLOL 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. What Angilol is and what it is used for

2. What you need to know before you take Angilol

3. How to take Angilol

4. Possible side effects

5. How to store Angilol

6. Contents of the pack and other information

1. WHAT ANGILOL IS AND WHAT IT IS USED FOR

The name of your medicine is Angilol. The active ingredient is propranolol. Angilol is produced as film-coated tablets in three different strengths. Each tablet contains 10 mg, 40 mg or 80 mg of propranolol hydrochloride.

Propanolol is one of a group of drugs called beta-blockers. It has effects on the heart and circulation and also on other parts of the body.

Angilol can be used for many conditions including:

• chest pain (angina)
• high blood pressure (hypertension)
• essential tremor, anxiety
• some arrhythmias (disorders of heart rhythm)
• hypertrophic cardiomyopathy (thickened heart muscle)
• protection of the heart after a myocardial infarction (heart attack)
• phaeochromocytoma (high blood pressure due to a tumour usually near a kidney) where an alpha-blocker is also prescribed
• help prevent additional heart attacks
• certain thyroid conditions (such as thyrotoxicosis, which is caused by an overactive thyroid gland)
• prevention of migraine
• bleeding in the oesophagus caused by high blood pressure in the liver.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGILOL

If you have ever had asthma or wheezing, do not take Angilol. Go back to your doctor or pharmacist.

Do not take Angilol:

• if you are allergic to propranolol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Angilol tablets.

Angilol should not be taken by people who;

• 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

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

Your doctor will know about these conditions. If you have one of these conditions, make sure your doctor knows about this before you take Angilol tablets.

Talk to your doctor or pharmacist before taking Angilol tablets.

Tell your doctor before you take this medicine if you:

• suffer from unstable angina (non exercise-induced sharp chest pain).
• get allergic reactions to such things as insect stings
• have an overactive thyroid gland (thyrotoxicosis). Angilol may hide the symptoms of thyrotoxicosis.
• have kidney or liver problems (including cirrhosis of the liver). If so, talk to your doctor because you may need to have some check-ups during your treatment.
• have diabetes as Angilol may change your normal response to low blood sugar, which usually involves an increase in heart rate. Angilol may cause low blood sugar levels even in patients who are diabetic.
• have any other health problems such as circulation disorders, heart problems, breathlessness or swollen ankles.

Other medicines and Angilol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines Angilol can interfere with the action of some other drugs and some drugs can have an effect on your medicines. The drugs which can cause some problems when taken together with your medicine are:

• disopyramide,
• amiodarone and propafenone (for irregular heartbeats)
• lidocaine
• verapamil
• diltiazem
• nifedipine
• nisoldipine
• nicardipine
• isradipine
• lacidipine (which are used to treat hypertension or angina)
• digoxin (for heart failure)
• adrenaline (a heart stimulant)
• ibuprofen and indomethacin (for pain and inflammation)
• chlorpromazine and thioridazine (for certain psychiatric disorders)
• theophylline (for asthma)
• warfarin (to thin the blood) and hydralazine (for hypertension)
• quinidine
• cimetidine (for stomach problems)
• rifampicin (for the treatment of tuberculosis)
• ergotamine, dihydroergotamine or rizatriptan (for migraine)

If you are taking clonidine (for hypertension or migraine) and Angilol 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.

Angilol with food, drink and alcohol

Alcohol may affect how this medicine works.

Operations

If you go into hospital to have an operation, tell the anaesthetist or the medical staff that you are taking Angilol.

Driving and using machines

Your medicine is unlikely to affect your ability to drive or operate machinery. However, some people may occasionally feel dizzy or tired while taking Angilol. If this happens to you, ask your doctor for advice.

Pregnancy, breast-feeding and fertility

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.

Angilol contains lactose

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

3. how to take angilol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Angilol tablets should be swallowed with a drink of water. Your doctor will have decided how many Angilol tablets you need to take each day depending on your condition. Follow your doctor’s instruc­tions about when and how to take your tablets. Please read the label on the container.

This will also tell you how many tablets to take and when you should take them. Ask your doctor or pharmacist if you are not sure. The following table shows the recommended total daily dosages for an adult:

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

Older people may be started on a lower dose.

If you take more Angilol 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.

If you accidentally take an overdose of your medicine, either call your doctor, or go to your nearest hospital casualty department straight away. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified.

If you forget to take Angilol tablets

If you forget to take your medicine, 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 are worried, ask your doctor or pharmacist for advice.

If you stop taking Angilol tablets

Do not stop taking this medicine without talking to your doctor first. In some cases, it may be necessary to stop taking the medicine gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

• 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 lightheaded 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 (may affect up to 1 in 10 people)

• nightmares or difficulty sleeping
• feeling tired or weak

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)

• 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 (may affect up to 1 in 10,000 people)
• New muscle weakness or 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.

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 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 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 Angilol contains

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

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

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

Manufacturer

DDSA Pharmaceuticals Limited,

84 Pembroke Road,

London, W8 6NX, UK

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

This leaflet was revised in 10/2020.

CL0095–0096–0097/O/PIL-Br/CL2