Inderal LA 160mg and Half-Inderal LA 80mg

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 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Inderal is and what it is used for
• 2. Before you take Inderal
• 3. How to take Inderal
• 4. Possible side effects
• 5. How to store Inderal
• 6. Further information

Do not take Inderal if:

• You have ever had asthma or wheezing. If this applies to you talk to your doctor or pharmacist.
• You are allergic (hypersensitive) to propranolol hydrochloride or any of the other ingredients in Inderal (see section 6: Further information).
• You have ever had any of the following heart problems:
  • heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
  • second- or third-degree heart block (a condition which may be treated by a pacemaker)
  • very slow or very uneven heart beats, very low blood pressure or very poor circulation
  • a type of chest pain (angina) called Prinzmetal's angina.
• You have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure.
• You have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).
• You have been fasting recently.

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

Take special care with Inderal

Check with your doctor or pharmacist before taking Inderal if:

• You have ever had an allergic reaction, for example to insect stings.
• You have poor blood circulation or controlled heart failure.
• You have first-degree heart block.
• You have sharp chest pain which is not caused by exercise (unstable angina).
• You have problems with your kidneys. You may need to have some check-ups during your treatment.
• You have problems with your liver (such as cirrhosis of the liver). You may need to have some check-ups during your treatment.
• You have diabetes. Your medicine may change how you respond to having low blood sugar (hypoglycaemia). You may feel your heart beating faster.
• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Inderal can affect the way some other medicines work and some medicines can have an effect on Inderal.

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

• Clonidine (for high blood pressure or migraine). If you are taking clonidine and Inderal 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.
• Verapamil, diltiazem, nifedipine, nisoldipine, nicardipine, isradipine or lacidipine (for high blood pressure or chest pain).
• Disopyramide, lidocaine, quinidine, amiodarone or propafenone (for an uneven heart beat).
• Digoxin (for heart problems).
• Warfarin (to thin the blood).
• Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
• Ibuprofen or indometacin (for pain and inflammation).
• Ergotamine or dihydroergotamine (for migraine).
• Chlorpromazine or thioridazine (for mental illness).
• Cimetidine (for stomach problems).
• Rifampicin (for tuberculosis).
• Theophylline (for asthma).
• Insulin.

Operations

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Inderal. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Inderal.

Taking Inderal with food and drink

If you frequently drink a lot of alcohol, talk to your doctor before having this medicine. This is because alcohol can affect how the medicine works.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

• Your medicine is not likely to affect you being able to drive or use any tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities.
• If you feel dizzy or tired when taking this medicine, do not drive or use any tools or machines.

Important information about some of the ingredients of Inderal Capsules

Inderal Capsules contain microcrystalline cellulose and titanium dioxide. These may cause a problem in a very small number of people who are sensitive to them.

Adults

• High blood pressure (hypertension): the usual dose is 160 mg a day. Your doctor may decide to increase this dose.
• Chest pain (angina): the usual dose is 80 mg to 240 mg a day.
• To prevent migraine: the usual dose is 80 mg to 240 mg a day.
• Essential tremor: the usual dose is 80 mg to 240 mg a day.
• Anxiety: the usual dose is 80 mg to 160 mg a day.
• Thyroid conditions (such as thyrotoxicosis): the usual dose is 80 mg to 240 mg a day.
• Bleeding in the food pipe (oesophagus) caused by high blood pressure in the liver: the usual dose is 80 mg to 320 mg a day.

Elderly people

If you are an elderly person, your doctor may decide to start you on a lower dose.

Children

Your medicine must not be given to children.

If you take more Inderal than you should

If you take more Inderal than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the capsules can be identified.

If you forget to take Inderal

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Inderal

Do not stop taking Inderal without talking to your doctor. In some cases, you may need to stop taking it gradually.

Common (affects less than 1 in 10 people)

• You may notice that your pulse rate becomes slower while you are taking the capsules. This is normal, but if you are concerned please tell your doctor about it.
• Cold hands and feet.
• Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud's disease).
• Disturbed sleep or nightmares.
• Feeling tired.

Uncommon (affects less than 1 in 100 people)

• Diarrhoea.
• Feeling sick (nausea).
• Being sick (vomiting).

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

• Heart block (which may cause an abnormal heart beat, dizziness, tiredness or fainting).
• Dizziness, particularly on standing up.
• Thinning of your hair.
• Mood changes.
• Feeling confused.
• Memory loss.
• Changes in personality (psychoses).
• Hallucinations.
• Tingling of your hands.
• Disturbances of vision.
• Dry eyes.
• Skin rash.
• Reduced numbers of platelets in your blood which may make you bruise more easily.
• Purplish marks on your skin.

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 blood samples every so often to check whether Inderal has had any effect on your blood.
• Low levels of sugar in the blood (hypoglycaemia). This can happen in people with or without diabetes. This includes elderly people, 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.

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people.

• Psoriasis (a skin condition).
• Being short of breath or having swollen ankles (if you have heart failure).
• Asthma or breathing problems.
• Poor circulation.

Do not be concerned by this list of side effects. You may not get any of them. 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.

What Inderal LA 160 mg capsules and Half-Inderal LA 80 mg capsules contain

The active substance is propranolol. Two different strengths are available.

Each Inderal LA 160 mg capsule contains 160 mg of propranolol in a long-acting form.

Each Half-Inderal LA 80 mg capsule contains 80 mg of propranolol in a long-acting form.

The other ingredients are erythrosine (E127), ethylcellulose Ph Eur. (E462), gelatin Ph Eur. (E441), iron oxide, methylhydroxypropylcellulose Ph Eur. (E464), microcrystalline cellulose Ph Eur. (E460), titanium dioxide Ph Eur. (E171), sodium lauryl sulphate Ph. Eur. and shellac (E904).

Inderal LA 160 mg capsules may also contain glycerol Ph Eur. (E422).

What Inderal LA 160 mg capsules and Half-Inderal LA 80 mg capsules look like and contents of the pack

Inderal LA 160 mg capsules and Half-Inderal LA 80 mg capsules are pink/lavender or white opaque capsules.

They come in calendar packs containing 28 capsules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for Inderal LA 160 mg capsules and Half-lnderal LA 80 mg capsules are held by

Inderal LA 160 mg capsules and Half-Inderal LA 80 mg capsules are manufactured by