Before taking your medicine

PACKAGE LEAFLET: INFORMATION FOR THE USER

Inderal Tablets are available in the following strengths: 10mg, 40mg and 80mg.

Your medicine is available using the name Inderal 40mg Tablets but will be referred to as Inderal throughout this leaflet.

Please read this leaflet carefully before you take your medicine. This leaflet only gives a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What you should know about your medicine

The active ingredient is propranolol.

Each film coated tablet contains 40mg propranolol hydrochloride.

Your medicine also contains the following inactive ingredients: lactose monohydrate, gelatine, magnesium stearate, carmellose calcium, hypromellose, glycerol, cochineal carminic acid (E120) and titanium dioxide (E171).

Inderal are round, pink tablets with a score line on one side and embossed with 'INDERAL 40' on the reverse.

Inderal is available in packs of 30 tablets.

Propranolol 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.

Manufacturer

Manufactured by: Corden Pharma GmbH, Plankstadt, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0607 POM

Inderal can be used for many conditions including hypertension (high blood pressure), angina (chest pain), some arrhythmias (disorders of heart rhythm), protection of the heart after a myocardial infarction (heart attack), prevention of migraine, essential tremor, anxiety, certain thyroid conditions (such as thyrotoxicosis, which is caused by an overactive thyroid gland), hypertrophic cardiomyopathy (thickened heart muscle), phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) and bleeding in the oesophagus caused by high blood pressure in the liver.

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

Do not take Inderal if you have previously had an allergic reaction to it, to propranolol, or to any of the other ingredients listed above.

Inderal should also not be taken by people with heart failure which is not under control or people with certain other conditions such as heart block, very slow or very irregular heartbeats, very low blood pressure or very poor circulation. It should also not be taken by people who are fasting or have been fasting recently, people who have phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) which is not being treated or by people who have metabolic acidosis or a particular type of chest pain called Prinzmetal's angina. Your doctor will know about these conditions. If you have one of these conditions, make sure your doctor knows about it before you take Inderal.

Do you get allergic reactions to such things as insect stings?

If so, tell your doctor.

Do you have diabetes? Inderal may change your normal response to low blood sugar, which usually involves an increase in heart rate. Inderal may cause low blood sugar levels even in patients who are not diabetic.

Do you suffer from unstable angina (non exercise-induced sharp chest pain)?

Do you have thyrotoxicosis? Inderal may hide the symptoms of thyrotoxicosis.

Do you 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.

Do you have any other health problems such as circulation disorders, heart problems, breathlessness or swollen ankles?

If so, tell your doctor.

Are you taking any other medicines? If so, tell your doctor.

Inderal can interfere with the action of some other drugs and some drugs can have an effect on your medicine. The drugs which can cause some problems when taken together with your medicine are: verapamil, diltiazem, nifedipine, nisoldipine, nicardipine, isradipine, lacidipine, (which are used to treat hypertension or angina), disopyramide, lidocaine, quinidine, amiodarone or propafenone (for irregular heartbeats), digoxin (for heart failure), adrenaline (a heart stimulant), ibuprofen and indometacin (for pain and inflammation), ergotamine, dihydroergotamine or rizatriptan (for migraine), chlorpromazine and thioridazine (for certain psychiatric disorders), cimetidine (for stomach problems), rifampicin (for the treatment of tuberculosis), theophylline (for asthma), warfarin (to thin the blood) and hydralazine (for hypertension).

Are you taking a drug called clonidine (for hypertension or migraine)? If you are taking clonidine and Inderal 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.

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

Are you pregnant or are you breast-feeding a baby? If so, tell your doctor.

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

Inderal contains a small amount of glycerol.

When glycerol is given in high doses it can cause headache, stomach upset and diarrhoea.

Inderal also contains lactose monohydrate.

If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Inderal.

Taking your medicine

Inderal should be swallowed with a drink of water. Your doctor will have decided how many Inderal 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 usual total daily dosages for an adult:

Hypertension (high blood pressure)    160mg to 320mg

Angina (chest pains)    120mg to 240mg

Arrythmias (disorders of heart rhythm)*	30mg to 160mg
Protection of the heart after a heart attack	160mg
Prevention of migraine*	80mg to 160mg
Essential tremor	80mg to 160mg
Anxiety	40mg to 120mg
Certain thyroid conditions (such as	30mg to 160mg
thyrotoxicosis)*
Hypertrophic cardiomyopathy (thickened	30mg to 160mg
heart muscle)

Phaeochromocytoma*    30mg to 60mg

Bleeding in the oesophagus caused by high 80mg to 160mg blood pressure in the liver

*Under some circumstances, Inderal 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.

Elderly patients may be started on a lower dose.

If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time.

Don't take two doses at the same time. If you are worried, ask your doctor or pharmacist for advice.

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

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

After taking your medicine

As with all medicines, undesirable events can sometimes be experienced with Inderal.

Common side effects that may occur (in 1% or more patients but less than 10%; between 1 in 10 and 1 in 100 patients)

Cold fingers and toes

The heart beating more slowly

Numbness and spasm in the fingers which is followed by warmth and pain (Raynaud's phenomenon)

Disturbed sleep/nightmares

Fatigue

Uncommon side effects that may occur (in 0.1% or more patients but less than 1%; between 1 in 100 and 1 in 1000 patients)

Diarrhoea

Nausea

Vomiting

Rare side effects that may occur (in 0.01% or more patients and less than 0.1%; between 1 in 1000 and 1 in 10000 patients)

Worsening of breathing difficulties, if you have or have had asthma

Breathlessness and/or swollen ankles, if you also have heart failure

Heart block which may cause an abnormal heart beat, dizziness, tiredness or fainting

Dizziness, particularly on standing up

Worsening of your blood circulation, if you already suffer from poor circulation Hair loss

Mood changes

Confusion

Memory loss

Psychosis or hallucinations (disturbances of the mind)

Tingling of the hands Disturbances of vision Dry eyes

Skin rash, including worsening of psoriasis Bruising more easily (thrombocytopaenia)

Purple spots on the skin (purpura)

Very rare side effects that may occur (in less than 0.01% patients; less than 1 in 10000 patients)

Severe muscle weakness (myasthenia gravis)

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 Inderal has had any effect on your blood.

Side effects that may occur with an unknown frequency

Low levels of blood sugar 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 a long-term liver disease.

Seizure linked to low levels of sugar in the blood.

Do not be alarmed by this list of possible events. You may not have any of them.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 reporting side effects, you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Store in the original container. Protect from light and moisture.

Do not store above 25°C.

Do not use this medicine after the expiry date (Exp) shown on the carton and blister labels.

If your doctor decides to stop the treatment, return any leftover medicine to the pharmacist. Only keep it if your doctor tells you to.

If your medicine appears to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you further.

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

Further information

This leaflet does not contain the complete information on Inderal. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Leaflet revision and issue date: 12.12.14

INDERAL® is a registered trademark of the AstraZeneca group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Propranolol Hydrochloride Tablets are available in the following strengths: 10mg, 40mg and 80mg.

Your medicine is available using the name Propranolol Hydrochloride 40mg Tablets but will be referred to as Propranolol Hydrochloride throughout this leaflet.

Please read this leaflet carefully before you take your medicine. This leaflet only gives a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What you should know about your medicine

The active ingredient is propranolol.

Each film coated tablet contains 40mg propranolol hydrochloride.

Your medicine also contains the following inactive ingredients: lactose monohydrate, gelatine, magnesium stearate, carmellose calcium, hypromellose, glycerol, cochineal carminic acid (E120) and titanium dioxide (E171).

Propranolol Hydrochloride are round, pink tablets with a score line on one side and embossed with 'INDERAL 40' on the reverse.

Propranolol Hydrochloride is available in packs of 30 tablets.

Propranolol 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.

Manufacturer

Manufactured by: Corden Pharma GmbH, Plankstadt, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0607 POM

Propranolol Hydrochloride can be used for many conditions including hypertension (high blood pressure), angina (chest pain), some arrhythmias (disorders of heart rhythm), protection of the heart after a myocardial infarction (heart attack), prevention of migraine, essential tremor, anxiety, certain thyroid conditions (such as thyrotoxicosis, which is caused by an overactive thyroid gland), hypertrophic cardiomyopathy (thickened heart muscle), phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) and bleeding in the oesophagus caused by high blood pressure in the liver.

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

Do not take Propranolol Hydrochloride if you have previously had an allergic reaction to it, to propranolol, or to any of the other ingredients listed above.

Propranolol Hydrochloride should also not be taken by people with heart failure which is not under control or people with certain other conditions such as heart block, very slow or very irregular heartbeats, very low blood pressure or very poor circulation.

It should also not be taken by people who are fasting or have been fasting recently, people who have phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) which is not being treated or by people who have metabolic acidosis or a particular type of chest pain called Prinzmetal's angina.

Your doctor will know about these conditions. If you have one of these conditions, make sure your doctor knows about it before you take Propranolol Hydrochloride.

Do you get allergic reactions to such things as insect stings?

If so, tell your doctor.

Do you have diabetes? Propranolol Hydrochloride may change your normal response to low blood sugar, which usually involves an increase in heart rate. Propranolol Hydrochloride may cause low blood sugar levels even in patients who are not diabetic.

Do you suffer from unstable angina (non exercise-induced sharp chest pain)?

Do you have thyrotoxicosis? Propranolol Hydrochloride may hide the symptoms of thyrotoxicosis.

Do you 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.

Do you have any other health problems such as circulation disorders, heart problems, breathlessness or swollen ankles?

If so, tell your doctor.

Are you taking any other medicines? If so, tell your doctor. Propranolol Hydrochloride can interfere with the action of some other drugs and some drugs can have an effect on your medicine. The drugs which can cause some problems when taken together with your medicine are: verapamil, diltiazem, nifedipine, nisoldipine, nicardipine, isradipine, lacidipine, (which are used to treat hypertension or angina), disopyramide, lidocaine, quinidine, amiodarone or propafenone (for irregular heartbeats), digoxin (for heart failure), adrenaline (a heart stimulant), ibuprofen and indometacin (for pain and inflammation), ergotamine, dihydroergotamine or rizatriptan (for migraine), chlorpromazine and thioridazine (for certain psychiatric disorders), cimetidine (for stomach problems), rifampicin (for the treatment of tuberculosis), theophylline (for asthma), warfarin (to thin the blood) and hydralazine (for hypertension).

If you frequently drink a lot of alcohol, this may affect how your tablets work.

Are you taking a drug called clonidine (for hypertension or migraine)? If you are taking clonidine and Propranolol Hydrochloride 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.

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

Are you pregnant or are you breast-feeding a baby? If so, tell your doctor.

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

Propranolol Hydrochloride contains a small amount of glycerol. When glycerol is given in high doses it can cause headache, stomach upset and diarrhoea.

Propranolol Hydrochloride also contains lactose monohydrate.

If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Propranolol Hydrochloride.

Taking your medicine

Propranolol Hydrochloride should be swallowed with a drink of water. Your doctor will have decided how many Propranolol Hydrochloride 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 usual total daily dosages for an adult:

Hypertension (high blood pressure)    160mg to 320mg

Angina (chest pains)    120mg to 240mg

Arrythmias (disorders of heart rhythm)*    30mg to 160mg

Protection of the heart after a heart attack 160mg

Prevention of migraine*    80mg to 160mg

Essential tremor    80mg to 160mg

Anxiety    40mg to 120mg

Certain thyroid conditions (such as    30mg to 160mg

thyrotoxicosis)*

Hypertrophic cardiomyopathy (thickened    30mg to 160mg

heart muscle)

Phaeochromocytoma*    30mg to 60mg

Bleeding in the oesophagus caused by high 80mg to 160mg blood pressure in the liver

*Under some circumstances, Propranolol Hydrochloride 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.

Elderly patients may be started on a lower dose.

If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time.

Don't take two doses at the same time. If you are worried, ask your doctor or pharmacist for advice.

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

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

After taking your medicine

As with all medicines, undesirable events can sometimes be experienced with Propranolol Hydrochloride.

Common side effects that may occur (in 1% or more patients but less than 10%; between 1 in 10 and 1 in 100 patients)

Cold fingers and toes

The heart beating more slowly

Numbness and spasm in the fingers which is followed by warmth and pain (Raynaud's phenomenon)

Disturbed sleep/nightmares

Fatigue

Uncommon side effects that may occur (in 0.1% or more patients but less than 1%; between 1 in 100 and 1 in 1000 patients)

Diarrhoea

Nausea

Vomiting

Rare side effects that may occur (in 0.01% or more patients and less than 0.1%; between 1 in 1000 and 1 in 10000 patients)

Worsening of breathing difficulties, if you have or have had asthma

Breathlessness and/or swollen ankles, if you also have heart failure

Heart block which may cause an abnormal heart beat, dizziness, tiredness or fainting

Dizziness, particularly on standing up

Worsening of your blood circulation, if you already suffer from poor circulation

Hair loss

Mood changes

Confusion

Memory loss

Psychosis or hallucinations (disturbances of the mind)

Tingling of the hands Disturbances of vision Dry eyes

Skin rash, including worsening of psoriasis Bruising more easily (thrombocytopaenia)

Purple spots on the skin (purpura)

Very rare side effects that may occur (in less than 0.01% patients; less than 1 in 10000 patients)

Severe muscle weakness (myasthenia gravis)

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 Propranolol Hydrochloride has had any effect on your blood.

Side effects that may occur with an unknown frequency

Low levels of blood sugar 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 a long-term liver disease.

Seizure linked to low levels of sugar in the blood.

Do not be alarmed by this list of possible events. You may not have any of them.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 reporting side effects, you can help provide more information on the safety of this medicine.

Storing your medicine

Keep out of the sight and reach of children.

Store in the original container. Protect from light and moisture.

Do not store above 25°C.

Do not use this medicine after the expiry date (Exp) shown on the carton and blister labels.

If your doctor decides to stop the treatment, return any leftover medicine to the pharmacist. Only keep it if your doctor tells you to.

If your medicine appears to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you further.

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

Further information

This leaflet does not contain the complete information on Propranolol Hydrochloride. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Leaflet revision and issue date: 12.12.14

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