INDERAL 10MG TABLETS

Active substance: PROPRANOLOL HYDROCHLORIDE

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Patient Information Leaflet Inderal propranolol hydrochloride
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 name of your medicine is Inderal. The active ingredient is propranolol. Inderal is produced as tablets in three different strengths. The tablets contain 10 mg, 40 mg or 80 mg of propranolol hydrochloride. Your medicine also contains the following inactive ingredients: calcium carboxymethylcellulose USNF, carmine BPC (E120), gelatin Ph Eur. (E441), glycerol Ph Eur. (E422), lactose Ph Eur., magnesium carbonate Ph Eur. (E504), magnesium stearate Ph Eur., methylhydroxypropylcellulose Ph Eur. (E464) and titanium dioxide Ph Eur. (E171). Inderal 10 mg and Inderal 40 mg tablets are produced in packs of 100 tablets. Inderal 80 mg tablets are produced in packs of 60 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. The Marketing Authorisations for Inderal Tablets are held by AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. Inderal is manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK. Inderal can be used for many conditions including hypertension (high blood pressure), angina (chest pain), some arrythmias (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.

Before taking your medicine
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 Prinzmetals 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). 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 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 tablets contain a small amount of glycerol. When glycerol is given in high doses it can cause headache, stomach upset and diarrhoea.

Taking your medicine
Inderal tablets 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 doctors 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) Angina (chest pains) Arrythmias (disorders of heart rhythm)* Protection of the heart after a heart attack Prevention of migraine* Essential tremor Anxiety Certain thyroid conditions (such as thyrotoxicosis)* Hypertrophic cardiomyopathy (thickened heart muscle) Phaeochromocytoma* 160 mg to 320 mg 120 mg to 240 mg 30 mg to 160 mg 160 mg 80 mg to 160 mg 80 mg to 160 mg 40 mg to 120 mg 30 mg to 160 mg 30 mg to 160 mg 30 mg to 60 mg

Bleeding in the oesophagus caused by high blood pressure in the liver 80 mg to 160 mg *Under some circumstances, Inderal can be used to treat children with these conditions. The dosage will be adjusted by the doctor according to the childs 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. Dont 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 (Raynauds 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. If you get any other undesirable events or if you think your medicine is causing any problems, tell your doctor or pharmacist.

Storing your medicine
Check the expiry date on the carton and dont use the medicine after that date. Keep your medicine in a safe place where children cannot see it or reach it. Your medicine could harm them. Keep your medicine below 30oC and away from strong light and dampness. If your doctor decides to stop treatment, return any leftover tablets to your pharmacist. Only keep them if the doctor tells you to.

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. The information applies only to Inderal. Leaflet updated: September 2011 AstraZeneca 2011 Inderal is a trade mark of the AstraZeneca group of companies.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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