INDERAL LA 160MG
Active substance: PROPRANOLOL HYDROCHLORIDE
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5.How to store Inderal
Keep your medicine in a safe place where children cannot see or reach it. Your medicine could harm them. Do not store above 25C. Protect your medicine from light and moisture. Store your capsules in the original package. Keep the calendar pack in the carton. Do not use your capsules after the expiry date which is stated on the carton. 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 that are no longer required. These measures will help to protect the environment.
Inderal LA 160 mg capsules and Half-Inderal LA 80 mg capsules are manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
Inderal LA 160 mg Capsules and Half-Inderal LA 80 mg Capsules
propranolol hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
P029633
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Reference number Inderal LA 17901/0019 160 mg Half-Inderal LA 17901/0020 80 mg This is a service provided by the Royal National Institute of Blind People.
6.Further information
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 longacting 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 HalfInderal 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-Inderal LA 80 mg capsules are held by AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. 4
P029633-1Leaflet.indd1
Leaflet prepared: November 2010. AstraZeneca 2010. Inderal LA is a trade mark of the AstraZeneca group of companies. CV 10 0116
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 In this leaflet: other ingredients in Inderal (see section 1. What Inderal is and what it is used for 6: Further information). 2. Before you take Inderal You have ever had any of the following heart problems: 3. How to take Inderal - heart failure which is not under 4. Possible side effects control (this usually makes you 5. How to store Inderal breathless and causes your ankles 6. Further information to swell) - second- or third-degree heart block 1.What Inderal is and what it is (a condition which may be treated by used for a pacemaker) The name of your medicine is Inderal LA - very slow or very uneven heart beats, 160 mg or Half-Inderal LA 80 mg (called very low blood pressure or very poor Inderal in the rest of this leaflet). Inderal circulation contains a medicine called propranolol - a type of chest pain (angina) called hydrochloride. This belongs to a group of Prinzmetals angina. medicines called beta-blockers. You have a tumour called Inderal is used for many conditions including: phaeochromocytoma that is not being High blood pressure (hypertension). treated. This is usually near your kidney Chest pain (angina). and can cause high blood pressure. Preventing migraines. You have been told that you have higher than normal levels of acid in your blood Essential tremor (shaking with an (metabolic acidosis). unknown cause). You have been fasting recently. Anxiety. Do not take Inderal if any of the above Some thyroid problems (such as apply to you. If you are not sure, talk to your thyrotoxicosis which is caused by an doctor or pharmacist before taking Inderal. overactive thyroid gland). 1
17/11/1013:11:00
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.
Bleeding in the food pipe (oesophagus) caused by high blood pressure in the liver. It works by the effects it has on the heart and circulation and also on other parts of the body.
2.Before you take 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). 2
P029633-1Leaflet.indd2
Ibuprofen or indometacin (for pain and inflammation). Ergotamine, dihydroergotamine or rizatriptan (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.
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. Elderly people Dry eyes. If you are an elderly person, your doctor Skin rash. may decide to start you on a lower dose. Reduced numbers of platelets in your blood Children which may make you bruise more easily. Your medicine must not be given to children. Purplish marks on your skin. If you take more Inderal than you should Very rare (affects less than 1 in 10,000 If you take more Inderal than prescribed people) by your doctor, talk to a doctor or go to a Severe muscle weakness (myasthenia hospital straight away. Take the medicine gravis). pack with you so that the capsules can be Changes to some of the cells or other identified. parts of your blood. Your doctor may take If you forget to take Inderal blood samples every so often to check If you forget to take a dose, take it as soon whether Inderal has had any effect on as you remember. However, if it is almost your blood. time for the next dose, skip the missed Low levels of sugar in the blood dose. Do not take a double dose to make (hypoglycaemia). This can happen in up for a forgotten dose. people with or without diabetes. This If you stop taking Inderal includes elderly people, people on Do not stop taking Inderal without talking to artificial kidneys (haemodialysis) or your doctor. In some cases, you may need people taking medicines for diabetes. to stop taking it gradually. It may also happen if you are fasting or in people with a long-term liver disease.
4.Possible side effects
3.How to take Inderal
Always take Inderal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many capsules to take each day and when to take them. Read the label on the carton to remind you what the doctor said. Swallow your Inderal capsules with a drink of water. Swallow whole. Do not chew.
Like all medicines, Inderal can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: 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 (Raynauds disease). Disturbed sleep or nightmares. Feeling tired. 3
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.
17/11/1013:11:00
Keep your medicine in a safe place where children cannot see or reach it. Your medicine could harm them. Do not store above 25C. Protect your medicine from light and moisture. Store your capsules in the original package. Keep the calendar pack in the carton. Do not use your capsules after the expiry date which is stated on the carton. 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 that are no longer required. These measures will help to protect the environment.
Inderal LA 160 mg capsules and Half-Inderal LA 80 mg capsules are manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
Inderal LA 160 mg Capsules and Half-Inderal LA 80 mg Capsules
propranolol hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
P029633
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Reference number Inderal LA 17901/0019 160 mg Half-Inderal LA 17901/0020 80 mg This is a service provided by the Royal National Institute of Blind People.
6.Further information
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 longacting 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 HalfInderal 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-Inderal LA 80 mg capsules are held by AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. 4
P029633-1Leaflet.indd1
Leaflet prepared: November 2010. AstraZeneca 2010. Inderal LA is a trade mark of the AstraZeneca group of companies. CV 10 0116
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 In this leaflet: other ingredients in Inderal (see section 1. What Inderal is and what it is used for 6: Further information). 2. Before you take Inderal You have ever had any of the following heart problems: 3. How to take Inderal - heart failure which is not under 4. Possible side effects control (this usually makes you 5. How to store Inderal breathless and causes your ankles 6. Further information to swell) - second- or third-degree heart block 1.What Inderal is and what it is (a condition which may be treated by used for a pacemaker) The name of your medicine is Inderal LA - very slow or very uneven heart beats, 160 mg or Half-Inderal LA 80 mg (called very low blood pressure or very poor Inderal in the rest of this leaflet). Inderal circulation contains a medicine called propranolol - a type of chest pain (angina) called hydrochloride. This belongs to a group of Prinzmetals angina. medicines called beta-blockers. You have a tumour called Inderal is used for many conditions including: phaeochromocytoma that is not being High blood pressure (hypertension). treated. This is usually near your kidney Chest pain (angina). and can cause high blood pressure. Preventing migraines. You have been told that you have higher than normal levels of acid in your blood Essential tremor (shaking with an (metabolic acidosis). unknown cause). You have been fasting recently. Anxiety. Do not take Inderal if any of the above Some thyroid problems (such as apply to you. If you are not sure, talk to your thyrotoxicosis which is caused by an doctor or pharmacist before taking Inderal. overactive thyroid gland). 1
17/11/1013:11:00
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.
Bleeding in the food pipe (oesophagus) caused by high blood pressure in the liver. It works by the effects it has on the heart and circulation and also on other parts of the body.
2.Before you take 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). 2
P029633-1Leaflet.indd2
Ibuprofen or indometacin (for pain and inflammation). Ergotamine, dihydroergotamine or rizatriptan (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.
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. Elderly people Dry eyes. If you are an elderly person, your doctor Skin rash. may decide to start you on a lower dose. Reduced numbers of platelets in your blood Children which may make you bruise more easily. Your medicine must not be given to children. Purplish marks on your skin. If you take more Inderal than you should Very rare (affects less than 1 in 10,000 If you take more Inderal than prescribed people) by your doctor, talk to a doctor or go to a Severe muscle weakness (myasthenia hospital straight away. Take the medicine gravis). pack with you so that the capsules can be Changes to some of the cells or other identified. parts of your blood. Your doctor may take If you forget to take Inderal blood samples every so often to check If you forget to take a dose, take it as soon whether Inderal has had any effect on as you remember. However, if it is almost your blood. time for the next dose, skip the missed Low levels of sugar in the blood dose. Do not take a double dose to make (hypoglycaemia). This can happen in up for a forgotten dose. people with or without diabetes. This If you stop taking Inderal includes elderly people, people on Do not stop taking Inderal without talking to artificial kidneys (haemodialysis) or your doctor. In some cases, you may need people taking medicines for diabetes. to stop taking it gradually. It may also happen if you are fasting or in people with a long-term liver disease.
4.Possible side effects
3.How to take Inderal
Always take Inderal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many capsules to take each day and when to take them. Read the label on the carton to remind you what the doctor said. Swallow your Inderal capsules with a drink of water. Swallow whole. Do not chew.
Like all medicines, Inderal can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: 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 (Raynauds disease). Disturbed sleep or nightmares. Feeling tired. 3
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.
17/11/1013:11:00
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.
