EUCARDIC 12.5MG TABLETS
Active substance: CARVEDILOL
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Patient Information Leaflet Eucardic 12.5 mg Tablets Carvedilol
UK/Malta Roche
Please 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 become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Eucardic is and what it is used for 2. Before you take Eucardic 3. How to take Eucardic 4. Possible side effects 5. How to store Eucardic 6. Further information
1.
What Eucardic is and what it is used for
Eucardic contains a medicine called carvedilol. This belongs to a group of medicines called beta-blockers. Eucardic is used to treat the following: Chronic heart failure. High blood pressure (hypertension). Angina (chest pain or discomfort that happens when your heart isnt getting enough oxygen). Eucardic works by making your blood vessels relax and widen. This helps to lower your blood pressure. If you have chronic heart failure, this makes it easier for your heart to pump blood around your body. If you have angina, this will help stop the chest pain. Your doctor may give you other medicines as well as Eucardic to help treat your condition.
2.
Before you take Eucardic
Do not take Eucardic if: You are allergic (hypersensitive) to carvedilol or any of the other ingredients of Eucardic (listed in Section 6: Further information). You have ever had wheezing due to asthma or other lung diseases. You have severe fluid retention (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously). You have problems with your liver. You have problems with your heart (for example heart block or slow heart beat). Eucardic is not suitable for some people with certain types of heart problem. You have very low blood pressure. You have a problem with the acid levels in your blood (metabolic acidosis). You have a growth on one of your adrenal glands (phaeochromocytoma). If you are not sure, talk to your doctor or pharmacist before taking Eucardic.
1 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
Take special care with Eucardic Check with your doctor or pharmacist before taking Eucardic if: You have problems with your kidneys. You have diabetes (high blood sugar). You wear contact lenses. You have problems with your blood vessels (peripheral vascular disease). You have ever had problems with your thyroid. You have ever had a serious allergic reaction (for example, sudden swelling, causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash). You have an allergy and are having treatment to desensitise you. You have problems with the blood circulation in your fingers and toes (Raynauds phenomenon). You have had a skin disorder called psoriasis, after taking beta-blocker medicines. You have a type of angina called Prinzmetals variant angina. If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Eucardic. 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 Eucardic can affect the way some medicines work. Also some other medicines can affect the way Eucardic works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Other medicines for your heart or blood pressure, including water tablets (diuretics), calcium channel blockers (for example diltiazem or verapamil), digoxin and amiodarone. Catecholamine-depleting agents (for example reserpine and Monoamine oxidase inhibitors (MAOIs, such as isocarboxide and phenelzine (used to treat depression)). Fluoxetine (used to treat depression). Medicines for diabetes, such as insulin or metformin. Clonidine (used to treat high blood pressure, migraine and flushing in the menopause). Rifampicin (used to treat infections). Ciclosporin (used after an organ transplant). Non-steroidal anti-inflammatory drugs (NSAIDs, for example aspirin, indomethacin and ibuprofen). Beta-agonist bronchodilators (used to treat chest tightness and wheezing due to asthma or other chest conditions (for example salbutamol and terbutaline sulphate)). Operations If you are going to have an operation, tell the doctor that you are taking Eucardic. This is because some anaesthetics can lower your blood pressure, and it may become too low. Pregnancy and breast-feeding Do not take Eucardic if you are pregnant, trying to get pregnant or breast-feeding, unless your doctor has told you to. Driving and using machines You may feel dizzy while taking Eucardic. This is more likely when you start treatment or if your treatment is changed, and when you drink alcohol. If this happens to you, do not drive or use any tools or machines. Talk to your doctor if you notice any other problems that might affect driving, using tools or machines while you are taking Eucardic. Important information about some of the ingredients of Eucardic This medicine contains lactose and sucrose, which are types of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
2 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
3.
How to take Eucardic
Always take Eucardic exactly as your doctor has told you. You should check with your doctor if you are not sure. Eucardic is not suitable for children under the age of 18 years. Swallow each tablet with a drink. Chronic heart failure: When used for heart failure, treatment with Eucardic should be started by a specialist doctor. You should take your tablets at the same time as eating some food. The usual starting dose is one 3.125 mg tablet twice a day for two weeks. Your doctor will then increase the dose slowly, over several weeks, up to 25 mg twice a day. If you weigh more than 85 kg (187 lb) the dose may be increased up to 50 mg twice a day. If you have stopped taking Eucardic for more than two weeks you should talk to your doctor. They will need you to go back to the starting dose again (see section If you stop taking Eucardic). High blood pressure: The usual starting dose is 12.5 mg once a day for two days. After two days the dose is usually 25 mg, once a day. If your blood pressure is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg a day. If you are elderly, you may not need any more than 12.5 mg a day to control your blood pressure. Angina: Adults The usual starting dose is 12.5 mg twice a day for two days. After two days the dose is usually 25 mg, twice a day. Elderly Your doctor will decide both your starting dose and the best dose for you to take in the longer term. The usual maximum dose is 50 mg each day, taken in smaller amounts (divided doses). If you take more Eucardic than you should If you take more Eucardic than you should or someone else takes your Eucardic, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen if you have taken more tablets than you should: a slow heart beat, feeling dizzy or light headed, becoming breathless, wheezy or extremely tired. If you forget to take Eucardic If you forget to take a dose, 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 to make up for a forgotten dose. If you stop taking Eucardic Do not stop taking this medicine without talking to your doctor. They may want you to stop taking Eucardic slowly over 1 to 2 weeks. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
3 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
4.
Possible side effects
Like all medicines Eucardic can cause side effects, although not everyone will get them. Very common (affect more than 1 in 10 people): Feeling dizzy. Headache. Feeling weak and tired. Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs. Low blood pressure. The signs include feeling dizzy or light-headed. Feeling dizzy, having a headache and feeling weak and tired are usually mild and more likely to happen at the beginning of your treatment. Common (affect less than 1 in 10 people): Infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat. Infections of the urinary tract which can cause problems in passing water. Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and being short of breath. Increase in weight. Increase in cholesterol levels (shown by a blood test). Loss of control of blood sugar in people with diabetes. Feeling depressed. Problems with your sight, sore or dry eyes due to fewer tears being made. A slow heart beat. Feeling dizzy or light-headed after standing up. Fluid retention. The signs include: overall swelling of your body, swelling of parts of your body for example your hands, feet, ankles and legs and an increase in how much blood you have in your body. Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers and a pain in your leg which gets worse when you walk. Breathing problems. Feeling sick or being sick. Diarrhoea. Stomach upset / indigestion. Pain, possibly in your hands and feet. Problems with your kidneys, including changes to how often you pass urine. Uncommon (affect less than 1 in 100 people) Disturbed sleep. Fainting. Tingling or numbness of your hands or feet. Problems with your skin, including skin rashes which may cover a lot of your body, a lumpy rash (hives), feeling itchy and dry skin patches. Increased sweating. Hair loss. Being unable to get an erection (erectile dysfunction). Constipation. Rare (affect less than 1 in 1,000 people): Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds. A stuffy nose, wheezing and flu-like symptoms. A dry mouth.
4 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
Very rare (affect less than 1 in 10,000 people): Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs. Allergic (hypersensitivity) reactions. The signs may include difficulty breathing or swallowing caused by sudden swelling of the throat, or face or swelling of your hands, feet and ankles. Kidney problems which show up in a blood test. Some women may have difficulty with bladder control when they pass water (urinary incontinence). This normally will get better when treatment is stopped. Eucardic can also cause development of the signs of diabetes in people who have a very mild form of diabetes called latent diabetes. If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
How to store Eucardic
Eucardic tablets should be kept in their original packaging to protect them from moisture and light. Eucardic tablets do not require any special temperature storage conditions. Keep out of the reach and sight of children. Do not use Eucardic after the expiry date printed on the pack. Do not throw away any left over tablets. Instead, return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.
6.
Further information
What Eucardic contains The active substance in Eucardic 12.5 mg Tablets is carvedilol. Each tablet contains 12.5 mg (milligrams) of carvedilol. Other ingredients are: lactose, sucrose, povidone (E1201), crospovidone (E1202), colloidal silicon dioxide (E551), magnesium stearate (E572), red iron oxide (E172) and yellow iron oxide (E172). What Eucardic looks like and contents of the pack Eucardic 12.5 mg Tablets are round and light brown in colour and have a score line on both sides. The tablets are, marked BM on one side and H3 on the other. Eucardic 12.5 mg Tablets are supplied in blister packs containing either 14, 28, 30 56 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW, United Kingdom This leaflet was last approved in June 2011
5 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
UK/Malta Roche
Please 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 become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Eucardic is and what it is used for 2. Before you take Eucardic 3. How to take Eucardic 4. Possible side effects 5. How to store Eucardic 6. Further information
1.
What Eucardic is and what it is used for
Eucardic contains a medicine called carvedilol. This belongs to a group of medicines called beta-blockers. Eucardic is used to treat the following: Chronic heart failure. High blood pressure (hypertension). Angina (chest pain or discomfort that happens when your heart isnt getting enough oxygen). Eucardic works by making your blood vessels relax and widen. This helps to lower your blood pressure. If you have chronic heart failure, this makes it easier for your heart to pump blood around your body. If you have angina, this will help stop the chest pain. Your doctor may give you other medicines as well as Eucardic to help treat your condition.
2.
Before you take Eucardic
Do not take Eucardic if: You are allergic (hypersensitive) to carvedilol or any of the other ingredients of Eucardic (listed in Section 6: Further information). You have ever had wheezing due to asthma or other lung diseases. You have severe fluid retention (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously). You have problems with your liver. You have problems with your heart (for example heart block or slow heart beat). Eucardic is not suitable for some people with certain types of heart problem. You have very low blood pressure. You have a problem with the acid levels in your blood (metabolic acidosis). You have a growth on one of your adrenal glands (phaeochromocytoma). If you are not sure, talk to your doctor or pharmacist before taking Eucardic.
1 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
Take special care with Eucardic Check with your doctor or pharmacist before taking Eucardic if: You have problems with your kidneys. You have diabetes (high blood sugar). You wear contact lenses. You have problems with your blood vessels (peripheral vascular disease). You have ever had problems with your thyroid. You have ever had a serious allergic reaction (for example, sudden swelling, causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash). You have an allergy and are having treatment to desensitise you. You have problems with the blood circulation in your fingers and toes (Raynauds phenomenon). You have had a skin disorder called psoriasis, after taking beta-blocker medicines. You have a type of angina called Prinzmetals variant angina. If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Eucardic. 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 Eucardic can affect the way some medicines work. Also some other medicines can affect the way Eucardic works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Other medicines for your heart or blood pressure, including water tablets (diuretics), calcium channel blockers (for example diltiazem or verapamil), digoxin and amiodarone. Catecholamine-depleting agents (for example reserpine and Monoamine oxidase inhibitors (MAOIs, such as isocarboxide and phenelzine (used to treat depression)). Fluoxetine (used to treat depression). Medicines for diabetes, such as insulin or metformin. Clonidine (used to treat high blood pressure, migraine and flushing in the menopause). Rifampicin (used to treat infections). Ciclosporin (used after an organ transplant). Non-steroidal anti-inflammatory drugs (NSAIDs, for example aspirin, indomethacin and ibuprofen). Beta-agonist bronchodilators (used to treat chest tightness and wheezing due to asthma or other chest conditions (for example salbutamol and terbutaline sulphate)). Operations If you are going to have an operation, tell the doctor that you are taking Eucardic. This is because some anaesthetics can lower your blood pressure, and it may become too low. Pregnancy and breast-feeding Do not take Eucardic if you are pregnant, trying to get pregnant or breast-feeding, unless your doctor has told you to. Driving and using machines You may feel dizzy while taking Eucardic. This is more likely when you start treatment or if your treatment is changed, and when you drink alcohol. If this happens to you, do not drive or use any tools or machines. Talk to your doctor if you notice any other problems that might affect driving, using tools or machines while you are taking Eucardic. Important information about some of the ingredients of Eucardic This medicine contains lactose and sucrose, which are types of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
2 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
3.
How to take Eucardic
Always take Eucardic exactly as your doctor has told you. You should check with your doctor if you are not sure. Eucardic is not suitable for children under the age of 18 years. Swallow each tablet with a drink. Chronic heart failure: When used for heart failure, treatment with Eucardic should be started by a specialist doctor. You should take your tablets at the same time as eating some food. The usual starting dose is one 3.125 mg tablet twice a day for two weeks. Your doctor will then increase the dose slowly, over several weeks, up to 25 mg twice a day. If you weigh more than 85 kg (187 lb) the dose may be increased up to 50 mg twice a day. If you have stopped taking Eucardic for more than two weeks you should talk to your doctor. They will need you to go back to the starting dose again (see section If you stop taking Eucardic). High blood pressure: The usual starting dose is 12.5 mg once a day for two days. After two days the dose is usually 25 mg, once a day. If your blood pressure is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg a day. If you are elderly, you may not need any more than 12.5 mg a day to control your blood pressure. Angina: Adults The usual starting dose is 12.5 mg twice a day for two days. After two days the dose is usually 25 mg, twice a day. Elderly Your doctor will decide both your starting dose and the best dose for you to take in the longer term. The usual maximum dose is 50 mg each day, taken in smaller amounts (divided doses). If you take more Eucardic than you should If you take more Eucardic than you should or someone else takes your Eucardic, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen if you have taken more tablets than you should: a slow heart beat, feeling dizzy or light headed, becoming breathless, wheezy or extremely tired. If you forget to take Eucardic If you forget to take a dose, 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 to make up for a forgotten dose. If you stop taking Eucardic Do not stop taking this medicine without talking to your doctor. They may want you to stop taking Eucardic slowly over 1 to 2 weeks. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
3 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
4.
Possible side effects
Like all medicines Eucardic can cause side effects, although not everyone will get them. Very common (affect more than 1 in 10 people): Feeling dizzy. Headache. Feeling weak and tired. Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs. Low blood pressure. The signs include feeling dizzy or light-headed. Feeling dizzy, having a headache and feeling weak and tired are usually mild and more likely to happen at the beginning of your treatment. Common (affect less than 1 in 10 people): Infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat. Infections of the urinary tract which can cause problems in passing water. Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and being short of breath. Increase in weight. Increase in cholesterol levels (shown by a blood test). Loss of control of blood sugar in people with diabetes. Feeling depressed. Problems with your sight, sore or dry eyes due to fewer tears being made. A slow heart beat. Feeling dizzy or light-headed after standing up. Fluid retention. The signs include: overall swelling of your body, swelling of parts of your body for example your hands, feet, ankles and legs and an increase in how much blood you have in your body. Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers and a pain in your leg which gets worse when you walk. Breathing problems. Feeling sick or being sick. Diarrhoea. Stomach upset / indigestion. Pain, possibly in your hands and feet. Problems with your kidneys, including changes to how often you pass urine. Uncommon (affect less than 1 in 100 people) Disturbed sleep. Fainting. Tingling or numbness of your hands or feet. Problems with your skin, including skin rashes which may cover a lot of your body, a lumpy rash (hives), feeling itchy and dry skin patches. Increased sweating. Hair loss. Being unable to get an erection (erectile dysfunction). Constipation. Rare (affect less than 1 in 1,000 people): Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds. A stuffy nose, wheezing and flu-like symptoms. A dry mouth.
4 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
Very rare (affect less than 1 in 10,000 people): Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs. Allergic (hypersensitivity) reactions. The signs may include difficulty breathing or swallowing caused by sudden swelling of the throat, or face or swelling of your hands, feet and ankles. Kidney problems which show up in a blood test. Some women may have difficulty with bladder control when they pass water (urinary incontinence). This normally will get better when treatment is stopped. Eucardic can also cause development of the signs of diabetes in people who have a very mild form of diabetes called latent diabetes. If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.
How to store Eucardic
Eucardic tablets should be kept in their original packaging to protect them from moisture and light. Eucardic tablets do not require any special temperature storage conditions. Keep out of the reach and sight of children. Do not use Eucardic after the expiry date printed on the pack. Do not throw away any left over tablets. Instead, return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.
6.
Further information
What Eucardic contains The active substance in Eucardic 12.5 mg Tablets is carvedilol. Each tablet contains 12.5 mg (milligrams) of carvedilol. Other ingredients are: lactose, sucrose, povidone (E1201), crospovidone (E1202), colloidal silicon dioxide (E551), magnesium stearate (E572), red iron oxide (E172) and yellow iron oxide (E172). What Eucardic looks like and contents of the pack Eucardic 12.5 mg Tablets are round and light brown in colour and have a score line on both sides. The tablets are, marked BM on one side and H3 on the other. Eucardic 12.5 mg Tablets are supplied in blister packs containing either 14, 28, 30 56 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW, United Kingdom This leaflet was last approved in June 2011
5 Eucardic-UKMT-PIL-v-1101-12.5-tab.doc
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.
