FOSINOPRIL SODIUM 20MG TABLETS
Active substance: FOSINOPRIL SODIUM
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FOSINOPRIL SODIUM 10 mg TABLETS FOSINOPRIL SODIUM 20 mg TABLETS
(fosinopril sodium)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In 1. 2. 3. 4. 5. 6. this leaflet: What Fosinopril is and what it is used for Before you take Fosinopril How to take Fosinopril Possible side effects How to store Fosinopril Further information.
breathing. If you develop these symptoms during treatment you should stop taking Fosinopril have diabetes suffer from a collagen vascular disease eg. scleroderma, SLE (also known as lupus, an allergic condition causing joint pain, skin rashes and fever suffer from heart valve disease, hardened arteries, aortic stenosis or an enlarged heart are black. It is generally the case that this medicine is less effective for you. are (or might become) pregnant. Fosinopri tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
3. HOW TO TAKE FOSINOPRIL Always take Fosinopril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water You can take Fosinopril with or without food To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. At the start of treatment your doctor will monitor your condition closely, take blood tests, check your kidney function and monitor the level of salts in your blood from time to time. This will happen more often if you have a kidney problems or a collagen vascular disease. Adults, elderly and children over 12 years old - To treat high blood pressure: The usual starting dose is 10 mg once a day. Your doctor may increase this after 4 weeks, to a dose which best controls your blood pressure. The usual daily dose needed is between 10 mg and 40 mg taken as a single dose. If you are already taking a diuretic ("water" tablet) your doctor will either monitor you very closely or stop the diuretic treatment for a few days before starting Fosinopril. To treat heart failure: You will also be taking other medicine for your condition, such as a diuretic ("water" tablet). The usual starting dose is 10 mg once a day. Your doctor will slowly increase this, if necessary up to 40 mg once a day. At the start of treatment your doctor will monitor your condition closely. In some cases your doctor may wish to take the precaution of placing you in hospital just for the start of therapy. People with liver or kidney problems - If you have liver or kidney problems, you may be more sensitive to the effects of Fosinopril. Your doctor will give you the lowest dose possible to control your condition. Children - Children 12 years old or younger should not take Fosinopril. If you take more Fosinopril than you should Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include low blood pressure, slower heart beat, dizziness, weakness, fainting and kidney failure. If you forget to take Fosinopril - Take your next dose when it is due. Do not take a double dose to make up for a forgotten dose. If you stop taking Fosinopril - Do not stop taking Fosinopril without speaking to your doctor first. If you stop taking the medicine your symptoms may return. You should check with your doctor or pharmacist if you are not sure. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Fosinopril can cause side effects, although not everybody gets them. If any of the following happen, stop taking Fosinopril and tell your doctor immediately or go to your nearest hospital emergency department: if you begin to itch, get short of breath or wheezy, and develop swelling of the face, hands, feet, mouth, throat or eyes. These are symptoms of a rare allergic reaction yellowing of your skin or whites of your eyes or
an increase of the liver markers in your blood (these may be signs of a liver problem). Other side effects include: dizziness, feeling unusually tired cough, itchy runny nose diarrhoea, stomach pain, feeling or being sick an irregular heart rhythm or missed beats chest pain itchy red skin, rashes muscle or joint pain tingling or numbness in the fingers and toes taste changes dizziness, light-headedness or fainting including when you are standing up inflammation of the pancreas which causes severe pain in the abdomen and back. Laboratory tests may show: a small decrease of the substance (haemoglobin) that carries oxygen in your blood a small increase of your blood urea level an increase of your blood potassium level a decrease of number of white cells in your blood which may cause more infections than usual; this is more likely in patients with kidney problems and a collagen vascular disease an increase in blood urea nitrogen (BUN) an increase of your blood creatinine level protein in your urine. If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE FOSINOPRIL Keep out of the reach and sight of children. Do not use Fosinopril after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. Do not store above 25C. Store in the original package. Keep the container tightly closed. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Fosinopril tablets contain - The active substance is fosinopril sodium. Each tablet contains either 10 mg or 20 mg fosinopril sodium. The other ingredients are pregelatinized maize starch, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, crospovidone, and glyceryl behenate. What Fosinopril tablets looks like and contents of the pack - Your medicine comes as a white to off-white tablet. The 10 mg tablets are rectangular shaped with 'G' scoreline 'G' on one side and 'FS' scoreline '10' on the other side. The 20 mg tablets are capsule shaped with 'G' scoreline 'G' on one side and 'FS' scoreline '20' on the other side. Fosinopril is available in blister packs of 10, 14, 20, 28, 30, 50, 60, 84, 90, 100 & 250 tablets or plastic containers of 30, 60 & 250 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.
1. WHAT FOSINOPRIL IS AND WHAT IT IS USED FOR Fosinopril belongs to the class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors that act on the heart and blood vessels. You may have been given Fosinopril to: lower your blood pressure if it is too high (a condition called hypertension) help your heart pump blood around your body if you have a condition known as heart failure and are also being treated with diuretics (drugs which help to remove excess fluid from the body). 2. BEFORE YOU TAKE FOSINOPRIL Do not take Fosinopril if you: are allergic (hypersensitive) to fosinopril sodium, any other ACE inhibitor or any of the other ingredients of this medicine (see Section 6 for a list of other ingredients). An allergic reaction may include rash, itching, swelling of face, lips, tongue, hands and feet, or breathing difficulties know you have a condition called angioneurotic oedema where your face, lips, hands or feet swell up, or you have breathing difficulties If you are more than 3 months pregnant. (It is also better to avoid Fosinopril in early pregnancy see pregnancy section.) have a condition known as renal artery stenosis (narrowing of the artery supplying blood to the kidney) Fosinopril is not licensed for use in patients who have recently had a heart attack. Take special care with Fosinopril - You should tell your doctor before taking this medicine if you: are dehydrated due to treatment with diuretic medicine, dialysis, dietary restriction of salt, vomiting or diarrhoea. You may be more likely to suffer from a very large drop in blood pressure when you start taking the tablets and may feel faint or light headed have kidney problems or need dialysis treatment have your blood fat (lipid) levels controlled using a method called LDL apheresis have ever suffered from a severe reaction (called angioedema) causing itching, wheezing or swelling of the face and tongue, which in some cases can lead to difficulty swallowing or
Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following: a diuretic eg. Amiloride, Spironolactone or Frusemide potassium supplements or potassium containing salt substitutes antacids (to relieve indigestion). Do not take antacids within 2 hours of your Fosinopril. pain killers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) used to treat pain and inflammation eg. Aspirin, Ibuprofen, Naproxen Lithium (used to treat certain mental illnesses) other medicines to treat high blood pressure eg. Methyldopa, Atenolol, Verapamil or Diltiazem immunosuppressants (used to suppress the immune system) as corticosteroids (used to treat arthritis and allergic reactions), Ciclosporin (used to prevent rejection of organ transplants) Digoxin (a heart medicine) as Fosinopril may interact with the lab test to monitor this medicine. If you are going to have an operation or need an anaesthetic tell your doctor or dentist that you are taking Fosinopril. ACE inhibitors can cause your blood pressure to fall (hypotension) during surgery or anaesthesia. In case you are on dialysis, serious allergic reactions may occur if your machine has components made of high flux polyacrylonitrile membranes and dextrane sulphate. This medicine should not be used in such cases. Pregnancy - You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking [Product] before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Fosinopril tablets . Fosinopril tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breastfeeding - Tell your doctor if you are breast-feeding or about to start breast-feeding. Fosinopril tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines - Do not drive or operate machinery if you feel dizzy, faint or tired while taking this medicine. These side effects may be worse if you drink alcohol at the same time.
34579/01
This leaflet was last approved in: 02/2012
ITEM CODE
(fosinopril sodium)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In 1. 2. 3. 4. 5. 6. this leaflet: What Fosinopril is and what it is used for Before you take Fosinopril How to take Fosinopril Possible side effects How to store Fosinopril Further information.
breathing. If you develop these symptoms during treatment you should stop taking Fosinopril have diabetes suffer from a collagen vascular disease eg. scleroderma, SLE (also known as lupus, an allergic condition causing joint pain, skin rashes and fever suffer from heart valve disease, hardened arteries, aortic stenosis or an enlarged heart are black. It is generally the case that this medicine is less effective for you. are (or might become) pregnant. Fosinopri tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
3. HOW TO TAKE FOSINOPRIL Always take Fosinopril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water You can take Fosinopril with or without food To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. At the start of treatment your doctor will monitor your condition closely, take blood tests, check your kidney function and monitor the level of salts in your blood from time to time. This will happen more often if you have a kidney problems or a collagen vascular disease. Adults, elderly and children over 12 years old - To treat high blood pressure: The usual starting dose is 10 mg once a day. Your doctor may increase this after 4 weeks, to a dose which best controls your blood pressure. The usual daily dose needed is between 10 mg and 40 mg taken as a single dose. If you are already taking a diuretic ("water" tablet) your doctor will either monitor you very closely or stop the diuretic treatment for a few days before starting Fosinopril. To treat heart failure: You will also be taking other medicine for your condition, such as a diuretic ("water" tablet). The usual starting dose is 10 mg once a day. Your doctor will slowly increase this, if necessary up to 40 mg once a day. At the start of treatment your doctor will monitor your condition closely. In some cases your doctor may wish to take the precaution of placing you in hospital just for the start of therapy. People with liver or kidney problems - If you have liver or kidney problems, you may be more sensitive to the effects of Fosinopril. Your doctor will give you the lowest dose possible to control your condition. Children - Children 12 years old or younger should not take Fosinopril. If you take more Fosinopril than you should Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include low blood pressure, slower heart beat, dizziness, weakness, fainting and kidney failure. If you forget to take Fosinopril - Take your next dose when it is due. Do not take a double dose to make up for a forgotten dose. If you stop taking Fosinopril - Do not stop taking Fosinopril without speaking to your doctor first. If you stop taking the medicine your symptoms may return. You should check with your doctor or pharmacist if you are not sure. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Fosinopril can cause side effects, although not everybody gets them. If any of the following happen, stop taking Fosinopril and tell your doctor immediately or go to your nearest hospital emergency department: if you begin to itch, get short of breath or wheezy, and develop swelling of the face, hands, feet, mouth, throat or eyes. These are symptoms of a rare allergic reaction yellowing of your skin or whites of your eyes or
an increase of the liver markers in your blood (these may be signs of a liver problem). Other side effects include: dizziness, feeling unusually tired cough, itchy runny nose diarrhoea, stomach pain, feeling or being sick an irregular heart rhythm or missed beats chest pain itchy red skin, rashes muscle or joint pain tingling or numbness in the fingers and toes taste changes dizziness, light-headedness or fainting including when you are standing up inflammation of the pancreas which causes severe pain in the abdomen and back. Laboratory tests may show: a small decrease of the substance (haemoglobin) that carries oxygen in your blood a small increase of your blood urea level an increase of your blood potassium level a decrease of number of white cells in your blood which may cause more infections than usual; this is more likely in patients with kidney problems and a collagen vascular disease an increase in blood urea nitrogen (BUN) an increase of your blood creatinine level protein in your urine. If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE FOSINOPRIL Keep out of the reach and sight of children. Do not use Fosinopril after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. Do not store above 25C. Store in the original package. Keep the container tightly closed. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Fosinopril tablets contain - The active substance is fosinopril sodium. Each tablet contains either 10 mg or 20 mg fosinopril sodium. The other ingredients are pregelatinized maize starch, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, crospovidone, and glyceryl behenate. What Fosinopril tablets looks like and contents of the pack - Your medicine comes as a white to off-white tablet. The 10 mg tablets are rectangular shaped with 'G' scoreline 'G' on one side and 'FS' scoreline '10' on the other side. The 20 mg tablets are capsule shaped with 'G' scoreline 'G' on one side and 'FS' scoreline '20' on the other side. Fosinopril is available in blister packs of 10, 14, 20, 28, 30, 50, 60, 84, 90, 100 & 250 tablets or plastic containers of 30, 60 & 250 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.
1. WHAT FOSINOPRIL IS AND WHAT IT IS USED FOR Fosinopril belongs to the class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors that act on the heart and blood vessels. You may have been given Fosinopril to: lower your blood pressure if it is too high (a condition called hypertension) help your heart pump blood around your body if you have a condition known as heart failure and are also being treated with diuretics (drugs which help to remove excess fluid from the body). 2. BEFORE YOU TAKE FOSINOPRIL Do not take Fosinopril if you: are allergic (hypersensitive) to fosinopril sodium, any other ACE inhibitor or any of the other ingredients of this medicine (see Section 6 for a list of other ingredients). An allergic reaction may include rash, itching, swelling of face, lips, tongue, hands and feet, or breathing difficulties know you have a condition called angioneurotic oedema where your face, lips, hands or feet swell up, or you have breathing difficulties If you are more than 3 months pregnant. (It is also better to avoid Fosinopril in early pregnancy see pregnancy section.) have a condition known as renal artery stenosis (narrowing of the artery supplying blood to the kidney) Fosinopril is not licensed for use in patients who have recently had a heart attack. Take special care with Fosinopril - You should tell your doctor before taking this medicine if you: are dehydrated due to treatment with diuretic medicine, dialysis, dietary restriction of salt, vomiting or diarrhoea. You may be more likely to suffer from a very large drop in blood pressure when you start taking the tablets and may feel faint or light headed have kidney problems or need dialysis treatment have your blood fat (lipid) levels controlled using a method called LDL apheresis have ever suffered from a severe reaction (called angioedema) causing itching, wheezing or swelling of the face and tongue, which in some cases can lead to difficulty swallowing or
Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following: a diuretic eg. Amiloride, Spironolactone or Frusemide potassium supplements or potassium containing salt substitutes antacids (to relieve indigestion). Do not take antacids within 2 hours of your Fosinopril. pain killers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) used to treat pain and inflammation eg. Aspirin, Ibuprofen, Naproxen Lithium (used to treat certain mental illnesses) other medicines to treat high blood pressure eg. Methyldopa, Atenolol, Verapamil or Diltiazem immunosuppressants (used to suppress the immune system) as corticosteroids (used to treat arthritis and allergic reactions), Ciclosporin (used to prevent rejection of organ transplants) Digoxin (a heart medicine) as Fosinopril may interact with the lab test to monitor this medicine. If you are going to have an operation or need an anaesthetic tell your doctor or dentist that you are taking Fosinopril. ACE inhibitors can cause your blood pressure to fall (hypotension) during surgery or anaesthesia. In case you are on dialysis, serious allergic reactions may occur if your machine has components made of high flux polyacrylonitrile membranes and dextrane sulphate. This medicine should not be used in such cases. Pregnancy - You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking [Product] before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Fosinopril tablets . Fosinopril tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breastfeeding - Tell your doctor if you are breast-feeding or about to start breast-feeding. Fosinopril tablets are not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines - Do not drive or operate machinery if you feel dizzy, faint or tired while taking this medicine. These side effects may be worse if you drink alcohol at the same time.
34579/01
This leaflet was last approved in: 02/2012
ITEM CODE
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.
