METFORMIN HYDROCHLORIDE 500MG FILM-COATED TABLETS
Active substance: METFORMIN HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin hydrochloride 500 mg film-coated tablets Metformin hydrochloride 850 mg film-coated tablets Metformin hydrochloride 1000 mg film-coated tablets (metformin hydrochloride) 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 side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Metformin hydrochloride is and what it is used for. 2. Before you take Metformin hydrochloride. 3. How to take Metformin hydrochloride. 4. Possible side effects. 5. How to store Metformin hydrochloride. 6. Further information. 1. WHAT METFORMIN HYDROCHLORIDE IS AND WHAT IT IS USED FOR
What Metformin hydrochloride is Metformin hydrochloride contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use. If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metformin hydrochloride helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metformin hydrochloride over a long period of time also helps to lower the risk of complications associated with diabetes. What Metformin hydrochloride is used for Metformin hydrochloride is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients. Adults can take Metformin hydrochloride on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin). Children 10 years and over and adolescents can take Metformin hydrochloride on its own or together with insulin. 2. BEFORE YOU TAKE METFORMIN HYDROCHLORIDE
Do not take Metformin hydrochloride if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see 'What Metformin hydrochloride contains' in section 6)
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if you have kidney or liver problems if you have uncontrolled diabetes, such as severe hyperglycaemia or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood. Symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath if you lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride below). if you have recently suffered an injury or trauma (shock). if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride below). if you are treated for heart failure or have recently had a heart attack, have severe problems with your circulation or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride' below) if you drink a lot of alcohol
If any of the above applies to you, talk to your doctor before you start taking this medicine. Take special care with Metformin hydrochloride Metformin hydrochloride may cause a very rare, but serious complication called lactic acidosis, particularly if your kidneys are not working properly. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate treatment. Stop taking Metformin hydrochloride immediately and tell your doctor straight away. The risk of lactic acidosis is increased if you: have poorly controlled diabetes have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness) undergo a prolonged period of fasting drink a lot of alcohol have liver problems have low levels of oxygen in the blood. You need to eat carbohydrates regularly throughout the day. If your doctor has given you advice on your diet, you need to continue to follow this. Metformin hydrochloride on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin hydrochloride together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart beating, visions disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar. Make sure you ask your doctor for advice, if you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream you need to have major surgery You must stop taking Metformin hydrochloride for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctors instructions precisely.
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Taking other medicines If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin hydrochloride for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice' above). Tell your doctor if you take any of the following medicines and Metformin hydrochloride at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin hydrochloride: diuretics (used to remove water from the body by making more urine) beta-2 agonists such as salbutamol or terbutaline (used to treat asthma) corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Metformin hydrochloride with food and drink Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis especially if you have liver problems or if you are undernourished. This also applies to medicines that contain alcohol. Pregnancy and breast-feeding During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment. It is recommended not to take this medicine if you are breast-feeding or if you are planning to breastfeed your baby. Ask you doctor or pharmacist for advice before taking any medicine. Driving and using machines Metformin hydrochloride on its own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines. However, take special care if you take Metformin hydrochloride together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms. 3. HOW TO TAKE METFORMIN HYDROCHLORIDE
Always take Metformin hydrochloride exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Metformin hydrochloride cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise. The usual dose is: Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin hydrochloride once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited. Adults usually start with 500 mg or 850 mg Metformin hydrochloride two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses. If you take insulin too, your doctor will tell you how to start Metformin hydrochloride.
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Monitoring your doctor will adapt your dose of Metformin hydrochloride to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person. your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally. How to take Metformin hydrochloride Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion. Do not crush or chew the tablets. Swallow each tablet with a glass of water. if you take one dose a day, take it in the morning (breakfast) if you take two divided doses a day, take them in the morning (breakfast) and evening (dinner) if you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner). If, after some time, you think that the effect of Metformin hydrochloride is too strong or too weak, talk to your doctor or pharmacist. If you take more Metformin hydrochloride than you should If you have taken more Metformin hydrochloride that you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Talk to your doctor or pharmacist straight away. If you forget to take Metformin hydrochloride Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin hydrochloride can cause side effects, although not everybody gets them. The following side effects may occur: Very common side effects (in more than 1 in 10 people) digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of the treatment with Metformin hydrochloride. It helps if you spread the doses over the day and if you take the tablets with or straight after a meal. If symptoms continue, stop taking Metformin hydrochloride and talk to your doctor. Common side effects (in less than 1 in 10 people) changes in taste. Very rare side effects (in less than 1 in 10,000 people) lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. If you get this complication, you will need immediate treatment. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, stop taking Metformin hydrochloride immediately and tell your doctor straight away. skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria). low vitamin B12 levels in the blood.
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abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine.
Children and adolescents Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults. 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. 5. HOW TO STORE METFORMIN HYDROCHLORIDE
Keep out of the reach and sight of children This medicinal product does not require any special storage conditions. Do not use Metformin hydrochloride after the expiry date which is stated on the carton, blister and bottle after EXP. The expiry date refers to the last day of the month. 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 Metformin hydrochloride contains The active substance is metformin (as the hydrochloride). Each 500 mg tablet contains 500 mg metformin hydrochloride equivalent to metformin base 390 mg. Each 850 mg tablet contains 850 mg metformin hydrochloride equivalent to metformin base 662.9 mg. Each 1000 mg tablet contains 1000 mg metformin hydrochloride equivalent to metformin base 780 mg. The other ingredients are: Core: povidone K-30, magnesium stearate, Film-coat: hypromellose, hydroxypropyl cellulose and macrogol 400 and 8000. What Metformin hydrochloride looks like and contents of the pack 500 mg: White, round, normal convex, film-coated tablets plain on both sides. 850 mg: White, round normal convex film coated tablet plain on both sides. 1000 mg: White, oval, film coated tablet, embossed MF and 3 on either side of the scoreline on one side and G on the other side. The tablet can be divided into equal halves. Metformin hydrochloride tablets are packed in blister packs (PVC aluminium) containing 10, 15, 20, 28, 30, 40, 50, 56, 60, 84, 90, 100 and 120 tablets and bottles (high density polyethylene) with caps (polypropylene) containing 180, 200, 300, 400 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer: Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
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McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Mylan BV, Dieselweg 25, 3752 LB Bunschoten, the Netherlands Mylan SAS (Saint Priest), 117 Allee des Parcs, 69 800 Saint Priest, France Orifice Medical AB, Aktergatan 2 and 4, S-271 53 Ystad, Sweden This leaflet was last approved in 08/2011.
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What Metformin hydrochloride is Metformin hydrochloride contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use. If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metformin hydrochloride helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metformin hydrochloride over a long period of time also helps to lower the risk of complications associated with diabetes. What Metformin hydrochloride is used for Metformin hydrochloride is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients. Adults can take Metformin hydrochloride on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin). Children 10 years and over and adolescents can take Metformin hydrochloride on its own or together with insulin. 2. BEFORE YOU TAKE METFORMIN HYDROCHLORIDE
Do not take Metformin hydrochloride if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see 'What Metformin hydrochloride contains' in section 6)
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if you have kidney or liver problems if you have uncontrolled diabetes, such as severe hyperglycaemia or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood. Symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath if you lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride below). if you have recently suffered an injury or trauma (shock). if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride below). if you are treated for heart failure or have recently had a heart attack, have severe problems with your circulation or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride' below) if you drink a lot of alcohol
If any of the above applies to you, talk to your doctor before you start taking this medicine. Take special care with Metformin hydrochloride Metformin hydrochloride may cause a very rare, but serious complication called lactic acidosis, particularly if your kidneys are not working properly. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate treatment. Stop taking Metformin hydrochloride immediately and tell your doctor straight away. The risk of lactic acidosis is increased if you: have poorly controlled diabetes have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness) undergo a prolonged period of fasting drink a lot of alcohol have liver problems have low levels of oxygen in the blood. You need to eat carbohydrates regularly throughout the day. If your doctor has given you advice on your diet, you need to continue to follow this. Metformin hydrochloride on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin hydrochloride together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart beating, visions disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar. Make sure you ask your doctor for advice, if you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream you need to have major surgery You must stop taking Metformin hydrochloride for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctors instructions precisely.
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Taking other medicines If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin hydrochloride for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice' above). Tell your doctor if you take any of the following medicines and Metformin hydrochloride at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin hydrochloride: diuretics (used to remove water from the body by making more urine) beta-2 agonists such as salbutamol or terbutaline (used to treat asthma) corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma) Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Metformin hydrochloride with food and drink Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis especially if you have liver problems or if you are undernourished. This also applies to medicines that contain alcohol. Pregnancy and breast-feeding During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment. It is recommended not to take this medicine if you are breast-feeding or if you are planning to breastfeed your baby. Ask you doctor or pharmacist for advice before taking any medicine. Driving and using machines Metformin hydrochloride on its own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines. However, take special care if you take Metformin hydrochloride together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms. 3. HOW TO TAKE METFORMIN HYDROCHLORIDE
Always take Metformin hydrochloride exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Metformin hydrochloride cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise. The usual dose is: Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin hydrochloride once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited. Adults usually start with 500 mg or 850 mg Metformin hydrochloride two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses. If you take insulin too, your doctor will tell you how to start Metformin hydrochloride.
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Monitoring your doctor will adapt your dose of Metformin hydrochloride to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person. your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally. How to take Metformin hydrochloride Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion. Do not crush or chew the tablets. Swallow each tablet with a glass of water. if you take one dose a day, take it in the morning (breakfast) if you take two divided doses a day, take them in the morning (breakfast) and evening (dinner) if you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner). If, after some time, you think that the effect of Metformin hydrochloride is too strong or too weak, talk to your doctor or pharmacist. If you take more Metformin hydrochloride than you should If you have taken more Metformin hydrochloride that you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Talk to your doctor or pharmacist straight away. If you forget to take Metformin hydrochloride Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin hydrochloride can cause side effects, although not everybody gets them. The following side effects may occur: Very common side effects (in more than 1 in 10 people) digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of the treatment with Metformin hydrochloride. It helps if you spread the doses over the day and if you take the tablets with or straight after a meal. If symptoms continue, stop taking Metformin hydrochloride and talk to your doctor. Common side effects (in less than 1 in 10 people) changes in taste. Very rare side effects (in less than 1 in 10,000 people) lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. If you get this complication, you will need immediate treatment. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, stop taking Metformin hydrochloride immediately and tell your doctor straight away. skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria). low vitamin B12 levels in the blood.
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abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine.
Children and adolescents Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults. 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. 5. HOW TO STORE METFORMIN HYDROCHLORIDE
Keep out of the reach and sight of children This medicinal product does not require any special storage conditions. Do not use Metformin hydrochloride after the expiry date which is stated on the carton, blister and bottle after EXP. The expiry date refers to the last day of the month. 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 Metformin hydrochloride contains The active substance is metformin (as the hydrochloride). Each 500 mg tablet contains 500 mg metformin hydrochloride equivalent to metformin base 390 mg. Each 850 mg tablet contains 850 mg metformin hydrochloride equivalent to metformin base 662.9 mg. Each 1000 mg tablet contains 1000 mg metformin hydrochloride equivalent to metformin base 780 mg. The other ingredients are: Core: povidone K-30, magnesium stearate, Film-coat: hypromellose, hydroxypropyl cellulose and macrogol 400 and 8000. What Metformin hydrochloride looks like and contents of the pack 500 mg: White, round, normal convex, film-coated tablets plain on both sides. 850 mg: White, round normal convex film coated tablet plain on both sides. 1000 mg: White, oval, film coated tablet, embossed MF and 3 on either side of the scoreline on one side and G on the other side. The tablet can be divided into equal halves. Metformin hydrochloride tablets are packed in blister packs (PVC aluminium) containing 10, 15, 20, 28, 30, 40, 50, 56, 60, 84, 90, 100 and 120 tablets and bottles (high density polyethylene) with caps (polypropylene) containing 180, 200, 300, 400 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer: Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
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McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Mylan BV, Dieselweg 25, 3752 LB Bunschoten, the Netherlands Mylan SAS (Saint Priest), 117 Allee des Parcs, 69 800 Saint Priest, France Orifice Medical AB, Aktergatan 2 and 4, S-271 53 Ystad, Sweden This leaflet was last approved in 08/2011.
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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.
