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Transcript PAGE 1: FRONT FACE (INSIDE OF REEL) Metformin hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER (Main) Pharma code 242 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 troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Metformin is and what it is used for 2. Before you take Metformin 3. How to take Metformin 4. Possible side effects 5. How to store Metformin 6. Further information 1 WHAT METFORMIN IS AND WHAT IT IS USED FOR What Metformin is Metformin 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 helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Metformin over a long period of time also helps to lower the risk of complications associated with diabetes. In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss. What Metformin is used for Metformin 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 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 on its own or together with insulin. 2 BEFORE YOU TAKE METFORMIN Do not take Metformin • If you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see 'What Metformin contains' in section 6) • If you have kidney or liver problems • If you have uncontrolled diabetes, such as with e.g. severe hyperglycaemia (high blood glucose, nausea, vomiting, dehydration, rapid weight loss or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma. 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' below) • 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' below) • If you are treated for heart failure or have recently had a heart attack, have severe problems with your circulatory system 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’ 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. 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 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 doctor’s instructions precisely. Take special care with Metformin • Metformin may cause a rare but serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straight away • Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take it 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, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar. 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 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 at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin: • 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) • Other medicines used to treat diabetes. 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 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, think you might be or are planning to become pregnant, so that he/she may change your treatment • Metformin is not recommended if you are breast-feeding or if you are planning to breast-feed your baby • Ask your doctor or pharmacist for advice before taking any medicine. Top of page cut-off to middle of registration mark: 44 mm. METFORMIN 500 mg TABLETS METFORMIN 850 mg TABLETS PAGE 2: REAR FACE (OUTSIDE OF REEL) Driving and using machines Metformin 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 together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). 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. These side effects most often happen at the beginning of the treatment with Metformin. 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 and talk to your doctor. Common side effects (in fewer than one in 10 users): • Changes in taste. Very rare side effects (in fewer than one in 10,000 users): • 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. HOW TO TAKE METFORMIN 3 Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle Always take Metformin exactly as your doctor has cramps, a general feeling of not being well with told you. Check with your doctor or pharmacist if severe tiredness, and difficulty in breathing. If you are not sure. this happens to you, you may need immediate Metformin cannot replace the benefits of a hospital treatment, as lactic acidosis may lead healthy lifestyle. Continue to follow any advice to coma. Stop taking Metformin immediately about diet that your doctor has given you and get and contact a doctor or the nearest hospital some regular exercise. straight away • Skin reactions such as redness of the skin Usual dose (erythema), itching or an itchy rash (urticaria) Children 10 years and over and adolescents • Low vitamin B12 levels in the blood usually start with 500 mg or 850 mg Metformin • Abnormalities in liver function tests or hepatitis once a day. The maximum daily dose is 2000 mg (inflammation of the liver; this may cause taken as 2 or 3 divided doses. Treatment of tiredness, loss of appetite, weight loss, with or children between 10 and 12 years of age is only without yellowing of the skin or whites of the recommended on specific advice from your eyes). If this happens to you, stop taking this doctor, as experience in this age group is limited. medicine and talk to your doctor. Adults usually start with 500 mg or 850 mg Children and adolescents Metformin two or three times a day. The maximum Limited data in children and adolescents showed daily dose is 3000 mg taken as 3 divided doses. that adverse events were similar in nature and If you take insulin too, your doctor will tell you severity to those reported in adults. how to start Metformin. If any of these side effects get serious, or if you Monitoring notice any side effects not listed in this leaflet, • Your doctor will perform regular blood glucose please tell your doctor or pharmacist. tests and adapt your dose of Metformin to your blood glucose levels. Make sure that you talk to 5 HOW TO STORE METFORMIN your doctor regularly. This is particularly important for children and adolescents or if you Keep out of the reach and sight of children. are an older person Do not use this medicine after the expiry date • Your doctor will also check at least once a year shown on the blister and the carton. The expiry how well your kidneys work. You may need date refers to the last day of the month. more frequent checks if you are an older person This medicinal product does not require any or if your kidneys are not working normally. special storage conditions. How to take Metformin Medicines should not be disposed of via Take the tablets with or after a meal. This will avoid wastewater or household waste. Ask your you having side effects affecting your digestion. pharmacist how to dispose of medicines no Do not crush or chew the tablets. Swallow each longer required. These measures will help to tablet with a glass of water. protect the environment. • If you take one dose a day, take it in the morning (breakfast) 6 FURTHER INFORMATION • If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner) What Metformin contains • If you take three divided doses a day, take them • The active substance is metformin hydrochloride. Metformin 500 mg: Each tablet contains 500 of in the morning (breakfast), at noon (lunch) and metformin hydrochloride corresponding to in the evening (dinner). 390 mg of metformin. If, after some time, you think that the effect of Metformin 850 mg: Each tablet contains 850 mg Metformin is too strong or too weak, talk to your of metformin hydrochloride corresponding to doctor or pharmacist. 662.9 mg of metformin If you take more Metformin than you should • The other ingredients are as follows: If you have taken more Metformin than you Core: povidone (K30/K90), anhydrous colloidal should have, you may experience lactic acidosis. silica, magnesium stearate Film-coating: Symptoms of lactic acidosis are vomiting, hypromellose (E464), macrogol 400 and the bellyache (abdominal pain) with muscle cramps, a colour titanium dioxide (E171). general feeling of not being well with severe What Metformin looks like and contents of the pack tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, Metformin comes in 2 different strengths of tablets as lactic acidosis may lead to coma. Contact a doctor which can be identified by their inscription: • Metformin 500 mg Tablets: white to off-white or the nearest hospital straight away. film-coated oval-shaped tablets, debossed with If you forget to take Metformin “93” on one side and “48” on the other. Do not take a double dose to make up for a • Metformin 850 mg Tablets: white to off-white forgotten dose. Take the next dose at the usual time. film-coated oval-shaped tablets, debossed with “93” on one side and “49” on the other. If you have any further questions on the use of Metformin 500 mg comes in packs of 20, 28, 30, 50, this product, ask your doctor or pharmacist. 56, 60, 84, 90, 100, 120, 180, 200, 400 and 500 tablets. Metformin 850 mg comes in packs of 20, 28, 30, 40, 4 POSSIBLE SIDE EFFECTS 50, 56, 60, 90, 100, 120, 180, 200, 250 and 300 tablets. Not all pack sizes may be marketed. Like all medicines, Metformin can cause side effects, although not everybody gets them. Marketing Authorisation Holder and Manufacturer is TEVA UK Ltd, Eastbourne, BN22 9AG The following side effects may occur: Very common side effects (in more than one in 10 This leaflet was last revised in December 2011 users): PL 00289/0340 • Digestive problems such as feeling sick PL 00289/0341 (nausea), being sick (vomiting), diarrhoea, 60910-Z bellyache (abdominal pain) and loss of appetite. 160 x 323 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.','url':'http://www.drugs.com/uk/metformin-500-mg-tablets-leaflet.html','og_descr':'Patient information for METFORMIN 500 MG TABLETS Including dosage instructions and possible side effects.
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