Package leaflet: Information for the patient. Metformin Actavis 500 mg and 850 mg filmcoated tablets. metformin hydrochloride

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1 Package leaflet: Information for the patient Metformin Actavis 500 mg and 850 mg filmcoated tablets metformin hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Metformin Actavis is and what it is used for 2. What you need to know before you take Metformin Actavis 3. How to take Metformin Actavis 4. Possible side effects 5. How to store Metformin Actavis 6. Contents of the pack and other information 1. What Metformin Actavis is and what it is used for Metformin Actavis is used in diabetes mellitus in adults, especially in overweight patients, when diet and exercise have not reduced sugar levels. Metformin Actavis lowers the blood sugar in diabetes without causing the levels to drop too low. Metformin Actavis can be used as single treatment or in combination with other oral medications (sulfonylureas) or together with insulin, to reduce the blood sugar. 2. What you need to know before you take Metformin Actavis Do not take Metformin Actavis - if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6). - if you have liver problems or drink a lot of alcohol - if you have severely reduced kidney function - if you have severe heart or pulmonary disease - If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see Risk of lactic acidosis below) 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 your breath developing an unusual fruity smell. - if you have a severe infection - if you are seriously dehydrated (lost a lot of water from your body, which can happen if you have severe sickness or diarrhoea) - in the condition of shock

2 Warnings and precautions Risk of lactic acidosis. Metformin Actavis may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). If any of the above apply to you, talk to your doctor for further instructions. Stop taking Metformin Actavis for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions. Stop taking Metformin Actavis and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat Lactic acidosis is a medical emergency and must be treated in a hospital. It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis. Surgery If you need to have major surgery you must stop taking Metformin Actavis during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Actavis. Hypoglycaemia When Metformin Actavis is taken together with other antidiabetic medications such as insulin or other antidiabetics such as sulphonureas or meglitinides, the possibility of low blood sugar (hypoglycaemia) can occur. Symptoms of low blood sugar such as sweating, shakiness, anxiety, palpitation of the heart and hunger might appear. In such cases it is often helpful to drink milk or take sugar or something similar. Patients should continue their diet with a regular distribution of carbohydrates during the day. Patients who are overweight should continue on their low energy diet. Usual laboratory tests for monitoring diabetes should be done on a regular basis. Control of kidney function During treatment with Metformin Actavis, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function. Other medicines and Metformin Actavis If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Metformin Actavis before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Actavis. Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metformin Actavis. It is especially important to mention the following: Glucocorticoids ( a group of antiinflammatory medicines used to treat for example asthma and inflammation of the skin)

3 Sympathomimetics (medicines affecting a certain part of the nervous system for example adrenaline and medicines used to treat asthma) medicines which increase urine production (diuretics) medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists) Metformin Actavis with alcohol Avoid excessive alcohol intake while taking Metformin Actavis since this may increase the risk of lactic acidosis (see section Warnings and precautions ). Pregnancy and breast-feeding Pregnancy During pregnancy, diabetes should not be treated with Metformin Actavis, but with insulin. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Breast-feeding Metformin Actavis passes on to human breast milk. Breast-feeding during metformin treatment is not recommended. Driving and using machines Metformin Actavis as a single drug treatment does not cause hypoglycemia and has therefore no effects on the ability of driving or using machines. Though, there is a risk for hypoglycemia when metformin is given in combination with other antidiabetic medicines or insulin, make sure you are not affected before driving or using machinery. 3. How to use Metformin Actavis Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults The usual dose of Metformin Actavis 500 mg is 1 tablet 2-3 times daily, but the dose may be increased to maximum 6 tablets daily. The usual dose of Metformin Actavis 850 mg is 1 tablet 2-3 times daily, but the dose may be increased to maximum 3 tablets daily. Elderly The dosage should be adjusted based on kidney function. Reduced kidney function If you have reduced kidney function, your doctor may prescribe a lower dose. The tablets should be taken together with food in order to reduce the risk for gastro-intestinal side effects. If you take more Metformin Actavis than you should If you suspect overdose or intoxication always contact your doctor, the hospital or toxicological information centre. Symptoms of overdose are feeling sick, vomiting, diarrhoea, metal taste, low blood sugar, lactic acidosis, circulatory disturbance and shock. If you forget to take Metformin Actavis Do not take a double dose to make up for a forgotten dose.

4 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Metformin Actavis may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section Warnings and precautions ). If this happens you must stop taking Metformin Actavis and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. Other side effects: Very common (may affect more than 1 in 10 people): diarrhoea, loss of appetite, feeling or being sick, stomach upset or pain, especially at the start of treatment. Common (may affect 1 in 10 people): change in taste. Very rare (may affect 1 in 10, 000 peolpe): a mild red rash, hepatitis (inflammation of the liver causing yellowing of the skin or eyes), changes in liver function tests. Some patients, who have been taking Metformin tablets for a long time, have experienced reduced levels of vitamin B 12 in their blood (a type of anaemia causing breathlessness on exertion, pale skin and poor resistance to infections). This would be detected by a blood test. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Metformin Actavis No special precautions for storage. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton or label after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Metformin Actavis contains - The active substance is metformin hydrochloride. Each tablet contains 500 mg or 850 mg metformin hydrochloride respectively. - The other ingredients are: Tablet core - povidone, stearic acid, silica, colloidal anhydrous. Film-coat - hypromellose, titanium dioxide (E171), macrogol 400. What Metformin Actavis looks like and the contents of the pack 500mg tablets: white, circular, biconvex, film-coated, impressed MF on one face. 850mg tablets: white, circular, biconvex, film-coated, impressed MH on one face. Metformin Actavis 500mg tablets are supplied in: Blister packs containing 30, 50, 100 tablets Plastic bottles containing 30, 50, 100, 300, 400 tablets

5 Metformin Actavis 850mg tablets are supplied in: Blister packs containing 20, 30, 60, 100 tablets Plastic bottles containing 20, 30, 60, 100 tablets Not all pack sizes may be marketed. Marketing Authorisation Holder Marketing Authorisation holder: Actavis Group PTC ehf. Reykjavikurvegi IS-220 Hafnarfjordur Isaland Manufacturer Actavis UK Limited Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. Dupnitsa 2600, Bulgaria This product is authorised in the Member States of the EEA under the following names: Sweden, Denmark, Finland: Metformin Actavis Portugal: Metformina Aurovitas This leaflet was revised in