Actosmet 15 Mg/850 Mg 56 Tablets

Description

Actosmet contains pioglitazone and metformin. It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient. This type 2 diabetes usually develops in adulthood particularly as a result of the person being overweight and where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces. Your doctor will check whether Actosmet is working 3 to 6 months after you start taking it. Actosmet helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. How to use The recommended dose is one tablet taken twice daily. If necessary your doctor may tell you to take a different dose. If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin. You should swallow the tablets with a glass of water. You may take your tablets with or just after food to reduce the chance of an upset stomach. If you are following a special diet for diabetes, you should continue with this while you are taking Actosmet. Warnings and precautions Do not take Actosmet If you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine. If you have heart failure or have had heart failure in the past. If you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties. If you have liver disease. If you drink alcohol excessively (either every day or only from time to time). 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 or have ever had bladder cancer. If you have blood in your urine that your doctor has not checked. If you have severely reduced kidney function. If you have a severe infection or are dehydrated. If you are breast-feeding. Warnings and Precautions Talk to your doctor or pharmacist before taking Actosmet: If you have a problem with your heart. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor. If you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision. If you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of becoming pregnant because you may ovulate again when you take Actosmet. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy. Side Effects Allergic reactions have been reported (frequency cannot be estimated from available data) in patients taking pioglitazone/metformin. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing, stop taking this medicine and talk to your doctor immediately. The following side effects have been experienced by some patients taking pioglitazone/metformin: Very common (may affect more than 1 in 10 people) Stomach ache Feeling sick (nausea) Vomiting Diarrhoea Loss of appetite Common (may affect up to 1 in 10 people) Localised swelling (oedema) Weight gain Headache Respiratory infection Abnormal vision Joint pain Impotence Blood in urine Reduction in blood count (anaemia) Numbness Taste disturbance Storage Information Store below 30°C. Store in the original carton. Drug Interactions Tell your doctor or pharmacist 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 Actosmet. It is especially important to mention the following: Gemfibrozil (used to lower cholesterol) Rifampicin (used to treat tuberculosis and other infections) Cimetidine (used to reduce stomach acid) Glucocorticoids (used to treat inflammation) Beta-2-agonists (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) Ingredients The active ingredient is pioglitazone hydrochloride and metformin hydrochloride. Tablet core: microcrystalline cellulose, povidone (K30), croscarmellose sodium and magnesium stearate. Film coat: hypromellose, macrogol 8000, talc and titanium dioxide. Specifications Actosmet 15 mg/850 mg film-coated tablets are oblong white to off-white film-coated tablets in aluminum blisters.