Glacera Plus 15/850 Mg 60 Tablets

Description

GLACERA PLUS contains pioglitazone and metformin hydrochloride. It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin hydrochloride 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 GLACERA PLUS is working 3 to 6 months after you start taking it. GLACERA PLUS 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 If therapy with a combination tablet containing pioglitazone and metformin hydrochloride is considered appropriate the recommended starting dose is: 15 mg/500 mg twice daily or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients with New York Heart Association (NYHA) Class I or Class II congestive heart failure: 15 mg/500 mg or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients inadequately controlled on metformin hydrochloride monotherapy: 15 mg/500 mg twice daily or 15 mg/850 mg once or twice daily (depending on the dose of metformin hydrochloride already being taken) and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients inadequately controlled on pioglitazone monotherapy: 15 mg/500 mg twice daily or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, for patients who are changing from combination therapy of pioglitazone plus metformin hydrochloride as separate tablets: GLACERA PLUS should be taken at doses that are as close as possible to the dose of pioglitazone and metformin hydrochloride already being taken. Warnings and precautions Do not take Glacera Plus: If you are allergic to pioglitazone, metformin hydrochloride 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 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. Warnings and precautions Consult your doctor, pharmacist or nurse before beginning to take Glacera Plus in the following conditions: 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. 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). Side Effects Glacera Plus may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis. If this happens you must stop taking Glacera Plus and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. The following side effects have been experienced by some patients taking Glacera Plus: Very common (may affect more than 1 in 10 people) Stomach ache Feeling sick (nausea) Vomiting Diarrhoea Loss of appetite Storage Information Store below 30°C. 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 Glacera Plus. 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 Each Tablet contains Pioglitazone Hydrochloride (Ph. Eur) equivalent to Pioglitazone 15 mg and Metformin Hydrochloride (Ph. Eur) 500 mg or 850 mg. Excipients: Microcrystalline Cellulose (PH 102), Croscarmellose Sodium, Povidone (K30), Magnesium Stearate, Opadry 03F180011 White and Purified Water.