Empagliflozin, Metformin tablets 5 mg/850 mg What Empagliflozin, Metformin is and what it is used for: This medicine contains two active substances empagliflozin and metformin. Each belongs to a group of medicines called “oral anti-diabetics”. These are medicines taken by mouth to treat type 2 diabetes. What is type 2 diabetes? Type 2 diabetes is a disease that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs. How Empagliflozin, Metformin works: Empagliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver. Thereby this medicine lowers the amount of sugar in your blood. This medicine can also help prevent heart disease. What Empagliflozin, Metformin is used for: Empagliflozin, Metformin is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and older) whose diabetes cannot be controlled by adding metformin alone or metformin with other medicines for diabetes. Empagliflozin, Metformin can also be combined with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection such as insulin. In addition, this medicine can be used as an alternative to taking both empagliflozin and metformin as single tablets. To avoid overdose, do not continue taking empagliflozin and metformin tablets separately, if you are taking this medicine. It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse Do not use Empagliflozin, Metformin : if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (very high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis 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 had a diabetic pre-coma; if you have severely reduced kidney function; if you have a severe infection if you have lost a lot of water from your body (dehydration), if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation if you have problems with your liver; if you drink large amounts of alcohol, either every day or only from time to time Warnings and precautions: Risk of lactic acidosis Empagliflozin, Metformin 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, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases). If any of the above apply to you, talk to your doctor for further instructions. Stop taking the medicine 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 the medicine 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. Children and adolescents: This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients. Other medicines and Empagliflozin, Metformin: 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 This medicine before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with this medicine. 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 This medicine. It is especially important to mention the following: medicines which increase urine production (diuretics), as This medicine may increase the risk of losing too much fluid. Your doctor may ask you to stop taking this medicine. other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia). medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib). bronchodilators (beta-2 agonists) which are used to treat asthma. corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis. 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). medicines that contain alcohol (see section ‘This medicine with alcohol’) iodinated contrast agents (medicines used during an X-ray) This medicine with alcohol Avoid excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis How to use Empagliflozin, Metformin : Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take: The dose of this medicine varies depending on your condition and the doses of diabetes medicines you currently take. Your doctor will adjust your dose as necessary and tell you exactly which strength of the medicine to take. The recommended dose is one tablet twice a day. Your doctor will normally start this medicine treatment by prescribing the strength of tablet that supplies the same dose of metformin you are already taking (850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozin (5 mg twice a day). If you are already taking both medicines separately, your doctor will start treatment with tablets of this medicine that will supply the same amount of both. If you have reduced kidney function, your doctor may prescribe a lower dose. Taking this medicine: Swallow the tablet whole with water. Take the tablets with meals to lower your chance of an upset stomach. Take the tablet twice daily by mouth. Your doctor may prescribe this medicine together with another diabetes medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health. Your doctor may need to adjust your doses to control your blood sugar. Appropriate diet and exercise help your body use its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor while taking this medicine. Possible side effects: Stop using the product and seek immediate medical attention if you develop urticaria, rash, tightness of the chest, wheezing, hypotension How to store Empagliflozin, Metformin: 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 blister and the carton after ‘EXP’. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering. A valid prescription should be available upon delivery

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