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Each JALRA tablet contains 50 mg of the active substance vildagliptin. JALRA is a medicine used to treat patients with type 2 diabetes whose condition cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Such medicines are known as oral antidiabetics. Type 2 diabetes develops if the body does not produce enough insulin or where the insulin that your body makes does not work as well as it should. It can also develop if the body produces too much glucagon. Insulin is a substance which helps to lower the level of sugar in your blood, especially after meals. Glucagon is another substance which triggers the production of sugar by the liver, causing the blood sugar to rise. The pancreas makes both of these substances. JALRA works by making the pancreas produce insulin and less glucagon. JALRA helps to control the blood sugar level. Your doctor will prescribe JALRA either alone or in combination with other antidiabetics depending on your condition. It is important that you continue to follow the diet and/or exercise advised for you whilst you are on treatment with JALRA. Ask your doctor if you have any questions about why this medicine has been prescribed for you. How to use Your doctor will tell you exactly how many tablets of JALRA to take. The usual dose of JALRA is 50 mg or 100 mg a day. The 50 mg dose should be taken as 50 mg once a day (morning). The 100 mg dose should be taken as 50 mg twice a day (morning and evening). Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Your doctor will prescribe JALRA either alone or in combination with other antidiabetics depending on your condition. When and how to take JALRA JALRA should be taken in the morning (50 mg once a day) or in the morning and in the evening (50 mg twice a day). The tablets should be swallowed whole with a glass of water. How long to take JALRA Continue taking JALRA every day for as long as your doctor tells you. You may have to stay on this treatment for a long period of time. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. If your doctor told you to stop your treatment with JALRA because of liver problems you should never start taking JALRA again. Warnings and precautions Do not take JALRA If you are allergic (hypersensitive) to vildagliptin or any of the other ingredients of JALRA. Take special care with JALRA If you are pregnant or plan to become pregnant. If you are breast-feeding. If you have kidney problems. If you have liver problems. If you are suffering from heart failure, your doctor will decide whether or not to prescribe JALRA depending on the degree of your condition. JALRA is not a substitute for insulin. You should therefore neither receive JALRA for the treatment of type 1 diabetes (i.e. your body does not produce insulin at all) nor for the treatment of a condition called diabetic ketoacidosis. If any of these apply to you, tell your doctor before you take JALRA. Side Effects You should stop taking JALRA and see your doctor immediately if you experience the following symptoms: Swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives (symptoms of severe allergic reaction called 'angioedema'). Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (possible symptoms of liver problems). Severe upper stomach pain (possible sign of inflamed pancreas). Other side effects: Some patients have had the following side effects while taking JALRA alone: Common: Dizziness. Uncommon: Headache, constipation, swollen hands, ankle or feet (edema). Some patients have had the following side effects while taking JALRA and metformin: Common: Trembling, headache, dizziness. Some patients have had the following side effects while taking JALRA and a sulphonylurea: Common: Trembling, headache, dizziness, weakness. Some patients have had the following side effects while taking JALRA and a glitazone: Common: Weight increase, swollen hands, ankle or feet (edema). Uncommon: Headache. Some patients have had the following side effects while taking JALRA and insulin (with or without metformin): Common: Headache, chills, nausea, decreased blood glucose, heartburn. Uncommon: Diarrhea, flatulence. Some patients have had the following side effects while taking JALRA with metformin and a sulphonylurea: Common: Dizziness, tremor, weakness, low level of glucose (sugar) in the blood, excessive sweating, If any of these affects you severely, tell your doctor. Some patients have experienced other side effects whilst taking JALRA alone or in combination with another antidiabetic medication: Itchy rash, localized peeling of skin or blisters. Storage Information Store in the original package. Do not store JALRA above 30°C. Ingredients The active substance of JALRA is vildagliptin. The other ingredients are: Lactose anhydrous, microcrystalline cellulose, sodium starch glycolate, magnesium stearate
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