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The most common side effects are hypoglycemia, thrush, urinary tract infections, increased need to visit the toilet, pain when urinating, changes in levels of blood fats, lowering of blood pressure. Check with your doctor as soon as possible if any of the following side effects occur: redness or rash of the penis or foreskin (yeast infection), signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion), signs of vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching), symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision), symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain, strong odour). Stop taking the medication and seek immediate medical attention if any of the following occur: fainting or lightheadedness when standing, severe dehydration (e.g., confusion, sweating stops, heart palpitations), severe hypoglycemia (low blood sugar; disorientation, loss of consciousness, seizure), signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat).
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When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
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