Product Details

What you need to know before you take Metformin Oral Solution

Do not take Metformin Oral Solution • if you are allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6) • if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high levels of blood glucose in your blood), nausea (feeling sick), vomiting (being sick), dehydration or rapid weight loss • if you have symptoms of a condition called ketoacidosis in which substances called ‘ketone bodies’ accumulate in the blood and can lead to diabetic pre-coma (unconsciousness). Symptoms include stomach pain, fast and deep breathing, sleepiness and unusual fruity odour of the breath (likened to the smell of pear drops) • if you have moderate or severe liver or kidney problems • if you become dehydrated (when you lose too much water from your body), due to long-lasting or severe diarrhoea, or if you have been sick several times in a short space of time. Dehydration may lead to kidney problems, which can put you at risk of lactic acidosis (see ‘Warnings and precautions’) • if you have a severe infection, such as an infection affecting your lungs, airways or your kidneys. Severe infections may lead to kidney problems, which can put you at risk of lactic acidosis (see ‘Warnings and precautions’ and Section 4 Possible side effects) • if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack of oxygen in your body tissues which can put you at risk of lactic acidosis (see “Warnings and precautions”) • if you drink a lot of alcohol. If any of the above applies to you, talk to your doctor, before you start taking this medicine. Warnings and precautions • Metformin Oral Solution may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly (kidney function may worsen when starting medication for high blood pressure, water retention and when starting treatment with Non-Steroidal AntiInflammatory Drugs (NSAIDs). • The risk of developing lactic acidosis is also increased with: o uncontrolled diabetes o prolonged fasting or alcohol intake o loss of body fluid (dehydration) due to severe diarrhoea or vomiting (being sick) o liver problems o any medical conditions in which a region of the body is deprived of oxygen (such as acute severe heart diseases). 3 • It is important you take your medication as prescribed, follow dietary instructions and keep up your regular exercise program because these measures can reduce the risk of lactic acidosis. • The onset of lactic acidosis can be subtle and the symptoms can be non-specific such as: o being sick (vomiting) o stomach ache (abdominal pain) with muscle cramps o a general feeling of not being well with severe tiredness o difficulty in breathing o further symptoms are reduced body temperature and heartbeat. If you experience some of these symptoms, stop taking this medicine and seek medical attention immediately. • Talk to your doctor or pharmacist before using Metformin Oral Solution if: o you need to have a diagnostic examination such as X-ray or scan involving the injection of contrast dyes that contain iodine into your bloodstream o you need to have surgery in which you will be given an anaesthetic (put to sleep). You must stop taking Metformin Oral Solution for a certain period of time before and after the examination or surgery. Your doctor will tell you what you need to do and will decide whether you need any other treatments during this time. It is important that you follow your doctor’s instructions precisely. • On its own this medicine does not cause hypoglycaemia (a condition when your blood glucose levels become too low). However, if you take Metformin Oral Solution together with other medicines used to treat diabetes (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms such as weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar. Children aged 10 and over and adolescents • This medicine may be used in children aged 10 and over either by itself or in combination with insulin. • Regular monitoring of children taking this medicine is recommended. Other medicines and Metformin Oral Solution • If you need to have an injection of a contrast dye medicine that contains iodine for a diagnostic examination such as an X-ray or scan, you will need to stop taking Metformin Oral Solution for a period of time both before and after the examination (at least 48 hours). It is important that you discuss this with your doctor beforehand. • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought without a prescription. 4 • You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin Oral Solution if you are taking or have recently taken: o diuretics (used to remove water from the body by making more urine) o beta-2 agonists such as salbutamol or terbutaline (used to treat asthma) o corticosteroids such as prednisolone (used to treat a variety of conditions including asthma and inflammation) o other medicines used to treat diabetes o Non-Steroidal Anti-Inflammatories (NSAIDS) such as diclofenac (used to treat inflammation). Metformin Oral Solution with food and drink Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis especially if you have liver problems or if you are undernourished. This also applies to medicines that contain alcohol. Pregnancy and breast-feeding • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor in case any changes will be needed to your treatment or monitoring of your blood glucose levels. • This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby. Driving and using machines • Taken on its own this medicine does not cause hypoglycaemia (a condition where your blood glucose levels become too low). This means that it will not affect your ability to drive or use machines. • If this medicine is taken with insulin or other medicines used to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin and meglitinides), it is possible that their combined effects may make you feel faint or dizzy. Other symptoms of hypoglycaemia include weakness, increased sweating, fast heartbeat, vision disorders and difficulty concentrating. If you experience any of these symptoms do not drive or operate machinery until you feel better. Important information about some of the ingredients of Metformin Oral Solution This medicine contains Sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).