Patient leaflet - METFORMIN HYDROCHLORIDE 500 MG FILM-COATED TABLETS
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Package leaflet: Information for the user Metformin hydrochloride 500 mg film-coated tablets
Metformin hydrochloride 850 mg film-coated tablets
Metformin hydrochloride 1000 mg film-coated tablets
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor,pharmacist or nurse.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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– The full name of this medicine is Metformin hydrochloride 500 mg, 850 mg, 1000mg film-coated tablets but within this leaflet it will be referred to as Metformin hydrochloride tablets.
What is in this leaflet
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1. What Metformin hydrochloride tablets are and what they are used for
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2. What you need to know before you take Metformin hydrochloride tablets
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3. How to take Metformin hydrochloride tablets
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4. Possible side effects
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5. How to store Metformin hydrochloride tablets
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6. Contents of the pack and other information
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1. What Metformin hydrochloride tablets are and what they are used for
Metformin hydrochloride tablets contain metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.
If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metformin hydrochloride tablets help to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin hydrochloride tablets over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin hydrochloride tablets are associated with either a stable body weight or modest weight loss.
Metformin hydrochloride tablets are used to treat patients with type 2 diabetes (also called ‘non-insulin dependent diabetes’) when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.
Adults can take Metformin hydrochloride tablets on their own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).
Children 10 years and over and adolescents can take Metformin hydrochloride tablets on their own or together with insulin.
2. what you need to know before you take metformin hydrochloride tablets
Do not take Metformin hydrochloride tablets if you:
- are allergic to (hypersensitive) to metformin or any of the other ingredients of this medicine (listed in section 6.)
- have liver problems
- have severely reduced kidney function
- have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) 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
- lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see ‚Warnings and precautions‘.)
- have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see ‚Warnings and precautions‘.)
- are treated for acute heart failure or have recently had a heartattack, have severe problems with your circulation (such as shock) orhave breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see ‚Warnings and precautions‘.)
- drink a lot of alcohol.
If any of the above applies to you, talk to your doctor before you start taking this medicine.
Make sure you ask your doctor for advice, if:
- you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
- you need to have major surgery.
You must stop taking Metformin hydrochloride tablets for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor’s instructions precisely.
Warnings and precautions
Risk of lactic acidosis
Metformin hydrochloride tablets 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 (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Metformin hydrochloride tablets 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 Metformin hydrochloride tablets 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.
If you need to have major surgery you must stop taking Metformin hydrochloride tablets during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin hydrochloride tablets.
Metformin hydrochloride tablets on their own do not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin hydrochloride tablets together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia 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.
During treatment with Metformin hydrochloride tablets, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Other medicines and Metformin hydrochloride tablets
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 Metformin hydrochloride tablets before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin hydrochloride tablets.
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 Metformin hydrochloride tablets. It is especially important to mention the following:
- 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)
- beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)
- corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma)
- 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)
- other medicines used to treat diabetes.
Metformin hydrochloride tablets with alcohol
Avoid excessive alcohol intake while taking Metformin hydrochloride tablets since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’).
Pregnancy and breast-feeding
During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment. This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.
Driving and using machines
Metformin hydrochloride tablets on their own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines. However, take special care if you take Metformin hydrochloride tablets together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heartbeat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. how to take metformin hydrochloride tablets
Always take Metformin hydrochloride tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Metformin hydrochloride tablets cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.
Recommended dose
Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin hydrochloride tablet once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg Metformin hydrochloride tablet two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses. If you have reduced kidney function, your doctor may prescribe a lower dose.
If you take insulin too , your doctor will tell you how to start Metformin hydrochloride tablets.
Monitoring
- Your doctor will perform regular blood glucose tests and will adapt your dose of Metformin hydrochloride tablets to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person.
- Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally.
How much to take
Take Metformin hydrochloride tablets with or after a meal. This will avoid you having side effects affecting your digestion. Do not crush or chew the tablets. Swallow each tablet with a glass of water.
- If you take one dose a day, take it in the morning (breakfast).
- If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner).
- If you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner).
If, after some time, you think that the effect of Metformin hydrochloride tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Metformin hydrochloride tablets than you should
If you have taken more Metformin hydrochloride tablets than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heartbeat. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Stop taking Metformin hydrochloride tablets immediately and contact a doctor or the nearest hospital straight away.
If you forget to take Metformin hydrochloride tablets
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:
Metformin hydrochloride tablets may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section ‘Warnings and precautions’). If this happens you must stop taking Metformin hydrochloride tablets and contact a doctor or the nearest hospital immediately , as lactic acidosis may lead to coma.
Very common side effects (in more than 1 in 10 people)
- digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of the treatment with Metformin hydrochloride tablets. It helps if you spread the doses over the day and if you take Metformin hydrochloride tablets with or straight after a meal. If symptoms continue, stop taking Metformin hydrochloride tablets and talk to your doctor.
- changes in taste.
- lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly
- Symptoms of lactic acidosis are non-specific (see section ‘Warning and precautions’)
- abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking Metformin hydrochloride tablets and talk to your doctor
- skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives)
- low vitamin B12 levels in the blood.
5. how to store metformin hydrochloride tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on blister, bottle and the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Metformin hydrochloride tablets contain
The active substance is metformin hydrochloride.
Each film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base.
Each film-coated tablet contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base.
Each film-coated tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base.
The other ingredients are:
Tablet core: Povidone, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate
Tablet coating: Opadry White containing Hypromellose, Macrogol, Titanium dioxide (E171)
What Metformin hydrochloride tablets look like and contents of the pack
500 mg:
White to off white, round, biconvex, film coated tablets with ‚LA15‘ debossed on one side and plain on the other side.
Blister: Clear PVC-Alu blister containing 7, 28, 30, 40, 50, 60, 84, 90, 100, 120, 200, 300, 400 tablets.
HDPE Bottle:
White opaque HDPE bottle with white opaque polypropylene child resistant closure with wad having induction sealing liner in pack size of 90 tablets.
850 mg:
White to off white, Capsule shaped, biconvex, film coated tablets with ‘L01’ debossed on one side and plain on the other side.
Blister: Clear PVC-Alu blister containing 7, 30, 40, 50, 56, 60, 90, 100, 120, 200 tablets.