Patient leaflet - METFORMIN HYDROCHLORIDE 500 MG PROLONGED-RELEASE TABLETS
Package leaflet: Information for the user
metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, or pharmacist.
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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,or pharmacist. 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 500,750,1000 mg Prolonged-release Tablets but within the leaflet it will be referred to as Metformin hydrochloride Tablets.
What is in this leaflet
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1. What Metformin hydrochloride Tablets is and what it is 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
1. what metformin hydrochloride tablets is and what it is used for
Metformin hydrochloride Tablets contains the active ingredient metformin hydrochloride and belongs to a group of medicines called biguanides, used in the treatment of diabetes.
Metformin hydrochloride Tablets is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus in adults when diet and exercise changes alone have not been enough to control blood glucose (sugar). Insulin is a hormone that enables body tissues to take glucose from the blood and to use it for energy or for storage for future use. People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms.
Metformin makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.
Metformin hydrochloride Tablets is associated with either a stable body weight or modest weight loss.
Metformin hydrochloride Tablets is specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin.
2. what you need to know before you take metformin hydrochloride tablets- if you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6).
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– If you have long-term liver problems.
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– If you have severely reduced kidney function.
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– If you 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.
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– If you have a severe infection or have recently suffered a severe injury.
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– If you have been treated for heart problems or have recently had a heart attack or have severe
circulatory problems or breathing difficulties.
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– If you are a heavy drinker of alcohol.
Warnings and precautions
If you have diabetes you should have your blood or urine tested for sugar regularly. 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 or if you have kidney problems).
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:
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– vomiting
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– stomach ache (abdominal pain)
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– muscle cramps
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– a general feeling of not being well with severe tiredness
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– difficulty in breathing
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– 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
You may see some remains of the tablets in your stools. Do not worry as this is normal for this type of tablet.
You should continue to follow any dietary advice that your doctor has given you and you should make sure that you eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your doctor.
Children and adolescents
Children and adolescents should not use this medicine. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
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 the injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin hydrochloride Tablets
Tell your doctor or pharmacist 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:
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– medicines which increase urine production (diuretics)
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– medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
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– certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
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– Steroids such as prednisolone, mometasone, beclometasone.
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– Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics.
Metformin hydrochloride Tablets with food, drink and alcohol
You should take Metformin hydrochloride Tablets with or immediately after food e.g. with your evening meal.
Avoid excessive alcohol intake while taking Metformin hydrochloride Tablets since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take this medicine if you are breast-feeding or if you are planning to breastfeed your baby.
Driving and using machines
Metformin hydrochloride Tablets taken on its own does not cause ‘hypoglycemia’ (symptoms of low blood sugar, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.
You should be aware, however, that Metformin hydrochloride Tablets taken with other antidiabetic medicines can cause low blood sugar, so in this case you should take extra care when driving or operating machinery.
3. how to take metformin hydrochloride tablets
Your doctor may prescribe Metformin hydrochloride Tablets for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
Usually you will start treatment with 500mg Metformin hydrochloride Tablets daily. After you have been taking Metformin hydrochloride Tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000mg of Metformin hydrochloride Tablets. If you have reduced kidney function, your doctor may prescribe a lower dose
How to take the tablets
Normally, you should take the tablets once a day, with your evening meal.
In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with food.
Swallow the tablets whole with a glass of water, do not chew, split or crush the tablets.
Use in children and adolescents
Children and adolescents below 18 years should not use this medicine.
Use in elderly
The dose will be determined after tests have been carried out on your kidney function.
If you take more Metformin hydrochloride Tablets than you should
If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact your doctor. These symptoms may include weakness, confusion, fast breathing and new onset of nausea, vomiting or stomach pain. If the overdose is large, lactic acidosis is more likely and this is a medical emergency requiring treatment in hospital (see also under ‘4. Possible side effects’).
If you forget to take Metformin hydrochloride Tablets
Take it as soon as you remember with some food. Do not take a double dose to make up for a forgotten dose.
If you stop taking Metformin hydrochloride Tablets
You should not stop taking this medicine without talking to your doctor first. If you stop takingMetformin hydrochloride Tablets, your blood sugar may rise again.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking Metformin hydrochloride Tablets and see your doctor immediately:
Very rare (may affect up to 1 in 10,000 people):
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Metformin hydrochloride Tablets may cause a very rare, 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.
Frequency not known (frequency cannot be estimated from the available data)
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– Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice. If you develop yellowing of the eyes and/or skin contact your doctor immediately.
Other possible side effects are listed by frequency as follows:
Very common (may affect more than 1 in 10 people):
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– Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you get these, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks.
Common (may affect up to 1 in 10 people):
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– Taste disturbance
Very rare (may affect up to 1 in 10,000 people):
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– Decreased vitamin B12 levels which may result in anaemia
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– Skin rashes including redness, itching and hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:
By reporting side affects you can help provide more information on the safety of this medicine.
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 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- the active substance is metformin (as hydrochloride). each prolonged-release tablet contains 500 mg, 750mg or 1000mg of metformin hydrochloride corresponding to 390mg, 585mg and 780mg metformin base, respectively.
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– The other ingredients are magnesium stearate, colloidal anhydrous silica, povidone K30 and hypromellose.
What Metformin hydrochloride Tablets looks like and contents of the pack
Metformin 500mg prolonged-release tablets are white to off-white, capsule shaped uncoated tablets, 16.50 mm in length, 8.20 mm in width and 6.70 mm in thickness, debossed with ‚XR500‘ on one side and plain on other side.
Metformin 750mg prolonged-release tablets are white to off-white, capsule shaped, uncoated tablets, 19.60 mm in length, 9.30 mm in width and 7.40 mm in thickness, debossed with ‚XR 750‘ on one side and plain on other side.
Metformin 1000mg prolonged-release tablets are white to off-white, capsule shaped, uncoated tablets, 21.10 mm in length, 10.10 mm in width and 8.90 mm in thickness, debossed with ‚XR 1000‘ on one side and plain on other side.
Metformin hydrochloride Tablets is available in blister packs containing 28 or 56 tablets.
Marketing Authorisation Holder
Generic Partners UK Ltd
1 Doughty Street
London
WC1N2PH
United Kingdom
Distributer
Co pharma
Unit 4, Metro Centre,
Tolpits Lane,
Watford,
WD18 9SS,
United Kingdom
Manufacturers
18 Owen Drive
Liverpool
Merseyside
L24 1YA
United Kingdom
Distributer
Strides Pharma UK Ltd.
Unit 4,
Metro Centre,
Tolpits Lane,
Watford,
WD18 9SS,
United Kingdom
This leaflet was last revised in 09/2018
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