Metformin Hydrochloride 1000 Mg Film Coated Tablets
Package leaflet: Information for the user Metformin 500 mg, 850 mg and 1000 mg film-coated tablets
Metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours.
• If you have any of the side effects including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
What is in this leaflet:
1. What Metformin tablets are and what they are used for
2. What you need to know before you take Metformin tablets
3. How to take Metformin tablets
4. Possible side effects
5. How to store Metformin tablets
6. Contents of the pack and other information
1. What Metformin tablets are and what they are used for
Metformin tablets contain the active ingredient metformin hydrochloride. Metformin hydrochloride belongs to a group of medicines called biguanides used for the treatment of non-insulin-dependent diabetes mellitus (type 2 diabetes) in adults and children from 10 years of age.
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 helps to lower your blood glucose to as normal a level as possible.
Metformin tablets are a medicine used to lower high blood sugar levels in patients with diabetes mellitus (type 2 diabetes); particularly in overweight patients when dietary management and exercise alone does not result in control of blood sugar.
Adults
Your doctor can prescribe Metformin tablets on their own (monotherapy) or in combination with other oral antidiabetic agents, or with insulin.
Children and adolescents
For children from 10 years of age and for adolescents the doctor can prescribe Metformin tablets alone (monotherapy) or in combination with insulin.
Do not take Metformin tablets
• 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, e.g. severe hyperglycaemia (very high levels of glucose in the blood) or ketoacidosis. Ketoacidosis is a state of health, where substances called 'ketone bodies' accumulate in the blood. Symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath
• if you have kidney problems.
• if your kidney function worsens as a consequence of e.g.
■ loss of too much water (dehydration) due to long-lasting vomiting or severe diarrhoea. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘take special care with Metformin’ below)
• If you have a severe infection, such as infection affecting your lung or bronchial system or your kidney. Severe infection may lead to kidney problems, which can put you at risk for lactic acidosis.(see ‘take special care with Metformin’ below)
• if you have acute or chronic diseases which may lead to reduced amount of oxygen in body tissues (tissue hypoxia) such as
■ heart failure, or difficulties breathing
■ recent heart attack (myocardial infarction)
■ collapse or trauma (shock)
• if you have liver problems, drink a lot of alcohol or suffer from alcoholism 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 surgery
You must stop taking Metformin 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 instruction precisely.
Warnings and precautions
Normal kidney function is essential for treatment with Metformin tablets because of the risk of developing hyperacidity of the blood. This is due to accumulation of lactic acid (lactic acidosis) and is mainly determined by your kidney function. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate treatment. Stop taking Metformin immediately and tell your doctor straight away.
Metformin in itself does not lead to hypoglycaemia (insufficient level of blood sugar), but if you take Metformin with other medicaments for the treatment of diabetes, which can cause hypoglycaemia (e.g. sulfonylureas, insulin or meglitinides) there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased
sweating, fast heart beating, visions disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.
Other medicines and Metformin tablets
If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice' above).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
During maintenance therapy with Metformin tablets starting or stopping any other medicinal therapy can interfere with your blood sugar control.
Please especially inform your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
• corticosteroids (e.g. prednisone) and sympathomimetics
• medicines which increase urine production (loop diuretics, e.g. furosemide)
• specific medicines for the treatment of bronchial asthma (P-agonists, e.g. salbutamol)
• iodinated contrast agents
• medicines containing alcohol.
• Non-steroidal anti-inflammatory drug
Metformin tablets with food, drink and alcohol
Drinking alcohol whilst being treated with Metformin tablets increases the risk of hypoglycaemia (low blood sugar levels) and lactic acidosis. Therefore, you should avoid consumption of alcohol while you are taking Metformin.
Pregnancy, breast-feeding and fertility
Diabetic women who are pregnant or planning to become pregnant, should not be treated with Metformin tablets. Instead, insulin should be used to maintain blood glucose levels as close to normal as possible. Inform your doctor if you are pregnant or thinking of becoming pregnant so that he or she can change you to insulin therapy.
This medicinal product should not be used while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Taking metformin alone (monotherapy) does not cause low blood sugar levels (hypoglycaemia) and therefore has no effect on your ability to drive or use machines.
Taking metformin in combination with other antidiabetic agents (e.g. sulphonylureas, Insulin or meglitinides) may cause low blood sugar levels (with symptoms, such as sweating, fainting, dizziness or weakness) and thus affecting your ability to drive and use machines or work safely. Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Metformin 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.
The dose of Metformin tablets should be determined by the doctor according to your blood sugar levels.
Unless prescribed differently by your doctor, the usual dose is:
Dosage for adults
The usual starting dose is 500 mg or 850mg metformin hydrochloride two or three times a day. The maximum daily dose is 3000 mg metformin hydrochloride, taken as 3 divided doses.
Dosage for children from 10 years of age and adolescents:
The usual starting dose is 500 mg 850mg metformin hydrochloride once a day The dosage can be increased up to the maximum recommended daily dose of 2000 mg metformin hydrochloride per day, 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.
Monitoring
• Your doctor will adapt your dose of Metformin 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 to take Metformin
Take the tablets during or after meals with an adequate amount of liquid. Do not chew the tablets. When taking 2 or more tablets you should spread them out over the day, e.g. 1 tablet each during or after breakfast and dinner.
Talk to your doctor if you think the dose of Metformin tablets are too high or too low.
If you take more Metformin tablets than you should
Inform your doctor immediately if you have taken more tablets than you should have. An overdose of Metformin tablets does not lead to hypoglycaemia but increases the risk of hyperacidity of the blood caused by lactic acid (lactic acidosis). Symptoms of early hyperacidity are similar to the side effects of metformin on the gastrointestinal tract: sickness, vomiting, diarrhoea and abdominal pain. In severe cases you could also get muscle pain and muscle cramps, very fast breathing which you cannot stop, as well as a clouding of consciousness and coma. This may develop within hours and requires immediate emergency treatment in a hospital.
If you forget to take Metformin tablets, take the prescribed amount of Metformin tablets at the next prescribed time and try to keep to the prescription in future. Do not take a double dose to make up for a forgotten dose.
If you stop taking Metformin tablets
If you stop treatment with Metformin tablets you have to be aware of the risk of uncontrolled blood sugar and of the long-term effects of diabetes mellitus such as damage on eyes, kidneys and blood vessels.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Metformin tablets can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Other side effects:
Very common (affects more than 1 in 10 people)
• upset stomach, feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache or loss of appetite. These side effects are most likely to happen at the start of treatment. It helps if you spread the doses over the day and if you take the tablets with or straight after a meal. If symptoms continue, stop taking Metformin and talk to your doctor.
Common (affects more than 1 in 100 people)
• taste of metal in your mouth
Very rare (affects fewer than 1 in 10,000 people)
• lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. If you get this complication, you will need immediate treatment. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, stop taking Metformin immediately and tell your doctor straight away.
• skin rash (including redness, itching, hives).
• low levels of vitamin B12. Over time this may lead to anaemia, a sore mouth or tongue or possibly numbness or tingling in the limbs.
The frequencies of the following side effects are very rare:
• 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 this medicine.
Children and adolescents
Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep this medicine out of the sight and reach of children. If a child is treated with Metformin, parents and caregivers are advised to oversee how this medicine is used.
Do not use Metformin tablets after the expiry date stated on the blister and the carton after "EXP".
Storage conditions
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Metformin tablets contain
The active substance is metformin hydrochloride.
Each film coated tablet contains 500 mg, 850 mg or 1000 mg metformin hydrochloride equivalent to 390 mg, 663 mg, and 780 mg of metformin respectively.
The other ingredients are:
Sodium Starch Glycolate (Type A), Povidone K-30, Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose 15cP, Talc, Titanium Dioxide (E 171), Macrogol 6000, Propylene Glycol.
What Metformin tablets looks like and contents of the pack
Metformin 500 mg film coated tablets are supplied as white to off white round, biconvex, film coated tablets which are plain on both sides.
Metformin 850 mg film coated tablets are supplied as white to off white capsule shaped, biconvex, film coated tablets with scoreline on one side and plain on other side.
Metformin 1000 mg film coated tablets are supplied as white to off white oval shaped, biconvex, film coated tablets, with a deep breakline on one side and breakline on other side.
Metformin 500 mg, 850 mg and 1000 mg film coated tablets are available in blisters containing 1 (x100), 9, 10, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 180, 200, 300, 500, 600 or 1000 film coated tablets or in plastic bottles containing 10, 20, 21, 30, 40, 50, 56, 60, 90, 100, 120, 180, 200, 300, 400, 500, 600 or 1000 film coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
USV Europe Limited,
The Podium, 1 Eversholt Street,
Euston, London NW1 2DN, United Kingdom
Manufacturers
The manufacturer is Accord Healthcare Limited, Sage house, 319 Pinner Road, north Harrow, Middlesex HA1 4HF, United Kingdom.
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Czech Republic Denmark Spain |
APO-METFORMIN 500 mg, 850 mg and 1000 mg Metformin Orifarm Metformin APOTEX 850 mg comprimidos recubiertos con pelicula |
|
The Netherlands |
Metformine HCL USV Europe 500 mg, 850 mg en 1000 mg filmomhulde tabletten |
|
Norway Sweden United Kingdom |
Metformin Orifarm Metformin Orifarm Metformin hydrochloride 500 mg, 850 mg and 1000 mg film coated tablets |
This leaflet was last approved on March 2014
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