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
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 signs of illness are the same as yours.
- 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.
What is in this leaflet:
1. What Metformin hydrochloride is and what it is used for
2. What you need to know before you take Metformin hydrochloride
3. How to take Metformin hydrochloride
4. Possible side effects
5. How to store Metformin hydrochloride tablets
6. Contents of the pack and other information
1. WHAT METFORMIN HYDROCHLORIDE IS AND WHAT IT IS USED FOR
What Metformin hydrochloride is
Metformin hydrochloride tablet contains 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 helps to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin hydrochloride over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin hydrochloride is associated with either a stable body weight or modest weight loss.
What Metformin hydrochloride is used for
Metformin hydrochloride is 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 on its 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 on its own or together with insulin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN HYDROCHLORIDE
Do not take Metformin hydrochloride
• if you are allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medicine (see 'What Metformin hydrochloride tablet contains' in section 6)
• if you have kidney or liver problems
• if you have uncontrolled diabetes, such as severe hyperglycaemia, nausea, vomiting, dehydration, rapid weight loss 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 unusual fruity odour of the breath
• if you 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 'Take special care with Metformin hydrochloride ' below)
• if you 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 'Take special care with Metformin hydrochloride ' below)
• if you are treated for 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 in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Take special care with Metformin hydrochloride ' below)
• 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.
Please note the following particular risk of lactic acidosis: 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 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
Please note the following particular risk of lactic acidosis: Metformin hydrochloride may cause a very rare, but serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake. 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, , as lactic acidosis may lead to coma. Stop taking Metformin hydrochloride tablets immediately and contact a doctor or the nearest hospital straight away.
Metformin hydrochloride on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin hydrochloride 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, visions disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.
Other medicines and Metformin hydrochloride
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 hydrochloride tablets for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice' above).
Tell your doctor if you take any of the following medicines and Metformin hydrochloride tablets at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin hydrochloride:
• angiotensin-converting enzyme inhibitors (used to treat a variety of heart and blood vessel conditions, such as high blood pressure or heart failure)
• diuretics (used to remove water from the body by making more urine)
• 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)
• other medicines used to treat diabetes
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Metformin hydrochloride tablets with food, drink and alcohol
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, breast-feeding and fertility
During pregnancy, you need insulin to treat your diabetes. 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.
Driving and using machines
Metformin hydrochloride on its 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 heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.
3. HOW TO TAKE METFORMIN HYDROCHLORIDE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Metformin hydrochloride 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 recommended dose is:
Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin hydrochloride tablets 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 tablets two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses.
If you take insulin too, your doctor will tell you how to start Metformin hydrochloride tablets.
Monitoring
• Your doctor will perform regular blood glucose test and 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 to take Metformin hydrochloride tablets
Take the 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 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 that you should have, you may experience lactic acidosis. 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 hospital tratment, as lactic acidosis may lead to coma. Talk to your doctor or pharmacist 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 medicine, 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:
Very common side effects (may affect 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. 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 hydrochloride tablets and talk to your doctor.
Common side effects (may affect up to 1 in 10 people)
• changes in taste.
Very rare side effects (may affect up to 1 in 10,000 people)
• lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly.
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 hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin hydrochloride immediately and contact a doctor or the nearest hospital straight away.
• skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria).
• low vitamin B12 levels in the blood.
• 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.
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: www.mhra.gov.uk/yellowcard. By reporting side effects 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. If a child is treated with Metformin hydrochloride tablets, parents and caregivers are advised to oversee how this medicine is used.
This medicinal product does not require any special storage conditions.
Do not use Metformin hydrochloride tablets after the expiry date which is stated on the label, carton or blister after 'EXP'. The expiry date refers to the last day of that month.
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Metformin hydrochloride tablet contains
- The active substance is metformin hydrochloride.
Metformin hydrochloride 500 mg tablets:
Each film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin.
Metformin hydrochloride 850 mg tablets:
Each film-coated tablet contains 850 mg metformin hydrochloride corresponding to 663 mg metformin.
- The other ingredients are:
Tablet core: Povidone, magnesium stearate.
Film-coating: Hypromellose, macrogol.
What Metformin hydrochloride tablets looks like and contents of the pack
Film-coated tablet.
Metformin hydrochloride 500 mg tablets:
White, round rdiametre 11mm1. biconvex, film-coated tablets with ‘A’ debossed on one side and ‘60’ debossed on the other side.
Metformin hydrochloride 850 mg tablets:
White, round rdiametre 12.70 mm1, biconvex, film-coated tablets with ‘A’ debossed on one side and ‘61’ debossed on the other side.
Metformin hydrochloride tablets are packed in a blister pack (Clear PVC / PVdC / aluminium) or (Clear PVC/Aluminium) or White opaque HDPE bottle packs with polypropylene closure.
Metformin hydrochloride 500 mg & 850 mg tablets:
Each box contains 20/28/30/40/42/50/56/60/70/80/84/90/98/100/120/180/200/ 300/400 film-coated tablets in blister packs, each blister containing 10 or 14 film-coated tablets. White opaque HDPE bottle packs containing 90,100, 400 or 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
Manufacturer
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
or
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria Diabetormin 850 mg/1000 mg Filmtabletten
Denmark Metformin “Aurobindo"
Estonia Metformin Aurobindo
Finland Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg tabletti,
kalvopaallysteinen
France METFORMINE ARROW LAB 500 mg/ 850 mg/ 1000 mg,
comprimes pellicules
Germany Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg
Filmtabletten
Greece GLYCOFREN 850 mg/ 1000 mg £-mKaAujiji£vo |j£ Aehto
uji£vio 5iaKa
Ireland Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg film-coated
tablets
Italy METFORMINA DOC Generici 500 mg/ 850 mg/ 1000 mg,
compresse rivestite con film
Latvia Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg, apvalkotas
tabletes
Netherlands Metformine HCl Aurobindo 500 mg/ 850 mg/ 1000 mg, filmomhulde tabletten
Poland Metformin Aurobindo
Portugal Metformina Aurobindo
Romania Metformin Aurobindo 500 mg/ 850 mg/ 1000 mg
comprimate filmate
Spain Metformina ratiopharm 850 mg comprimidos recubiertos
con pelfcula
Sweden Metformin Aurobindo
United Kingdom Metformin hydrochloride 500 mg/ 850 mg film-coated tablets
This leaflet was last revised in 07/2015.
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