METFORMIN HYDROCHLORIDE 500MG FILM-COATED TABLETS

Active substance: METFORMIN HYDROCHLORIDE

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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
(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.
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 contains the active substance metformin hydrochoride, 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.
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 to metformin or any of the other ingredients of this medicine (listed in section 6)
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if you have kidney or liver problems
if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea,
vomiting, dehydration, rapid weight loss or ketoacidosis. Ketoacidosis is a condition in which
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 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’ below).
if you have recently suffered an injury or trauma (shock).
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 'Warnings and precautions’ below).
if you are treated for heart failure or have recently had a heart attack, have severe problems with
your circulation 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 'Warnings and precautions' 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Metformin hydrochloride.
Metformin hydrochloride may cause a very rare, but serious complication called lactic acidosis,
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 tell your doctor straight away.
The risk of lactic acidosis is increased if you:
• have poorly controlled diabetes
• have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body
and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination
and muscular stiffness)
• undergo a prolonged period of fasting
• drink a lot of alcohol
• have liver problems
• have low levels of oxygen in the blood.
You need to eat carbohydrates regularly throughout the day. If your doctor has given you advice on
your diet, you need to continue to follow this.
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.
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.
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Children and adolescents
Metformin hydrochloride is not recommended for use in children under 10 years of age. 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.

Other medicines and Metformin hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
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
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 at the same
time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of
Metformin hydrochloride:
• 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)
Metformin hydrochloride with 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 and breast-feeding
During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are pregnant, think
you may be pregnant or are planning to have a baby, so that he or she may change your treatment.
It is recommended not to take this medicine if you are breast-feeding or if you are planning to breastfeed your 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 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 in adults is 500 mg or 850 mg Metformin hydrochloride two or three times a
day. The maximum daily dose is 3000 mg taken as 3 divided doses.

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If you take insulin too, your doctor will tell you how to start Metformin hydrochloride.
Use in children 10 years of age and over and adolescents
Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin
hydrochloride 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.
Monitoring
• your doctor will adapt your dose of Metformin hydrochloride 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.
Method of administration
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).
The 1000 mg tablet can be divided into equal doses.
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 than you should
If you have taken more Metformin hydrochloride 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. Talk to your doctor
or pharmacist straight away.
If you forget to take Metformin hydrochloride
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you stop taking Metformin hydrochloride
If you suddenly stop taking Metformin hydrochloride your blood glucose level may rise. Speak to your
doctor before stopping this medicine.
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.
If you think you may have any of the following side effects, stop taking this medicine
immediately and go to your nearest hospital emergency room straight away. These side effects
are very rare (may affect up to 1 in 10,000 people) but you may need immediate medical
attention:
- 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. Lactic acidosis can lead to coma

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-

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).

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 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)

• skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria)
• low vitamin B12 levels in the blood.
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 the 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

Keep out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after
EXP. The expiry date refers to the last day of the 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 any medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Metformin hydrochloride contains
The active substance is metformin (as hydrochloride).
Each 500 mg tablet contains 500 mg metformin hydrochloride equivalent to metformin base 390 mg.
Each 850 mg tablet contains 850 mg metformin hydrochloride equivalent to metformin base 662.9 mg.
Each 1000 mg tablet contains 1000 mg metformin hydrochloride equivalent to metformin base 780
mg.
The other ingredients are:
Core: povidone K-30, magnesium stearate,
Film-coat: hypromellose, hydroxypropyl cellulose and macrogol 400 and 8000.
What Metformin hydrochloride looks like and contents of the pack
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500 mg: White, round, normal convex, film-coated tablets plain on both sides.
850 mg: White, round, normal convex, film-coated tablets plain on both sides.
1000 mg: White, oval, film coated tablet, debossed “MF” and “3” on either side of the breakline on
one side and “G” on the other side.
Metformin hydrochloride tablets are packed in blister packs (PVC aluminium) containing 10, 15, 20,
28, 30, 40, 50, 56, 60, 84, 90, 100, 120 and 180 tablets and bottles (high density polyethylene) with
caps (polypropylene) containing 180, 200, 300, 400 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Ltd. t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland
Mylan BV, Dieselweg 25, 3752 LB Bunschoten, the Netherlands
This leaflet was last revised in 04/2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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