Skip to Content

UK Edition. Click here for US version.

METFORMIN 1000 MG FILM-COATED TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

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.
 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. Do not pass it on to others. It may harm them, even if their symptoms 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 is and what it is used for
2. What you need to know before you take Metformin
3. How to take Metformin
4. Possible side effects
5. How to store Metformin
6. Contents of the pack and other information

1. What Metformin is and what it is used for
Metformin 500 mg, 850 mg and 1000 mg 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 helps to lower your blood glucose to as normal a
level as possible.
If you are an overweight adult, taking Metformin over a long period of time also helps to lower the risk of complications
associated with diabetes. Metformin is associated with either a stable body weight or modest weight loss.
Metformin 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 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 on its own or together with insulin.

2. What you need to know before you take Metformin
Do not take Metformin











if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see ‘What
Metformin 500 mg, 850 mg and 1000 mg contains’ in section 6).
if you have severely reduced kidney function.
if you have liver problems.
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.
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').
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').
if you are treated for acute 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 'Warnings and precautions').
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.
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 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 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 diseases).
If any of the above apply to you, talk to your doctor for further instructions.
It is important to you to comply with your medication intake, dietary instructions and regular exercise program
because this can reduce the risk of lactic acidosis.
Stop taking Metformin 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 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 during and for some time after the
procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin.
During treatment with Metformin, 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.
Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin
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

If you need to have an injection of a contrast medium that contain iodine into your bloodstream, for example in
the context of an X-ray or scan, you must stop taking Metformin before or at the time of the injection. Your
doctor will decide when you must stop and when to restart your treatment with Metformin.

1

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.
It is especially important to mention the following:
• medicines which increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAIDs 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).
• other medicines used to treat diabetes.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Metformin with alcohol

Avoid excessive alcohol intake while taking Metformin since this may increase the risk of lactic acidosis (see
section “Warnings and precautions”). 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, 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 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 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
Always take Metformin exactly as your doctor 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.

Recommended dose
Children 10 years and over and adolescents usually start with 500 mg or 850 mg metformin 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 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.
Monitoring
• Your doctor will perform regular blood glucose tests and 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 Metformin with or after a meal. This will avoid you having side effects affecting your digestion.
Swallow each tablet with a glass of water.
500 and 850 mg: The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
1000 mg: The tablet can be divided into equal doses.




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 is too strong or too weak, talk to your doctor or pharmacist.
If you take more Metformin than you should
If you have taken more Metformin that 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 heart beat. If you
experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead
to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straight away.
If you forget to take Metformin
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, Metformin can cause side effects, although not everybody gets them. The following side effects may
occur.

Metformin 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 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. It helps if you
spread the doses over the day and if you take Metformin with or straight after a meal. If symptoms continue, stop
taking Metformin and talk to your doctor.
Common side effects (in less than 1 in 10 people)
• changes in taste.
Very rare side effects (in less than 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 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 heart beat. If you experience some of these symptoms, you should seek immediately medical
attention, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the
nearest hospital straight away.
• 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
and talk to your doctor.
• skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).
• low vitamin B12 level 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 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
Keep 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.
This medicinal product does not require any special storage conditions.
Do not use Metformin after the expiry date which is stated on the carton or the blister after ‘EXP’. The expiry date refers to
the last day of that month.

2

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 500 mg, 850 mg or 1000 mg contains




The active substance is metformin hydrochloride.
One film-coated tablet of Metformin 500 mg contains 500 mg metformin hydrochloride corresponding to 390 mg
metformin base.
One film-coated tablet of Metformin 850 mg contains 850 mg metformin hydrochloride corresponding to 662.9 mg
metformin base.
One film-coated tablet of Metformin 1000 mg contains 1000 mg metformin hydrochloride corresponding to 780 mg
metformin base.
The other ingredients are povidone (K-25), magnesium stearate, hypromellose (5 mPas), Macrogol 6000, Titanium
dioxide (E 171), Talc.

What Metformin looks like and contents of the pack
Metformin 500 mg film-coated tablets are white to off-white, oval film-coated tablets with break mark
on one face. The tablets are supplied in blister packs of 28, 84 or 500 tablets.
Metformin 850 mg film-coated tablets are white to off-white, oblong film-coated tablets with break mark on
both faces. The tablets are supplied in blister packs of 56 or 300 tablets.
Metformin 1000 mg film-coated tablets are white to off-white, oblong film-coated tablets with break mark on
both faces. The tablets are supplied in blister packs of 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Apollo Generics Limited
Unit 6 The Gallery
Furness Avenue
Formby, Liverpool
L373NP
United Kingdom
Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning
Germany

This leaflet was last approved in October 2017.

3

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide