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METFORMIN 1000 MG FILM-COATED TABLETS

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fPACKAGE LEAFLET: INFORMATION FOR THE USER

Metformin 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 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.

In this leaflet:
1.
What Metformin is and what it is used for
2.
Before you take Metformin tablets
3.
How to take Metformin tablets
4.
Possible side effects
5.
How to store Metformin tablets
6.
Further information

1.

What Metformin is and what it is used for

What Metformin is
Metformin film-coated tablets contain metformin, a medicine used 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 properly
use 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.
What Metformin is used for
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.

Before you take Metformin tablets

DO NOT take Metformin tablets:

if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine
(see 'What Metformin tablets contain' in section 6)

if you have kidney or liver problems

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if you have uncontrolled diabetes, such as severe hyperglycaemia 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 'Take special care with Metformin'
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' 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 'Take special care with Metformin'
below)
if you drink a lot of alcohol
if you are breast-feeding.

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 tablets 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.
Take special care with Metformin
Metformin 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 treatment.
Stop taking Metformin tablets immediately and tell your doctor straight away.
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, glinides), there is a risk of hypoglycaemia. If you
experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart
beating, vision disorders or difficulty in concentration it usually helps to eat or drink something
containing sugar.
Taking 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 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 at the same time. You may
need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin:

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)
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corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or
in asthma).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking Metformin tablets with food and drink
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, you think you might be or are planning to become pregnant, so that he or
she may change your treatment.
Do not take this medicine 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, glinides).
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 tablets

Always take Metformin tablets exactly as your doctor has told you to. 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.
Usual 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 take insulin too, your doctor will tell you how to start taking metformin.
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 tablets
Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion.
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Do not crush or chew the tablets. Swallow each tablet with a glass of water.
The 1000 mg tablet has a scoreline which can help you break the tablet to make it easier to swallow.
The scoreline is not intended to divide the tablet 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 tablets than you should
If you have taken more metformin than 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 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 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:
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 the
tablets with or straight after a meal.
If symptoms continue, stop taking Metformin tablets 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. 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 reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria).

low vitamin B12 levels in the blood.
The frequencies of the following side effects are not known:

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
4

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.

5.
tablets

How to store Metformin

Keep out of the reach and sight of
children.
If a child is treated with Metformin 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 tablets 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.
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.
information

Further

What Metformin
contain

tablets

The active substance is metformin. This is present in the form of metformin
hydrochloride.
Metformin 1000 mg
tablets:
Each film-coated tablet contains 1000 mg metformin hydrochloride, corresponding to 780
mg metformin.
- The other ingredients
are: Tablet core:
Povidone, magnesium
stearate. Film-coating:
Hypromellose, macrogol 400 and macrogol
6000.

Metformin 1000 mg
tablets:
White, oval, biconvex, film-coated tablets with a scoreline between ‘6’ and ‘2’ on one side and
‘A’ debossed on the other. The scoreline is only to facilitate breaking for ease of swallowing and
not to divide into equal doses.
Metformin tablets are packed in a blister
pack.
5

Metformin 1000 mg
tablets:
Each box contains 20/30/40/50/60/70/80/90/100/120/180 film-coated tablets in blister packs.

Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Manufacturer
Pfizer Service Company bvba,
10 Hoge Wei,
B-1930 Zaventum,
Belgium,
or
Pfizer Italia s.r.l.,
Località Marino del Tronto,
Ascoli Piceno,
Italy.

or
Pfizer PGM,
Zone Industrielle,
29,route des Industries,
37530 Poce-sur-Cisse,
France.

This leaflet was last approved in 07/2013.

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Expand Transcript

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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