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METFORMIN 500MG FILM-COATED TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN 500mg & 850mg 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 effect not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Metformin Tablets are and what they are 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 TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your Medicine is Metformin 500mg Tablets
or Metformin 850mg Tablets. They contain the active
ingredient called Metformin hydrochloride.
Metformin is one of a group of medicines called oral
hypoglycaemics, which work by reducing the level of
sugar in the blood.
Metformin tablets are used for the treatment of type II
diabetes (a condition in which your body does not make
enough insulin or where the insulin that your body
produces does not work as well as it should) not controlled
by diet and exercise alone. Your doctor may prescribe
Metformin tablets for you to take on its own or in
combination with other oral anti-diabetic medicines called
sulphonylureas, or insulin.
2. BEFORE YOU TAKE METFORMIN TABLETS
Do not take Metformin Tablets if you:
• are allergic to Metformin Hydrochloride or any of the
ingredients in this medicine (see section 6)
• have failed to respond to the treatment with other
anti-diabetics, called sulphonylureas
• have had serious complications with your diabetes
(eg.diabetic coma or ketones in your urine)
• suffer from kidney disorders
• have problems with your liver
• have had heart failure or have recently had a heart
attack
• have problems with your circulation causing, for
example, frequent cramp in your calves or leg ulcers
that do not heal
• have had a serious infection or recently suffered trauma
(shock)
• are dehydrated (eg if you have suffered from diarrhoea
or vomiting recently)
• are on a very low calorie diet (less than 1000 calories
per day)
• are a heavy drinker of alcohol
• have been told that the amount of oxygen in your
blood is low

Take special care with Metformin tablets:
Tell your doctor before you start to take this medicine if you:
• are elderly
• are a patient with prostatic hypertrophy or impairment
of micturition
• have low blood pressure
• are likely to have surgery under general anaesthesia
within the next few days
• are going to have a certain type of x-ray with an
injectable dye. You will need to stop taking Metformin
Tablets at the time of and for a few days after the
procedure.
If you are already on insulin you should only be started on
a course of treatment with Metformin tablets in hospital.
Taking other medicines
You should tell your doctor if you are taking or have taken
any of the following medicines as they may interact with
your Metformin Tablets.
Examples of medicines that can affect Metformin tablets are:
• Medicines like Insulin, other antidiabetics and guar
• Monoamine-oxidase inhibitors (MAO inhibitors) used
to treat depression
• Antibiotics known as Tetracyclines, such as
Oxytetracycline
• Anti-inflammatory painkillers like Salicylates or
Pyrazolones
• Medicine like Cyclophosphamide used to treat cancer
• Beta-blockers, such as Atenolol for high blood
pressure
• Medicines like ACE inhibitors, such as Lisinopril for
high blood pressure
• Other medicines used to treat high blood pressure such
as Clonidine, Reserpine, Diazoxide or Guanethidine
• Adrenaline and other sympathomimetics used to treat
allergic conditions and heart attacks
• Glucagon used to control hypoglycaemia (low blood
sugar)
• Thyroid hormones such as Thyroxine sodium used for
underactive thyroid glands
• Water tablets (Diuretics) like Furosemide
• H2 blockers, such as Cimetidine, used to heal stomach
ulcers
• Phenprocoumone, used to thin the blood
• Oestrogen and progesterone (female) hormones, such
as the ‘‘Pill’’, or hormone replacement therapy
• Antipsychotic drugs, such as Phenothiazines
• Medicines such as Steroids used to treat inflammatory
and allergic disorders
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and Breast Feeding
Do not take Metformin Tablets if you are, or planning to
become pregnant. Tell you doctor if you are breast feeding
before taking this medicine.
Driving and using machines
Metformin tablets on their own should not affect your
ability to drive, but if you are taking any other medicines
which lower the blood sugar it is possible that their
combined effects could make you feel faint, dizzy, weak
or jittery. If this happens you should not drive or operate
any machinery until you have recovered.

Taking Metformin Tablets with food and alcohol
You can take Metformin Tablets with or after food. Do not
drink excessive alcohol or take medicines that contain
alcohol whilst taking these tablets.
You should continue to follow any dietary advice that
your doctor has given you and should make sure that you
eat carbohydrates regularly throughout the day. If you are
overweight, you should contain with your energy
restricted diet.
3. HOW TO TAKE METFORMIN TABLETS
Always take Metformin Tablets exactly as your doctor has
told you.You should check with your doctor or pharmacist
if you are not sure.
If you are taking Metformin tablets continuously, you
should have regular blood tests to check your blood
glucose levels, kidney function and vitamin B12 levels.
Method of Administration
These tablets should be taken with a glass of water during
or after meals. Do not chew.
Dosage
Adults and elderly: The usual starting dose is one 500mg
tablet three times a day or one 850mg tablet twice a day,
which is gradually increased until the right dose for you is
found. The maximum dose is six 500mg tablets or three
850mg tablets daily taken in divided doses.
Children: Metformin Tablets should not be taken by
children.
If you take more Metformin tablets than you should
If you or anyone else has swallowed a lot of the tablets all
together, contact your nearest hospital casualty
department or doctor immediately.
If you forget to take Metformin Tablets
If you forget to take a dose, take it as soon as you
remember. Do not take a double dose to make up for a
forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin Tablets can cause
side-effects, although not everybody gets them. Stop
taking Metformin Tablets and tell your doctor
immediately if you experience any of the following side
effects.
• Allergic Reactions. An allergic reaction may include a
rash, itching, swelling of throat or difficulty in breathing.
Below are the other side effects that you may experience:
Common side effects
• Symptoms of upset stomach such as abdominal pain,
nausea, vomiting, diarrhoea or loss of appetite
• Metallic taste
Taking the tablets during or after meals usually helps to
prevent these effects. When an increase in the dose is
prescribed, a gradual change to the higher dose lessens the
likelihood of these symptoms occurring.
Very rare side effects
• Redness of the skin (rash) and/or itching
• Lower blood sugar than normal (Hypoglycaemia)
• Hepatitis (a liver disoder)
• Decrease of Vitamin B12 levels




Decrease in the number of cells in the blood, including
a lower red blood count (anaemia)
A condition called as lactic acidosis (excess of lactic
acid in your blood), particularly those whose kidneys
are not working properly. Symptoms include: Feeling
cold or uncomfortable, severe nausea or vomiting,
abdominal pain, unexplained weight loss, or rapid
breathing).

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 at
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 TABLETS
Keep out of the sight and reach of children.
Do not use Metformin Tablets after the expiry date which
is stated on the pack. The expiry date refers to the last date
of that month. Do not store above 25°C. Store in the
original package.
6. FURTHER INFORMATION
What Metformin Tablets contain:
The active substance is Metformin Hydrochloride.
The other ingredients are:
Sodium Starch Glycollate, Maize Starch, Povidone,
Colloidal Anhydrous Silica, Magnesium Stearate,
Hypromellose, Titanium Dioxide E171, Propylene
Glycol, Macrogol 6000 and Purified Talc.
What Metformin Tablets look like and contents of pack:
Metformin 500mg Tablets: White/off white, round,
biconvex tablets marked FIL/M500 on one side and plain
on the other.
Metformin 850mg Tablets: White/off white, round,
biconvex tablets marked FIL/M850 on one side and plain
on the other.
Pack size
500mg - 28, 84, 504 tablets in blister pack and 504 tablets
in securitainers.
850mg - 56, 84, 308 tablets in blister pack and 308 tablets
in securitainers.
Not all pack sizes may be marketed.
This leaflet was last revised in: February 2016
PL 21880/0199
PL 21880/0200

0199-0200/O/PIL/001/I
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail: info@medreich.co.uk

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Further information

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

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