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METFORMIN 500 MG FILM-COATED TABLETS BP

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

METFORMIN 500mg FILM-COATED TABLETS BP
METFORMIN 850mg FILM-COATED TABLETS BP
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 500mg / 850mg film-coated tablets BP are and what they are used for
2. Before you take Metformin 500mg / 850mg film-coated tablets BP
3. How to take Metformin 500mg / 850mg film-coated tablets BP
4. Possible side effects
5. How to store Metformin 500mg / 850mg film-coated tablets BP
6. Further information

1. WHAT METFORMIN 500 mg / 850 mg
FILM-COATED TABLETS BP ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Metformin 500mg film-coated
tablets BP or Metformin 850mg film-coated tablets BP.
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 500mg / 850mg film-coated tablets BP 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 500mg / 850mg
film-coated tablets BP for you to take on their own or in
combination with other oral anti-diabetic medicines called
sulfonylureas, or insulin.

2. BEFORE YOU TAKE METFORMIN 500 mg
/ 850 mg FILM-COATED TABLETS BP
Do not take Metformin 500mg / 850 mg film-coated
tablets BP 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 sulfonylureas
• have had serious complications with your diabetes (e.g.
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 (e.g. 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 500mg / 850mg
film-coated tablets BP:
Talk to 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
500mg / 850mg film-coated tablets BP 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 500mg / 850mg
film-coated tablets BP 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 500mg / 850mg film-coated tablets BP.
Examples of medicines that can affect Metformin 500mg /
850mg film-coated tablets BP are:
• Medicines like insulin, other antidiabetics and guar
• Monoamine-oxidase inhibitors (MAO inhibitors) used to
treat depression
• Antibiotics know as tetracyclines, such as oxytetracycline
• Lipid regulating drugs, such as clofibrate and nicotinic
acid derivatives
• 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 medicine
obtained without prescription.
Pregnancy and Breast Feeding
Do not take Metformin 500mg / 850mg film-coated tablets
BP if you are, or planning to become pregnant. Tell your
doctor if you are breast feeding before taking this medicine.

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Driving and using machines
Metformin 500mg / 850 mg film-coated tablets BP 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 500mg / 850 mg film-coated
tablets BP with food and alcohol
You can take Metformin 500mg / 850mg film-coated
tablets BP 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 continue with your energy
restricted diet.

3. HOW TO TAKE METFORMIN 500 mg /
850 mg FILM-COATED TABLETS BP
Always take Metformin 500mg / 850mg film-coated tablets
BP exactly as your doctor or pharmacist has told you. You
should check with your doctor or pharmacist if you are not
sure.
If you are taking Metformin 500mg / 850mg film-coated
tablets BP 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 film-coated tablet three times a day or one 850mg
film-coated tablet twice a day, which is gradually
increased until the right dose for you is found. The
maximum dose is six 500mg film-coated tablets or three
850mg film-coated tablets daily taken in divided doses.
Children: Metformin tablets should not be taken by
children.
If you take more Metformin 500mg / 850mg
film-coated tablets BP 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 500mg / 850mg
film-coated tablets BP
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 500mg / 850mg film-coated
tablets BP 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 disorder)

• 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 in 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).
Some people may have side-effects when taking this
medicine. If you have any unwanted side-effects or if you
notice any side-effect not listed in this leaflet, please tell your
doctor, pharmacist or other healthcare professional.
Also you can help to make sure that medicines remain as
safe as possible by reporting any unwanted side-effects via
the internet at www.mhra.gov.uk/yellowcard alternatively
you can call Freephone 0808 100 3352 (available between
10am-2pm Monday – Friday) or fill in a paper form available
from your local pharmacy.

5. HOW TO STORE METFORMIN 500 mg /
850 mg FILM-COATED TABLETS BP
Keep out of the sight and reach of children.
Do not use Metformin 500mg / 850mg film-coated tablets
BP after the expiry date which is stated on the pack. The
expiry date refers to the last day of that month. Do not
store above 25°C. Store in the original bottle / blister pack
to protect from light and moisture.

6. FURTHER INFORMATION
What Metformin 500mg / 850 mg film-coated tablets
BP 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 500mg / 850 mg film-coated tablets
BP look like and contents of the pack:
Metformin 500mg film-coated tablets BP: White/off white,
round, biconvex, tablets marked tablets marked FIL on one
M500
side and plain on the other.
Metformin 850mg film-coated tablets BP: White/off white,
round, biconvex tablets marked FIL on one side and plain
M850
on the other.
Pack sizes
500mg - 28, 84, 504 film-coated tablets in blister packs
and 504 tablets in securitainers.
850mg - 56, 84, 308 film-coated tablets in blister packs
and 308 tablets in securitainers.
Not all pack sizes may be marketed.
Product MA Holder: GlobeGen Laboratories Ltd.,
1406 Coventry Road, Yardley, Birmingham, B25 8AE, UK.
Manufacturer (1): Milpharm Limited, Area,
Odyssey Business Park, West End Road, South Ruislip
HA4 6QD, United Kingdom.
Manufacturer (2): Medreich PLC, Warwick House,
Plane Tree, Crescent, Feltham, TW13 1HF, UK
This leaflet was last revised in June 2016.
PL41318/0024, PL41318/0025

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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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