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METFORMIN 500MG TABLETS BP

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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Package leaflet: Information for the user

Metformin 500mg
and 850mg Tablets
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 tablets are and what
they are used for
2 What you need to know before you take
Metformin tablets
3 How to take Metformin tablets
4 Possible side effects
5 How to store Metformin tablets
6 C
 ontents of the pack and other
information

1 W
 hat Metformin tablets are and what they are
used for

Metformin tablets belong to a group of medicines called biguanide
hypoglycaemic agents. These work by lowering the amount of sugar
in the blood.
Metformin tablets may be used for the treatment of non-insulin
dependent (type 2) diabetes which cannot be controlled by diet and
exercise alone. Your doctor may prescribe metformin for you to take
on its own or in combination with other oral antidiabetic medicines
or insulin.

2 W
 hat you need to know before you take
Metformin tablets

Do not take Metformin tablets and tell your doctor if
you:

• are allergic Metformin hydrochloride or any of the ingredients in
this medicine (listed in section 6). An allergic reaction may include
a rash, itching, difficulty breathing or swelling of the face,lips, throat
or tongue
• have liver, heart or breathing problems
• have severely reduced kidney function
• a re a heavy drinker of alcohol (alcoholism)
• h ave recently had a heart attack
• h ave 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.
• are dehydrated (e.g. if you have suffered from diarrhoea or
vomiting recently)
• h ave had a serious infection or recently suffered trauma (shock)
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Warnings and precautions

Talk to your doctor or pharmacist before taking Metrfomin if you:
• h ave been told that the amount of oxygen in your blood is low
•d
 rink too much alcohol
• have fasted for a long time
• h ave a high level of ketones in the body (ketosis).
Risk of lactic acidosis
Metformin tablets 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 disease).
If any of the above applies to you, talk to your doctor for further
instructions.
Stop taking Metformin tablets 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 tablets 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
• s tomach ache (abdominal pain)
•m
 uscle cramps
• a general feeling of not being well with severe tiredness
•d
 ifficulty in breathing
• r educed body temperature and heartbeat
Lactic acidosis is a medical emergency and must be treated in a
hospital.

Other medicines and Metformin tablets

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. Especially:
•m
 edicines to treat high blood pressure such as ACE inhibitors
• c orticosteroids (strong anti-inflammatory medicines, e.g.
prednisolone)
•m
 edicines to treat asthma (e.g. salbutamol, terbutaline,
salmeterol, formoterol).
If you need to have an injection of a contrast medium that contains
iodine into your bloodstream, for example in the context of an X-ray
or scan, you must stop taking Metformin tablets before or at the time
of the injection. Your doctor will decide when you must stop and
when to restart your treatment with Metformin tablets.
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 tablets. It is especially important to mention
the following:
•m
 edicines which increase urine production (diuretics)
•m
 edicines used to treat pain and inflammation (NSAID and COX-2inhibitors, such as ibuprofen and celecoxib)
• c ertain medicines for the treatment of high blood pressure (ACE
inhibitors and angiotensin II receptor antagonists)

continued over page

Metformin with Alcohol

Avoid excessive alcohol intake while taking Metformin tablets since
this may increase the risk of lactic acidosis (see section “Warnings and
precautions”).

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Make sure your blood sugar levels are under control before you drive or
operate machinery.

Diet

Continue to follow any dietary advice that your doctor has given you and
make sure that you eat carbohydrates regularly throughout the day. If you
are overweight, you should continue with your carbohydrate restricted
diet.

Surgery

If you need to have major surgery you must stop taking Metformin tablets
during and for some time after the procedure. Your doctor will decide
when you must stop and when to restart your treatment with Metformin
tablets.

Tests

During treatment with Metformin tablets, 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. Some patients, who have
been taking Metfomin for a long time have experienced reduced levels
of vitamin B12 in their blood. Therefore an annual check on vitamin B12
levels may be carried out.

3 How to take Metformin tablets

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets with or after food. Take this medicine for as long as
your doctor tells you to.

Doses:

Adults: The recommended dose is one tablet two or three times a day.
Your doctor may adjust your dose depending on your blood sugar levels.
The maximum daily dose is 3g.
Elderly: If you are elderly and have reduced kidney function, your doctor
may prescribe a different dose.
Use in children and adolescents: Your doctor will decide if this medicine
is suitable.
Reduced kidney function
If you have reduced kidney function, your doctor may prescribe a lower
dose.

If you take more Metformin tablets than you should:

If you (or someone else) swallow a lot of the tablets at the same time, or if
you think a child may have swallowed any, contact your nearest hospital
casualty department or tell your doctor immediately. Signs of an overdose
include stomach pain, low body temperature, difficulty breathing or coma.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is
nearly time for your next dose. Then go on as before. Never double up on
the next dose to make up for the one missed.

can be signs of a serious diabetic problem.
•M
 etformin tablets 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 tablets and contact a doctor or the nearest hospital
immediately, as lactic acidosis may lead to coma.
Tell your doctor if you notice any of the following side effects or notice
any other effects not listed:
•V
 ery common (occurs in more than 1 in 10 users): diarrhoea, loss of
appetite, feeling or being sick, stomach upset or pain, especially at the
start of treatment.
•C
 ommon (occurs in less than 1 in 10 users): metallic or change in taste.
•V
 ery rare (occurs in less than 1 in 10, 000 users): a mild red rash, hepatitis
(yellowing of the skin or eyes), changes in liver function tests.
Some patients, who have been taking Metformin tablets for a long time,
have experienced reduced levels of vitamin B12 in their blood (a type of
anaemia causing breathlessness on exertion, pale skin and poor resistance
to infections). This would be detected by a blood test.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 reach and sight of children.
Do not store the tablets above 25ºC. Do not use Metformin tablets after
the expiry date stated on the label/carton/bottle. 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 Contents of the pack and other information
What Metformin tablets contain

• The active substance (the ingredient that makes the tablet work) is
metformin hydrochloride. Each tablet contains either 500mg or 850mg of
the active ingredient.
• The tablets also contain: povidone (E1201), stearic acid, colloidal
anhydrous silica.
• The coating contains: methylhydroxypropylcellulose (E464),
titanium dioxide (E171), polyethylene glycol.

What Metformin tablets look like and contents of
the pack
Metformin tablets are white, circular, biconvex, film-coated
tablets.
Metformin tablets are available in pack sizes of 28s, 56s and
84s.
Not all pack sizes may be available.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str,
Dupnitsa 2600, Bulgaria
This leaflet was last revised in December 2016

4 Possible side effects

Like all medicine, this medicine can cause side effects, although not
everybody gets them,
Stop taking Metformin tablets and contact your doctor at once if you
experience:
•A
 n allergic reaction: hives, skin rash affecting the whole body, swelling
of the face, lips, tongue or throat, or difficulty breathing or swallowing.
This is a very serious but rare side effect. You may need urgent medical
attention or hospitalisation.
• S igns of serious problem with your diabetes (diabetic ketoacidosis
or lactic acidosis) such as unexpected weight loss, severe nausea
or vomiting (feeling or being sick), uncontrolled rapid breathing or
abdominal pains. These symptoms can be severe, quick to appear and

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Actavis, Barnstaple, EX32 8NS, UK

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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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