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METFORMIN 500MG TABLETS BP

Active substance(s): METFORMIN HYDROCHLORIDE

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Metformin 500mg
and 850mg Tablets
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.

In this leaflet
1 W
 hat Metformin tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What 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.

Before you take
2 

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

• have ever had an allergic reaction to Metformin
tablets or any of the ingredients in the tablet (see
section 6). An allergic reaction may include a rash,
itching, difficulty breathing or swelling of the face, lips,
throat or tongue
• have kidney, liver, heart or breathing problems
• are a heavy drinker of alcohol (alcoholism)
• have recently had a heart attack
• have had serious complications with your diabetes
(e.g. diabetic coma or ketones in your urine)
• are dehydrated (e.g. if you have suffered from
diarrhoea or vomiting recently)
• have had a serious infection or recently suffered
trauma (shock)

Check with your doctor or pharmacist before
taking Metformin tablets if you:
• have been told that the amount of oxygen in your
blood is low
• drink too much alcohol
• have fasted for a long time
• have a high level of ketones in the body (ketosis).

Taking other medicines

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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).

Alcohol

You are advised not to drink alcohol with this medicine.
If you have any questions, discuss this with your doctor.

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 see another doctor or go into hospital for surgery
or x-rays, tell them you are taking Metformin. You may
be given advice to stop Metformin tablets for a while.

Tests

If you have diabetes, you should have your blood or
urine tested for sugar regularly. Your doctor should
check your kidney function at least once a year
(more often if you are elderly or have kidney problems).
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.

continued top of next column

continued over page

148x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Metformin 500mg & 850mg Tablets PIL - UK

approved for print/date

1. Black

item no: AAAH7025

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 25.02.15

min pt size: 7

originated by: S.Anson
revision date: 09.03.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

2.
3.
4.
5.
6.
Non Printing Colours
1. Text safe area
2.
3.

Metformin Tablets
500 & 850mg x28, 56 & 84’s (UK)
JDE No.:

50847293

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 1943
Date Sent:
23/02/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

How to take
3 

Always take Metformin tablets exactly as your doctor has told
you. If you are not sure, check with your doctor or pharmacist.

How to store
5 

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.

Swallow the tablets with or after food. Take this medicine for
as long as your doctor tells you to.
Doses:
Adults: 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.
Children: Your doctor will decide if this medicine is suitable.

Further information
6 

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.

Possible side effects
4 

Stop taking Metformin tablets and contact your doctor at
once if you experience:
• An 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.
• Signs 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 can be signs
of a serious diabetic problem.

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 February 2015

Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
• Very 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.
• Common (occurs in less than 1 in 10 users): metallic or
change in taste.
• Very 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.
continued top of next column
50847293 AAAH7025

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)
colours/plates:

Metformin 500mg & 850mg Tablets PIL - UK

approved for print/date

1. Black

item no: AAAH7025

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 25.02.15

min pt size: 7

originated by: S.Anson
revision date: 09.03.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

2.
3.
4.
5.
6.
Non Printing Colours
1. Text safe area
2.
3.

Metformin Tablets
500 & 850mg x28, 56 & 84’s (UK)
JDE No.:

50847293

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 1943
Date Sent:
23/02/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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