METFORMIN 1000 MG TABLETS

Active substance: METFORMIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

Metformin 1000 mg film−coated tablets (metformin hydrochloride)
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.
What is in this leaflet:
1
2
3

1

What Metformin is and what it is used for
What you need to know before you take Metformin
How to take Metformin

Metformin contains metformin, a medicine 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 use properly 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. Metformin is associated with
either a stable body weight or modest weight loss.
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.

What you need to know
before you take Metformin

Do not take Metformin
if you are allergic to metformin or any of the other
ingredients of this medicine (listed in section 6)
if you have kidney or liver problems
if you have uncontrolled diabetes, with e.g. severe
hyperglycaemia (high blood glucose), nausea,
vomiting, dehydration, rapid weight loss 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 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 ’Warnings
and precautions 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 ’Warnings
and precautions’ below).
if you are treated for heart failure or have recently had
a heart attack, have severe problems with your
circulation (such as shock) 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
’Warnings and precautions below)
if you drink a lot of alcohol
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

Hard to Read?

5
6

Possible side effects
How to store Metformin
Contents of the pack and other information

You must stop taking Metformin 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.

What Metformin is and what
it is used for

What Metformin is

2

4

Warnings and precautions
Please note the following particular risk of lactic
acidosis.
Metformin may cause a very rare, but serious complication
called lactic acidosis, particularly if your kidneys are not
working properly. The risk of lactic acidosis is also
increased with uncontrolled diabetes, prolonged fasting or
alcohol intake. 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 hospital treatment, as lactic acidosis may
lead to coma. Stop taking Metformin immediately and
contact a doctor or the nearest hospital 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, meglitinides), there is a risk of hypoglycaemia. If you
experience symptoms of hypoglycaemia such as weakness,
dizziness, increased sweating, fast heart beating, visions
disorders or difficulty in concentration, it usually helps to eat
or drink something containing sugar.
Other medicines and Metformin
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:
diuretics (used to remove water from the body by
making more urine).
beta−2 agonists such as salbutamol or terbutaline
(used to treat asthma)
corticosteroids (used to treat a variety of conditions,
such as severe inflammation of the skin or in asthma)
other medicines used to treat diabetes
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Metformin with alcohol
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.
This medicine is not recommended if you are breast−feeding
or if you are planning to breast−feed your baby.
Driving and using machinery
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,
meglitinides). Symptoms of hypoglycaemia include

Phone

continued....

0800 970 6115

for help
Till−Ver.4.1s

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

day and if you take Metformin with or straight after a
meal. If symptoms continue, stop taking Metformin
and talk to your doctor.
Common, may affect up to 1 in 10 people
changes in taste.

How to take Metformin

Always take this medicine exactly as your doctor has told
you. You should 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.
* Tablets containing 500 mg and 850 mg active substance
metformin hydrochloride are also available, for individual
dose adjustment.
The recommended dose is:
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.

Very rare, may affect up to 1 in 10,000 people
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 Metformin and talk
to your doctor.
skin reactions such as redness of the skin (erythema),
itching or an itchy rash (hives).
low vitamin B12 levels in the blood.
Children and adolescents
Limited data in children and adolescents showed that
adverse events were similar in nature and severity to those
reported in adults.
If you get any of the side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this
leaflet.

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
Metformin.
Monitoring
Your doctor will perform regular blood glucose tests
and 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
Take Metformin with or after a meal. This will avoid you
having side effects affecting your digestion.
Do not crush or chew the tablets. Swallow each tablet with a
glass of water.
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)
The score line is only there to help you break the tablet if
you have difficulty swallowing it whole.
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 than you should
If you have taken more Metformin that 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. If this happens to you,
you may need immediate hospital treatment, as lactic
acidosis may lead to coma. Contact a doctor or the
nearest hospital straight away.
If you forget to take Metformin
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

5

How to store Metformin

Keep this medicine out of the sight and reach of children. If
a child is treated with Metformin, 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 this medicine after the expiry date which is
stated on the carton, the bottle or the blister after ’EXP ’.
The expiry date refers to the last day of that month.
Do not throw away medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
environment.

6

Contents of the pack and
other information

What Metformin contains
The active substance is metformin hydrochloride.
Each film−coated tablet contains 1000 mg metformin
hydrochloride equivalent to 780 mg of metformin.
The other ingredients are:
Povidone K 90, magnesium stearate, hypromellose,
macrogol 4000, colouring agent titanium dioxide (E171)
What Metformin looks like and contents of the pack
Metformin are white, oval, biconvex film−coated tablets,
scored, embossed ˆM 1G˜ on one side and available in
PVC aluminium blisters of 20, 30, 60, 90, 120,180,
200 and 300 tablets
HDPE bottles with LDPE caps of 100 and 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd
3 Howard Road.
Eaton Socon, St Neots
Cambridgeshire,
PE19 8ET
United Kingdom.
This medicinal product is authorised in the Member
States of the EEA under the following names:

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Metformin can rarely cause a serious condition 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 hospital treatment, as lactic acidosis may
lead to coma. Stop taking Metformin immediately and
contact a doctor or the nearest hospital straight away.

Metformin 1000mg film−coated tablets − PL 11311/0258

This leaflet was last revised in March 2013.

Other possible side effects
Very common, may affect 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

Hard to Read?

Phone

0800 970 6115

for help
Till−Ver.4.1s

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Metformin
1000mg Tablets
PIL
175 x 360 mm
Font SansSerif − Min. Text 8pt
Till−Ver.4.1s
14/03/2013
Pantone Black CVC

Expand view ⇕

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.

Hide
(web3)