METFORMIN 500 MG TABLETS

Active substance: METFORMIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PAGE 1: FRONT FACE (INSIDE OF REEL)

Metformin hydrochloride

PACKAGE LEAFLET: INFORMATION
FOR THE USER

(Main)

Pharma code 242

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 become troublesome,
or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Metformin is and what it is used for
2. Before you take Metformin
3. How to take Metformin
4. Possible side effects
5. How to store Metformin
6. Further information

1

WHAT METFORMIN IS AND WHAT IT IS
USED FOR

What Metformin is
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.
In clinical studies, use of metformin was 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.

2

BEFORE YOU TAKE METFORMIN

Do not take Metformin
• If you are allergic (hypersensitive) to metformin
or any of the other ingredients of this medicine
(see 'What Metformin contains' in section 6)
• If you have kidney or liver problems
• If you have uncontrolled diabetes, such as 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 'Take special care with
Metformin' 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 'Take special care
with Metformin' below)

• If you are treated for heart failure or have
recently had a heart attack, have severe
problems with your circulatory system 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 'Take special care
with Metformin’ 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.
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.
Take special care with Metformin
• Metformin may cause a 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
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 it together with
other medicines to treat diabetes that can cause
hypoglycaemia (such as sulphonylureas, insulin,
glinides), there is a risk of hypoglycaemia. If you
experience symptoms of hypoglycaemia such
as weakness, dizziness, increased sweating, fast
heart beating, vision disorders or difficulty in
concentration, it usually helps to eat or drink
something containing sugar.
Taking other medicines
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.
Taking Metformin with food and drink
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, think
you might be or are planning to become
pregnant, so that he/she may change your
treatment
• Metformin is not recommended if you are
breast-feeding or if you are planning to
breast-feed your baby
• Ask your doctor or pharmacist for advice before
taking any medicine.

Top of page cut-off to middle of registration mark: 44 mm.

METFORMIN 500 mg TABLETS
METFORMIN 850 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Driving and using machines
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 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.

These side effects most often happen at the
beginning of the treatment with Metformin. It
helps if you spread the doses over the day and
if you take the tablets with or straight after a
meal. If symptoms continue, stop taking
Metformin and talk to your doctor.

Common side effects (in fewer than one in 10 users):
• Changes in taste.
Very rare side effects (in fewer than one in 10,000
users):
• Lactic acidosis. This is a very rare but serious
complication particularly if your kidneys are not
working properly. If you get this complication,
you will need immediate treatment.
HOW TO TAKE METFORMIN
3
Symptoms of lactic acidosis are vomiting,
bellyache (abdominal pain) with muscle
Always take Metformin exactly as your doctor has
cramps, a general feeling of not being well with
told you. Check with your doctor or pharmacist if
severe tiredness, and difficulty in breathing. If
you are not sure.
this happens to you, you may need immediate
Metformin cannot replace the benefits of a
hospital treatment, as lactic acidosis may lead
healthy lifestyle. Continue to follow any advice
to coma. Stop taking Metformin immediately
about diet that your doctor has given you and get
and contact a doctor or the nearest hospital
some regular exercise.
straight away
• Skin reactions such as redness of the skin
Usual dose
(erythema), itching or an itchy rash (urticaria)
Children 10 years and over and adolescents
• Low vitamin B12 levels in the blood
usually start with 500 mg or 850 mg Metformin
• Abnormalities in liver function tests or hepatitis
once a day. The maximum daily dose is 2000 mg
(inflammation of the liver; this may cause
taken as 2 or 3 divided doses. Treatment of
tiredness, loss of appetite, weight loss, with or
children between 10 and 12 years of age is only
without yellowing of the skin or whites of the
recommended on specific advice from your
eyes). If this happens to you, stop taking this
doctor, as experience in this age group is limited.
medicine and talk to your doctor.
Adults usually start with 500 mg or 850 mg
Children and adolescents
Metformin two or three times a day. The maximum
Limited data in children and adolescents showed
daily dose is 3000 mg taken as 3 divided doses.
that adverse events were similar in nature and
If you take insulin too, your doctor will tell you
severity to those reported in adults.
how to start Metformin.
If any of these side effects get serious, or if you
Monitoring
notice any side effects not listed in this leaflet,
• Your doctor will perform regular blood glucose please tell your doctor or pharmacist.
tests and adapt your dose of Metformin to your
blood glucose levels. Make sure that you talk to
5 HOW TO STORE METFORMIN
your doctor regularly. This is particularly
important for children and adolescents or if you Keep out of the reach and sight of children.
are an older person
Do not use this medicine after the expiry date
• Your doctor will also check at least once a year shown on the blister and the carton. The expiry
how well your kidneys work. You may need
date refers to the last day of the month.
more frequent checks if you are an older person
This medicinal product does not require any
or if your kidneys are not working normally.
special storage conditions.
How to take Metformin
Medicines should not be disposed of via
Take the tablets with or after a meal. This will avoid wastewater or household waste. Ask your
you having side effects affecting your digestion.
pharmacist how to dispose of medicines no
Do not crush or chew the tablets. Swallow each
longer required. These measures will help to
tablet with a glass of water.
protect the environment.
• If you take one dose a day, take it in the
morning (breakfast)
6 FURTHER INFORMATION
• If you take two divided doses a day, take them
in the morning (breakfast) and evening (dinner) What Metformin contains
• If you take three divided doses a day, take them • The active substance is metformin hydrochloride.
Metformin 500 mg: Each tablet contains 500 of
in the morning (breakfast), at noon (lunch) and
metformin hydrochloride corresponding to
in the evening (dinner).
390 mg of metformin.
If, after some time, you think that the effect of
Metformin 850 mg: Each tablet contains 850 mg
Metformin is too strong or too weak, talk to your
of metformin hydrochloride corresponding to
doctor or pharmacist.
662.9 mg of metformin
If you take more Metformin than you should
• The other ingredients are as follows:
If you have taken more Metformin than you
Core: povidone (K30/K90), anhydrous colloidal
should have, you may experience lactic acidosis.
silica, magnesium stearate Film-coating:
Symptoms of lactic acidosis are vomiting,
hypromellose (E464), macrogol 400 and the
bellyache (abdominal pain) with muscle cramps, a
colour titanium dioxide (E171).
general feeling of not being well with severe
What Metformin looks like and contents of the pack
tiredness, and difficulty in breathing. If this happens
to you, you may need immediate hospital treatment, Metformin comes in 2 different strengths of tablets
as lactic acidosis may lead to coma. Contact a doctor which can be identified by their inscription:
• Metformin 500 mg Tablets: white to off-white
or the nearest hospital straight away.
film-coated oval-shaped tablets, debossed with
If you forget to take Metformin
“93” on one side and “48” on the other.
Do not take a double dose to make up for a
• Metformin 850 mg Tablets: white to off-white
forgotten dose. Take the next dose at the usual time.
film-coated oval-shaped tablets, debossed with
“93” on one side and “49” on the other.
If you have any further questions on the use of
Metformin 500 mg comes in packs of 20, 28, 30, 50,
this product, ask your doctor or pharmacist.
56, 60, 84, 90, 100, 120, 180, 200, 400 and 500 tablets.
Metformin 850 mg comes in packs of 20, 28, 30, 40,
4 POSSIBLE SIDE EFFECTS
50, 56, 60, 90, 100, 120, 180, 200, 250 and 300 tablets.
Not all pack sizes may be marketed.
Like all medicines, Metformin can cause side
effects, although not everybody gets them.
Marketing Authorisation Holder and Manufacturer is
TEVA UK Ltd, Eastbourne, BN22 9AG
The following side effects may occur:
Very common side effects (in more than one in 10 This leaflet was last revised in December 2011
users):
PL 00289/0340
• Digestive problems such as feeling sick
PL 00289/0341
(nausea), being sick (vomiting), diarrhoea,
60910-Z
bellyache (abdominal pain) and loss of appetite.
160 x 323

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)