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METFORMIN HYDROCHLORIDE 1000 MG FILM COATED TABLETS

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

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Artwork No.

280417/1

Colours Used

Customer

Morningside

Balck

Description

Metabet Leaflet

Keyline (not to print)

Market

UK

Language

English

Size

190 x 400 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.
e-mail : prasad.pdp@gmail.com
Ph : +91-9845156610

2

Date

11-07-17

Software

Illustrator 11

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Package leaflet: Information for the user

Metformin hydrochloride
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Metformin tablets.

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. Contents of the pack and other information
1. What Metformin tablets are and what they are used
for
Metformin tablets contain the active ingredient metformin
hydrochloride. Metformin hydrochloride belongs to a group of
medicines called biguanides used for the treatment of noninsulin-dependent diabetes mellitus (type 2 diabetes) in
adults and children from 10 years of age.
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.

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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.

Dosage for adults
The usual starting dose is 500 mg or 850mg metformin
hydrochloride two or three times a day. The maximum daily
dose is 3000 mg metformin hydrochloride, taken as 3 divided
doses.

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.

Dosage for children from 10 years of age and adolescents:
The usual starting dose is 500 mg 850mg metformin
hydrochloride once a day
The dosage can be increased up to the maximum
recommended daily dose of 2000 mg metformin
hydrochloride per day, 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.

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.

Monitoring
Your doctor 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.

!

If you have reduced kidney function, your doctor may
prescribe a lower dose. Your dose may be adjusted if you are
elderly.
How to take Metformin
Take the tablets during or after meals with an adequate
amount of liquid. Do not chew the tablets. When taking 2 or
more tablets you should spread them out over the day, e.g. 1
tablet each during or after breakfast and dinner.

Other medicines and Metformin tablets
Tell your doctor if you are taking, have recently taken or might
take any other medicines.

Children and adolescents
For children from 10 years of age and for adolescents the
doctor can prescribe Metformin tablets alone (monotherapy)
or in combination with insulin.

Talk to your doctor if you think the dose of Metformin tablets
are too high or too low.

If you need to have an injection of 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.

2. What you need to know before you take Metformin
tablets

!

If you take more Metformin tablets than you should
Inform your doctor immediately if you have taken more
tablets than you should have. An overdose of Metformin
tablets does not lead to hypoglycaemia but increases the risk
of hyperacidity of the blood caused by lactic acid (lactic
acidosis). Symptoms of early hyperacidity are similar to the
side effects of metformin on the gastrointestinal tract:
sickness, vomiting, diarrhoea and abdominal pain. In severe
cases you could also get muscle pain and muscle cramps,
very fast breathing which you cannot stop, as well as a
clouding of consciousness and coma. This may develop
within hours and requires immediate emergency treatment in
a hospital.

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:

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corticosteroids (e.g. prednisone) and sympathomimetics
medicines which increase urine production (diuretics)
medicines used to treat pain and inflammation (NSAID
and COX-2-inhibitors, such as ibuprofen and celecoxib)
certain medicines for the treatment of high blood pressure
(ACE inhibitors and angiotensin II receptor antagonists)
specific medicines for the treatment of bronchial asthma
(β-agonists, e.g. salbutamol)

If you forget to take Metformin tablets
If you forget to take Metformin tablets, take the prescribed
amount of Metformin tablets at the next prescribed time and
try to keep to the prescription in future. Do not take a double
dose to make up for a forgotten dose.

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

If you stop taking Metformin tablets
If you stop treatment with Metformin tablets you have to be
aware of the risk of uncontrolled blood sugar and of the longterm effects of diabetes mellitus such as damage on eyes,
kidneys and blood vessels.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist or nurse.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

4. Possible side effects

Diabetic women who are pregnant or planning to become
pregnant, should not be treated with Metformin tablets.
Instead, insulin should be used to maintain blood glucose
levels as close to normal as possible. Inform your doctor if
you are pregnant or thinking of becoming pregnant so that he
or she can change you to insulin therapy.

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 surgery

This medicinal product should not be used while breastfeeding.

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 instruction
precisely.

Driving and using machines
Taking metformin alone (monotherapy) does not cause low
blood sugar levels (hypoglycaemia) and therefore has no
effect on your ability to drive or use machines.
Taking metformin in combination with other antidiabetic
agents (e.g. sulphonylureas, Insulin or meglitinides) may
cause low blood sugar levels (with symptoms, such as

!

The dose of Metformin tablets should be determined by the
doctor according to your blood sugar levels.

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.

Adults
Your doctor can prescribe Metformin tablets on their own
(monotherapy) or in combination with other oral antidiabetic
agents, or with insulin.

Do not take Metformin tablets
if you are allergic to metformin hydrochloride or any of
the other ingredients of this medicine (listed in section 6).
if you have 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.
! if you have severely reduced kidney function.
! if your kidney function worsens as a consequence of e.g.
! loss of too much water (dehydration) due to long-lasting
vomiting or severe diarrhoea. 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 infection affecting
your lung or bronchial system or your kidney. Severe
infection may lead to kidney problems, which can put you
at risk for lactic acidosis.(see 'take special care with
Metformin' below)
! if you have acute or chronic diseases which may lead to
reduced amount of oxygen in body tissues (tissue
hypoxia) such as
! heart failure, or difficulties breathing
! recent heart attack (myocardial infarction)
! collapse or trauma (shock)
! if you have liver problems, drink a lot of alcohol or suffer
from alcoholism

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Metformin tablets 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.

Unless prescribed differently by your doctor, the
recommended dose is:

Lactic acidosis is a medical emergency and must be treated
in a hospital.

Metformin tablets are a medicine used to lower high blood
sugar levels in patients with diabetes mellitus (type 2
diabetes); particularly in overweight patients when dietary
management and exercise alone does not result in control of
blood sugar.

3. How to take Metformin tablets

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 apply to you, talk to your doctor for further
instructions.

Symptoms of lactic acidosis include:
vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of not being well with severe tiredness
difficulty in breathing
reduced body temperature and heartbeat

of appetite, weight loss, with or without yellowing of the
skin or whites of the eyes). If this happens to you, stop
taking this medicine.

sweating, fainting, dizziness or weakness) and thus affecting
your ability to drive and use machines or work safely.
Symptoms of hypoglycaemia include weakness, dizziness,
increased sweating, fast heartbeat, vision disorders or
difficulty in concentration. Do not drive or use machines if you
start to feel these symptoms.

Metformin 500 mg, 850 mg and 1000 mg film-coated 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 or nurse.
! This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their sign of
illness are the same as yours.
! If you get any of the side effects, talk to your doctor or
pharmacist or nurse. This includes any side effects not
listed in this leaflet. See section 4.

Production

Like all medicines, this medicine can cause side effects,
although not everybody gets them. Most of the side effects
are mild to moderate and will generally disappear after a few
days to a few weeks of treatment. Do not be alarmed by this
list of possible side effects. You may not experience any of
them.
Metformin 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.

Ask your doctor or pharmacist for advice before taking any
medicine.

!

The frequencies of the following side effects are very
rare:
abnormalities in liver function tests or hepatitis
(inflammation of the liver; this may cause tiredness, loss

Other side effects:

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Very common (may affect more than 1 in 10 people)
feeling sick (nausea), being sick (vomiting), diarrhoea,
stomach ache or loss of appetite. These side effects are
most likely to happen at the start of treatment. 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 (may affect up to 1 in 10 people)
taste disturbance
Very rare (may affect up to 1 in 10,000 people)
skin rash (including redness, itching, hives).
low levels of vitamin B12. Over time this may lead to
anaemia, a sore mouth or tongue or possibly numbness
or tingling in the limbs.
Children and adolescents
Limited data in children and adolescents showed that
adverse events were similar in nature and severity to those
reported in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 the side effects you can help provide more
information on the safety of this medicine.
5. How to store Metformin tablets
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.
Do not use Metformin tablets after the expiry date stated on
the blister and the carton after "EXP". The expiry date refers
to the last day of that month.
Storage conditions
This medicine does not require any special storage
conditions.
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 is metformin hydrochloride.
Each film coated tablet contains 500 mg, 850 mg or 1000 mg
metformin hydrochloride equivalent to 390 mg, 663 mg, and
780 mg of metformin respectively.
The other ingredients are:
Sodium Starch Glycolate (Type A), Povidone K-30, Maize
Starch, Colloidal Anhydrous Silica, Magnesium Stearate,
Hypromellose 15cP, Talc, Titanium Dioxide (E 171), Macrogol
6000, Propylene Glycol.
What Metformin tablets looks like and contents of the
pack
Metformin 500 mg film coated tablets are supplied as white to
off white round, biconvex, film coated tablets which are plain
on both sides.
Metformin 850 mg film coated tablets are supplied as white to
off white capsule shaped, biconvex, film coated tablets with
scoreline on one side and plain on other side.
Metformin 1000 mg film coated tablets are supplied as white
to off white oval shaped, biconvex, film coated tablets, with a
deep breakline on one side and breakline on other side.
Metformin 500 mg, 850 mg and 1000 mg film coated tablets
are available in blisters containing 1 (x100), 9, 10, 20, 21, 30,
40, 50, 56, 60, 84, 90, 100, 120, 180, 200, 300, 500, 600 or
1000 film coated tablets or in plastic bottles containing 10, 20,
21, 30, 40, 50, 56, 60, 90, 100, 120, 180, 200, 300, 400, 500,
600 or 1000 film coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
USV Europe Limited,
The Podium, 1 Eversholt Street,
Euston, London NW1 2DN, United Kingdom
Manufacturers
Morningside Pharmaceuticals Limited
5 Pavilion Way, Castle Business Park, Loughborough,
Leicestershire,
LE11 5GW, UK

This medicinal product is authorised in the Member
States of the EEA under the following names:
Denmark
Metformin Orifarm
Metformine HCL USV Europe 500 mg,
The Netherlands
850 mg en 1000 mg filmomhulde
tabletten
Norway
Metformin Orifarm
Sweden
Metformin Orifarm
United Kingdom
Metformin hydrochloride 500 mg,
850 mg and 1000 mg film coated
tablets
This leaflet was last revised in July 2017.

Expand Transcript

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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