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METFORMIN TABLETS 850MG

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

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Metformin Tablets 500mg and 800mg

PL 4416-0300-1

PATIENT INFORMATION LEAFLET
Metformin Tablets 500mg and 850mg
What you should know about Metformin
Please read this leaflet carefully before you start to take your medicine. This leaflet provides a
summary of the information available on your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
The name of your medicine is Metformin Tablets 500mg or 850mg.
What is in your Medicine?
Each film-coated tablet contains 500mg or 850mg of the active ingredient, metformin
hydrochloride. They also contain: sodium starch glycollate, maize starch, povidone, colloidal
anhydrous silica, magnesium stearate, methylhydroxypropylcellulose, propylene glycol,
polyethylene glycol, purified talc, and titanium dioxide (E171).
Metformin Tablets are supplied in packs of 28 and 56. However, the quantity dispensed by the
pharmacist will be according to your prescription.
Metformin belongs to a group of medicines called biguanide antihyperglycaemics which help to
bring down the blood sugar levels when you have diabetes.
The product licence holder and manufacturer is: Sandoz Ltd, Woolmer Way, Bordon, Hants.
GU35 9QE
How to take/use this medicine
Metformin Tablets are commonly prescribed for patients with maturity onset-type of diabetes
mellitus (non-insulin dependent/Type II diabetes) when dietary measures are inadequate to
control the diabetes, especially if the patient is overweight, or if attempts to achieve control
with sulphonylureas (an alternative group of medicines used for diabetes) and exercise have
been unsuccessful.
Metformin may also be used with sulphonylureas, in which case your doctor will closely
monitor your treatment.
Before taking your medicine
DO NOT take this medicine before telling your doctor if:

you are, or might be pregnant, or you are breast-feeding,

you have previously experienced sensitivity to metformin, or any of the other
ingredients in this medicine,

you have severely reduced kidney function.

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 precoma.
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Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath
developing an unusual fruity smell.
you have had diabetic coma, ketosis, or lactic acidosis,
you have recently had a serious infection, injury or operation,
you are dehydrated, or you have been vomiting or have had diarrhoea recently,
you suffer from heart disease, eg heart failure, or you have had a recent heart attack,
you have chronic breathing problems, or have poor circulation
you have liver or kidney problems.

Warnings and precautions
Risk of lactic acidosis
Metformin 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.
Stop taking Metformin 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 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

stomach ache (abdominal pain)

muscle cramps

a general feeling of not being well with severe tiredness

difficulty in breathing

reduced body temperature and heartbeat
Lactic acidosis is a medical emergency and must be treated in a hospital.
If you need to have major surgery you must stop taking Metformin during and for some time
after the procedure. Your doctor will decide when you must stop and when to restart your
treatment with Metformin.
During treatment with Metformin, 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.

Other medicines and Metformin

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Metformin Tablets 500mg and 800mg

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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. It is especially important to mention the following: […]




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)

If you have to see the dentist, go to the hospital for an operation or treatment or are seen by a
different doctor for any reason, make sure that they know you have diabetes and that you are
taking metformin. This is very important if you are to be given an anaesthetic or have to stop
eating and drinking for a while before any medical tests are carried out. 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 before or at the time of the
injection. Your doctor will decide when you must stop and when to restart your treatment with
Metformin.
The control of your blood sugar levels must be regularly monitored while taking metformin, as
usual.
Your doctor may need to carry out regular blood tests whilst you are taking this medicine in
order to monitor the control of your diabetes, vitamin B12 levels and kidney function.
Patients taking metformin alone do not usually become hypoglycaemic. However if you are
also taking a sulphonylurea, hypoglycaemia may occur; in which case the normal caution with
driving or operating machines should be observed.
Metformin with alcohol
Avoid excessive alcohol intake while taking Metformin since this may increase the risk of lactic
acidosis (see section “Warnings and precautions”).
Taking your medicine
Recommended doses follow. Doctors sometimes prescribe different doses to these: if this
applies to you, discuss it with your doctor, if you have not already done so. You should always
follow your doctor’s instructions as to how and when to take your medicine. Your pharmacist
may be able to advise if you are not sure. Exactly how many tablets to take and when to take
them will be written on the label. Please read it carefully.
Metformin Tablets should be swallowed whole with a drink of water, with meals.
Adults and elderly patients without kidney problems: The usual initial dose of metformin is one
500mg tablet 3 times daily, or one 850mg tablet twice daily. Control of your diabetes may
occur in a few days, but can often take up to 2 weeks. The dose may be slowly increased by
your doctor, if necessary,
to a maximum dose
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to
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PIL.0300-1.006.0d
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outcome of referral Art 31 + RFI

Metformin Tablets 500mg and 800mg

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of 3,000mg (3g) daily. Once control is obtained your doctor may decide to reduce your dosage.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Children: Metformin Tablets are not recommended for children.
You should finish all the tablets your doctor has prescribed. DO NOT stop taking your
medicine, even if you feel better, as it may be dangerous to stop taking the medicine without
your doctor’s advice.
If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is
due within 2 hours take a single dose now and miss the next dose. Never take two doses
together. Continue with your treatment at the correct times.
If you take one extra dose, this may unbalance the control of your diabetes especially if you are
also taking other medicines. Contact your doctor if you are worried about this. If you, or
anyone else has taken an overdose, contact your nearest hospital accident and emergency
department straight away.
Possible side effects
As with all medicines, Metformin Tablets may have unwanted effects in some patients,
particularly when they first start to take them. Stomach upsets such as nausea, diarrhoea,
abdominal pain, vomitting or loss of appetite may occur but taking your tablets with or after
meals may reduce this. The effects may wear off as treatment continues and the diabetes
becomes controlled. Another common side effect is a metallic taste in the mouth. If you suffer
badly from these effects, contact your doctor who might lower your dose temporarily.
You may absorb less vitamin B12 from your diet which, if not recognised early, could result in
anaemia. If there is a tendency to bruise easily, you bleed from the gums or elsewhere, you
become less resistant to infections, or you feel very tired and look pale, see your doctor.
Your blood glucose level may become too low (hypoglycaemia) though this is less likely than
with sulphonylurea drugs for diabetes. Symptoms are sweating, weakness, hunger, dizziness,
trembling, headache, palpitations and confusion. Take sugar lumps or glucose at the first sign
of these symptoms, as you normally would for hypoglycaemia.
Metformin 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”), where high levels of
lactic acid may build up in the blood. It is more likely if you have existing kidney problems. If
this happens you must stop taking Metformin and contact a doctor or the nearest hospital
immediately, as lactic acidosis may lead to coma. Early indicators of this may be nausea,
vomiting, diarrhoea, and lower abdominal pain which can come on suddenly or become worse.
Other signs are tiredness, abnormally fast or deep breathing, or unexplained weight loss. This is
a serious condition; therefore contact your doctor immediately if you have some or all of these
symptoms.

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V016: Update to SPC&PIL in line with
outcome of referral Art 31 + RFI

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Metformin Tablets 500mg and 800mg

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Other side effects that you may also experience include anorexia, erythema, urticaria, pruritus,
hepatitis and skin rashes
If you have any of these effects and they become worse, inconvenient or upsetting, see your
doctor or pharmacist.
If you experience any other unpleasant effects which you think could be caused by this
medicine you should contact your doctor or pharmacist for advice.
Storing your medicine
Do not take any of the tablets after the expiry date printed on the container. Any out of date
medicines should be returned to your pharmacist for disposal.
Metformin Tablets should be stored below 25°C in a dry place.
If you notice any defects in the tablets, such as broken or chipped tablets, take them to your
pharmacist for advice.
Date of preparation: December 2016.
Keep all medicines out of the reach of children. Your medicines can harm them.
REMEMBER, this medicine is for you. Only a doctor can prescribe it for you. Never give it to
others.
It may harm them even if their symptoms are the same as yours.
This leaflet applies to Metformin Tablets 500mg and 850mg only.

PIL.0300-1.006.0d

V016: Update to SPC&PIL in line with
outcome of referral Art 31 + RFI

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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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