Glucophage SR 750mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Metformin hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
A10BA02
INN (International Name):
Metformin hydrochloride
Dosage:
750mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF:

PAGE 4

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Reporting of side effects

If you get any side effects, talk to your doctor or

pharmacist. 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 or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more

information on the safety of this medicine.

Keep out of the sight and reach of children

Store in the original package to protect from light

and moisture.

Do not take the tablets after the expiry date which is

stated on the carton and blister labels after 'Exp'

The expiry date refers to the last day of that month.

If the tablet becomes discoloured or shows any

signs of deterioration, seek the advice of your

pharmacist.

Remember if your doctor tells you to stop taking this

medicine, return any unused medicine to your

pharmacist for safe disposal. Only keep this

medicine if your doctor tells you to.

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.

What the tablet contains

The active ingredient in Glucophage SR is metformin

hydrochloride.

Each prolonged release tablet contains 750mg

metformin hydrochloride equivalent to 585mg

metformin.

The other ingredients are carmellose sodium,

hypromellose 100 000 cPs, magnesium stearate and

purified water.

What Glucophage SR looks like and contents of

the pack

Glucophage SR is white to off-white

capsule-shaped

tablet marked with ‘750’ on one side and plain on the

other side.

It is available in blister pack of 60 tablets.

Manufactured by: Savio Industrial S.r.I., Via Emilia,

21 - 27100 Pavia, Italy.

Procured from within the EU and repackaged by

the Product Licence holder: B&S Healthcare, Unit 4,

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Glucophage

®

SR 750mg prolonged release tablets;

PL 18799/3083

Leaflet date: 23.11.2018

Glucophage is a registered trademark of Merck Sante.

Useful tips

If you smoke, try to stop

Take regular exercise

Drink as little alcohol as possible

Look after your feet. Ask about this at the surgery or

hospital

Carry a card, bracelet or disk saying you are

diabetic

Visit your diabetic clinic regularly

If you want more information about diabetes

contact:

Diabetes UK Central Office

Macleod House

10 Parkway

London NW1 7AA

Tel: 020 7424 1000

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the

leaflet in a format suitable for you.

What is in this leaflet:

1. What Glucophage SR is and what it is used for

2. What you need to know before you take

Glucophage SR

3. How to take Glucophage SR

4. Possible side effects

5. How to store Glucophage SR

6. Content of the pack and other information

Glucophage SR contains the active ingredient

metformin hydrochloride and belong to a group of

medicines called biguanides, used in the treatment of

Type 2 (non-insulin dependent) diabetes mellitus.

Glucophage SR is used together with diet and exercise

to lower the risk of developing Type 2 diabetes in

overweight adults, when diet and exercise alone for 3

to 6 months have not been enough to control blood

glucose (sugar). You are at high risk of developing

Type 2 diabetes if you have additional conditions like

high blood pressure, age above 40 years, an abnormal

amount of lipids (fat) in the blood or a history of

diabetes during pregnancy.

The medicine is particularly effective if you are aged

below 45 years, are very overweight, have high blood

glucose levels after a meal or developed diabetes

during pregnancy.

Glucophage SR is used for the treatment of Type 2

diabetes when diet and exercise changes alone have

not been enough to control blood glucose (sugar).

Insulin is a hormone that enables body tissues to take

glucose from the blood and to use it for energy or for

storage for future use. People with Type 2 diabetes do

not make enough insulin in their pancreas or their body

does not respond properly to the insulin it does make.

This causes a build-up of glucose in the blood which

can cause a number of serious long-term problems so

it is important that you continue to take your medicine,

even though you may not have any obvious symptoms.

Glucophage SR makes the body more sensitive to

insulin and helps return to normal the way your body

uses glucose.

Glucophage SR is associated with either a stable body

weight or modest weight loss.

Glucophage SR is specially made to release the drug

slowly in your body and therefore is different to many

other types of tablet containing metformin.

Do not take Glucophage SR if:

you are allergic to metformin or to any of the other

ingredients of this medicine (listed in section 6). An

allergic reaction may cause a rash, itching or

shortness of breath.

you have liver problems.

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 pre-coma.

Symptoms include stomach pain, fast and deep

breathing, sleepiness or your breath developing an

unusual, fruity smell.

POM

Package leaflet: Information for the user

Glucophage

®

SR 750mg prolonged release tablets

(metformin hydrochloride)

This medicine is intended for adult patients only

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. Do not pass it on to others. It may harm them, even if their symptoms 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. See section 4.

The name of your medicine is Glucophage SR 750mg prolonged release tablets but will be referred to as Glucophage

SR throughout this leaflet. Please note that the leaflet also contains information about other strengths Glucophage SR

500mg and 1000mg prolonged release tablets.

1. What Glucophage SR is and what it is used for

2. What you need to know before you take

Glucophage SR

5. How to store Glucophage SR

6. Contents of the pack and other information

PAGE 2

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you have lost too much water from your body

(dehydration). Dehydration may lead to kidney

problems, which can put you at risk for lactic

acidosis (see 'Warnings and precautions').

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’).

you have been treated for acute heart problems or

have recently had a heart attack or have severe

circulatory problems or 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’).

you are a heavy drinker of alcohol.

you are under 18 years of age.

Warnings and precautions

Risk of lactic acidosis

Glucophage SR 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 Glucophage SR 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 Glucophage SR 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

Glucophage SR during and for some time after the

procedure. Your doctor will decide when you must stop

and when to restart your treatment with Glucophage

During treatment with Glucophage SR, 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.

If you are older than 75 years, treatment with

Glucophage SR should not be started to lower the risk

of developing type 2 diabetes.

You may see some remains of the tablets in your

stools. Do not worry - this is normal for this type of

tablet.

You should continue to follow any dietary advice that

your doctor has given you and you should make sure

that you eat carbohydrates regularly throughout the

day.

Do not stop taking this medicine without speaking to

your doctor.

Other medicines and Glucophage SR

If you need to have an injection of a contrast medium

that contains iodine into your bloodstream, in the

context of an X-ray or scan, you must stop taking

Glucophage SR before or at the time of injection. Your

doctor will decide when you must stop and when to

restart your treatment with Glucophage SR.

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

Glucophage SR. It is especially important to mention

the following:

Medicines which increase urine production

(diuretics (water tablets) such as furosemide).

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).

Steroids such as prednisolone, mometasone,

beclometasone.

Sympathomimetic medicines including epinephrine

and dopamine used to treat heart attacks and low

blood pressure. Epinephrine is also included in

some dental anaesthetics.

Medicines that may change the amount of

Glucophage SR in your blood, especially if you

have reduced kidney function (such as verapamil,

rifampicin, cimetidine, dolutegravir, ranolazine,

trimethoprim, vandetanib, isavuconazole, crizotinib,

olaparib).

Glucophage SR with alcohol:

Avoid excessive alcohol intake while taking

Glucophage SR since this may increase the risk of

lactic acidosis (see section ‘Warnings and

precautions’).

Pregnancy and breast-feeding

Do not take Glucophage SR if you are pregnant or

breast-feeding.

Ask your doctor or pharmacist for advice before taking

any medicine.

Driving and using machines

Glucophage SR taken on its own does not cause

‘hypos’ (symptoms of low blood sugar or

hypoglycaemia, such as faintness, confusion and

increased sweating) and therefore should not affect

your ability to drive or use machinery.

You should be aware, however, that Glucophage SR

taken with other antidiabetic medicines can cause

hypos, so in this case you should take extra care when

driving or operating machinery.

Your doctor may prescribe Glucophage SR for you to

take on its own, or in combination with other oral

antidiabetic medicines or insulin.

Always take Glucophage SR exactly as your doctor

has told you.

You should check with your doctor or pharmacist if you

are not sure.

Swallow the tablets whole with a glass of water, do not

chew.

Recommended dose

Usually you will start treatment with 500 milligrams

Glucophage SR daily. After you have been taking

Glucophage SR for about 2 weeks, your doctor may

measure your blood sugar and adjust the dose. The

maximum daily dose is 2000 milligrams of

Glucophage SR.

If you have reduced kidney function, your doctor may

prescribe a lower dose.

Normally, you should take the tablets once a day, with

your evening meal.

In some cases, your doctor may recommend that you

take the tablets twice a day. Always take the tablets

with food.

If you take more Glucophage SR than you should

If you take extra tablets by mistake you need not worry,

but if you have unusual symptoms, contact your doctor.

If the overdose is large, lactic acidosis is more likely.

Symptoms of lactic acidosis are non-specific, such as

vomiting, bellyache with muscle cramps, a general

feeling of not being well with severe tiredness, and

difficulty in breathing. Further symptoms are reduced

body temperature and heart beat. If you experience

some of these symptoms, you should immediately

seek medical attention, as lactic acidosis may lead to

coma. Stop taking Glucophage SR immediately and

contact a doctor or the nearest hospital straightaway.

If you forget to take Glucophage SR

Take it as soon as you remember with some food. Do

not take a double dose to make up for a forgotten

dose.

Like all medicines, Glucophage SR can cause side

effects, although not everybody gets them. The

following side effects may occur:

Glucophage SR 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

Glucophage SR and contact a doctor or the nearest

hospital immediately, as lactic acidosis may lead to

coma.

Glucophage SR may cause abnormal liver function

tests and hepatitis (inflammation of the liver) which

may result in jaundice (may affect up to 1 user in

10,000). If you develop yellowing of the eyes and/or

skin contact your doctor immediately.

Other possible side effects are listed by frequency as

follows:

Very common (affects more than 1 person in 10):

Diarrhoea, nausea, vomiting, stomach ache or loss

of appetite. If you get these, do not stop taking the

tablets as these symptoms will normally go away in

about 2 weeks. It helps if you take the tablets with

or immediately after a meal.

Common (affects less than 1 person in 10, but more

than 1 person in 100):

Taste disturbance

Very rare (affects less than 1 person in 10,000):

Decreased vitamin B

levels

Skin rashes including redness, itching and hives.

3. How to take Glucophage SR

4. Possible side effects

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