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DIAGEMET XL 500MG PROLONGED-RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diagemet XL 500mg Prolonged-release Tablets
(Metformin Hydrochloride)

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 get serious, or if you notice any side-effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Diagemet XL 500mg Prolonged-release Tablets are and what they are used for
2. Before you take Diagemet XL 500mg Prolonged-release Tablets
3. How to take Diagemet XL 500mg Prolonged-release Tablets
4. Possible side-effects
5. How to store Diagemet XL 500mg Prolonged-release Tablets
6. Further information

1. WHAT DIAGEMET XL 500mg PROLONGED-RELEASE TABLETS ARE
AND WHAT THEY ARE USED FOR

Diagemet XL 500mg Prolonged-release Tablets contain the active ingredient metformin hydrochloride
and belong to a group of medicines called biguanides, used in the treatment of diabetes.
Diagemet XL 500mg Prolonged-release Tablets are used for the treatment of type 2 (non-insulin
dependent) diabetes mellitus 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. Diagemet XL 500mg Prolonged-release Tablets make the body more sensitive
to insulin and help to lower your blood glucose levels. Diagemet XL 500mg Prolonged-release Tablets
are specially made to release the drug slowly in your body and therefore are different to the
immediate release type of tablets containing metformin hydrochloride which release the drug
immediately.

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Date

02.03.2017
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Diagemet XL 500mg Prolonged-release
Tablets
Product Title

Please read the back of this leaflet. 24998803

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2. BEFORE YOU TAKE DIAGEMET XL 500mg PROLONGED-RELEASE TABLETS

Do not take Diagemet XL 500mg Prolonged-release Tablets if you:
• are allergic to metformin hydrochloride or any of the other ingredients listed (see section 6 Further
Information). An allergic reaction may cause a rash, itching or shortness of breath
• have long term kidney or liver problems or if you have severely reduced kidney function
• have uncontrolled diabetes or other serious conditions, with, for example, severe hyperglycaemia
(high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, dehydration, 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
• have a severe infection or have recently suffered a severe injury
• need to have an X-ray examination involving the injection of a dye into the bloodstream
• have been treated for heart problems, have recently had a heart attack or have severe circulatory
problems or breathing difficulties
• are a heavy drinker
• are under 18 years of age.
Warnings and precautions
Talk to your doctor before taking Diagemet XL 500mg Prolonged-release tablets.
Risk of lactic acidosis
Diagemet XL 500mg Prolonged-release 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.
After you have started taking your medicine:
If you have diabetes you should have your blood or your urine tested for sugar regularly. During treatment
with Diagemet XL 500mg Prolonged-release 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.
Stop taking Diagemet XL 500mg Prolonged-release 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.
Stop taking Diagemet XL 500mg Prolonged-release 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.
Symptoms of lactic acidosis include:
• nausea or vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing or uncontrolled rapid breathing
• reduced body temperature and heartbeat
Lactic acidosis is a medical emergency and must be treated in a hospital.
You may see some remains of the tablets in your stools. Do not worry – this is normal for this type of
tablet.
If you need to have major surgery, or an operation under general anaesthetic, you must stop taking
Diagemet XL 500mg Prolonged-release tablets during and for some time after the procedure. Your doctor
will decide when you must stop and when to restart your treatment with Diagemet XL 500mg
Prolonged-release tablets.
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.
Taking Diagemet XL 500mg Prolonged-release Tablets with other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicine obtained without a prescription.
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 Diagemet XL 500mg Prolonged-release tablets. It is especially important to mention the following:
• steroids such as prednisolone, mometasone, beclometasone
• beta-2-agonists such as salbutamol used for asthma
• medicines which increase urine production (diuretics) such as bendromethazide
• 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 (such as lisinopril, enalapril)
and angiotensin II receptor antagonists)
• you should avoid drinking alcohol and using alcohol-containing medicines as this will increase your
risk of lactic acidosis (see section “Warnings and precautions”).
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 Diagemet XL 500mg Prolonged-release
tablets before or at the time of the injection. Your doctor will decide when you must stop and when to
restart your treatment with Diagemet XL 500mg Prolonged-release tablets.

Diagemet XL 500mg Prolonged-release Tablets with food, drink and alcohol
You should take Diagemet XL 500mg Prolonged-release Tablets with or immediately after food.
You should avoid drinking alcohol and using alcohol-containing medicines as this will increase the risk
of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and Breast-feeding
Do not take Diagemet XL 500mg Prolonged-release Tablets if you are pregnant or breast-feeding. Ask
your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Diagemet XL 500mg Prolonged-release Tablets taken on their own do not cause ‘hypos’ (symptoms
of low blood sugar or hypoglycaemia, such as feeling faint, confusion and increased sweating) and
therefore should not affect your ability to drive or use machinery. You should be aware however, that
Diagemet XL 500mg Prolonged-release Tablets taken with other antidiabetic medicines can cause
‘hypos’, so in this case you should take extra care when driving or operating machinery.

3. HOW TO TAKE DIAGEMET XL 500mg PROLONGED RELEASE TABLETS

Your doctor may prescribe Diagemet XL 500mg Prolonged-release Tablets for you to take on their
own, or in combination with other oral antidiabetic medicine or insulin.
Always take Diagemet XL 500mg Prolonged-release Tablets exactly as your doctor has told you to.
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.
Usually, you will start treatment with Diagemet XL 500mg Prolonged-release Tablets daily. After you
have been taking Diagemet XL 500mg Prolonged-release Tablets for about 2 weeks, your doctor may
measure your blood sugar and adjust the dose. The maximum daily dose is 3000mg of Diagemet XL
Prolonged-release Tablets. 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. In this case, take your tablet with your morning and evening meal.
If you take more Diagemet XL 500mg Prolonged-release Tablets than you should
If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact
your doctor.
These symptoms may include weakness, confusion, fast breathing and new onset of nausea,
vomiting or stomach pain.
If the overdose is large, lactic acidosis is more likely and this is a medical emergency requiring
treatment in hospital (see also section 4 Possible side-effects).
If you forget to take Diagemet XL 500mg Prolonged-release Tablets
Take it as soon as you remember, with some food. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Diagemet XL 500mg Prolonged-release tablets
Do not stop taking this medicine without speaking to your doctor.

11.16pt
8pt
Helvetica Neue
28s / 56s

24998803

148mm x 370mm

IG Code

Dimensions

4

Date

02.03.2017
Leaflet

Proof No.

8pt

Pack Size

24998803

Component

*Trademark

Diagemet XL 500mg Prolonged-release
Tablets

Marketing Authorisation Holder and Manufacturer:
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
This leaflet was last revised in February 2017.

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What Diagemet XL 500mg Prolonged-release Tablets contain
The active substance in Diagemet XL 500mg Prolonged-release Tablets is metformin hydrochloride.
Each tablet contains 500mg of metformin hydrochloride. The other ingredients are stearic acid,
shellac, povidone, colloidal silicon anhydrous, magnesium stearate, isopropyl alcohol, hypromellose,
hydroxypropyl cellulose, titanium dioxide, propylene glycol, macrogol and talc.
What Diagemet XL 500mg Prolonged-release Tablets look like and contents of the pack
These tablets are off-white coloured, oval, biconvex, film coated tablets plain on both sides.
20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, 600 tablets in blister strips composed of PVC/PVDC 40g.
20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, 600 tablets in HDPE (High Density Polyethylene)
bottles. HDPE bottles are composed of a two-piece plastic continuous thread closure with
aluminium-foil induction seal (innerseal).
Not all pack sizes may be marketed.
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.

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6. FURTHER INFORMATION

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5. HOW TO STORE DIAGEMET XL 500mg PROLONGED RELEASE TABLETS

Keep Diagemet XL 500mg Prolonged-release Tablets out of the sight and reach and of children.
Do not use them after the expiry date that is printed on the pack after "EXP". The expiry date refers
to the last day of that month.
This medicinal product 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.

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Like all medicines, Diagemet XL 500mg Prolonged-release Tablets can cause side-effects, although
not everybody gets them.
If you notice any of the following stop taking Diagemet XL 500mg Tablets and see your doctor
immediately:
• unexpected weight loss
• very severe nausea or vomiting
• very fast breathing which you cannot stop
• stomach pains or feeling cold.
Diagemet XL 500mg Prolonged-release 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 Diagemet XL 500mg Prolonged-release Tablets and contact a doctor or the
nearest hospital immediately, as lactic acidosis may lead to coma.
• Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice. 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 B12 levels.
• skin rashes including redness, itching and hives.
Reporting of side effects
If you get any side effects, talk to your doctor, 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 side effects you can help provide more information on the safety of this medicine.

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4. POSSIBLE SIDE-EFFECTS

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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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