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DIAGEMET XL 500MG PROLONGED-RELEASE TABLETS

Active substance(s): 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
dependant) 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.

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 ketosis (this is a symptom of uncontrolled diabetes in which substances called ‘ketone
bodies’ accumulate in the blood – you may notice that your breath has an unusual, fruity odour)
• have long term kidney or liver problems
• have had serious complications with your diabetes or other serious conditions which resulted in
rapid weight loss, nausea, vomiting or dehydration
• 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.
Take special care with Diagemet XL 500mg Prolonged-release Tablets
After you have started taking your medicine:
If you have diabetes you should have your blood or your urine tested for sugar regularly. You should
return to your doctor at least once a year to check the function of your kidneys (more often if you are
elderly or if you have kidney problems).
If you start to lose weight unexpectedly or suffer severe nausea or vomiting, uncontrolled rapid
breathing or abdominal pains, stop taking the medicine and tell your doctor straight away. This
can be a sign of a rare, but serious complication with your diabetes called ‘lactic acidosis’
which means there is too much acid in the blood (see also section 4 Possible side-effects).
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 an X-ray examination involving the injection of a dye, tell your doctor that you
take Diagemet XL 500mg Prolonged-release Tablets, as you may need to stop taking them for a few
days afterwards.
Tell your doctor if you are going to have an operation under general anaesthetic, as you may need to
stop taking Diagemet XL 500mg Prolonged-release Tablets for a couple of days before and after the
procedure.
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.
If you are taking any of the following medicines, your blood sugar levels may need to be checked
more often and your dose adjusted:
• steroids such as prednisolone, mometasone, beclometasone
• beta-2-agonists such as salbutamol used for asthma
• diuretics (water tablets) such as bendromethazide
• ACE inhibitors such as lisinopril, enalapril
• you should avoid drinking alcohol and using alcohol-containing medicines as this will increase your
risk of lactic acidosis (see section 4 Possible side-effects).
Taking Diagemet XL 500mg Prolonged-release Tablets with food and drink:
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 4 Possible side-effects).
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.
Please read the back of this leaflet.

* Trademark

24998802

GEN/DIA/PIL/330_02
12/01/2015

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. 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.

4. POSSIBLE SIDE-EFFECTS
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.
These can be signs of serious problems with your diabetes and may mean you have a very rare side
effect called 'lactic acidosis' (too much acid in the blood). If this happens, see a doctor as you will
need treatment straight away.
• 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 B 12 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.

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.

6. FURTHER INFORMATION
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.

POM
Marketing Authorisation Holder and Manufacturer:
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
This leaflet was last revised in March 2015

* Trademark

24998802

GEN/DIA/PIL/330_02
12/01/2015

MHRA Header Box
Product
Title

Diagemet XL 500mg
Prolonged Release Tablets Genus

Component

Leaflet

Pack Size

28's

IG code

24998802

Dimensions

148 x 340mm

Proof No.

02

Colours used
Black

Fonts used
Helvetica 55 Roman
Helvetica 75 Bold

Date

12/01/2015

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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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