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MEIJUMET 500MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Meijumet 500 mg prolonged release tablets can
cause side effects, although not everybody gets them. The
following side effects may occur:
Meijumet 500 mg 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 Meijumet 500 mg prolonged
release tablets and contact a doctor or the
nearest hospital immediately, as lactic acidosis
may lead to coma.
Meijumet 500 mg prolonged release tablets 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: may affect more than 1 in 10 people:
• 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: may affect up to 1 in 10 people:
• Taste disturbance
Very rare: may affect up to 1 in 10,000 people
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives
Reporting of suspected adverse reactions
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.
By reporting side effects, you can help provide more information
on the safety of this medicine.
5. HOW TO STORE MEIJUMET 500 MG PROLONGED
RELEASE TABLETS
Keep Meijumet 500 mg prolonged release tablets out of the sight
and reach of children. Do not use this medicine after the expiry date
which is stated on the carton 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. CONTENTS
OF
THE
PACK AND
OTHER
INFORMATION
What Meijumet 500 mg prolonged release tablets contain:
Each prolonged release tablet contains 500 milligrams of the active
ingredient metformin hydrochloride equivalent to 390 mg
metformin. The other ingredients are microcrystalline cellulose,
hypromellose, Povidone and magnesium stearate.
What Meijumet 500 mg prolonged release tablets looks like and
contents of the pack
Meijumet 500 mg prolonged release tablets are white to off-white,
capsule shaped, biconvex tablets, approximately 18 mm x 8.5 mm,
debossed with ‘M2’ on one side and plain on other side.
Meijumet 500 mg prolonged release tablets are available in Alu
-PVC/PVdC blister packs of 28’s and 56’s.
Meijumet 500 mg prolonged release tablets: PL 21880/0159
This leaflet was last revised in April 2017
0159/O/PIL/001/I
POM
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk
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1215866-V1

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Meijumet 500 mg

prolonged release tablets
Metformin Hydrochloride
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 signs of illness are
the same as yours
• 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. See section 4
What is in this leaflet
1. What Meijumet 500 mg prolonged release tablets are and what
they are used for
2. What you need to know before you take Meijumet 500 mg
prolonged release tablets
3. How to take Meijumet 500 mg prolonged release tablets
4. Possible Side effects
5. How to store Meijumet 500 mg prolonged release tablets
6. Contents of the pack and other information
1. WHAT MEIJUMET 500 MG PROLONGED RELEASE
TABLETS ARE AND WHAT THEY ARE USED FOR
Meijumet 500 mg prolonged release tablets contain the active
ingredient metformin hydrochloride and belong to a group of
medicines called biguanides, used in the treatment of diabetes.
Meijumet 500 mg prolonged release tablets is 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. Meijumet 500 mg prolonged release
tablets make the body more sensitive to insulin and helps return to
normal the way your body uses glucose.
Meijumet 500 mg prolonged release tablets are associated with
either a stable body weight or modest weight loss.
Meijumet 500 mg prolonged release tablets are specially made to
release the drug slowly in your body and therefore are different to
many other types of tablet containing metformin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEIJUMET 500 MG PROLONGED RELEASE TABLETS:
Do not take Meijumet 500 mg prolonged release tablets 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
which can lead to diabetic pre-coma. Symptoms include
stomach pain, fast and deep breathing, sleepiness or your breath
developing an unusual, fruity smell.
• 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 ‘Warning and precautions’).
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This section is continued overleaf

• You have a severe infection, such as an infection affecting your
lung or bronchial system or your kidney. Sever infections may
lead to kidney problems, which can put you at risk for lactic
acidosis (see ‘Warning 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
‘Warning and precautions’).
• You are a heavy drinker of alcohol.
• You are under 18 years of age.
Warning and precautions
Risk of lactic acidosis
Meijumet 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.
Stop taking Meijumet 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 Meijumet 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:
• 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 Meijumet
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 Meijumet 500mg prolonged release tablets.
During treatment with Meijumet 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.
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.
Other Medicines and Meijumet 500mg prolonged release tablets:
If you need to have an inj ection 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 Meijumet 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 Meijumet 500mg prolonged release tablets.
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 Meijumet 500mg prolonged release tablets. 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)
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• Steroids such as prednisolone, mometasone, beclomethasone.
• 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 Meijumet 500mg
prolonged release tablets in your blood, especially if you have
reduced kidney function (such as Verapamil, rifampicin,
cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib,
isavuconazole, crizotinib, olaparib)
Meijumet 500mg prolonged release tablets with alcohol:
Avoid excessive alcohol intake while taking Meijumet 500mg
prolonged release tablets since this may increase the risk of lactic
acidosis (see section “Warnings and precautions”).
Pregnancy and breast-feeding
Do not take Meijumet 500 mg 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
Meijumet 500 mg prolonged release tablets 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 Meijumet 500 mg 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 MEIJUMET 500 MG PROLONGED
RELEASE TABLETS
Your doctor may prescribe Meijumet 500 mg prolonged release
tablets for you to take on its own, or in combination with other oral
antidiabetic medicines or insulin.
Always take Meijumet 500 mg prolonged release tablets 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 Meijumet 500
mg prolonged release tablets daily. After you have been taking
Meijumet 500 mg prolonged release tablets for about 2 weeks, your
doctor may measure your blood sugar and adjust the dose. The
maximum daily dose is 2000 milligrams of Meijumet 500 mg
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.
If you take more Meijumet 500 mg 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. 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 heartbeat. If you experience some of these
symptoms. You should immediately seek medical attention, as
lactic acidosis may lead to coma. Stop taking Meijumet 500mg
prolonged release tablets immediately and contact a doctor or the
nearest hospital straight away.
If you forget to take Meijumet 500 mg 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 Meijumet 500 mg prolonged release tablets
If you stop treatment with Meijumet 500 mg prolonged release
tablets without medical advice, your blood sugar levels may
increase. Late symptoms of diabetes, such as damage to the eyes,
kidneys and vessels, may occur.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist or nurse.
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Leaflet Folding pattren to be refered against Layout No.: 9917213-00

Product

Meijumet PR Tablets - 500 mg - S/L - English - PIL

Customer

MEDREICH PLC, UK

Reason
for Issue

AWR No.:
New Text from UK. Old Code: 1215866-V1

Related
FG Codes

1304113 / 14

Item Code

121XXXX-V1 (WOA)

Pharmacode No. 1028

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MED/MEI/PIL/02
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0159/O/PIL/001/I

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MEDREICH LIMITED

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WIN\\192.168.1.33\pdc\Artworks\Medreich\UK Products\Apcer Pharma\Meijumet\Metformin PR Tablets\500 mg\PIL\
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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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