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MEIJUMET 1000MG PROLONGED RELEASE TABLETS

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

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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 TABLETS
Keep Meijumet 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 tablets contain:
The active substance is Meijumet 750 mg equivalent to 585 mg
metformin and Metformin 1000mg equivalent to 780mg
metformin. The other ingredients are: microcrystalline cellulose,
hypromellose, povidone and magnesium stearate.
What Meijumet tablets looks like and contents of the pack
Meijumet 750mg prolonged release Tablets are 18 mm x 8.5 mm,
white to off-white, capsule shaped biconvex tablets, debossed with
‘750’ on one side and plain on other side.
Meijumet 1000mg prolonged release Tablets are 22 mm x 10 mm,
white to off-white, oval shaped biconvex tablets, debossed with
‘1000’ on one side and plain on other side.
Meijumet Tablets are supplied in blister packs of 14, 28 and 56
tablets and containers of 120 and 170 tablets.
Not all pack sizes may be marketed.
Meijumet 750 mg prolonged release tablets: PL 21880/0178
Meijumet 1000 mg prolonged release tablets: PL 21880/0179
This leaflet was last revised in June 2017

0178/O/PIL/001/I
0179/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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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Meijumet 750 mg and 1000mg
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
• The name of this medicine is Meijumet 750mg prolonged release
tablets and Meijumet 1000mg prolonged release tablets but it
will be referred to as Meijumet Tablets throughout this leaflet.
What is in this leaflet:
1. What Meijumet tablets are and what they are used for
2. What you need to know before you take Meijumet tablets
3. How to take Meijumet tablets
4. Possible Side effects
5. How to store Meijumet tablets
6. Contents of the pack and other information
1. WHAT MEIJUMET TABLETS ARE AND WHAT THEY
ARE USED FOR
Meijumet tablets contain the active ingredient metformin
hydrochloride and belong to a group of medicines called
biguanides, used in the treatment of diabetes. Meijumet 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 tablets make the body more
sensitive to insulin and helps return to normal the way your body
uses glucose.
Meijumet tablets are associated with either a stable body weight or
modest weight loss.
Meijumet 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 TABLETS:
Do not take Meijumet 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 severly 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’).
This section is continued overleaf
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• 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 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 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 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
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 tablets.
During treatment with Meijumet 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.
Do not stop taking this medicine without speaking to your doctor.
Other Medicines and Meijumet tablets:
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 Meijumet 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 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 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)
• Steroids such as prednisolone, mometasone, beclomethasone.
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• 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 tablets in
your blood, especially if you have reduced kidney function (such
as Verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,
trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
Meijumet tablets with alcohol:
Avoid excessive alcohol intake while taking Meijumet tablets since
this may increase the risk of lactic acidosis (see section “Warnings
and precautions”).
Pregnancy and breast-feeding
Do not take Meijumet tablets if you are pregnant or breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Meijumet 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 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 TABLETS
Your doctor may prescribe Meijumet tablets for you to take on its own,
or in combination with other oral antidiabetic medicines or insulin.
Always take Meijumet 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 one metformin hydrochloride
500mg prolonged release tablet 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 tablets. Please
note that Meijumet Tablets cannot be split to administer a 500mg
dose. Your doctor will prescribe an alternative product. 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 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 tablets immediately and contact a
doctor or the nearest hospital straight away.
If you forget to take Meijumet tablets
Take it as soon as you remember with some food. Do not take a
double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Meijumet tablets can cause side effects,
although not everybody gets them. The following side effects may
occur:
Meijumet 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 tablets and contact a doctor or the
nearest hospital immediately, as lactic acidosis may lead to coma.
Meijumet 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.
This section is continued overleaf
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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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