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GLENTEK 50MG FILM-COATED TABLETS

Active substance(s): RILUZOLE / RILUZOLE / RILUZOLE

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SAME SIZE ARTWORK
LEAFLET SIZE: 180 mm x 220 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER
Glentek 50 mg film-coated tablets
riluzole
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 only. 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.
What is in this leaflet:
1. What Glentek 50 mg Film-coated Tablets is and what
it is used for
2. What you need to know Glentek 50 mg Film-coated
Tablets
3. How to take Glentek 50 mg Film-coated Tablets
4. Possible side effects
5. How to store Glentek 50 mg Film-coated Tablets
6. Contents of the pack and other information
1. What Glentek 50 mg film-coated tablets is and
what it is used for
What Glentek 50 mg Film-coated Tablets are
The active substance in Glentek is riluzole which acts on
the nervous system.
What Glentek 50 mg Film-coated Tablets are used
for
Glentek is used in patients with amyotrophic lateral
sclerosis (ALS).
ALS is a form of motor neurone disease where attacks of
the nerve cells responsible for sending instructions to
the muscles lead to weakness, muscle waste and
paralysis.
The destruction of nerve cells in motor neurone disease
may be caused by too much glutamate (a chemical
messenger) in the brain and spinal cord. Glentek stops
the release of glutamate and this may help in preventing
the nerve cells being damaged.
Please consult your doctor for more information about
ALS and the reason why this medicine has been
prescribed for you.
2. What you need to know before you take Glentek
50 mg film-coated tablets
Do not take Glentek 50 mg Film-coated Tablets
- if you are allergic (hypersensitive) to riluzole or any of
the other ingredients of Glentek (listed in section 6).
- if you have any liver disease or increased blood
levels of some enzymes of the liver (transaminases).
- if you are pregnant or breast-feeding.
Warnings and precautions
Talk to your doctor before taking Glentek 50 mg filmcoated tablets:

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VERSION: 08 (UK)

- if you have any liver problems: yellowing of your skin
or the white of your eyes (jaundice), itching all over,
feeling sick, being sick
- if your kidneys are not working very well
- if you have any fever: it may be due to a low number of
white blood cells which can cause an increased risk of
infection
If any of the above applies to you, or if you are not
sure, tell your doctor who will decide what to do.
Children and adolescents
If you are less than 18 years of age, the use of Glentek
50 mg film-coated tablets is not recommended because
there is no information available in this population.
Other medicines and Glentek 50 mg film-coated
tablets:
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
You MUST NOT take Glentek if you are or think you may
be pregnant, or if you are breast feeding.
If you think you may be pregnant, or if you intend to
breast-feed, ask your doctor for advice before taking
Glentek.
Driving and using machines
You can drive or use any tools or machines, unless you
feel dizzy or light headed after taking this medicine.
3. How to take Glentek 50 mg film-coated tablets
Always take Glentek exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.
The recommended dose is one tablet, twice a day.
The tablets should be taken by mouth, every 12 hours,
at the same time of the day each day (e.g. in the morning
and evening).
If you take more Glentek 50 mg Film-coated Tablets
than you should
If you take too many tablets, contact your doctor or the
nearest hospital emergency department immediately.
If you forget to take Glentek 50 mg Film-coated
Tablets

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If you forget to take your tablet, leave out that dose
completely and take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten
tablet.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Glentek can cause side effects,
although not everybody gets them.
IMPORTANT
Tell your doctor immediately if you experience this side
effect of unknown frequency (frequency cannot be
estimated from the available data):
- any fever (increase in temperature) because
Glentek may cause a decrease in the number of
white blood cells. Your doctor may want to take a
blood sample to check the number of white blood
cells, which are important in fighting infections.
- any of the following symptoms: yellowing of your skin
or the white of your eyes (jaundice), itching all over,
feeling sick, being sick, as this may be signs of liver
disease (hepatitis).Your doctor may do regular blood
tests while you are taking Glentek to make sure that
this does not occur.
Tell your doctor immediately if you experience
these side effects of uncommon frequency (may
affect up to 1 in 100 people)
- cough or difficulties in breathing, as this may be a sign
of lung disease (called interstitial lung disease).
- serious allergic reactions, signs include skin rash,
itchiness, difficulty breathing, swelling of the face,
tongue or throat.
- inflammation of the pancreas (pancreatitis), which
causes severe pain in the abdomen and the back.
Other side effects
Very common side effects (may affect more than 1 in
10 people) of Glentek are:
- tiredness
- feeling sick
- increased blood levels of some enzymes of the liver
(transaminases).
Common side effects (may affect up to 1 in 10 people)
of Glentek are:
- dizziness - numbness or
- vomiting
tingling of the mouth
- sleepiness - increase in heart beat - diarrhoea
- headache - abdominal pain
- pain
Uncommon side effects (may affect up to 1 in 100
people) of Glentek are:
- anaemia
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not

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DATE:12-05-16
VERSION: 08 (UK)

listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, website:
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 GLENTEK 50 MG FILMCOATED TABLETS
Keep out of the sight and reach of children.
Do not use Glentek after the expiry date which is stated
on the carton and the blister 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 Glentek 50 mg Film-coated Tablets contains
The active substance is riluzole.
Each film-coated tablet contains 50 mg of riluzole.
The other ingredients are:
Core: Calcium hydrogen phosphate anhydrous,
Cellulose microcrystalline, Croscarmellose sodium,
Silica colloidal anhydrous, Magnesium stearate;
Coating:
Hypromellose, Titanium Dioxide (E171),
Macrogol-400.
What Glentek 50 mg Film-coated Tablets looks like
and contents of the pack
Glentek 50 mg film-coated Tablets are supplied as:
White to off-white, capsule shaped, bevelled edged filmcoated tablets, engraved with '381' on one side and 'G'
on other side.
Glentek 50 mg film-coated Tablets are available in
PVC/PVDC aluminium blisters of 28, 56, 98 film-coated
tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2 B Draycott Avenue,
Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143, 566 17 Vysoké Mýto,
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom
This leaflet was last revised in 05/2016

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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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