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GLENTEK 50MG FILM-COATED TABLETS

Active substance(s): RILUZOLE

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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.
- 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
over, feeling sick, being sick
1. What Glentek 50 mg Film-coated Tablets are and
- if your kidneys are not working very well
what they are used for
- if you have any fever: it may be due to a low number
2. Before you take Glentek 50 mg Film-coated
of white blood cells which can cause an increased
Tablets
risk of infection
3. How to take Glentek 50 mg Film-coated Tablets
- if you are less than 18 years of age. The use of
4. Possible side effects
Glentek is not recommended in children because
5. How to store Glentek 50 mg Film-coated Tablets
there is no information available in this population.
6. Further information
If any of the above applies to you, or if you are not
sure, tell your doctor who will decide what to do.
1. WHAT GLENTEK 50 MG FILM-COATED
TABLETS ARE AND WHAT THEY ARE USED
Taking other medicines
FOR
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines
What Glentek 50 mg Film-coated Tablets are
obtained without a prescription.
The active substance in Glentek is riluzole which acts
on the nervous system.
Pregnancy and breast-feeding
You MUST NOT take Glentek if you are or think you
What Glentek 50 mg Film-coated Tablets are used
may be pregnant, or if you are breast feeding.
for
Glentek is used in patients with amyotrophic lateral
If you think you may be pregnant, or if you intend to
sclerosis (ALS).
breast-feed, ask your doctor for advice before taking
Glentek.
ALS is a form of motor neurone disease where attacks
of the nerve cells responsible for sending instructions
Driving and using machines
to the muscles lead to weakness, muscle waste and
You can drive or use any tools or machines, unless you
paralysis.
feel dizzy or light headed after taking this medicine.
The destruction of nerve cells in motor neurone
3. HOW TO TAKE GLENTEK 50 MG FILM-COATED
disease may be caused by too much glutamate (a
TABLETS
chemical messenger) in the brain and spinal cord.
Always
take Glentek exactly as your doctor has told
Glentek stops the release of glutamate and this may
you.
You
should check with your doctor or pharmacist
help in preventing the nerve cells being damaged.
if you are not sure.
Please consult your doctor for more information about
The recommended dose is one tablet, twice a day.
ALS and the reason why this medicine has been
The tablets should be taken by mouth, every 12 hours,
prescribed for you.
at the same time of the day each day (e.g. in the
morning and evening).
2. BEFORE YOU TAKE GLENTEK 50 MG FILMCOATED TABLETS
If you take more Glentek 50 mg Film-coated Tablets
than you should
Do not take Glentek 50 mg Film-coated Tablets
If you take too many tablets, contact your doctor or the
- if you are allergic (hypersensitive) to riluzole or any
nearest hospital emergency department immediately.
of the other ingredients of Glentek.
- if you have any liver disease or increased
If you forget to take Glentek 50 mg Film-coated
blood levels of some enzymes of the liver
Tablets
(transaminases).
If you forget to take your tablet, leave out that dose
- if you are pregnant or breast-feeding.
completely and take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten
Take special care with Glentek 50 mg Film-coated
tablet.
Tablets
Tell your doctor:
If you have any further questions on the use of this
- if you have any liver problems: yellowing of your
product, ask your doctor or pharmacist.
skin or the white of your eyes (jaundice), itching all



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Glentek (Riluzole) Tablets_UK (Insert_Fr)

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4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Glentek can cause side effects,
although not everybody gets them.
IMPORTANT
Tell your doctor immediately
- if you experience 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.
- if you experience 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.
- if you experience cough or difficulties in breathing,
as this may be a sign of lung disease (called
interstitial lung disease).
Very common side effects (affecting more than 1 in
10 patients) of Glentek are:
- tiredness
- feeling sick
- increased blood levels of some enzymes of the liver
(transaminases).
Common side effects (affecting between 1 in 10 and
1 in 100 patients) of Glentek are:
- dizziness - numbness or tingling of - vomiting
the mouth
- sleepiness - increase in heart beat
- diarrhoea
- headache - abdominal pain
- pain
Uncommon side effects (affecting between 1 in 100
and 1 in 1000 patients) of Glentek are:
- anaemia
- allergic reactions
- inflammation of the pancreas (pancreatitis).
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE GLENTEK 50 MG FILMCOATED TABLETS
Keep out of the reach and sight 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.



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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
film-coated 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 filmcoated 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 medicinal product is authorised in the Member
States of the EEA under the following names:
Denmark
Glentek
Finland
Glentek 50 mg kalvopäällysteiset
tabletit
France
Glentek 50 mg, comprimé pelliculé
Germany
Glentek 50 mg Filmtabletten
Ireland
Glentek 50 mg Film-coated Tablets
Italy
Glentek
Spain
Glentek 50 mg comprimidos
recubiertos con película
Sweden
Glentek
The Netherlands Glentek 50 mg filmomhulde
tabletten
The United
Glentek 50 mg Film-coated Tablets
Kingdom
This leaflet was last revised in 04/2014.

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40gsm Bible Paper


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Sanjay

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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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