Glentek 50mg Film coated Tablets

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 signs of illness 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 before you take 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

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.

Do not take Glentek 50 mg Film-coated Tablets

• if you are allergic to riluzole or any of the other ingredients of this medicine (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 film-coated tablets:

• 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:

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

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.

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

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.

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).

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
• sleepiness
• headache
• numbness or tingling of the mouth
• increase in heart beat
• abdominal pain
• vomiting
• diarrhoea
• pain

Uncommon side effects (may affect up to 1 in 100 people) of Glentek are:

• anaemia
• allergic reactions
• inflammation of the pancreas (pancreatitis).

Reporting of side effects

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, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer