50 mg film-coated tablets
riluzole
1. What Glentek is and what it is used for
What Glentek is
The active substance in Glentek is riluzole which acts on the nervous system.
What Glentek is used for
Glentek is used in patients with amyotrophic lateral sclerosis ( ALS ).
ALS is a type of motor neuron disease in which attacks the nerve cells, which are responsible for sending instructions to the muscles, leading to weakness, muscle wasting, and paralysis.
The breakdown of nerve cells in a motor neuron disease can be due to too much glutamate (a chemical messenger) in the brain and spinal cord. Glentek stops the release of glutamate and this can help prevent nerve cells from being destroyed.
Ask your doctor for more information about ALS and why you have been prescribed this medicine.
Riluzole contained in Glentek may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Glentek
Do not take Glentek:
- if you are allergic (hypersensitive) to riluzole or any of the other ingredients of this medicine (listed in section 6)
- if you have any liver disease or high blood levels of certain liver enzymes ( transaminases )
- if you are pregnant or breastfeeding .
Warnings and cautions
Talk to your doctor before taking Glentek:
- if you have liver problems: skin or whites of the eyes have turned yellow (jaundice), itching all over your body, you feel nauseous, suffer from vomiting
- if your kidneys are not working so well
- if you have a fever : it may be due to a low number of white blood cells , which may 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 young people
If you are under 18 years of age, the use of Glentek is not recommended as data are not available for this patient group.
Other medicines and Glentek
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
You should NOT take Glentek if you are pregnant or think you may be pregnant, or if you are breastfeeding.
If you think you may be pregnant, or if you are planning to breastfeed, ask your doctor for advice before taking Glentek.
Driving and using machines
You can drive and use tools or machines unless you feel dizzy or dizzy after taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to take Glentek
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet twice daily.
The tablets should be taken by mouth, every 12 hours at the same time each day (eg morning and evening).
If you take more Glentek than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Glentek
If you forget to take a tablet, skip the one dose and take the next tablet as usual.
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, this medicine can cause side effects, although not everybody gets them.
IMPORTANT
Tell your doctor immediately
- if you get a fever (elevated temperature) as Glentek may reduce the number of white blood cells . Your doctor may want to take a blood test to check the number of white blood cells , which are important in fighting infection .
- if you experience any of the following symptoms: skin or whites of the eyes turn yellow (jaundice), itching all over the body, nausea, vomiting, as these symptoms may be signs of liver disease ( hepatitis ). Your doctor may need to do regular blood tests while you are taking Glentek to make sure this does not happen.
- if you have a cough or difficulty breathing, as this may be a sign of a lung disease (called interstitial lung disease).
Other side effects are :
A very common side effect is (can occur in more than 1 in 10) by treatment with Glentek is:
- fatigue
- nausea
- elevated blood levels of certain liver enzymes ( transaminases )
Common side effects are (may affect up to 1 in 10) by treatment with Glentek is:
| – dizziness | tingling in the mouth | vomiting |
| – drowsiness | increase in heart rate one | – diarrhea |
| – headache | – abdominal pain | – pain |
Less common side effects are (may affect up to 1 in 100) the treatment with Glentek is:
- anemia
- allergic reactions
- inflammation of the pancreas ( pancreatitis )
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Glentek
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 packaging and other information
Content declaration
- The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
- Other ingredients are:Tablet core: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate;Coating: hypromellose, titanium dioxide (E171), macrogol 400.
What the medicine looks like and contents of the pack
Glentek 50 mg film-coated tablets are supplied as:
White to off-white, capsule-shaped, film-coated tablets with beveled edges, marked with “381” on one side and “G” on the other side
Glentek 50 mg film-coated tablets are available in PVC / PVDC / aluminum blisters containing 28, 56, 98 film-coated tablets.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194 Gröbenzell,
Germany
Manufacturer
Glenmark Pharmaceuticals sro
Fibichova 143, 566 17 Vysoké Mýto,
Czech Republic
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Germany, Sweden, Netherlands, UK: Glentek