50 mg film-coated tablets
Riluzole
What Riluzole Stada is and what it is used for
What Riluzol Stada is
The active substance in Riluzole Stada is riluzole, which acts on the nervous system.
What Riluzol Stada is used for
Riluzole Stada is used in patients with amyotrophic lateral sclerosis ( ALS ).
ALS is a type of motor neuron disease 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. Riluzole Stada 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 Riluzole Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Riluzole Stada
Do not use Riluzol Stada
- 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 high blood levels of certain liver enzymes ( transaminases ),
- if you are pregnant or breastfeeding.
Warnings and cautions
Talk to your doctor before taking Riluzole Stada:
- 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 you have a cough or breathing problem, then this may be a sign of a lung disease (called interstitial lung disease).
If any of the above applies to you or if you are not sure, talk to your doctor, who will decide what to do next.
Children and young people
If you are under 18 years of age, the use of Riluzole Stada is not recommended as data are not available for this patient group.
Other medicines and Riluzol Stada
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
You must NOT take Riluzole Stada if you are or think you may be pregnant, or if you are breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
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.
Riluzole Stada contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘ sodium-free. is next to “sodium-free”.
How to use Riluzol Stada
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 use more Riluzole Stada than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Riluzole Stada
If you forget to take one 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.
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) Riluzole Stada 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 your body, nausea or vomiting, as these may be signs of liver disease ( hepatitis ). Your doctor may need to do regular blood tests while you are taking Riluzole Stada, to check that this is not happening
- if you have a cough or difficulty breathing, as this may be a sign of a lung disease (called interstitial lung disease)
- if you have allergic reactions, swelling of the face, lips, tongue, or throat in connection with breathing difficulties and/or difficulty swallowing ( angioedema ).
Other side effects ar
Very common side effects ( may affect more than 1 user in 10):
- fatigue
- nausea
- elevated blood levels of certain liver enzymes ( transaminases ).
Common side effects ( may affect up to 1 in 10 people):
- dizziness
- somnolence
- headache
- numbness or tingling in the mouth
- increased heart rate
- abdominal pain
- vomiting
- diarrhea
- pain
Uncommon side effects ( may affect up to 1 in 100 people):
- anemia
- inflammation of the pancreas ( pancreatitis )
How to store Riluzol Stada
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.
Blister (aluminum / aluminum): no special storage instructions.
Blister (aluminum / PVC): Store the blister card in the outer carton. Sensitive to light. This medicine does not have any specific storage instructions regarding temperature.
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.
Contents of the pack 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, pregelatinized maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
- Tablet coating: OPADRY AMB white 03F28689 consisting of hypromellose, macrogol 6000, and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Riluzole Stada is white or off-white, oval, and biconvex film-coated tablets, measuring 5.2 x 10 mm, marked with RL 50 on one side.
Blister packs of 14, 20, 28, 56, 60, 84, 98, 112, 140 and 168 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers:
Specifar SA
1, 28 Octovriou str.
123 51, Ag. Varvara, Athens
Greece
Actavis ehf
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Stada Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Centrafarm Services BV
New Donk 9
4879 AC Etten Leur
Netherlands
Eurogenerics NV
Heizel Esplanade B22
1020 Brussels
Belgium
PharmaCoDane ApS.
Marielundvej 46A
2730 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark