50 mg film-coated tablet
riluzole
What Riluzole Actavis is and what it is used for
The active substance in Riluzole Actavis is riluzole, which acts on the nervous system.
Riluzole Actavis is used in patients with amyotrophic lateral sclerosis ( ALS ).
ALS is a form of motor neuron disease, in which attacks on the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle wasting, and paralysis.
The destruction of nerve cells in motor neuron diseases can be caused by too much glutamate (a chemical messenger) in the brain and spinal cord. Riluzole Actavis stops the release of glutamate and this can help prevent nerve cells from being damaged.
Consult your doctor for more information about ALS and why this medicine has been prescribed for you.
Riluzole contained in Riluzole Actavis 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 Actavis
Do not take Riluzole Actavis
- 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 elevated blood levels of certain liver enzymes ( transaminases ) in your blood.
- if you are pregnant or breastfeeding.
Warnings and cautions
Tell your doctor or pharmacist before taking Riluzole Actavis
- if you have liver problems: yellowing of the skin or whites of your eyes (jaundice), itching everywhere, nausea, vomiting
- if your kidneys are not working 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 apply to you, or you are not sure, talk to your doctor who will decide what to do.
Children and young people
If you are younger than 18 years. The use of Riluzole Actavis is not recommended for use in children as there is no information available on this patient population.
Other medicines and Riluzole Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should NOT take Riluzole Actavis if you are pregnant or think you may be pregnant, or if you are breastfeeding.
Driving and using machines
You can drive or 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 vigilance. 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 Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.
How to take Riluzol Actavis
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is one tablet twice a day.
The tablets should be taken orally every 12 hours at the same time each day (eg morning or evening).
If you take more Riluzole Actavis than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to take Riluzole Actavis
If you forget to take your tablet, skip that dose 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
IMPORTANT
Stop taking Riluzole Actavis and contact a doctor immediately or see your nearest emergency department if you experience symptoms of angioedema, such as:
– swelling of the face, lips, tongue, or throat
difficulty swallowing
– hives and difficulty breathing.
Tell your doctor immediately
- if you experience fever (elevated temperature) Riluzole Actavis may cause a decrease in white blood cell count. 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: yellowing of the skin or whites of your eyes (jaundice), itching all over your body, nausea, vomiting, as this may be a sign of liver disease ( hepatitis ). Your doctor may take regular blood tests while you are taking Riluzole Actavis to make sure this does not occur.
- if you have a cough or difficulty breathing, as this may be a sign of lung disease (called interstitial lung disease).
Other side effects ar
Very common side effects (which may affect more than 1 in 10 people) when treated with Riluzole Actavis are:
– fatigue
– nausea
elevated levels of certain liver enzymes ( transaminases ) in the blood.
Common side effects (which may affect up to 1 in 10 people) when treated with Riluzole Actavis are:
– dizziness
– drowsiness
– headache
numbness or tingling sensation in the mouth
– palpitations
– abdominal pain
vomiting
– diarrhea
– pain.
Uncommon side effects (may affect up to 1 in 100 people) when treated with Riluzole Actavis are:
– anemia _ _ _
– allergic reactions
– pancreatitis ( pancreatitis ).
How to store Riluzol Actavis
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 blister and carton after EXP. The expiration date is the last day of that month.
Blister (aluminum / aluminum): No special storage instructions.
Blister (aluminum / PVC): Store the blisters in the outer carton. Sensitive to light. No special temperature 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.
Contents of the pack and other information
Content declaration
– The active substance is riluzole. Each film-coated tablet contains 50 mg of riluzole.
– The other ingredients are:
– Tablet core: calcium hydrogen phosphate, pregelatinized maize starch, croscarmellose sodium, anhydrous colloidal 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 Actavis are white or off-white, oval, and biconvex film-coated tablets marked RL 50 on one side.
Blister packs: 28, 30, 56, and 60 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Specifier SA
1, 28 Octovriou str.
123 51 Ag. Varvara
Athens
Greece