How to use Riluzole Sun
Contents of the leaflet
- Package Leaflet: Information for the User
- Riluzole SUN, 50 mg, Film-Coated Tablets
- What is Riluzole SUN and What is it Used for
- Important Information Before Taking Riluzole SUN
- When Not to Take Riluzole SUN
- Warnings and Precautions
- If any of the Above Applies to You, or if You are Not Sure, Consult Your Doctor, who will Decide what to Do.
- Children and Adolescents
- Riluzole SUN and Other Medications
- Pregnancy and Breastfeeding
- Driving and Using Machines
- Riluzole SUN Contains Sodium
- How to Take Riluzole SUN
- Possible Side Effects
- How to Store Riluzole SUN
- Package Contents and Other Information
- What Riluzole SUN Contains
- What Riluzole SUN Looks Like and Contents of the Package
- Marketing Authorization Holder and Importer
- For Further Information about this Medication, Contact the Local Representative of the Marketing Authorization Holder:
- This Medication is Authorized for Use in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the Following Names:
Package Leaflet: Information for the User
Riluzole SUN, 50 mg, Film-Coated Tablets
Riluzole
Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
- Keep this Package Leaflet, You May Need to Read it Again.
- If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
- This Medication has been Prescribed for You Only. Do not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as Yours.
- If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
Package Leaflet Contents:
- 1. What is Riluzole SUN and What is it Used for
- 2. Important Information Before Taking Riluzole SUN
- 3. How to Take Riluzole SUN
- 4. Possible Side Effects
- 5. How to Store Riluzole SUN
- 6. Package Contents and Other Information
1. What is Riluzole SUN and What is it Used for
What is Riluzole SUN
The Active Substance of Riluzole SUN is Riluzole, which Acts on the Nervous System.
What is Riluzole SUN Used for
Riluzole SUN is Used in Patients with Amyotrophic Lateral Sclerosis (ALS).
Amyotrophic Lateral Sclerosis is a Form of Motor Neuron Disease, in which the Destruction of Motor Neurons Leads to Muscle Weakness, Atrophy, and Paralysis.
The Destruction of Motor Neurons in Motor Neuron Disease may be Caused by Excessive Glutamate (a Neurotransmitter) in the Brain and Spinal Cord. Riluzole SUN Inhibits the Release of Glutamate and may Help Prevent the Destruction of Motor Neurons.
Ask Your Doctor for a More Detailed Explanation of Amyotrophic Lateral Sclerosis and the Reason for Prescribing this Medication to You.
2. Important Information Before Taking Riluzole SUN
When Not to Take Riluzole SUN
- If You are Allergic to Riluzole or any of the Other Ingredients of this Medication (Listed in Section 6)
- If You have Liver Disease or Elevated Levels of Certain Liver Enzymes (Aminotransferases) in the Blood
- If You are Pregnant or Breastfeeding
Warnings and Precautions
Before Taking Riluzole SUN, Discuss the Following with Your Doctor:
- If You have any Liver Problems: Yellowing of the Skin or Eyes (Jaundice), Itching, Nausea, Vomiting
- If You have Kidney Function Disorders
- If You have a Fever (which may Indicate a Low White Blood Cell Count, Increasing the Risk of Infection)
If any of the Above Applies to You, or if You are Not Sure, Consult Your Doctor, who will Decide what to Do.
Children and Adolescents
If You are Under 18 Years of Age, the Use of Riluzole SUN is Not Recommended, as there is No Information Available for this Age Group.
Riluzole SUN and Other Medications
Tell Your Doctor about all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.
Pregnancy and Breastfeeding
Do Not Take Riluzole SUN if You are Pregnant or Think You may be Pregnant, or if You are Breastfeeding.
If You are Pregnant or Breastfeeding, Think You may be Pregnant, or Plan to Become Pregnant, Consult Your Doctor Before Taking this Medication.
Driving and Using Machines
You can Drive a Car, Use Tools, or Operate Machinery if You do not Experience Dizziness or a Feeling of Empty Head after Taking this Medication.
Riluzole SUN Contains Sodium
This Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which means it is Essentially Sodium-Free.
3. How to Take Riluzole SUN
Always Take this Medication Exactly as Your Doctor has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
The Recommended Dose is One Tablet Twice a Day.
Take the Tablets Orally, Every 12 Hours, at the Same Time Each Day (e.g., Morning and Evening).
Overdose of Riluzole SUN
If You Take More Tablets than Recommended, Contact Your Doctor or the Nearest Hospital Emergency Department Immediately.
Missing a Dose of Riluzole SUN
If You Forget to Take a Tablet, Skip the Missed Dose and Take the Next Tablet at the Usual Time.
Do Not Take a Double Dose to Make up for the Missed Tablet.
If You Have any Further Questions about Taking this Medication, Ask Your Doctor or Pharmacist.
4. Possible Side Effects
Like all Medications, Riluzole SUN can Cause Side Effects, although not Everybody Gets them.
IMPORTANT INFORMATION
Seek Medical Attention Immediately:
- If You Experience a Fever (Increased Temperature), as Riluzole SUN may Cause a Decrease in White Blood Cell Count. Your Doctor may Order a Blood Test to Check Your White Blood Cell Count, which is Important for Fighting Infections.
- If You Experience any of the Following Symptoms: Yellowing of the Skin or Eyes (Jaundice), Itching, Nausea, Vomiting, as these may be Signs of Liver Disease (Hepatitis). While Taking Riluzole SUN, Your Doctor may Order Regular Blood Tests to Ensure You do not have Liver Disease.
- If You Experience a Cough or Difficulty Breathing, as these may be Symptoms of Lung Disease (Interstitial Lung Disease)
Other Side Effects
Very Common Side Effects(may Affect more than 1 in 10 People) of Riluzole SUN include:
- Fatigue
- Nausea
- Increased Levels of Certain Liver Enzymes (Aminotransferases) in the Blood
Common Side Effects(may Affect up to 1 in 10 People) of Riluzole SUN include:
- Dizziness
- Drowsiness
- Headache
- Numbness or Tingling of the Mouth
- Increased Heart Rate
- Abdominal Pain
- Vomiting
- Diarrhea
- Pain
Uncommon Side Effects(may Affect up to 1 in 100 People) of Riluzole SUN include:
- Anemia
- Allergic Reactions
- Pancreatitis
Reporting Side Effects
If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide more Information on the Safety of this Medication.
5. How to Store Riluzole SUN
Keep this Medication out of the Sight and Reach of Children.
There are no Special Storage Instructions for this Medication.
Do not Use this Medication after the Expiration Date Stated on the Carton and Blister Pack after EXP. The Expiration Date refers to the Last Day of the Month.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist how to Dispose of Medications no Longer Required. This will Help Protect the Environment.
6. Package Contents and Other Information
What Riluzole SUN Contains
- The Active Substance is Riluzole. Each Film-Coated Tablet Contains 50 mg of Riluzole.
- The Other Ingredients are: Tablet Core: Calcium Hydrogen Phosphate Anhydrous (E341), Microcrystalline Cellulose (E460), Povidone K30 (E1201), Sodium Carboxymethylcellulose (E468), Colloidal Anhydrous Silica (E551), Talc, Magnesium Stearate (E572). Tablet Coating: Opadry White 03B68903, which Contains Hypromellose 6cP, Titanium Dioxide (E171), Talc, Macrogol 400.
What Riluzole SUN Looks Like and Contents of the Package
White or Almost White, Round, Biconvex Film-Coated Tablets with "538" Engraved on one Side and a Smooth Surface on the Other.
Riluzole SUN is Available in Packs Containing 56 or 98 Tablets (4 or 7 Blisters of 14 Tablets Each) and is Taken Orally.
Not all Pack Sizes may be Marketed.
Marketing Authorization Holder and Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
For Further Information about this Medication, Contact the Local Representative of the Marketing Authorization Holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75
This Medication is Authorized for Use in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the Following Names:
Germany:
Riluzol SUN 50 mg Film-Coated Tablets
Italy:
Riluzolo SUN 50 mg Film-Coated Tablets
Spain:
Riluzol SUN 50 mg Film-Coated Tablets EFG
United Kingdom - Northern Ireland:
Riluzole SUN 50 mg Film-Coated Tablets
Date of Last Revision of the Package Leaflet:
- Country of registration
- Dosage formTablets, 50 mg
- ATC codeN07XX02
- Active substance
- Prescription requiredNo
- ImporterSun Pharmaceutical Industries Europe B.V.
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to Riluzole SunDosage form: Tablets, 50 mgActive substance: riluzoleManufacturer: PRO.MED.CS. Praha a.s. PRO.MED.CS. Praha a.s.Prescription requiredDosage form: Tablets, 10 mgActive substance: fampridinePrescription requiredDosage form: Tablets, 10 mgActive substance: fampridineManufacturer: Balkanpharma-Dupnitsa ADPrescription not required
Online doctors for Riluzole Sun
Discuss questions about Riluzole Sun, including use, safety considerations and prescription review, subject to medical assessment and local regulations.
Get Riluzole Sun Prescription Online
Fill in a 2-min form
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Doctor reviews your case
Usually within 30 minutes. They may ask follow-up questions via chat.
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Electronic prescription sent to your email — valid across Spain.
Frequently Asked Questions
Riluzole Sun does not require a prescription in Poland. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in Riluzole Sun is riluzole. This information helps identify medicines with the same composition but different brand names.
Riluzole Sun is manufactured by Sun Pharmaceutical Industries Europe B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether Riluzole Sun is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy Riluzole Sun in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (riluzole) include Riluzol Pmcs, Fampridine Sandoz, Fampridine Teva. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
















