Riluzole Sun

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: