Consumer medicine information

1. Why am I using Riluzole Sandoz?

Riluzole Sandoz contains the active ingredient riluzole. Riluzole Sandoz is used in the treatment of amyotrophic lateral sclerosis (ALS), a form of motor neurone disease which can cause muscle degeneration and muscle weakness.
For more information, see Section 1. Why am I using Riluzole Sandoz? in the full CMI.

2. What should I know before I use Riluzole Sandoz?

Do not use if you have ever had an allergic reaction to riluzole or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. Talk to your doctor if you smoke cigarettes or consume caffeine.
For more information, see Section 2. What should I know before I use Riluzole Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Riluzole Sandoz and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Riluzole Sandoz?

• The recommended dose is usually one tablet two times a day.

• Riluzole Sandoz may not work as well if it is taken at the same time as your meals. Riluzole Sandoz should not be taken immediately before or after meals, especially meals which may contain food high in fat.

• Swallow Riluzole Sandoz tablets whole with a full glass of water. Do not chew the tablets.

5. What should I know while using Riluzole Sandoz?

6. Are there any side effects?

All medicines can have side effects. Tell your doctor or pharmacist if you do not feel well whilst you are taking Riluzole Sandoz. Most of the side effects from taking Riluzole Sandoz are minor and temporary, such as headache, nausea and weakness. However, some serious side effects may need urgent medical attention. Examples of serious side effects include severe upper stomach pain and itching or yellowing of the skin.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Riluzole.

2 Qualitative and Quantitative Composition

Each Riluzole Sandoz 50 mg film-coated tablet contains 50 mg riluzole, a benzothiazole.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Riluzole Sandoz 50 mg film-coated tablets: white, capsule shaped, debossed with the text 'RLZ' on one side.

4 Clinical Particulars

4.9 Overdose

Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma and methemoglobinaemia have been observed in isolated cases. Severe methemoglobinaemia may be rapidly reversible after treatment with methylene blue.
In case of overdose, treatment should be supportive and symptomatic.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There was no evidence of a genotoxic potential in standard assays for gene mutations (microbial mutagenicity test, mouse lymphoma assay in L5178Y cells) and chromosomal damage (chromosomal aberrations in human lymphocytes in vitro, rat cytogenetic assay in vivo and mouse micronucleus assay).
Carcinogenicity. Two long-term (2 years) carcinogenicity studies have been completed in rats and mice. Riluzole showed no evidence of carcinogenic potential in rats and mice treated orally for 2 years at doses of 10 and 20 mg/kg/day, respectively. These doses were approximately 0.85 times the recommended maximum dose of 100 mg daily, on an mg/m² basis.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Riluzole is a white to slightly yellow, fine crystalline, nonhygroscopic powder. It is very slightly soluble in water and 0.1 N sodium hydroxide, sparingly soluble in 0.1 N hydrochloric acid and very soluble in methanol, acetone, acetonitrile, dichloromethane and dimethyl sulfoxide. Riluzole has a pKa of 3.8 and a log P (octanol/0.1 N aq. HCl) of 0.69.
The chemical name of riluzole is 2-amino-6-trifluoromethoxybenzothiazole. Its empirical formula is C₈H₅F₃N₂OS (MW: 234.20) and its chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRILUZO.gif CAS number. 1744-22-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/RILSANST.gif