Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 GILENYA 0.5 mg hard capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each capsule contains 0.5 mg fingolimod (as hydrochloride).

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Hard capsule

Capsule of 16 mm with bright yellow opaque cap and white opaque body; imprint with black ink, “FTY0.5 mg” on cap and two radial bands imprinted on the body with yellow ink.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

- Patients with high disease activity despite treatment with a beta-interferon.

These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.

- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

4.2 Posology and method of administration

 The treatment should be initiated and supervised by a physician experienced in multiple sclerosis.

Posology

The recommended dose of Gilenya is one 0.5 mg capsule taken orally once daily. Gilenya can be taken with or without food.

If a dose is missed treatment should be continued with the next dose as planned.

Patients can switch directly from beta interferon or glatiramer acetate to Gilenya provided there are no signs of relevant treatment-related abnormalities, e.g. neutropenia.

Special populations

Elderly population

Gilenya should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy (see section 5.2).

Renal impairment

Gilenya was not studied in patients with r