Posology : מינונים

4.2    Posology and method of administration
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.

Posology

The starting dose is 120 mg twice a day. After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4).

If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses. Otherwise, the patient should wait until the next scheduled dose.

Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.

Dimethyl fumarate Teva should be taken with food (see section 5.2). For those patients who may experience flushing or gastrointestinal adverse reactions, taking Dimethyl fumarate Teva with food may improve tolerability (see sections 4.4, 4.5 and 4.8).

Special populations

Elderly
Clinical studies of Dimethyl fumarate had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients (see section 5.2). Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.

Renal and hepatic impairment
Dimethyl fumarate has not been studied in patients with renal or hepatic impairment. Based on clinical pharmacology studies, no dose adjustments are needed (see section 5.2). Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).

Paediatric population
The safety and efficacy of Dimethyl fumarate in children and adolescents aged 10 to 18 years have not yet been established.
Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made. There is no relevant use of Dimethyl fumarate in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.

Method of administration

For oral use.
The capsule should be swallowed whole. The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the tablets (contained in the capsule) prevents irritant effects on the gut.

If necessary to ease swallowing, you may open the capsule and swallow all the tablets inside it one after the other, immediately after opening.