DIMETHYL FUMARATE MYLAN Gastro-resistant hard capsule Ref.[50260] Active ingredients: Dimethyl fumarate

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 Mylan should be taken with food (see section 5.2). For those patients who may experience flushing or gastrointestinal adverse reactions, taking Dimethyl fumarate Mylan 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 pellets prevents irritant effects on the gut.

Cases of overdose with dimethyl fumarate have been reported. The symptoms described in these cases were consistent with the known adverse reaction profile of dimethyl fumarate. There are no known therapeutic interventions to enhance elimination of dimethyl fumarate nor is there a known antidote. In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated.

3 years.

Bottle pack after opening 180 days.

Do not store above 30°C.

120 mg gastro-resistant hardcapsules: 14 gastro-resistant hard capsules in PVC/PE/PVdC aluminium blister packs and unit dose blister packs and white High density polyethylene (HDPE) bottles with a white opaque polypropylene screw cap with aluminium induction seal liner wad containing 14 or 60 gastro-resistant hard capsules.

240 mg gastro-resistant hard capsules 56 or 168 gastro-resistant hard capsules in PVC/PE/PVdC aluminium blister packs and unit dose blister packs and white High density polyethylene (HDPE) bottles with a white opaque polypropylene screw cap with aluminium induction seal liner wad containing 56 or 168 gastro-resistant hard capsules.

Not all pack sizes may be marketed.

No special requirements.