EXELON CAPSULE 4.5 MG [SIN10037P]

Product Info

EXELON CAPSULE 4.5 MG

[SIN10037P]

INDICATIONS

Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable Alzheimer’s Disease or Alzheimer’s Disease.

Treatment of patients with mild to moderately severe dementia associated with Parkinson’s disease.

DOSAGE REGIMEN AND ADMINISTRATION

Administration

Dosage regimen

Initial dose

1.5 mg twice a day.

Dose titration

The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks’ treatment at that dose level.

If adverse effects (e.g., nausea, vomiting, abdominal pain, or loss of appetite) or weight decrease are observed during treatment, these may respond to omitting one or more doses. If adverse effects persist, the daily dose should be reduced to the previous well-tolerated dose.

Maintenance dose

1.5 mg to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well-tolerated dose.

Recommended maximum daily dose

6 mg twice a day.

Re-initiation of therapy

The incidence and severity of adverse events are generally increased with higher doses.

If treatment is interrupted for longer than three days, treatment should be re-initiated with the lowest daily dose and titrated as described above.

Special populations

Pediatric patients (below 18 years)

The use of Exelon in pediatric patients has not been studied and is therefore not recommended.

Method of administration

Exelon hard capsules or Exelon oral solution should be administered twice a day, with morning and evening meals.

Renal impairment or hepatic impairment

No dose adjustment is necessary in patients with renal or hepatic impairment. However, due to increased exposure in moderate renal and mild to moderate hepatic impairment, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose dependent adverse reactions. Patients with severe hepatic impairment have not been studied (see sections CLINICAL PHARMACOLOGY – Special population and WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CONTRAINDICATIONS

The use of Exelon is contraindicated in patients with:

• Known hypersensitivity to rivastigmine, to other carbamate derivatives or to the excipients of the formulation (see section DESCRIPTION AND COMPOSITION – Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine transdermal patch (see section WARNINGS AND PRECAUTIONS – Skin reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)