SALAGEN Film-coated tablet Ref.[7848] Active ingredients: Pilocarpine

Posology

For head and neck cancer patients

The recommended initial dose for adults is 1 tablet of 5 mg three times daily. The maximal therapeutic effect is normally obtained after 4 to 8 weeks of therapy. For patients who have not responded sufficiently after 4 weeks and who tolerate the dose of 5 mg three times daily, doses of up to a maximum of 30 mg daily may be considered. However, higher daily doses are probably accompanied by an increase in drug-related adverse effects. Therapy should be discontinued if no improvement in xerostomia is noted after 2 to 3 months of therapy.

For Sjögren’s syndrome patients

The recommended dose for adults is one tablet of 5 mg four times daily. For patients who have not responded sufficiently to a dosage of 5 mg four times daily and who tolerate this dosage, increasing the dose up to a maximum of 30 mg daily, divided over the day, may be considered. Therapy should be discontinued if no improvement in the symptoms of dry mouth and dry eyes is noted after 2 to 3 months.

Special Populations

Use in the elderly

There is no evidence to suggest that dosage should be different in the elderly.

Paediatric population

The safety and efficacy of this medicinal product in the paediatric population have not been established.

Use in patients with impaired hepatic function

Patients with moderate and severe cirrhosis should start treatment on a reduced daily dosage schedule. Depending on the safety and tolerability, the dosage may gradually be increased to the normal daily dosage schedule of 5 mg three times a day.

Use in patients with impaired renal function

Insufficient information is available to determine the importance of renal excretion of pilocarpine and its metabolites so as to recommend dosage adjustments for patients with renal insufficiency (see Section 4.4 and Section 5.2).

Method of administration

For head and neck cancer patients

Tablets should be taken with a glass of water during or directly after meals. The last tablet should always be taken in conjunction with the evening meal.

For Sjögren’s syndrome patients

Tablets should be taken with a glass of water at mealtimes and bedtime.

Overdose may lead to a ‘cholinergic crisis’ characterised by both muscarinic and nicotinic effects.

Signs of overdose due to muscarinic effects may include abdominal cramps, diarrhoea, nausea and vomiting, involuntary defecation and urination, sweating, salivation, increased bronchial secretions, miosis, bradycardia and hypotension.

Nicotinic effects may include involuntary twitching, fasciculations and generalised weakness.

Parenteral atropine may be used as an antidote to the muscarinic effects. Supportive treatment should be given as required; artificial respiration should be instituted if respiratory depression is severe.

3 years.

Do not store above 25°C.

Store in the original package in order to protect from light and moisture.

Salagen is distributed for sale in perforated Al/PVC/PVDC blisters.

Each blister contains 14 or 21 tablets.

A carton contains 1, 2 or 6 of the 14-tablet blisters, or 1 or 4 of the 21-tablet blisters.

Not all pack sizes may be marketed.

No special requirements.