Each coated tablet contains:

active ingredient: amitriptyline hydrochloride – 25.0 mg;

For a full list of excipients see section 6.1.

Posology

Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increments.

Major depressive disorder

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability.

Adults

Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose can be increased by 25 mg every other day up to 150 mg daily divided into two doses.

The maintenance dose is the lowest effective dose.

Elderly patients over 65 years of age and patients with cardiovascular disease Initially 10 mg – 25 mg daily.

The daily dose may be increased up to 100 mg – 150 mg divided into two doses, depending on individual patient response and tolerability.

Doses above 100 mg should be used with caution. The maintenance dose is the lowest effective dose.

Paediatric population

Amitriptyline should not be used in children and adolescents aged less than 18 years, as long term safety and efficacy have not been established (see section 4.4).

Duration of treatment

The antidepressant effect usually sets in after 2 – 4 weeks. Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time usually up to 6 months after recovery in order to prevent relapse.

Neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine prophylaxis

Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. Generally, the lowest effective dose should be used for the shortest duration required to treat the symptoms.

Adults

Recommended doses are 25 mg – 75 mg daily in the evening. Doses above 100 mg should be used with caution.

The initial dose should be 10 mg – 25 mg in the evening. Doses can be increased with 10 mg – 25 mg every 3 – 7 days as tolerated.

The dose can be taken once daily, or be divided into two doses. A single dose above 75 mg is not recommended.

The analgesic effect is normally seen after 2 – 4 weeks of dosing.

Elderly patients over 65 years of age and patients with cardiovascular disease A starting dose of 10 mg – 25 mg in the evening is recommended.

Doses above 75 mg should be used with caution.

It is generally recommended to initiate treatment in the lower dose range as recommended for adult. The dose may be increased depending on individual patient response and tolerability.

Paediatric population

Amitriptyline should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established (see section 4.4).

Duration of treatment

Neuropathic pain

Treatment is symptomatic and should therefore be continued for an appropriate length of time. In many patients, therapy may be needed for several years. Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.

Prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine in adults

Treatment must be continued for an appropriate length of time. Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.

Nocturnal enuresis

Paediatric population

The recommended doses for:

• children aged 6 to 10 years: 10 mg – 20 mg. A suitable dosage form should be used for this age group.
• children aged 11 years and above: 25 mg – 50 mg daily The dose should be increased gradually.

Dose to be administered 1-1½ hours before bedtime.

An ECG should be performed prior to initiating therapy with amitriptyline to exclude long QT syndrome.

The maximum period of treatment course should not exceed 3 months.

If repeated courses of amitriptyline are needed, a medical review should be conducted every 3 months.

When stopping treatment, amitriptyline should be withdrawn gradually.

Special populations

Reduced renal function

This medicinal product can be given in usual doses to patients with renal failure.

Reduced liver function

Careful dosing and, if possible, a serum level determination is advisable. Cytochrome P450 inhibitors of CYP2D6

Depending on individual patient response, a lower dose of amitriptyline should be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to amitriptyline treatment (see section 4.5).

Known poor metabolisers of CYP2D6 or CYP2C19

These patients may have higher plasma concentrations of amitriptyline and its active metabolite nortriptyline. Consider a 50% reduction of the recommended starting dose.

Method of administration

Amitriptyline tablet is for oral use.

The tablets should be swallowed with water.

Discontinuation of treatment

When stopping therapy the drug should be gradually withdrawn during several weeks.

Pharmacotherapeutic group: Antidepressants; Non-selective monoamine reuptake inhibitors

ATC code: N06AA09

List of Excipients:

tablet core:

microcrystalline cellulose

lactose monohydrate

povidone

maize starch

sodium starch glycolate

magnesium stearate

talc purified

tablet coating:

hypromellose

titanium dioxide

propylene glycol

talc purified

color yellow (riboflavin)

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134482/1734095746965.pdf