AMFEXA Tablet Ref.[27655] Active ingredients: Dexamfetamine

Posology

Treatment must be under the supervision of a specialist in childhood and/or adolescents behaviour disorders.

Careful dose titration is necessary at the start of treatment with dexamfetamine. Dose titration should be started at the lowest possible dose.

The recommended starting daily dose is 5 mg once or twice daily (e.g. at breakfast and lunch), increasing if necessary by weekly increments of 5 mg in the daily dose according to tolerability and degree of efficacy observed.

In the treatment of hyperkinetic disorders / ADHD, the times at which the doses of Amfexa 5 mg Tablets are administered should be selected to provide the best effect when it is most needed to combat school and social behavioural difficulties. Normally the first increasing dose is given in the morning. Amfexa 5 mg Tablets should not be taken too late after lunch time to avoid disturbances of sleep.

The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.

The maximum daily dose in children and adolescents usually is 20 mg, although doses of 40 mg may in rare cases be necessary for optimum titration

Long-term use

Long-term usefulness of dexamfetamine for extended periods (over 12 months) in children and adolescents with ADHD should be periodically re-evaluated for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy. It is recommended that dexamfetamine is de-challenged at least once yearly to assess the child’s condition (preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.

Dose reduction and discontinuation

Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.

Special populations

Children under 6 years of age

The safety and efficacy of Amfexa 5 mg Tablets in children aged 0 to 6 years has not been established.

Therefore Amfexa 5 mg Tablets should not be used in children under the age of 6 years.

Use in Adults

Amfexa 5 mg Tablets is not licensed for use in adults. The safety and efficacy of dexamfetamine in adults have not been established.

Elderly

Amfexa 5 mg Tablets should not be used in the elderly. Safety and efficacy of dexamfetamine has not been established in this age group.

Patients with renal or hepatic insufficiency

There is no experience with the use of dexamfetamine in patients with renal or hepatic insufficiency.

Thus, dexamfetamine should be used with special caution in this patient group by taking care of titration and dosage

Method of administration

Oral use.

The tablets may be swallowed whole with the aid of liquids, or alternatively, in cases of swallowing problems the tablets can be divided.

The tablet score lines enable division of the tablet into four parts. For division, the tablet is placed onto a hard surface with its cross- scored, convex side downwards and is then pushed carefully with the index finger at the centre of its top side. The tablet then breaks into four parts. Drinking some fluids, e.g. water, should follow the intake of the divided tablets.

The effect of food on the absorption of dexamfetamine from Amfexa 5 mg Tablets has not been studied; therefore, a possible effect of food on absorption cannot be excluded. Therefore, it is recommended that Amfexa 5 mg Tablets should be taken in a standardised manner in relation to the timing of meals, i.e. that doses should be given at the same times, relative to the time of meals, on each day, preferably with or immediately after meals.

Signs and symptoms

Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, aggression, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, mydriasis, dryness of mucous membranes, flushing, headache, hyperpyrexia, chest pain, tachycardia, palpitations, cardiac arrhythmias, hypertension, respiratory depression, coma, circulatory collapse, and death.

Individual patient response may vary widely and toxic manifestations may occur with quite small overdoses.

Treatment

There is no specific antidote to dexamfetamine overdose. Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting when the medicinal product has been taken less than one hour before. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.

Excessive stimulation or convulsions may be treated with benzodiazepines.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

36 months.

Do not store above 25°C.

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

Boxes containing 20, 30, 50, or 100 tablets in PVC/PE/PVdC clear blisters heat sealed to aluminium foil.

Not all pack sizes may be marketed.

No special requirements.