ASCALIX SYRUP 750 MG / 5ML - summary of medicine characteristics

1. NAME OF THE MEDICINAL PRODUCT

Ascalix Syrup 750mg/5ml

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Piperazine Citrate equivalent to Piperazine Hydrate BP 750mg/5ml

3. PHARMACEUTICAL FORM

Oral Syrup

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

The oral treatment of Enterobiasis and Ascariasis infestation.

4.2 Posology and method of administration

Treatment of Pinworm or Threadworm.___________­____________

Take by mouth the following dose once daily for seven days: Adults and Children over 12 years 15ml (three 5ml spoonfuls) Children 5 to 12 years 10ml (two 5ml spoonfuls)__________­___

Children 2 to 4 years 5ml (one 5ml spoonful)________­_______

Children 1 to 2 years 2.5ml (half a 5ml spoonful)

Treatment of Roundworm.___________­_____________________

Take by mouth the following dose once only:_____________

Adults and Children over 12 years 30ml (six 5ml spoonfuls) Children 8 to 12 years 20ml (four 5ml spoonfuls)__________

Children 3 to 8 years 15ml (three 5ml spoonfuls)___________

Children 1 to 2 years 7.5ml (one and one half 5ml spoonful)

Ascalix is not recommended for children under 1 year.

4.3 Contraindications

Sensitivity to piperazine, renal failure or previous history of epilepsy.

Moderate to severe hepatic impairment.

4.4 Special warnings and precautions for use

Use with caution in patients with severe malnutrition and anaemia. In ascariasis, if the patient has normal bowel movements, a purgative is not necessary but if patient is constipated, it is necessary to purge the patient about 12 hours after treatment so that the worms are expelled before the effects of the drug wears off.

4.5 Interactions with other medicinal products and other forms of interaction

It may potentiate the extrapyramidal effects in patients receiving phenothiazines. Pyrantel pamoate antagonises the modes of action of piperazine and therefore should not be co-administered.

4.6 Pregnancy and lactation

Piperazine should not be given at any time during pregnancy except on medical advice.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

In the recommended dosage side-effects are not common but the following have been reported:

Gastro-intestinal disturbance

Drowsiness, confusion, ataxia, reduced muscle tension

Clonic contractions have occurred but are only likely if neurological abnormalities or renal disease exist. Abdominal cramps, headaches, dizziness, tremors, choreirform movements, hyporeflexia, nystagmus, seizures, blurred vision, paralytic strabismus and rarely, cataracts.

Allergic reactions occasionally encountered include:

Skin reactions, arthralgia, fever, oedema and tachycardia. Urticaria, photodermatitis, erythema multiforme, purpura, eczematous skin reactions, lacrimation, rhinorrhoea and rarely, broncospasm.

4.9 Overdose

The symptoms of overdose are likely to be as in Undesirable effects (4.8).

Ensure adequate fluid intake and adopt supportive measures according to symptoms. Gastric lavage is only useful if piperazine ingestion is very recent.

Administer anti-convulsants if indicated.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Piperazine is an anthelmintic effective against roundworm and threadworm. In roundworms piperazine produces muscle paralysis and the worms are then expelled with the faeces.

Piperzine affects all stages of roundworm in the gut. The mode of action of piperazine on threadworm is not fully understood.

5.2 Pharmacokinetic properties

Piperazine is readily absorbed from the gastro-intestinal tract and is excreted in the urine partially as degraded products.

There is a wide variation in the rate at which piperazine is excreted by different individuals.

5.3 Preclinical safety data

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Glycerin

Sodium Saccharin

Hydroxybenzoates (Methyl, Ethyl Propyl and Butyl)

Propylene Glycol

Flavouring (Malaga Raisin Essence, Morella Cherry Essence)

Caramel (E150)

Water

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store in a cool place.

6.5 Nature and contents of container

75ml Amber glass bottle.

6.6 Instructions for use, handling and disposal

No special instructions required.

Wallace Manufacturing Chemists Ltd.

Wallace House

51–53 Stert Street

Abingdon

Oxfordshire OX14 3JF

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00400/5005R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

06 March 1973, 24 March 1994