Ascalix Syrup 750mg/5ml
PRODUCT SUMMARY
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 l0ml (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
PHARMACEUTICAL PARTICULARS
6.
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.
MARKETING AUTHORISATION HOLDER
7
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 THE AUTHORISATION
06 March 1973, 24 March 1994
10 DATE OF REVISION OF THE TEXT
17/04/2009