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ASCALIX SYRUP 750MG/5ML
Active substance(s): PIPERAZINE HYDRATE
NAME OF THE MEDICINAL PRODUCT
Ascalix Syrup 750mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Piperazine Citrate equivalent to Piperazine Hydrate BP 750mg/5ml
The oral treatment of Enterobiasis and Ascariasis infestation.
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.
Sensitivity to piperazine, renal failure or previous history of epilepsy.
Moderate to severe hepatic impairment.
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.
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.
Pregnancy and lactation
Piperazine should not be given at any time during pregnancy except on
Effects on ability to drive and use machines
In the recommended dosage side-effects are not common but the following
have been reported:
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.
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.
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.
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
Preclinical safety data
List of excipients
Hydroxybenzoates (Methyl, Ethyl Propyl and Butyl)
Flavouring (Malaga Raisin Essence, Morella Cherry Essence)
Special precautions for storage
Store in a cool place.
Nature and contents of container
75ml Amber glass bottle.
Instructions for use, handling and disposal
No special instructions required.
MARKETING AUTHORISATION HOLDER
Wallace Manufacturing Chemists Ltd.
51-53 Stert Street
Oxfordshire OX14 3JF
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
06 March 1973, 24 March 1994
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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