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ASCALIX SYRUP 4G/30ML

Active substance(s): PIPERAZINE HYDRATE / PIPERAZINE HYDRATE / PIPERAZINE HYDRATE

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Transcript
PRODUCT SUMMARY
1.

NAME OF THE MEDICINAL PRODUCT

Ascalix Syrup 4g/30ml

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Piperazine Citrate equivalent to Piperazine Hydrate BP 4g/30ml

3.

PHARMACEUTICAL FORM
Oral Syrup

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
The oral treatment of roundworm infestation.

4.2

Posology and method of administration
Treatment of Roundworm.
Take by mouth the following dose once only:
Adults and Children over 8 years
30ml (the contents of the bottle)
Children 3 to 8 years
20ml (four 5ml spoonfuls)
Children 1 to 2 years
10ml (two 5ml spoonfuls)
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) and 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
30ml Beatson Clarke Winchester.

6.6

Instructions for use/handling
No special instructions required.

7

MARKETING AUTHORISATION HOLDER
Wallace Manufacturing Chemists Ltd.
Wallace House
51-53 Stert Street
Abingdon
Oxfordshire OX14 3JF
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 0400/5000R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06 April 1973, 19 April 1994

10

DATE OF REVISION OF THE TEXT
17/04/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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