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Ascalix Syrup 4g/30ml

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

6.1    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.

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 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