INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PIPRALEN® ELIXIR

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

PIPRALEN® ELIXIR

COMPOSITION:
Each 5 mL contains:
  Piperazine citrate equivalent to 750 mg piperazine hydrate.
Preservatives:
  Benzoic acid 0,1 % m/v
  Propyl hydroxybenzoate 0,01 % m/v
PHARMACOLOGICAL CLASSIFICATION:
A 12 Anthelmintics, Bilharzia medicines, Filaricides etc.

PHARMACOLOGICAL ACTION:
Piperazine is an anthelmintic effective against the intestinal nematodes. Ascaris lumbricoides (roundworm) and Enterobius vermicularis (pinworm, threadworm). The mechanism of action is not fully understood but piperazine produces a flaccid muscle paralysis in susceptible worms which are then dislodged from their position by the movement of the gut and are expelled in the faeces.

INDICATIONS:
For the elimination of threadworms and the treatment of roundworm infection.

CONTRA-INDICATIONS:
Piperazine is contra-indicated in patients with liver disease, epilepsy or renal failure.

WARNINGS:
Should be used with care in patients with latent epilepsy, neurological disturbances and impaired renal function.
The anthelmintic effect of piperazine may be antagonised by pyrantel.
Caution has been advised in patients receiving phenothiazines because of the possibility that piperazine might enhance their adverse effects.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
For Threadworms
Treatment to be continued for seven days
Infants (9 - 24 months):
Take one quarter 5 mL medicine measure two times daily.
Children (2 - 3 years):
Take one half 5 mL medicine measure two times daily.
Children (4 - 6 years):
Take one half 5 mL medicine measure three times daily.
Children (7 - 12 years):
Take one 5 mL medicine measure two times daily.
Adults:
Take one 5 mL medicine measure three times daily.

For Roundworms
Children (under 18 kg):
Take four 5 mL medicine measures (20 mL) as a single dose with the evening meal.
Adults and children (over 18 kg):
Take six 5 mL medicine measures (30 mL) as a single dose with the evening meal.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, diarrhoea abdominal pain, headache and urticaria occasionally occur. Severe neurotoxicity has been reported with symptoms including somnolence, dizziness, nystagmus, muscular incoordination and weakness, ataxia, myoclonic contractions, chioreiform movements, tremor, convulsions and loss of reflexes. Hypersensitivity reactions may occur. Cataract formation has been reported on rare occasions. Transient visual disturbances such as blurred vision have occurred occasionally.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage are nausea, vomiting, diarrhoea, abdominal pain, headache, paraesthesia and urticaria.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Bright orange liquid.

PRESENTATION:
30 mL, 100 mL, 2,5 L.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and heat
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
H924 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25.11.1974 K2958

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