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Zentel 20 ML Sus and 200 MG Tablets GDS23 PDF
Zentel 20 ML Sus and 200 MG Tablets GDS23 PDF
SCHEDULING STATUS:
S4
COMPOSITION:
Excipients:
Tablet core: lactose, maize starch, povidone, sodium lauryl sulphate, sodium starch
(orange, passion fruit, vanilla) and the preservatives potassium sorbate 0,39 % m/v,
PHARMACOLOGICAL CLASSIFICATION:
A.12 Anthelmintics
PHARMACOLOGICAL ACTION:
D2013-1565 Page 1 of 7
Pharmacodynamic properties
Animal studies have shown that albendazole exhibits vermicidal, ovacidal and
larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerisation.
This causes the disruption of the helminth metabolism, including energy depletion,
Pharmacokinetic properties
main metabolite, the sulfoxide, attains a maximum of 0,25 to 0,30 µg/ml after
approximately 2½ hours.
The half-life of the sulfoxide in the plasma is 8½ hours. The metabolite is essentially
INDICATIONS:
CONTRA-INDICATIONS:
albendazole or constituents.
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WARNINGS AND SPECIAL PRECAUTIONS:
Leucopenia may occur when ZENTEL was used for periods longer than
recommended.
childbearing age should initiate treatment during the first week of menstruation
in areas with high taenosis infection. Patients may experience neurological symptoms
inflammatory reaction caused by death of the parasite within the brain. Symptoms may
occur soon after treatment, appropriate steroid and anticonvulsant therapy should be
started immediately.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
Effects on ability to drive and use machines: Since dizziness has been reported
tasks.
INTERACTIONS:
relevance of this is unknown, but may result in decreased efficacy, especially in the
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PREGNANCY AND LACTATION:
Usual Dose:
single dose in both adults and children over two years of age.
The usual dose in children between one and two years of age is 10 ml (200 mg) of
may be inadequate and the dose may be given for three consecutive days.
Note:
If the patient is not cured after three weeks, a second course of treatment may be
Albendazole has not been adequately studied in children under one year of age.
A single 400 mg daily dose (two 200 mg tablets or 20 ml suspension) for five days.
Some people, particularly young children, may experience difficulties swallowing the
tablets whole and should be encouraged to chew the tablets with a little water;
Elderly:
Impairment below).
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Renal impairment:
Hepatic impairment:
monitored.
SIDE EFFECTS:
Data from large clinical studies were used to determine the frequency of very common
reactions (i.e. those occurring at < 1/10 000) were mainly determined using post-
marketing data and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency: Very
common ≥ 1/10, common ≥ 1/100 to < 1/10, uncommon ≥ 1/1 000 to < 1/100, rare
≥ 1/10 000 and < 1/1 000, very rare < 1/10 000.
Gastrointestinal disorders:
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Hepatobiliary disorders:
TREATMENT:
IDENTIFICATION:
almost odourless.
PRESENTATION:
ZENTEL 200 mg tablets are available in blister pack strips of two tablets and packs of
100 x 2 tablets.
STORAGE INSTRUCTIONS:
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REGISTRATION NUMBER:
REGISTRATION:
39 Hawkins Avenue
Epping Industria 1
7460
02 October 2015
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