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Logo CIPEX (Suspension)
CIPEX TABLETS (Tablets)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CIPEX (Suspension)
CIPEX TABLETS (Tablets)

COMPOSITION:
CIPEX TABLETS: Each tablet contains mebendazole 100 mg
Inactive ingredients include colloidal silicon dioxide, polysorbate 80, maize starch, magnesium stearate, microcrystalline cellulose, orange flavour, saccharin sodium, sodium starch glycollate, Sunset Yellow Supra and talc.
Sugar free formulation.
CIPEX:        Each 5 mL contains mebendazole 100 mg
Preservatives:
  Methylparaben         0,2% m/v
  Propylparaben         0,02% m/v
Inactive ingredients include Avicel RC 591, banana flavour, cardamom flavour, Carmoisine supra, methylcellulose, citric acid, purified water, SAPMG (simethicone emulsion), sodium lauryl sulphate.
CIPEX contains 2,8 sorbitol per 10 mL (the maximum daily recommended dose).
Products containing sorbitol may have a laxative effect or cause diarrhoea.

PHARMACOLOGICAL CLASSIFICATION:
A. 12 Anthelmintics, bilharzia medicines, filaricides, etc.

PHARMACOLOGICAL ACTION:
Mebendazole is a broad-spectrum anthelmintic. Its action is independent of its systemic concentration. It causes selective disappearance of cytoplasmic microtubules in the tegumental and intestinal cells of affected worms. Secretory substances accumulate in the Golgi areas, secretion of acetylcholinesterase and uptake of glucose is impaired, and glycogen is depleted, resulting in depletion of the worms' energy sources and their slow death.

INDICATIONS:
CIPEX
is indicated for the treatment of single and mixed helminth infestations such as:
Ascariasis (large roundworm).
Intestinal capillariasis.
Enterobius (pinworm).
Trichuriasis (whipworm).
Ancylostoma duodenale (hookworm).
Necator americanus (hookworm).
Strongyloides stercoralis (threadworm).
Taenia spp (tapeworm).
Ternidens deminutus.
CIPEX is also indicated in the treatment of infestations by Moniliformis moniliformis.

CONTRA-INDICATIONS:
Hypersensitivity to mebendazole or to any of the other ingredients.
Pregnancy and lactation.

PREGNANCY AND LACTATION
CIPEX
is contra-indicated during pregnancy and lactation (see CONTRA-INDICATIONS)

DOSAGE AND DIRECTIONS FOR USE:
Tablets can be swallowed whole, chewed, or crushed and given with food or liquid.
For infestations with all worms: excluding tapeworm, threadworm and Capillaria philippinensis:
Adults and children over 2 years
:
One 5 mL medicine measure of CIPEX suspension or one CIPEX tablet twice daily (morning and evening) for three consecutive days.
If the patient is not cured within three to four weeks a second course of treatment should be given.
For tapeworm infestations (Taeniaspecies):
Adults and children over 2 years:
One 5 mL medicine measure of CIPEX suspension or one CIPEX tablet twice daily (morning and evening) for six consecutive days.
For threadworm infestations (Strongyloidesstercoralis):
Adults:
Two 5 mL medicine measures (10 mL) of CIPEX suspension or two (2) CIPEX tablets twice daily (morning and evening) for three consecutive days.
Children:
One 5 mL medicine measure of CIPEX suspension or one CIPEX tablet twice daily (morning and evening) for three consecutive days.
The dosage should be repeated if the patient is still infested after three to four weeks.
For Capillaria philippinensis infestations:
Adults and children over 12 years:
Two 5 mL medicine measures (10 mL) of CIPEX suspension or two (2) CIPEX tablets to be given twice daily (morning and evening) for at least 20 days. This medicine is not recommended for children under the age of 12 years with capillariasis.
For children under 2 years:
See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS".
In worm-eradication campaigns the standard course for each specific species should be administered every quarter during the first year.
If a helminth is not susceptible to the standard dosage, the treatment course should be increased and/or higher doses than the standard dosage for a specific species is recommended.
The efficacy of CIPEX is dependent upon the duration of physical contact between the medicine and parasite. When gastrointestinal transit time is accelerated, e.g., in diarrhoea, it is necessary to repeat the dose at more frequent intervals daily.
Fasting or purging is not required.
High dose therapy should be taken with meals, preferably with a high fat content.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Blood and lymphatic system disorders:
Less frequent:         Neutropenia.
The following side-effects have been reported and frequencies are unknown:        Bone marrow depression, which can be severe has been reported with high doses. Agranulocytosis can occur,
Immune system disorders:
Less frequent:         Allergic reactions (with high doses).
Neuropsychiatric system disorders:
Less frequent:        Dizziness, headache.
Gastrointestinal system disorders:
Less frequent:        Gastrointestinal disturbances such as transient abdominal pain, diarrhoea and vomiting have occurred.
Hepatobiliary system disorders:
The following side-effects have been reported and frequencies are unknown:        Raised liver enzymes (with high doses)
Skin and subcutaneous tissue disorders:
Less frequent:        Alopecia (with high doses)
Special Precautions:
The use of CIPEX in children below two years of age is not well documented, and as there have been very exceptional reports of convulsions in this age group, CIPEX oral suspension should only be given to very young children if their worm infestations interfere with nutritional status and physical development.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS".
Treatment is symptomatic and supportive.

IDENTIFICATION:
CIPEX:        A light pink coloured homogeneous suspension with a characteristic banana-cardamom odour.
CIPEX TABLETS: Orange coloured and flavoured circular, flat, bevelled tablet, plain on both sides.

PRESENTATION:
CIPEX:        30 mL glass bottles, with measuring cup.
CIPEX TABLETS: Blister strips of 6 tablets packed in 6's, 60's or 300's

STORAGE INSTRUCTIONS:
Store at or below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
CIPEX:        30/12/0245
CIPEX TABLETS: 32/12/0538

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
.
Building 9, Parc du Cap,
Mispel Street, Bellville, 7530, RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 2009

© CIPLA MEDPRO (PTY) LTD
4353K

Namibia: [NS1]
Cipex        : 06/12/0074
Cipex Tablets        : 10/12/0482

Botswana: [S3]
Cipex: BOT 9900394

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2014/05/cipex-PI-2015.pdf

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