Pripsen Mebendazole Tablets 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pripsen Mebendazole Tablets 100mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mebendazole 100.00mg USP For excipients, see 6.1
3 PHARMACEUTICAL FORM
Chewable Tablets
A mottled off-white, round, flat faced tablet with a bevelled edge.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of threadworm (enterobiasis) infestation.
4.2 Posology and method of administration
Route of Administration: Oral
Adults, the elderly and children over two years old:
One tablet to be chewed or swallowed whole. The efficacy in threadworm infestations is such that treatment failure will be rare. However, the possibility of re-infection means that some patients may require a second tablet after two weeks, if re-infected.
It is strongly recommended that all members of the family are treated at the same time.
Not recommended for children under two years of age.
4.3 Contraindications
Hypersensitivity to mebendazole or to any of the excipients listed in section 6.1.
Not to be taken during pregnancy or whilst breast feeding.
Mebendazole has not been studied extensively in children under two years of age - for this reason it is not currently recommended for children under two years of age.
4.4 Special warnings and precautions for use
1) If, after two weeks, you need to take the second tablet, following which your symptoms persist, then consult your doctor.
2) Patients with rare hereditary problems of fructose intolerance should not take this medicine as it contains sorbitol.
Mebendazole is classified as possibly porphyrinogenic; use with caution in vulnerable patients and only when no safer alternative is available.
A case-control study of a single outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis has suggested a possible association with the concomitant use of metronidazole with mebendazole. Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided.
Labels/leaflet state:
Do not give to children under 2 years of age.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
This product contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
4.5 Interaction with other medicinal products and other forms of interaction
The hepatic metabolism of mebendazole is possibly inhibited by cimetidine resulting in increased plasma concentrations.
Concomitant use of mebendazole and metronidazole should be avoided (see section 4.4).
4.6 Pregnancy and lactation
Mebendazole has shown embryotoxic and teratogenic activity in rats at single oral doses. No such findings have been reported in the rabbit, dog, sheep or horse. Since there is a risk that Mebendazole could produce foetal damage if taken during pregnancy, it is contraindicated in pregnant women. No information on secretion into breast milk is available so mothers taking the drug should not breast feed.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Side effects reported have been minor. Possible side effects are summarised below: (frequencies not known: cannot be estimated from the available data).
Immune system disorders
Hypersensitivity
Nervous system disorders
Convulsions, dizziness, headache
Gastrointestinal disorders
Abdominal pain and diarrhoea (may be related to expulsion of worms), flatulence, hepatitis
Skin and subcutaneous tissue disorders
Angioedema, exanthema, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Raised liver enzyme values, alopecia and bone marrow depression have been reported following high dose mebendazole treatment.
Overdosage should be treated symptomatically with supportive measures and gastric lavage with activated charcoal as necessary. Symptoms of acute overdosage would be expected to include gastrointestinal disturbances, abdominal pain, headache, dizziness, pyrexia and convulsions.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
P02C A01 - Antinematodal agents, benzimidazole derivatives Anthelmintic.
5.2 Pharmacokinetic properties
Mebendazole is poorly absorbed from the gastrointestinal tract (5-10%) and undergoes extensive first pass elimination, being metabolised in the liver, eliminated in the bile as unchanged drug and metabolites and excreted in the faeces. Only about 2% of the drug is excreted unchanged or as metabolites in the urine. Mebendazole is highly protein bound.
5.3
Preclinical safety data
No data of relevance which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol E420 Orange Flavour Magnesium Stearate Povidone K30 Maize Starch Croscarmellose Sodium Sodium Saccharin
6.2 Incompatibilities
None
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
250 micron white, opaque rigid, uPVC 20p Aluminium foil blisters in cardboard cartons in packs of two tablets or eight tablets.
6.6 Special precautions for disposal
None given
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER
PL 00240/0085
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/04/2005
10 DATE OF REVISION OF THE TEXT
01/03/2015