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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