Pripsen Mebendazole Tablets 100 mg

1. Name Of The Medicinal Product

Pripsen Mebendazole Tablets 100 mg

Mebendazole Tablets 100 mg

Boots Family Threadworm Tablets

2. Qualitative And Quantitative Composition

Mebendazole 100.00 mg 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 any of the ingredients.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

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. Hypersensitivity reactions including exanthema, rash, urticaria and angioedema have been reported rarely. Transient abdominal pain and diarrhoea have been reported only rarely in cases of massive infestation and expulsion of worms. (Slight headache and dizziness have occasionally been reported).

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, Benzimadazole 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 a highly bound protein

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 20µ Aluminium foil blisters in cardboard cartons in packs of two, four tablets or eight tablets.

6.6 Special Precautions For Disposal And Other Handling

None given.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0085

9. Date Of First Authorisation/Renewal Of The Authorisation

6 September 2002

10. Date Of Revision Of The Text

05/05/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable