Vermox 100mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mebendazole

Available from:

LTT Pharma Limited

ATC code:

P02CA; P02CA01

INN (International Name):

Mebendazole

Dosage:

100 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Benzimidazole derivatives; mebendazole

Authorization status:

Authorised

Authorization date:

2011-05-27

Patient Information leaflet

- This medicine is used to treat threadworm and
other common worm infections of the gut.
- This medicine is for use by adults and children
aged over 2 years.
- DO NOT USE THIS MEDICINE:
- There are some people who should not use this
medicine. _To find out if you are one of them see _
_section 2 _
▶
- If you have ever had a BAD REACTION to any of the
ingredients. _To view the list of ingredients see _
_section 6 _
▶
- SPEAK TO YOUR DOCTOR:
- If you are taking any other medicines. _See section _
_2 _
▶
- FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These
are shown in the dosage table. _See section 3 _
▶
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU
USE THIS MEDICINE. Keep the leaflet: you might need
it again.
IN THIS LEAFLET:
What the medicine is for
Before taking this medicine
How to take this medicine
Possible side effects
Storing this medicine
Further information
Further advice regarding threadworms
WHAT THE MEDICINE IS FOR
Vermox Tablets is a medicine which is used to treat
threadworms (sometimes known as pinworms)
and other common worm infections eg (whipworm,
roundworm, hookworm). The tablets contain
mebendazole, which is one of a group of medicines
called ‘anthelmintics’.
This medicine is for use in adults and children aged
over 2 years.
BEFORE TAKING THIS MEDICINE
This medicine is suitable for most adults and
children, but a few people should not use it. If you
are in any doubt, talk to your doctor or pharmacist.
DO NOT USE THIS MEDICINE…
•
If you are HYPERSENSITIVE (allergic) to any of the
ingredients.
•
If it is for a CHILD UNDER 2 YEARS.
•
If you are PREGNANT OR THINK YOU ARE PREGNANT.
•
If you are BREAST-FEEDING.
If any of these apply to you, GET ADVICE FROM A
DOCTOR OR PHARMACIST BEFORE USING VERMOX
TABLETS.
TALK TO YOUR DOCTOR OR PHARMACIST...
•
If you are taking any OTHER MEDICINES,
INCLUDING:
•
_Metronidazole_ (a drug used to treat BACTERIAL
AND PROTOZOAN INFECTIONS) as a serious skin
reaction can rarely occur.
•
_Cimetidine_ (a medicine used to treat excess
STOMACH ACID

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vermox 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg mebendazole.
Excipients: Each tablet also contains 0.06 mg sunset yellow (E110).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Greece:_
Faintly orange circular, flat, half-scored, bevel-edged tablet with
‘Me 100’ inscribed on one side and ‘Janssen’ on the
other.
The half-score line is only to facilitate breaking for ease of
swallowing and not to divide into equal halves.
4 CLINICAL PARTICULARS
As per PA0330/046/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/046/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cellulose microcrystalline
Sodium starch glycolate
Talc
Starch maize
Saccharin sodium
Magnesium stearate
Vegetable oil hydrogenated
Tetrarome orange
Sillicon dioxide colloidal
Sodium lauryl sulfate
Sunset yellow (E110)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store about 25°C.
Keep blister in the outer carton in order to protect from light.
6.5 NATURE AND CONTEN