Vermox 100mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mebendazole

Available from:

Imbat 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:

2011-02-11

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERMOX™ 100MG TABLETS
(Mebendazole)
•
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.
1.
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 e.g. 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.
2.
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 ACIDITY).
If you are not sure about any of the medicines you are taking, show
the bottle or the pack

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 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 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
Microcrystalline Cellulose
Sodium Starch Glycollate
Talc
Maize Starch
Saccharin Sodium
Magnesium Stearate
Hydrogenated Vegetable Oil
Tetrarome Orange
Colloidal Dioxide Silica
Sodium Laurilsulfate
Sunset Yellow (E110)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strip and outer package of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Keep the blister in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Outer