Vermox 100 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mebendazole

Available from:

PCO Manufacturing Ltd.

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:

2018-01-19

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VERMOX
® 100 MG 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_.

YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU
FEEL WORSE AFTER A FEW DAYS.
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 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

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2020
CRN009VH1
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vermox 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg mebendazole.
Excipient(s) with known effect: Each tablet also contains sunset
yellow (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Romania_
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 glycolate
Talc
Maize starch
Saccharin sodium
Magnesium stearate
Hydrogenated vegetable oil
Orange flavour
Colloidal anhydrous silica
Sodium laurilsulfate
Sunset Yellow (E110)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
27 July 2020
CRN009VH1
Page 2 of 2
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
Blister strip in a pack containing 6 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/440/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19
th
January 2018
10 DATE OF REVISION OF THE TEXT
July 2020