Vermox 100mg/5ml Oral Suspension

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 mg/5ml

Pharmaceutical form:

Oral suspension

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 suffer from any of the conditions mentioned
in _Section 2. See section 2 _
▶
- 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 Suspension is a medicine, which is used to
treat threadworms (sometimes known as pinworms)
and other common worm infections e.g. (whipworm,
roundworm, hookworm). The medicine contains
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 you are BREAST-FEEDING.
•
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
SUSPENSION.
TALK TO YOUR DOCTOR OR PHARMACIST...
•
If you have been told by your doctor that you have
an INTOLERANCE TO SOME SUGARS.
•
If you are taking any OTHER MEDICINES,
including:
•
_Metronidazole_ (a drug used to trea

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vermox 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 100 mg of mebendazole.
Excipients: Each 5ml also contains 500 mg of sucrose, 9 mg of
methylparahydroxybenzoate (E218) and 1 mg of
propylparahydroxybenzoate (E216).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension
_Product imported from Greece:_
A banana-flavoured opaque white oral suspension.
4 CLINICAL PARTICULARS
As per PA0823/057/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0823/057/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sucrose
Cellulose microcrystalline & Carmellose sodium
Methylparahydroxybenzoate (E218)
Propylparahydroxybenzoate (E216)
Methylcellulose
Sodium lauryl Sulphate
Banana flavor
Citric acid monohydrate
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Keep bottle in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass flask with a child resistant screw cap.
A 5 ml dosing spoon graduate