Vermox 100mg/5ml oral suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEBENDAZOLE

Available from:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC code:

P02CA01

INN (International Name):

MEBENDAZOLE 20 mg/ml

Pharmaceutical form:

ORAL SUSPENSION

Composition:

MEBENDAZOLE 20 mg/ml

Prescription type:

POM

Therapeutic area:

ANTHELMINTICS

Authorization status:

Authorised

Authorization date:

2007-01-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VERMOX
® 100 MG/5 ML ORAL SUSPENSION
Mebendazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours
•
If you get side effects and they become serious or if you notice any
side effects not
listed in this leaflet, please tell your doctor or pharmacist. See
section 4
IN THIS LEAFLET
1.
What Vermox suspension is and what it is used for
2.
Before you use Vermox suspension
3.
How to use Vermox suspension
4.
Possible side effects
5.
How to store Vermox suspension
6.
Further information
7.
Further advice regarding worms
1.
1.
WHAT VERMOX SUSPENSION IS AND WHAT IT IS USED FOR
The name of your medicine is Vermox 100 mg/5 ml oral suspension
(referred to as
Vermox suspension in this leaflet). It contains a medicine called
mebendazole. It is one
of a group of medicines called ‘anthelmintics’.
Vermox suspension is used to treat worm infections of the gut such as:
•
threadworms (pinworms)
•
other common worm infections (such as whipworm, roundworm, hookworm)
This medicine is for use in adults and children aged over 2 years.
You or your child has been advised to take Vermox suspension because
you have a
worm infection. Worms can infect anyone. It does not necessarily mean
that your
hygiene is poor.
To stop you and your family infecting others or re-infecting
yourselves, follow the advice
below for at least six weeks:
•
Keep nails short
•
Discourage nail biting or finger sucking
•
Wear pyjamas or underclothes in bed
•
In the mornings, wash your bottom thoroughly
•
Use a separate towel for each person in the house
•
Change clothes regularly
•
Wash and iron bed linen regularly
•
Wash hands and nails well after using the toilet and before meals
2.
BEFORE YOU USE VERMOX SUSPENSION
DO NOT

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 of suspension also contains 500mg of sucrose, 9mg
of methyl
parahydroxybenzoate (E218) and 1mg of propyl parahydroxybenzoate
(E216).
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White homogenous oral suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Broad spectrum gastro-intestinal antihelmintic indicated for the
treatment of:
_Enterobius vermicularis_
(threadworm/pinworm)
_Oxyuris vermicularis _
_Trichuris trichuria_
(whipworm)
_Ascaris lumbricoides_
(large roundworm)
_Ancylostoma duodenale_
(common hookworm)
_Necator americanus_
(American hookworm)
There is no evidence that Vermox Suspension is effective in the
treatment of
cysticercosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 2 years of age:
_ _
_Enterobiasis: _
1 x 5ml (1 dosing cup)
It is highly recommended that a second dose is taken after two weeks,
if reinfection is
suspected.
_Ascariasis, trichuriasis, ancylostomoasis, necatoriasis _
and mixed infections
_: _
1 x 5ml (1 dosing cup) bd for three days.
Children under 2 years of age:
Vermox has not been extensively studied in children below the age of 2
years.
Currently available data are described in section 4.4, 4.8 and 5.2,
but no recommendations on
a posology can be made.
Because of the lack of sufficient safety data, Vermox should not be
used in children below the
age of 1 year (see section 4.4, 4.8 and 5.2).
Method of administration.
Oral Use
Vermox oral suspension should be considered for patients such as young
children who are
unable to swallow the tablet.
4.3
CONTRAINDICATIONS
Vermox is contra-indicated in pregnancy and in patients who have shown
hypersensitivity to the product or any components.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not recommended in the treatment of children under 2 years.