Vermox 100mg Tablets

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 100 mg

Pharmaceutical form:

TABLET

Composition:

MEBENDAZOLE 100 mg

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 TABLET
Mebendazole
READ ALL OF THIS LABEL 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 tablets is and what it is used for
2.
Before you use Vermox Tablets
3.
How to use Vermox Tablets
4.
Possible side effects
5.
How to store Vermox tablets
6.
Further information
7.
Further advice regarding worms
1.
WHAT VERMOX TABLETS IS AND WHAT IT IS USED FOR
The name of your medicine is Vermox 100 mg tablets (referred to as
Vermox tablets in
this leaflet). Vermox tablets contain a medicine called mebendazole.
It is one of a group
of medicines called ‘antihelmintics’.
Vermox tablets are 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 tablets because you
have a worm
infection. Worms can infect anyone. It does not necessarily mean that
your hygiene is
poor.
2.
BEFORE YOU USE VERMOX TABLETS
DO NOT USE VERMOX TABLETS IF:
•
You are allergic to anything in Vermox tablets (listed in section 6
below)
•
You are pregnant
Do not use this medicine if any of the above applies to you. If you
are not sure, talk to
your doctor or pharmacist before using Vermox tablets.
WARNINGS AND PRECAUTIONS
•
Vermox tablets should not be given to children under 2 years of age.
•
Vermox has not been extensively studied in children younger than 2
years of
age. The decision to use Vermox in children aged 1 to 2 years shou

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 0.06mg of sunset yellow (E110).
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Flat, circular, pale orange tablets with “Me/100” on one side and
‘JANSSEN” on the
other.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of
_Trichuris trichuria_
(whipworm),
_Enterobius vermicularis_
(pinworm or threadworm),
_Ascaris lumbricoides_
(roundworm),
_Ancylostoma _
_duodenale_
(common hookworm),
_Necator americanus_
(American hookworm) in
single or mixed gastrointestinal infestations.
There is no evidence that Vermox Tablets are effective in the
treatment of
cysticercosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 2 years of age:
For the control of trichuriasis, ascariasis and hookworm infections,
one tablet twice a
day for three consecutive days.
For the control of enterobiasis a single tablet is administered. It is
highly
recommended that a second tablet is taken after two weeks, if
re-infection is
suspected.
Tablets may be chewed or swallowed whole. Crush the tablet before
giving it to a
young child. Always supervise a child while they are taking this
medicine.
Vermox oral suspension should be considered for patients such as young
children who
are unable to swallow the tablet.
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.
4.3
CONTRAINDICATIONS
Vermox is contraindicated in pregnancy and in patients who have shown
hypersensitivity to the product or any components.
4.4
SPECIAL WARNINGS