Vermox 100mg/5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mebendazole

Available from:

Janssen-Cilag Ltd

ATC code:

P02CA01

INN (International Name):

Mebendazole

Dosage:

20mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05050100; GTIN: 5012674076187

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VERMOX
® 100
MG/5
ML ORAL SUSPENSION
Mebendazole
Vermox is a registered trademark
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
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. 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 SUS

Summary of Product characteristics

OBJECT 1
VERMOX 100 MG/5 ML ORAL SUSPENSION
Summary of Product Characteristics Updated 04-Jul-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Vermox 100 mg/5 ml oral suspension
2. Qualitative and quantitative composition
Each 5 ml of suspension contains 100 mg of mebendazole.
Excipients: Each 5 ml also contains 500 mg of sucrose, 9 mg of methyl
parahydroxybenzoate (E218) and
1 mg of propyl parahydroxybenzoate (E216).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Oral suspension.
White homogeneous oral suspension.
4. Clinical particulars
4.1 Therapeutic indications
Broad spectrum gastrointestinal anthelmintic 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 is effective in the treatment of
cysticercosis.
4.2 Posology and method of administration
Method of administration.
Oral Use
Adults and children over 2 years:
_Enterobiasis:_
1 x 5 ml (1 dosing cup).
It is highly recommended that a second dose is taken after 2 weeks, if
reinfection is suspected.
_Ascariasis, trichuriasis, ancylostomiasis, necatoriasis _and mixed
infections:
1 x 5 ml (1 dosing cup) bd for three days.
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 and precautions for use
Not recommended in the treatment of children under 2 years.
A case-control study of a single outbreak of Stevens-Johnson syndrome
/toxic epidermal necrolysis
(SJS/TEN) suggested a possible association with the concomitant use of
metronidazole with
mebendazole. Although there are no additional data on this potential
interaction, concomitant use of
mebendazole and metronidazole should be avoided.
Vermox oral suspension contains sucrose. Patients with rare hereditary
problems of fruct