VERMOX SD SUSPENSION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Johnson & Johnson (Pty) Ltd û East London

Dosage:

See ingredients

Pharmaceutical form:

SUSPENSION

Composition:

EACH 10,0 ml SUSPENSION CONTAINS MEBENDAZOLE 500,0 mg

Authorization status:

Registered

Authorization date:

2001-12-02

Patient Information leaflet

Johnson & Johnson (Pty) Ltd
VERMOX
® SD SUSPENSION SUSPENSION
Each 10 mL suspension contains:
500 mg mebendazole
DATE OF CLINICAL APPROVAL: 20 April 2022
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S1
VERMOX
® SD SUSPENSION
MEBENDAZOLE
CONTAINS SUGAR (150 MG SUCROSE PER ML).
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
VERMOX
®
SD suspension is available without a doctor’s prescription, for you
to treat a mild
illness. Nevertheless, you still need to take VERMOX
®
SD suspension carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1.
What VERMOX
®
SD suspension is and what it is used for.
2.
What you need to know before you take VERMOX
®
SD suspension.
3.
How to take VERMOX
®
SD suspension.
4.
Possible side effects.
5.
How to store VERMOX
®
SD suspension.
6.
Contents of the pack and other information.
1.
WHAT VERMOX
® SD SUSPENSION IS AND WHAT IT IS USED FOR
VERMOX
®
SD suspension belongs to a group of medicines known as anthelmintics.
It is used to
Johnson & Johnson (Pty) Ltd
VERMOX
® SD SUSPENSION SUSPENSION
Each 10 mL suspension contains:
500 mg mebendazole
DATE OF CLINICAL APPROVAL: 20 April 2022
Page 2 of 9
treat worm infections of the gut, such as:
-
Pinworm (_Enterobius vermicularis_);
-
Whipworm (_Trichuris trichiura_);
-
Roundworm (_Ascaris lumbricoides_);
-
Hookworm (_Ancylostoma duodenale_; _Necator americanus_);
This medicine is for use in adults and children (see section 2).
You or your child has been advised to take VERMOX
®
SD 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 suckin

Summary of Product characteristics

Johnson & Johnson (Pty) Ltd
VERMOX
® SD SUSPENSION SUSPENSION
Each 10 mL suspension contains:
500 mg mebendazole
DATE OF CLINICAL APPROVAL: 20 April 2022
Page 1 of 11
PROFESSIONAL INFORMATION FOR VERMOX
® SD SUSPENSION
SCHEDULING STATUS
S1
1.
NAME OF THE MEDICINE
VERMOX
®
SD
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle (10 mL suspension) contains 500 mg mebendazole.
_Excipients with known effect: _
Preservatives:
Methylparaben 0,18 % _m/v_
Propylparaben 0,02 % _m/v_
Contains alcohol: Ethyl alcohol: 0,48 % _v/v_
Contains sugar (150 mg sucrose per mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension.
White to off-white suspension with a chocolate flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VERMOX
®
SD suspension is indicated for the treatment of single and mixed
helminth
gastrointestinal infestations caused by:
Johnson & Johnson (Pty) Ltd
VERMOX
® SD SUSPENSION SUSPENSION
Each 10 mL suspension contains:
500 mg mebendazole
DATE OF CLINICAL APPROVAL: 20 April 2022
Page 2 of 11
-
NEMATODES SUCH AS:
-
_Trichuris trichiura_
(whipworm)
-
_Ancylostoma duodenale_
(hookworm)
-
_Necator americanus_
(hookworm)
-
_Ascaris lumbricoides_
(large roundworm)
-
_Enterobius vermicularis_
(pinworm)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
WHIPWORM; HOOKWORM; LARGE ROUNDWORM; PINWORM:
Adults and children older than 1 year: 10 mL given as a single dose.
A single dose of VERMOX
®
SD suspension may not be sufficient to cure infestations with
hookworm and whipworm (_Trichuris_) although a substantial reduction
in egg count can be
expected.
A second course of treatment should be given to those patients who are
still infected three to four
weeks after the first course.
In worm-eradication campaigns the standard course should be
administered every quarter during
the first year.
The efficacy of VERMOX
®
SD suspension is dependent upon the duration of physical contact
between the medicine and parasite.
For infants under 1 year of age, see “section 4.3 and 4.4".