ROMITU 3 mg Tabletten

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

IVERMECTINE

Available from:

Substipharm 24 rue Erlanger 75016 PARIJS (FRANKRIJK)

ATC code:

P02CF01

INN (International Name):

IVERMECTINE

Pharmaceutical form:

Tablet

Composition:

BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; ZETMEEL, GEPREGELATINEERD,

Administration route:

Oraal gebruik

Therapeutic area:

Ivermectin

Product summary:

Hulpstoffen: BUTYLHYDROXYANISOL (E 320); CELLULOSE, MICROKRISTALLIJN (E 460); MAGNESIUMSTEARAAT (E 470b); ZETMEEL, GEPREGELATINEERD;

Authorization date:

2018-04-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROMITU 3 MG TABLETTEN
Ivermectin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ROMITU is and what it is used for
2.
What you need to know before you take ROMITU
3.
How to take ROMITU
4.
Possible side effects
5.
How to store ROMITU
6.
Contents of the pack and other information
1.
WHAT ROMITU IS AND WHAT IT IS USED FOR
ROMITU contains a medicine called ivermectin. This is a type of
medicine which is used for
infections caused by some parasites.
It is used to treat:

an infection in your gut called intestinal strongyloidiasis
(anguillulosis). This is caused by a
type of round worm called _“_Strongyloides stercoralis”.

an infection of your blood called microfilaraemia due to “lymphatic
filariasis”. This is caused
by an immature worm called “Wuchereria bancrofti”. ROMITU does not
work against adult
worms, only against immature worms.

skin mites (scabies). This is when tiny mites burrow under your skin.
This can cause severe
itching. ROMITU should only be taken when your doctor has proven or
thinks you have
scabies.
ROMITU WILL NOT STOP YOU FROM GETTING ONE OF THESE INFECTIONS. It does
not work against adult
worms.
ROMITU should only be taken when your doctor has proven or thinks you
have a parasite infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROMITU
DO NOT TAKE ROMITU
if you are allergic to ivermectin or any of the other ingredients of
this medicine (listed in section 6).
In general, if you experience unusual symptoms

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ROMITU 3 mg Tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 3 mg of ivermectin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
The tablets are round, white or almost white, flat chamfered with a
diameter of 5.5 mm and thickness
of 2.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of gastrointestinal strongyloidiasis (anguillulosis).
•
Treatment of suspected or diagnosed microfilaraemia in patients with
lymphatic filariasis due to
_Wuchereria bancrofti_
.
•
Treatment of human sarcoptic scabies. Treatment is justified when the
diagnosis of scabies has
been established clinically and/or by parasitological examination.
Without formal diagnosis
treatment is not justified in case of pruritus.
Official guidelines should be taken into consideration. Official
guidelines will normally include WHO
and public health authorities’ guidelines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of gastrointestinal strongyloidiasis
The recommended dosage is one single oral dose of 200 micrograms of
ivermectin per kg body
weight.
For guidance, the dose, as determined by the patient’s weight, is as
follows:
BODY WEIGHT (KG)
DOSE (NUMBER OF 3 MG TABLETS)
15 to 24
one
25 to 35
two
36 to 50
three
51 to 65
four
66 to 79
five
≥ 80
six
Treatment of microfilaraemia caused by
_Wuchereria bancrofti _
2
The recommended dosage for mass distribution for the treatment of
microfilaraemia caused by
_Wuchereria bancrofti _
is a single oral dose once every 6 months designed to provide
approximately
150 to 200 μg/kg of body weight.
_ _
In endemic areas where treatment can only be administered once every
12 months, the recommended
dosage is 300 to 400 μg/kg of body weight to maintain adequate
suppression of microfilaraemia in
treated patients.
For guidance, the dose, as determined by the patient’s weight, is as
follows:
BODY WEIGHT (KG)
DOSE WHEN GIVEN ONCE EVERY 6
MONTHS (NUMBE