ROZEX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METRONIDAZOLE

Available from:

A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

ATC code:

D06BX01

Pharmaceutical form:

GEL

Composition:

METRONIDAZOLE 7.5 MG/G

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

LABORATORIES GALDERMA, FRANCE

Therapeutic group:

METRONIDAZOLE

Therapeutic area:

METRONIDAZOLE

Therapeutic indications:

Topical application for the treatment of inflammatory papules, pustules and erythema of rosacea.

Authorization date:

2013-12-31

Patient Information leaflet

P
ATIENT LEAFLET ACCORDING TO THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor’s prescription only
ROZEX
GEL
ACTIVE INGREDIENT:
Metronidazole (0.75% w/w)
For a list of inactive ingredients, please see section 6.
Also see 'Important information about some of the medicine’s
ingredients' in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions,
please refer to your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Rozex is intended for topical treatment of inflammation, redness and
irritation, due to
Rosacea.
THERAPEUTIC GROUP:
Antibacterial substance of the Imidazole group for topical use.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
● If you are sensitive to any type of food or medicine, inform your
doctor before using this
medicine.
● Avoid contact of the gel with the eyes. If the gel accidentally
comes in contact with the
eyes, wash the area with a large quantity of lukewarm water.
● While using the medicine, avoid exposure to strong sunlight and/or
to ultra–violet (UV)
light e.g. solariums, tanning lamps.
● Do not use the medicine unnecessarily and/or for a prolonged
period, without consulting
your doctor.
BEFORE STARTING THE TREATMENT, TELL YOUR DOCTOR if you suffer or have
suffered in the past
from a blood system disorder.
PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE
RECENTLY TAKEN ANY
OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITION
SUPPLEMENTS.
In particular, inform your doctor or pharmacist if you are taking any
of the following
medicines (it should be noted that the following list mentions the
active ingredients in the
medicines. If you are not sure whether you are

Summary of Product characteristics

_Page 1 of 4_
Rozex-DL-November 2021-03
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
TRADE NAME OF THE MEDICAL PRODUCT
Rozex
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w/w
Excipients with known effect:
One gram of gel contains:
Propylene glycol 30mg
Propyl parahydroxybenzoate 0.2mg/g
Methyl parahydroxybenzoate 0.8 mg/g
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
Colorless to pale yellow homogenous gel, which may turn to slightly
brown colour over time.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical application for the treatment of inflammatory papules,
pustules and erythema of
rosacea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For topical administration only.
The average period of treatment is three to four months. The
recommended duration of
treatment should
not be exceeded. However, if a clear benefit has been demonstrated,
continued therapy for a further three to four months period may be
considered by the
prescribing physician depending on the severity of the condition. In
clinical studies, topical
metronidazole therapy for rosacea has been continued for up to 2
years. In the absence of a
clear clinical improvement, therapy should be stopped.
_Older people_: The dosage recommended in the elderly is the same as
that recommended in
adults.
_Paediatric population_: Not recommended. Safety and efficacy have not
been established.
Method of administration
:
Rozex gel should be applied in a thin layer to the affected areas of
the skin twice daily,
morning and evening. Areas to be treated should be washed with a mild
cleanser before
application. Patients may use non-comedogenic and non-astringent
cosmetics after
application of Rozex gel.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Page 2 of 4_
Contact with mucous membranes should be avoided.
Rozex gel has been reported to cause lacrimation of the eyes,
therefore, contact with the
eyes