Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rozex, 0.75% (7.5 mg/g), cream
Metronidazolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What is Rozex cream and what is it used for
Important information before using Rozex cream
How to use Rozex cream
Possible side effects
How to store Rozex cream
Contents of the pack and other information

1. What is Rozex cream and what is it used for

Rozex cream is a topical medicine containing the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial properties.
Indications:
Topical treatment of inflammatory lesions characterized by papules and pustules in rosacea.
Topical treatment of skin infections.

2. Important information before using Rozex cream

When not to use Rozex cream:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Rozex cream, discuss this with your doctor or pharmacist.
Rozex cream is intended for topical use only. Care should be taken to avoid contact with the eyes or mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with plenty of water.
If skin irritation symptoms occur, contact your doctor, who may recommend less frequent application or temporary discontinuation of therapy.
During treatment, avoid exposure to sunlight and artificial sources of ultraviolet radiation (e.g. sunbeds).
Metronidazole is a nitroimidazole derivative and should be used with caution in patients with blood disorders. If the patient has any blood disease or is taking anticoagulant medicines, this should be reported to the doctor.
Do not use the medicine longer than prescribed by your doctor.

Rozex cream and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to use.
The risk of interactions with systemically acting medicines is unlikely due to minimal absorption of Rozex cream following topical application. In rare patients taking oral metronidazole, reactions similar to those observed after alcohol consumption during disulfiram treatment (a medicine used in the treatment of alcoholism) have been reported after drinking alcohol.
Oral metronidazole may potentiate the anticoagulant effect of warfarin and coumarin derivatives, leading to prolonged prothrombin time. It is not known whether topically applied metronidazole affects prothrombin time.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Rozex cream may be used during pregnancy only if considered necessary by the doctor.

Breastfeeding
Do not use this medicine during breastfeeding. The doctor will decide whether to discontinue Rozex cream treatment or to stop breastfeeding.

Fertility
No data available.

Driving and operating machinery
Rozex cream has no effect or has a negligible effect on the ability to drive and operate machinery.

Rozex cream contains the following excipients:

cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
22 mg of benzyl alcohol (E 1519) in each gram. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Rozex cream

This medicine should always be used exactly as recommended by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Rozex cream is intended for topical application to the skin. A thin layer of the medicine should be
applied to the affected skin areas twice daily (in the morning and evening).
Before application, the treated areas should be cleansed with an emulsion for special care of sensitive and
delicate facial skin. After applying Rozex cream, patients may use only cosmetics that do not cause comedones and do not have an astringent effect.
The treatment period usually lasts from 3 to 4 months. The duration of use should not be extended.
However, if a clear improvement has occurred, the treating physician may recommend continuing therapy for an additional 3 or 4 months, depending on the severity of the lesions.
Elderly patients
No dose adjustment is required in elderly patients.
Use in children
Rozex cream is not recommended for use in children due to lack of data on safety and efficacy.
Missed dose of Rozex cream
Apply the medicine as soon as possible. If it is almost time for the next dose, do not apply a double dose to make up for the missed dose.
In case of accidental ingestion of the medicine
Seek immediate medical advice from a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Below is a list of adverse reactions categorized by their frequency of occurrence:
Common (occurring in no more than 1 in 10 treated patients):
dry skin, redness, itching, skin discomfort (burning, stinging, pain),
skin irritation, worsening of acne symptoms.
Uncommon (occurring in no more than 1 in 100 treated patients):
hypogeusia, tingling and numbness of extremities, metallic taste in mouth, nausea.
Unknown frequency (frequency cannot be estimated from available data):
contact dermatitis, skin peeling, facial swelling.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rozex cream

Keep the medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Rozex cream contains

The active substance is metronidazole. 1 g of cream contains 7.5 mg of metronidazole.
The other ingredients are: benzyl alcohol (E 1519), isopropyl palmitate, glycerol, liquid sorbitol, non-crystallizing, emulsifying wax (cetylstearyl alcohol, stearyl alcohol), lactic acid and/or sodium hydroxide, purified water.

What Rozex cream looks like and contents of the pack
Rozex is a white to off-white, shiny cream.
Rozex cream is packed in an aluminium tube containing 30 g of cream, with a cardboard carton.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible entity in Slovakia, country of export:
Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4
92927 La Défense Cedex, Paris
France
Manufacturer:
Laboratoires Galderma
Z.I. - Mondesir
74540 Albys-sur-Cheran
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Slovakia, country of export: 46/0033/03-S
Parallel import authorization number: 139/24