Package leaflet: Information for the user

Rozex
0.75% (7.5 mg/g) cutaneous emulsion
Metronidazolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Rozex is a cutaneous emulsion containing the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial activity.
Indications:
Topical treatment of skin lesions in rosacea.

2. Important information before using Rozex emulsion

When not to use Rozex:

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 emulsion, discuss this with your doctor or pharmacist.
Rozex emulsion is intended for topical use only. Care should be taken to avoid contact with the eyes or mucous membranes. In case of accidental contact with the eyes, rinse thoroughly with plenty of water.
If skin irritation occurs, 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 disorder or is taking anticoagulant medicines, this should be reported to the doctor.
Do not use the medicine for longer than prescribed by the doctor.

Rozex and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, including those 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 emulsion following topical application.
In a small number of patients taking oral metronidazole, reactions similar to those seen after alcohol consumption during disulfiram treatment (a medicine used in the treatment of alcoholism) have been observed after drinking alcohol.
Oral metronidazole may potentiate the effect of warfarin and coumarin derivatives (anticoagulant medicines), leading to prolonged prothrombin time. It is unknown whether topical application of 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 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 treatment with Rozex should be discontinued or whether breastfeeding should be stopped.

Fertility
No data available.

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

Rozex emulsion contains the following excipients:

potassium sorbate and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
13 mg of benzyl alcohol in each gram of emulsion. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Rozex emulsion

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Rozex emulsion is intended for topical application to the skin. A thin layer of the medicine should be
applied to the affected skin areas twice daily (morning and evening).
Before application, the treated areas should be cleansed with an emulsion specially designed for
the care of sensitive and delicate facial skin. After applying Rozex emulsion, patients may use only
cosmetics that do not cause comedones and have no astringent effect.
The treatment period usually lasts from 3 to 4 months. The duration of use should not be prolonged.
However, if a clear improvement occurs, the treating physician may recommend continuing therapy
for an additional 3 or 4 months, depending on the severity of the lesions.
Elderly patients
No dosage adjustment is necessary in elderly patients.
Use in children
Rozex is not recommended for use in children due to lack of data on safety and efficacy.
If you forget to apply Rozex emulsion
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
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 all medicines, 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 not more than 1 in 10 treated patients):
dry skin, redness, itching, sensation of skin discomfort (burning, skin pain/stinging), skin irritation, worsening of acne symptoms.
Uncommon (occurring in not more than 1 in 100 treated patients):
hypogeusia, tingling and numbness of limbs, metallic taste in the mouth, nausea.
Unknown (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 of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rozex emulsion

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C. Do not store in the refrigerator. Do not freeze.
Do not use this medicine after the expiry date stated on the carton and tube after: EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rozex emulsion contains

The active substance is metronidazole. 1 g of cutaneous emulsion contains 7.5 mg of metronidazole.
The other ingredients are: carbomer, glycerol, macrogol 400, benzyl alcohol (E1519), PEG-21 stearate ether, macrogol stearates, stearyl alcohol, light liquid paraffin, cyclomethicone, potassium sorbate (E202), lactic acid, sodium hydroxide, purified water.

What Rozex emulsion looks like and contents of the pack
Rozex is a white to off-white, clear, liquid emulsion.
Rozex emulsion is available in tubes containing 30 g of cutaneous emulsion, packed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
tel.: +48 22 331 21 80

Manufacturer:
Laboratoires Galderma
Zone Industrielle, Montdésir,
74540 Alby-sur-Chéran, France