Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
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 the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Rozex gel is and what it is used for
Rozex gel for topical use contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial activity.
Indications:
Topical treatment of inflammatory lesions characterized by papules and pustules in rosacea.
Topical treatment of skin infections.

2. Important information before using Rozex gel

When not to use Rozex

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

Warnings and precautions
Before starting treatment with Rozex gel, discuss it with your doctor or pharmacist.
Rozex gel is intended for external 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 you have any blood disorder or are taking anticoagulant medicines, inform your doctor.
Do not use the medicine longer than prescribed by your doctor.

Rozex and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
The risk of systemic drug interactions is unlikely due to minimal absorption of Rozex gel following topical application.
In a small number of patients taking oral metronidazole, alcohol consumption has been associated with reactions similar to those seen when alcohol is consumed during disulfiram therapy (a medicine used in the treatment of alcoholism).
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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Rozex may be used during pregnancy only if, in the opinion of the doctor, it is necessary.

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

Fertility
No data available.

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

Rozex gel contains:

methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (delayed-type reactions possible),
30 mg of propylene glycol (E1520) in each gram of gel. Propylene glycol may cause skin irritation.

3. How to use Rozex gel
Always use this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Rozex gel is intended for topical application to the skin. A thin layer of the gel should be applied to the affected skin areas twice daily (morning and evening).
Before application, cleanse the affected areas with an emulsion for special care of sensitive and delicate facial skin. After applying Rozex gel, patients may use only cosmetics that do not cause comedones and do not have an astringent effect.
The treatment duration is usually 3 to 4 months. The duration of use should not be extended. However, if a clear improvement occurs, the treating doctor may recommend continuing therapy for an additional 3 or 4 months, depending on the severity of the lesions.

Elderly patients
No dosage adjustment is required 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 miss a dose of Rozex gel
Apply the missed dose 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 one.

In case of accidental ingestion
Seek medical advice immediately.
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 product may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below are categorized according to their frequency of occurrence:
Common (occurring in not more than 1 in 10 treated patients):
dry skin, redness, itching, skin discomfort (burning, skin pain/stinging), skin irritation, worsening of rosacea symptoms.
Uncommon (occurring in not more than 1 in 100 treated patients):
hypoaesthesia, tingling and numbness of extremities, metallic taste in 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 those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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 may 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 gel
Keep the medicine out of the sight and reach of children.
Store below 25°C. 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Rozex gel contains

The active substance is metronidazole. 1 g of gel contains 7.5 mg of metronidazole.
Other ingredients: disodium edetate, carbomer 940, propylene glycol (E1520), methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), sodium hydroxide, purified water.

What Rozex gel looks like and contents of the pack
Rozex is a colourless to yellow or light brown gel.
Rozex gel is packed in aluminium tubes containing 15 g or 30 g of gel, with a cardboard carton.
Not all pack sizes may be marketed.

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

Manufacturer:
Laboratoires Galderma
Z.I. Montdésir
74540 Alby-sur-Chéran
France