Rozex

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Rozex, 0.75% (7.5 mg/g), cream
Metronidazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Rozex cream and what is it used for
• 2. Important information before using Rozex cream
• 3. How to use Rozex cream
• 4. Possible side effects
• 5. How to store Rozex cream
• 6. Contents of the pack and other information

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

Rozex cream for topical use on the skin contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial action.

Indications:

Local treatment of inflammatory lesions of papules and pustules in rosacea.
Local 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Rozex cream, discuss it with your doctor or pharmacist.
Rozex cream is intended for use on the skin only. Be careful not to get the medicine in your eyes or on mucous membranes. If the medicine accidentally comes into contact with your eyes, rinse them with a large amount of water.
If skin irritation occurs, contact your doctor, who may recommend less frequent use of the medicine or temporary discontinuation of therapy.
During treatment, avoid exposure to sunlight and artificial sources of ultraviolet radiation (e.g., sunlamps).
Metronidazole is a nitroimidazole derivative and should be used with caution in patients with blood diseases. If the patient has any blood disease or is taking blood-thinning medicines, they should tell their doctor.
Do not use the medicine for longer than your doctor recommends.

Rozex cream and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
The risk of interactions with systemic medicines is low due to the minimal absorption of Rozex cream after topical application. In a few patients taking metronidazole orally, reactions similar to those that occur when drinking alcohol during disulfiram treatment (a medicine used to treat alcoholism) have been observed after drinking alcohol.
Metronidazole taken orally may enhance 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, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Rozex cream may be used during pregnancy only if your doctor considers it necessary.
Breastfeeding
Do not use the medicine during breastfeeding. Your doctor will decide whether to stop treatment with Rozex cream or stop breastfeeding.
Fertility
No data are available.

Driving and using machines

Rozex cream has no influence or negligible influence on the ability to drive and use machines.

Rozex cream contains excipients:

• -cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis),
• 22 mg of benzyl alcohol (E 1519) per gram. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Rozex cream

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Rozex cream is for use on the skin only. Apply a thin layer of the medicine to the affected areas of the skin twice a day (morning and evening).
Before use, wash the treated areas with a special emulsion for sensitive and delicate skin care. After applying Rozex cream, patients can use only cosmetics that do not cause comedones and do not have a drying effect.
The treatment period is usually 3 to 4 months. The treatment period should not be extended. However, if there is significant improvement, your doctor may recommend continuing therapy for another 3 or 4 months, depending on the severity of the condition.

Elderly patients

No dose adjustment is necessary in elderly patients.

Use in children

Rozex cream is not recommended for use in children due to the lack of data on safety and efficacy.

Missing a 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

Contact your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the frequency indicated below:
Common (occurring in less 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 less than 1 in 100 treated patients):
numbness, tingling, and prickling of limbs, metallic taste in the mouth, nausea.
Unknown (frequency cannot be estimated from the available data):
contact dermatitis, skin exfoliation, facial swelling.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rozex cream

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What 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 (cetyl 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 light beige, shiny cream.
Rozex cream is packed in a 30 g aluminum tube in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Slovakia, the country of export:

Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4
92927 La Défense Cedex, Paris
France

Manufacturer:

Laboratoria Galderma
Z.I. - Mondesir
74540 Alby sur Cheran
France

Parallel importer:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Slovakia, the country of export: 46/0033/03-S

Parallel import authorization number: 139/24

Date of leaflet approval: 29.03.2024

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