Rozex

Package Leaflet: Information for the Patient

Rozex

0.75% (7.5 mg/g) Gel

Metronidazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Rozex gel for cutaneous use contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial action.

Indications:

Local treatment of inflammatory lesions of papules and pustules, in the course of rosacea.
Local treatment of skin infections.

2. Important information before using Rozex gel

When not to use Rozex

Warnings and precautions

Before starting treatment with Rozex gel, discuss it with your doctor or pharmacist.
Rozex gel is for cutaneous use only. Be careful not to get the medicine in your eyes or on mucous membranes. If the medicine accidentally gets into your eyes, rinse them with plenty of water.
If skin irritation occurs, contact your doctor, who may recommend less frequent application of the medicine or temporary interruption 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 you have any blood disease or are taking anticoagulant medicines, tell your doctor.
Do not use the medicine for longer than your doctor recommends.

Rozex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, even those not prescribed.
The risk of interactions with systemic medicines is low due to the low absorption of Rozex gel 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.
Oral metronidazole may enhance the anticoagulant effect of warfarin and coumarin derivatives, leading to prolonged prothrombin time. It is not known whether topical 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 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 or stop breastfeeding.

Fertility

No available data.

Driving and using machines

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

What Rozex gel contains

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

3. How to use Rozex gel

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Rozex gel is for cutaneous use 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 gel, patients can use only cosmetics that do not cause comedones and do not have a drying effect.
Treatment usually lasts from 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 is not recommended for use in children due to the lack of data on safety and efficacy.

Missing a dose of Rozex gel

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:
Common (may affect up to 1 in 10 people):
dry skin, redness, itching, skin discomfort (burning, skin pain/stinging), skin irritation, worsening of rosacea symptoms.
Uncommon (may affect up to 1 in 100 people):
numbness, tingling, and numbness of limbs, metallic taste, nausea.
Unknown (cannot be estimated from the available data):
contact dermatitis, skin exfoliation, facial swelling.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rozex gel

Keep this 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 which is stated on the carton and tube after EXP.
The expiry date refers to the last day of that month.
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 gel contains

• The active substance is metronidazole. 1 g of gel contains 7.5 mg of metronidazole.
• The other ingredients are disodium edetate, carbomer 940, propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, purified water.

What Rozex gel looks like and contents of the pack

Rozex is a colorless to yellow or light brown gel.
Rozex gel is packed in aluminum tubes containing 15 g or 30 g of gel, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Galderma Polska Sp. z o.o.
Puławska 145
02-715 Warsaw
Poland
Phone: +48 22 331 21 80
Manufacturer:
Laboratoires Galderma
Z.I. Montdésir
74540 Alby-sur-Chéran
France

Date of last revision of the leaflet: