ROZEX 7.5 mg/g Emulsion

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Rozex
3. 75% (7.5 mg/g) skin emulsion
   1. Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient
   2. Table of contents of the leaflet:
4. What is Rozex emulsion and what is it used for
   1. Indications:
5. Important information before using Rozex emulsion
   1. When not to use Rozex:
   2. Warnings and precautions
   3. Rozex and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Pregnancy
   6. Breastfeeding
   7. Fertility
   8. Driving and using machines
   9. Rozex emulsion contains excipients:
6. How to use Rozex emulsion
   1. Elderly patients
   2. Use in children
   3. Missing a dose of Rozex emulsion
   4. In case of accidental ingestion of the medicine
7. Possible side effects
   1. Reporting side effects
8. How to store Rozex emulsion
9. Package contents and other information
   1. What Rozex emulsion contains
   2. What Rozex emulsion looks like and what the pack contains
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Rozex

0.75% (7.5 mg/g) skin emulsion

Metronidazole

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Rozex emulsion and what is it used for
• 2. Important information before using Rozex emulsion
• 3. How to use Rozex emulsion
• 4. Possible side effects
• 5. How to store Rozex emulsion
• 6. Package contents and other information

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

Rozex is a skin emulsion containing the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial action.

Indications:

Local 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Rozex emulsion, the patient should discuss it with their doctor or pharmacist.
Rozex emulsion is for skin use only. The patient should be careful not to get the medicine in their eyes or on mucous membranes. If the medicine accidentally comes into contact with the eyes, they should be rinsed with a large amount of water.
If skin irritation occurs, the patient should contact their doctor, who may recommend less frequent use of the medicine or a temporary interruption of therapy.
During treatment, the patient should 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 diseases. If the patient has any blood disease or is taking anticoagulant medicines, they should inform their doctor.
The medicine should not be used for longer than recommended by the doctor.

Rozex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, even those that are available without a prescription.
The risk of interactions with systemic medicines is unlikely due to the low absorption of Rozex emulsion after local 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 effect of warfarin and coumarin derivatives (anticoagulant medicines), leading to prolonged prothrombin time. It is not known whether topical metronidazole affects prothrombin time.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

Rozex may be used during pregnancy only if the doctor considers it necessary.

Breastfeeding

The medicine should not be used during breastfeeding. The doctor will consider whether to stop treatment with Rozex or stop breastfeeding.

Fertility

No data are available.

Driving and using machines

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

Rozex emulsion contains excipients:

• potassium sorbate and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis),
• 13 mg of benzyl alcohol per 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 as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Rozex emulsion is for local use on the skin. A thin layer of the medicine should be applied to the affected areas of the skin twice a day (morning and evening).
Before use, the treated areas should be washed with a special care emulsion for sensitive and delicate facial skin. After applying Rozex emulsion, 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, the doctor may recommend continuing therapy for another 3 or 4 months, depending on the severity of the disease.

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 emulsion

The patient should apply the medicine as soon as possible. If it is almost time for the next dose, the patient should not apply a double dose to make up for the missed dose.

In case of accidental ingestion of the medicine

The patient should contact their doctor immediately.
If the patient has any further doubts about using the medicine, they should consult their 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 are listed with their frequency of occurrence:
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 numbness of limbs, metallic taste in the mouth, nausea.
Unknown (frequency cannot be estimated from available data):
contact dermatitis, skin exfoliation, facial swelling.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rozex emulsion

The medicine should be stored out of 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rozex emulsion contains

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

What Rozex emulsion looks like and what the pack contains

Rozex is a white to light beige, clear liquid emulsion.
Rozex emulsion is available in tubes containing 30 g of skin emulsion, in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
phone: +48 22 331 21 80

Manufacturer:

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

Date of last revision of the leaflet: