ROZEX 7.5 mg/g GEL

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rozex 7.5 mg/g gel

Metronidazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Rozex is and what it is used for
2. What you need to know before you use Rozex
3. How to use Rozex
4. Possible side effects

5 Storage of Rozex

1. Contents of the pack and other information

1. What Rozex is and what it is used for

Rozex gel contains metronidazole, an antibiotic belonging to the imidazole group, for cutaneous use.

This medicine is used for the treatment of rosacea.

2. What you need to know before you use Rozex gel

Do not use Rozex gel

• If you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Rozex gel.

• If you observe intense local irritation at the application site, reduce the frequency of application and consult your doctor, who will indicate whether you should temporarily or permanently stop using the medicine.
• If you have had blood or coagulation disorders, inform your doctor before starting treatment with Rozex Gel.
• You should avoid getting the product in contact with mucous membranes and eyes, as it may cause tearing (lacrimation).
• You should avoid exposure to UV radiation (sunbathing, sunlamps, solar lamps) during treatment with Rozex gel.

Using Rozex gel with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines, especially medicines for blood coagulation, alcohol detoxification, and alcohol.

Pregnancy and breastfeeding

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 taking this medicine.

Treatment with Rozex gel is not recommended if you are pregnant or breastfeeding.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

Rozex gel containspropyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218)andpropylene glycol (E-1520)

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate and methyl parahydroxybenzoate.

This medicine contains 30 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

3. How to use Rozex

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Apply the gel to the affected areas twice a day, in the morning and at night before bedtime.

• Before applying the gel, clean the affected area with a mild cleanser and dry the affected area.
• Apply a thin layer of gel.
• Gently massage.
• After application, wash your hands carefully.

You can use non-comedogenic (non-acnegenic) and non-astringent cosmetics after applying Rozex.

Use in children

Do not use in children. There is no experience with the use of this medicine in children.

If you use more Rozex than you should

This medicine is not to be ingested. It is for external use only.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you forget to use Rozex

Do not apply a double dose to make up for forgotten doses.

If you stop treatment with Rozex gel

Your doctor will indicate the duration of your treatment with Rozex. Do not stop treatment before, as the desired effect will not be achieved.

If you have any other questions about 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.

This medicine may occasionally cause unwanted side effects at the application site, such as:

• Frequent side effects (may affect up to 1 in 10 people))

• Dry skin
• Erythema (redness of the skin)
• Pruritus (itching of the skin)
• Discomfort in the skin (burning, pain/stinging)
• Skin irritation
• Worsening of rosacea (disease of the central part of the face that consists of redness and itching of the cheeks and chin)

• Uncommon side effects (may affect up to 1 in 100 people)

• Hypoesthesia (decreased sensitivity)
• Paresthesia (altered sensitivity)
• Dysgeusia (altered taste, metallic taste)
• Nausea

• Side effects of unknown frequency (frequency cannot be estimated from the available data)

• Contact dermatitis (eczema due to contact with the gel)
• Exfoliation of the skin
• Facial swelling

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rozex

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the packaging after CAD/EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rozex gel

• The active substance is metronidazole (each gram of gel contains 7.5 mg of metronidazole).
• The other ingredients are carbomer 940, disodium edetate, propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), propylene glycol (E-1520), sodium hydroxide, and purified water.

Appearance of the product and contents of the pack

Rozex is a colorless, pale yellow or slightly brown gel.

Rozex gel is available in packs containing 30 g.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratoires Galderma

Alby-sur-Chéran

(France)

Date of last revision of this leaflet:02/2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/