Rozex 7.5 mg/g gel

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rozex 7.5 mg/g gel

Metronidazole

Read the entire leaflet carefully before you start using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rozex is and what it is used for
2. What you need to know before using 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 skin (cutaneous) use.

This medicine is used for the treatment of rosacea.

2. What you need to know before using Rozex gel

Do not use Rozex gel

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Rozex gel

• If you experience severe local irritation at the application site, reduce the frequency of application and consult your doctor, who will advise whether you should temporarily or permanently stop using the medicine.
• If you have previously suffered from blood or coagulation disorders, inform your doctor before starting to use Rozex Gel.
• You must avoid contact of the product with mucous membranes and eyes, as it may cause tearing (lacrimation).
• You should avoid exposure to UV radiation (sunbathing, sunbeds, solar lamps) during treatment with Rozex gel.

Using Rozex gel with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, especially medications affecting blood coagulation, alcohol withdrawal treatments, or alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Driving and operating machinery

The effect of this medicine on the ability to drive or operate machinery is none or negligible.

Rozex gel contains propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), and propylene 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 instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Apply the gel to the affected areas twice daily, in the morning and at night before going to bed.

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

You may use non-comedogenic (which do not cause pimples) and non-astringent (which do not dry the skin) cosmetics after applying Rozex.

Use in children

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

If you use more Rozex than you should

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

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

If you forget to use Rozex

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

If you stop using Rozex gel

Your doctor will advise you on the duration of your treatment with Rozex. Do not stop treatment early, as the desired effect will not be achieved.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

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

• Dry skin

• Erythema (redness of the skin)

• Pruritus (itching of the skin)

• Skin discomfort (burning, pain/stinging)

• Skin irritation

• Worsening of rosacea (a condition affecting the central part of the face characterized by redness and itching of the cheeks and chin)

• Uncommon adverse effects (may affect up to 1 in every 1,000 people)

• Hypoaesthesia (reduced sensitivity)

• Paresthesia (altered sensation)

• Dysgeusia (altered taste with a metallic taste)

• Nausea

• Adverse effects with unknown frequency (frequency cannot be estimated from the available data)

• Contact dermatitis (eczema due to contact with the gel)

• Skin peeling

• Facial swelling

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This 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 components are carbomer 940, disodium edetate, propyl p-hydroxybenzoate (E-216), methyl p-hydroxybenzoate (E-218), propylene glycol (E-1520), sodium hydroxide and purified water.

Appearance of the product and contents of the pack

Rozex is a colourless, 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 the most recent revision of this leaflet: 02/2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/