PROSPECTO : INFORMATION FOR THE USER

Rozex 7.5 mg/g gel

Metronidazole

Read this prospect carefully before starting to use the medication, as it contains important information for you.

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

If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed only to you and should not be given to others, 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 not listed in this prospect. See section 4.

1.What is Rozex and for what it is used

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

3.How to use Rozex

4.Possible adverse effects

5Storage of Rozex

6.Contents of the package and additional information

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

This medication is used for the treatment of rosacea.

Do not use Rozex gel

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use 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 definitively stop using the medication.
• If you have had blood or coagulation disorders, inform your doctor before starting to use Rozex Gel.
• Avoid allowing the product to come into contact with mucous membranes and the eyes, as it may cause tearing (lacrimation).
• Avoid exposure to UV radiation (sunbathing, solarium, sun lamps) during treatment with Rozex gel.

Use of Rozex gel with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Inform your doctor or pharmacist if you are taking or have taken recently any other medication, especially medications for blood coagulation, alcohol dependence, and alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking a medication.

The use of Rozex gel is not recommended if you are pregnant or breastfeeding.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Rozex gel containspropylparaben (E-216), methylparaben (E-218)andpropylene glycol (E-1520)

It may cause allergic reactions (possibly delayed) because it contains propylparaben and methylparaben.

This medication contains 30 mg of propylene glycol in each gram.

Propylene glycol may cause skin irritation.

Follow exactly the administration instructions for this medication as indicated 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 2 times a day, 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.
• Apply a thin layer of gel.
• Perform a gentle massage.
• After application, wash your hands carefully.

You can use non-comedogenic cosmetics (that do not cause blackheads) and non-astringent cosmetics (that do not dry out) after applying Rozex.

Use in children

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

If you use more Rozex than you should

This medication should not be ingested. It is only for external use.

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

If you forgot to use Rozex

Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Rozex gel

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

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

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

• Rare adverse effects (may affect up to 1 in 1000 people)

• Hypoesthesia (decreased sensitivity)
• Paresthesia (alteration of sensitivity)
• Disgeusia (alteration of taste to a metallic flavor)
• Nausea

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

- Contact dermatitis (eczema caused by contact with the gel)

- Skin exfoliation

- Facial swelling

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rozex gel

• The active ingredient ismetronidazole (each gram of gel contains 7.5 mg of metronidazole).
• The other components arecarbomer 940, disodium edetate, propylparaben (E-216), methylparaben (E-218), propylene glycol (E-1520), sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging

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

Rozex gel is available in containers containing 30 g.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Laboratoires Galderma

Alby-sur-Chéran

(France)

Date of the last review of this leaflet:02/2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/