ZENAVAN 50 mg/g GEL

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

Do not use Zenavan

• If you are allergic to etofenamate or any of the other components of this medication (listed in section 6).
• On wounds, eczematous lesions, mucous membranes, or sunburns.
• If you have suffered any allergic reaction (rhinitis, asthma, itching, difficulty breathing, urticaria, shock or other) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zenavan.

• Do not apply to wounds, eczematous lesions, mucous membranes, or sunburns.

Apply only to intact skin.

• Avoid contact with the eyes and mucous membranes. In case of contact, rinse abundantly with water.
• Do not use on large areas or for prolonged periods. It may cause skin irritation and dryness.

Use exclusively on the affected area.

• Do not use occlusive dressings.
• Avoid applying it to the same area where other topical medications have been applied.
• Do not expose the treated area to the sun to reduce the risk of photosensitivity reactions.
• If you have asthma, chronic obstructive pulmonary disease, hay fever, nasal polyps, or chronic respiratory infections, consult your doctor before using this medication.
• Consult your doctor if you suffer from: gastroduodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart, liver, or kidney problems.

Children

Do not use in children under 12 years due to the lack of data on its efficacy and safety.

Using Zenavan with other medications

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

Although no interactions with other medications have been observed, it should not be used in conjunction with other topical medications in the same area, including other analgesics.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy unless your doctor considers it necessary.

Do not use this medication during the third trimester of pregnancy, as it may prolong labor and contribute to bleeding in the mother and baby.

Breastfeeding

During breastfeeding, this medication should only be used in small areas and for a short period.

At high doses, it may cross the placental barrier and pass into breast milk.

Driving and using machines

The influence of this medication on the ability to drive and use machines is zero or insignificant.

Zenavan contains fragrances with d-limonene.

D-limonene may cause allergic reactions.

3. How to use Zenavan

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adults and children over 12 years:

Apply 3 or 4 times a day a portion of 5 to 10 cm of gel (corresponding to approximately 1.7-3.3 g of gel) to the affected area, with a gentle massage for absorption.

Wash your hands after each application.

If symptoms worsen or persist after 7 days of treatment, you should consult a doctor.

Elderly patients (over 65 years)

No dose modification is required for this group of patients.

Patients with kidney or liver problems

No dose modification is required for this group of patients.

Use in children

Do not administer to children under 12 years due to the lack of data on safety and efficacy in this population.

If you use more Zenavan than you should

Due to its topical use, it is unlikely that overdose cases will occur. Nevertheless, if you have used much more medication than you should (the contents of a tube), it is recommended to eliminate the medication by washing the affected area with plenty of water. The symptoms that may appear due to overdose are: skin irritation, headaches, dizziness, or stomach pain.

Normally, toxic doses are not reached by oral route. But if this occurs, gastric lavage or induction of vomiting and administration of activated charcoal should be performed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The rareside effects (may affect up to 1 in 1,000 people) are:

• Redness of the skin.

The very rareside effects (may affect up to 1 in 10,000 people) are:

• Cutaneous allergic reactions (itching, red skin, rash, edema), bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

The side effects of unknown frequency(cannot be estimated from the available data) are:

• Sun-induced skin allergic reaction.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use:

http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zenavan

Keep this medication out of sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Zenavan composition

• The active ingredient is etofenamate. Each gram of gel contains 50 mg of etofenamate.
• The other components (excipients) are: carbomer 940, tromethamine, isopropyl alcohol, macrogol 400, emulgin M-8, pine essential oil, eucalyptus essential oil (d-limonene), and purified water.

Product appearance and package contents

Transparent and colorless gel.

It is presented in an aluminum tube containing 60 grams of gel.

Marketing authorization holder

Laboratorios BIAL, S.A.,

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Manufacturer

Farmasierra Manufacturing, S.L.,

Ctra. De Irún, Km 26,200

28709 San Sebastián de los Reyes (Madrid)

Date of the last revision of this leaflet:09/2019

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