Package Insert: Information for the Patient

Zenavan 50 mg/g Gel

etofenamate

Read this entire package insert carefully before starting to use this medication, as it contains important information for you

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

- Keep this package insert, as you may need to refer to it again.

- If you need advice or more information, consult your pharmacist.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

- You should consult a doctor if your condition worsens or does not improve after 7 days.

1. What is Zenavan and what is it used for

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

3. How to use Zenavan

4. Possible adverse effects

5 Storage of Zenavan

6. Contents of the package and additional information

Zenavan contains the active ingredient etofenamate and belongs to the group of nonsteroidal anti-inflammatory drugs. Etofenamate acts as a local analgesic and anti-inflammatory.

This medication is used in adults and adolescents (over 12 years old) for the local relief of mild and occasional pain and inflammation caused by: small bruises, blows, strains, torticollis or other contractures, lower back pain, and mild sprains resulting from a twist.

You should inform your doctor if it worsens or does not improve after seven days.

No use Zenavan

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

- Do not apply over wounds, eczematous lesions, mucous membranes, or sunburns.

- If you have had an allergic reaction (rhinitis, asthma, itching, difficulty breathing, urticaria, shock, or others) caused by acetylsalicylic acid or other nonsteroidal 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 over wounds, eczematous lesions, mucous membranes, or sunburns.

Apply only to intact skin.

- Avoid contact with the eyes and mucous membranes. In case of contact, wash abundantly with water.

- Do not use in large areas or for a prolonged period. It may cause skin irritation and dryness.

Use exclusively in the affected area.

- Do not use occlusive dressings.

- Avoid applying it in 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 have: peptic ulcer, ulcerative colitis, coagulation disorders, high blood pressure, heart problems, liver problems, or kidney problems.

Children

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

Use of Zenavan with other medications

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

Although no interactions with other medications have been observed, do not use it together 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy except if 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 of time.

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

Driving and operating machines

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

Zenavan contains fragrances with d-limonene.

D-limonene may cause allergic reactions.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 approximately to 1.7-3.3 g of gel) to the affected area, using a gentle massage for its absorption.

Wash your hands after each application.

If symptoms worsen or persist after 7 days of treatment, you must consult your doctor.

Patients over 65 years old

No dose adjustment is required for this group of patients.

Patients with renal or hepatic problems

No dose adjustment is required for this group of patients.

Use in children

Do not administer in children under 12 years due to the absence 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 cases of overdose will occur. Nevertheless, if you have used much more of the 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. However, 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 Toxicological Information Service, phone 91 562 04 20.

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 all people will experience them.

Adverse effectsare rare(may affect up to 1 in 1,000 people) are:

• Redness of the skin.

Adverse effectsare very rare(may affect up to 1 in 10,000 people) are:

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

Adverse effects ofunknown frequency(cannot be estimated from available data) are:

• Sun-induced skin allergic reaction.

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 to

through the Spanish System of Pharmacovigilance of Medicines for Human Use:

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

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

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging, after CAD. 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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Zenavan

− The active principle is etofenamate. Each gram of gel contains 50 mg of etofenamate.

− The other components (excipients) are: carbomer 940, trolamine, isopropyl alcohol, macrogol 400, emulgin M-8, pine albar essential oil, eucalyptus essential oil (d-limonene) and purified water.

Appearance of the product and contents of the packaging

Transparent and colorless gel.

Presented in an aluminum tube containing 60 grams of gel.

Holder of the marketing authorization

Laboratorios BIAL, S.A.,

C/ Alcalá 265, Edificio 2, 2nd Floor

28027 Madrid

Spain

Responsible for manufacturing

Farmasierra Manufacturing, S.L.,

Irún Highway, Km 26,200

28709 San Sebastián de los Reyes (Madrid)

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

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