Zenavan 50 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Zenavan 50 mg/g gel
etofenamate
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read 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 adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days.
Contents of this leaflet:
- What Zenavan is and what it is used for
- What you need to know before using Zenavan
- How to use Zenavan
- Possible side effects
- How to store Zenavan
- Contents of the pack and other information
1. What Zenavan is and what it is used for
Zenavan contains the active substance etofenamate and belongs to the group of non-steroidal anti-inflammatory drugs. Etofenamate acts as a local analgesic and anti-inflammatory.
This medicine is used in adults and adolescents (over 12 years of age) for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, sprains, torticollis or other muscle spasms, lumbago, and mild sprains resulting from twisting injuries.
You should inform your doctor if your condition worsens or does not improve after seven days.
2. What you need to know before starting to use Zenavan
Do not use Zenavan
- If you are allergic to etofenamate or to any of the other components of this medicine (listed in section 6).
- On wounds, eczematous lesions, mucous membranes, or sunburns.
- If you have previously experienced an allergic reaction (rhinitis, asthma, itching, breathing difficulties, urticaria, shock, or other reactions) caused by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- If you are in the third trimester of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Zenavan.
- Do not apply on wounds, eczematous lesions, mucous membranes, or sunburns.
Apply only on intact skin.
- Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with plenty of water.
- Do not use over large areas or for prolonged periods. This may cause skin irritation and dryness.
Use exclusively on the affected area.
- Do not use occlusive dressings.
- Avoid applying it to areas where other topical medicines have been applied.
- Avoid exposing the treated area to sunlight to reduce the risk of photosensitivity reactions.
- If you have asthma, chronic obstructive respiratory disease, hay fever, nasal polyps, or chronic respiratory infections, consult your doctor before using this medicine.
- Consult your doctor if you have: gastroduodenal ulcer, ulcerative colitis, coagulation disorders, high blood pressure, or heart, liver, or kidney problems.
Children
Do not use in children under 12 years of age due to insufficient data on efficacy and safety.
Use of Zenavan with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to use any other medicines.
Although no interactions with other medicines have been observed, Zenavan should not be used simultaneously with other topical medicines on the same area, including other analgesics.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless your doctor considers it necessary.
Do not use this medicine during the third trimester of pregnancy, as it may prolong labor and contribute to bleeding in both mother and baby.
Breastfeeding
During breastfeeding, this medicine should only be used on small areas and for a short duration.
At high doses, it may cross the placental barrier and pass into breast milk.
Driving and using machines
The effect of this medicine on the ability to drive and operate machinery is none or negligible.
Zenavan contains fragrances with d-limonene.
D-limonene may cause allergic reactions.
3. How to use Zenavan
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose in adults and children over 12 years of age:
Apply 3 to 4 times daily a 5 to 10 cm portion of gel (corresponding approximately to 1.7–3.3 g of gel) to the affected area, using gentle massage to aid absorption.
Wash your hands after each application.
If symptoms worsen or persist for more than 7 days of treatment, you should consult your doctor.
Elderly patients (over 65 years of age)
No dose adjustment is required for this patient group.
Patients with renal or hepatic impairment
No dose adjustment is required for this patient group.
Use in children
Do not administer to children under 12 years of age due to lack of data on safety and efficacy in this population.
If you use more Zenavan than you should
Due to its topical use, poisoning is unlikely. However, if you have used a much larger amount than recommended (the entire contents of a tube), it is recommended to remove the medication by washing the affected area thoroughly with abundant water. Symptoms that may occur in case of overdose include: skin irritation, headache, dizziness, or stomach pain.
Oral toxic doses are normally not reached. However, if this occurs, gastric lavage or induction of vomiting should be performed, along with administration of activated charcoal.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
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 experiences them.
Rare adverse effects (may affect up to 1 in 1,000 people) are:
- Skin redness.
Very rare adverse effects (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 of unknown frequency (cannot be estimated from available data) are:
- Allergic skin reaction upon exposure to sunlight.
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 Medicinal Products:
http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Zenavan
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.
6. Contents of the pack and other information
Composition of Zenavan
- The active substance 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.
Appearance of the product and contents of the pack
Clear, colorless gel.
It is supplied 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
28706 San Sebastián de los Reyes (Madrid)
Date of the most recent revision of this leaflet: 09/2019
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”.