PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Brufen Anti-inflammatory local 5% gel

etofenamate
Please read this leaflet carefully before using this medicine because it contains important information for you.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 1–2 weeks.

Contents of this leaflet:

What Brufen Anti-inflammatory local is and what it is used for
What you need to know before using Brufen Anti-inflammatory local
How to use Brufen Anti-inflammatory local
Possible side effects
How to store Brufen Anti-inflammatory local
Contents of the pack and other information
What Brufen Anti-inflammatory local is and what it is used for

Brufen Anti-inflammatory local 5% gel is a medicine containing etofenamate, a locally-acting anti-inflammatory agent.
Brufen Anti-inflammatory local is indicated in adults for:

the local treatment of pain and inflammation affecting joints, muscles, tendons, and ligaments.

Consult your doctor if you do not feel better or if you feel worse after 1–2 weeks.

2. What you need to know before using Brufen Anti-inflammatory local

Do not use Brufen Anti-inflammatory local

if you are allergic to etofenamate or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to flufenamic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs).
if you are in the third trimester of pregnancy.
if you are breastfeeding.
if you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Brufen Anti-inflammatory local.
Avoid applying Brufen Anti-inflammatory local 5% gel:

on open wounds
on inflamed skin presenting with red spots or itching.

Avoid contact of Brufen Anti-inflammatory local 5% gel:

with eyes and mucous membranes (e.g. mouth, nose).

Do not expose the treated area to sunlight and/or sunbeds during treatment and for two weeks
following.
If you suffer from asthma, chronic obstructive respiratory diseases, hay fever, chronic nasal mucosa swelling (so-called nasal polyps), or chronic obstructive airway diseases or chronic airway infections, especially when combined with hay fever symptoms, use Brufen Anti-inflammatory local only after taking appropriate precautions and under strict medical supervision.
Children must not come into contact with skin areas treated with this medicine.
The use, especially if prolonged, of topical skin products may lead to allergic reactions. In such cases, discontinue treatment and consult your doctor (see section "Possible side effects").
Do not take this medicine orally.
If you have previously experienced allergies, use Brufen Anti-inflammatory local with appropriate caution.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended, as safety and efficacy have not been established.
Other medicines and Brufen Anti-inflammatory local
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
This medicine should be used during the first and second trimesters of pregnancy only after careful assessment of the benefit-risk balance.
This medicine is contraindicated during the third trimester of pregnancy and during breastfeeding.
Driving and using machines
Brufen Anti-inflammatory local does not affect the ability to drive or operate machinery.

3. How to use Brufen Anti-inflammatory local

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–3 applications per day, applied to the affected area.
How to use Brufen Anti-inflammatory local:

apply a thin layer of gel (a strip of 5–10 cm) to the affected area
gently massage to promote absorption of the gel.

Duration of treatment
Treatment usually lasts 1–2 weeks.
If symptoms persist after this period, consult your doctor, who will decide whether to continue treatment with this medicine or change therapy.
If you use more Brufen Anti-inflammatory local than you should
If you accidentally use large amounts of this medicine, contact your doctor or go to the nearest hospital.
If you apply excessive doses of this medicine, for example, if you apply the contents of one tube or more of gel over the entire body surface within a short period of time, undesirable effects may occur such as:

headache
dizziness
stomach discomfort
In these cases, remove the product with water and contact your doctor.

If you forget to use Brufen Anti-inflammatory local
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Brufen Anti-inflammatory topical, especially if prolonged, as with other topical products, an allergic reaction may occur. In such a case, STOP treatment immediately and consult your doctor.
The following side effects have also been observed and reported; their frequency cannot be determined:

Effects related to the skin

redness of the skin
irritation
itching
skin rash
swelling (edema)
formation of blisters on the skin

The possible side effects listed above generally occur at the site of application and disappear if cream application is discontinued.

inflammation of the skin (allergic contact dermatitis)
redness of the skin with appearance of wheals and itching (urticaria)
widespread swelling of the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brufen Anti-inflammatory topical

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Brufen Anti-inflammatory local contains

The active substance is etofenamate (1 g of gel contains 50 mg of etofenamate)
The other components are:
macrogol-5-oleyl ether, macrogol-10-oleyl ether, macrogol 400, carbomer, isopropyl alcohol, sodium hydroxide, purified water

Description of the appearance of Brufen Anti-inflammatory local and contents of the pack
Brufen Anti-inflammatory local 5% gel comes in a 40 g tube.
Marketing Authorization Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Manufacturer
November 2025