BRUFEN 5% Gel

Зміст інструкції

1. Brufen Antinfiammatorio locale 10% cream
   1. What is Brufen Antinfiammatorio locale and what is it used for
   2. What you need to know before using Brufen Antinfiammatorio locale
   3. How to use Brufen Antinfiammatorio locale
   4. Possible side effects
   5. How to store Brufen Antinfiammatorio locale
   6. Contents of the pack and other information
2. Brufen Antinfiammatorio locale 5% gel
   1. What you need to know before using Brufen Antinfiammatorio locale
   2. How to use Brufen Antinfiammatorio locale
   3. Possible side effects
   4. How to store Brufen Antinfiammatorio locale
   5. Contents of the pack and other information

Brufen Antinfiammatorio locale 10% cream

Etofenamate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 1-2 weeks.

Contents of this leaflet:

• 1. What Brufen Antinfiammatorio locale is and what it is used for
• 2. What you need to know before you use Brufen Antinfiammatorio locale
• 3. How to use Brufen Antinfiammatorio locale
• 4. Possible side effects
• 5. How to store Brufen Antinfiammatorio locale
• 6. Contents of the pack and other information

1. What is Brufen Antinfiammatorio locale and what is it used for

Brufen Antinfiammatorio locale 10% cream is a medicine based on etofenamate, a
anti-inflammatory for local use.
Brufen Antinfiammatorio locale is indicated in adults:

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

See 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 Antinfiammatorio locale

Do not use Brufen Antinfiammatorio locale

• 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 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
Consult your doctor or pharmacist before using Brufen Antinfiammatorio locale.
Avoid applying Brufen Antinfiammatorio locale 10% cream:

• on open wounds
• on inflamed skin that presents with red spots, itching.

Avoid contact of Brufen Antinfiammatorio locale 10% cream:

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

You must wash your hands after applying the product and avoid contact with these parts
of the body.
Do not expose the treated area to the sun and/or solarium during treatment and for the two weeks
afterwards.
If you suffer from asthma, chronic obstructive respiratory diseases, hay fever or
chronic swelling of the nasal mucous membranes (so-called nasal polyps) or chronic obstructive diseases of the
airways or chronic airway infections, especially if combined with manifestations of
hay fever, use Brufen Antinfiammatorio locale only after taking some precautions and
under strict medical control.
Children must not come into contact with the skin areas treated with the medicine.
The use, especially if prolonged, of products to be applied to the skin can cause allergies. In this
case, stop the treatment and ask your doctor for advice (see section “Possible side effects”).
Do not take this medicine orally.
If you have experienced allergies in the past, use Brufen Antinfiammatorio locale with due caution.

Children and adolescents
Use in children and adolescents under the age of 18 is not recommended, as
safety and efficacy have not been established.

Other medicines and Brufen Antinfiammatorio locale
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Pregnancy and breastfeeding
Driving and using machines
Brufen Antinfiammatorio locale does not affect the ability to drive vehicles and operate machinery.

Brufen Antinfiammatorio locale contains Benzyl alcohol
This medicine contains 25.5 to 49.5 mg of benzyl alcohol in a 5-10 cm strip of cream,
equivalent to 15 mg/1g of cream.
Benzyl alcohol can cause allergic reactions and mild local irritation.

3. How to use Brufen Antinfiammatorio locale

Use this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 2-4 applications per day, corresponding to the affected area.

How to useBrufen Antinfiammatorio locale:

• apply a light layer of cream (a strip of 5-10 cm) to the affected area
• gently massage to promote cream penetration.

Duration of treatment
Usually, a treatment of 1-2 weeks is sufficient.
If symptoms persist after this period, consult your doctor who will evaluate whether to continue treatment with this medicine or change therapy.

If you use more Brufen Antinfiammatorio locale than you should
If you accidentally use large quantities of medicine, consult your doctor or go to the nearest hospital.
If you use excessive doses of this medicine, for example, apply the contents of a tube or more of cream to the entire body surface in a short period of time, undesirable effects such as:

• headache
• dizziness
• discomfort in the epigastric region In these cases, remove the product with water and contact your doctor.

If you forget to use Brufen Antinfiammatorio locale
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 Antinfiammatorio locale, especially if prolonged, as well as with
other products for local use, allergy may occur. In this case STOPtreatment
and ask your doctor for advice.
In addition, the following side effects have been observed and reported, whose frequency cannot
be established:

Effects relating to the skin

• redness of the skin
• irritation
• itching
• skin rash
• swelling (edema)
• formation of blisters on the skin The possible side effects reported above generally occur in the treated skin area and disappear if application of the cream is stopped
• inflammation of the skin (allergic contact dermatitis)
• redness of the skin with the appearance of wheals and itching (urticaria)
• widespread skin swelling

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor. You can also report side effects directly through the national reporting system at:
https://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 Antinfiammatorio locale

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Brufen Antinfiammatorio locale contains

• the active ingredient is: etofenamate (1 g of cream contains 100 mg of etofenamate)
• the other ingredients are: mixture of mono and glycerides of palmitic and stearic acids, isopropyl myristate, polyoxymethylene (100) stearate, benzyl alcohol, anhydrous citric acid, disodium citrate dihydrate, hypromellose, purified water.

Description of the appearance of Brufen Antinfiammatorio locale and contents of the pack
Brufen Antinfiammatorio locale 10% cream is presented in a 50g tube.

Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
Meda Manufacturing GmbH,
Neurather Ring 1
51063 Cologne
Germany

Brufen Antinfiammatorio locale 5% gel

Etofenamate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 1-2 weeks.

Contents of this leaflet:

• 1. What is Brufen Antinfiammatorio locale and what it is used for
• 2. What you need to know before using Brufen Antinfiammatorio locale
• 3. How to use Brufen Antinfiammatorio locale
• 4. Possible side effects
• 5. How to store Brufen Antinfiammatorio locale
• 6. Contents of the pack and other information
• 1. What isBrufen Antinfiammatorio locale and what it is used for

Brufen Antinfiammatorio locale 5% gel is a medicine containing etofenamate, a
non-steroidal anti-inflammatory drug for local use.
Brufen Antinfiammatorio locale is indicated in adults:

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

See a 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 Antinfiammatorio locale

Do not use Brufen Antinfiammatorio locale

• if you are allergic to etofenamate or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to flufenamic acid or 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
Consult your doctor or pharmacist before using Brufen Antinfiammatorio locale.
Avoid applying Brufen Antinfiammatorio locale 5% gel:

• to open wounds
• to inflamed skin that presents with red spots, itching.

Avoid contact of Brufen Antinfiammatorio locale 5% gel:

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

Do not expose the treated area to the sun and/or solarium during treatment and for the two weeks
afterwards.
If you suffer from asthma, chronic obstructive diseases of the respiratory system, hay fever or
chronic swelling of the nasal mucous membranes (so-called nasal polyps) or chronic obstructive
airway diseases or chronic airway infections, especially if combined with manifestations of
hay fever, use Brufen Antinfiammatorio locale only after taking some precautions and
under strict medical supervision.
Children must not come into contact with the skin areas treated with the medicine.
The use, especially if prolonged, of products to be applied to the skin can cause allergies. In such
cases, discontinue treatment and consult your doctor (see section “Possible side effects”).
Do not take this medicine orally.
If you have experienced allergies in the past, use Brufen Antinfiammatorio locale with due 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 Antinfiammatorio locale
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
This medicine should be used in the first and second trimester of pregnancy after
carefully evaluating the risk/benefit ratio.
This medicine is contraindicated during the third trimester of pregnancy and during breastfeeding
with breast milk.

Driving and using machines
Brufen Antinfiammatorio locale does not affect the ability to drive vehicles and operate machinery.

3. How to use Brufen Antinfiammatorio locale

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 2-3 applications per day, corresponding to the affected area.

How to useBrufen Antinfiammatorio locale :

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

Duration of treatment
Usually, a treatment of 1-2 weeks is sufficient.
If symptoms persist after this period, consult your doctor who will assess whether to continue treatment with this medicine or change therapy.

If you use more Brufen Antinfiammatorio locale than you should
If you accidentally use large amounts of medicine, consult your doctor or go to the nearest hospital.
If you use excessive doses of this medicine, for example, apply the contents of a tube or more of gel to the entire body surface in a short period of time, undesirable effects such as:

• headache
• dizziness
• discomfort in the epigastric region. In these cases, remove the product with water and contact your doctor.

If you forget to use Brufen Antinfiammatorio locale
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 Antinfiammatorio locale, especially if prolonged, as well as with
other products for local use, allergy may occur. In this case STOPtreatment
and ask your doctor for advice.
In addition, the following side effects have been observed and reported, whose frequency cannot
be established:

Effects relating to the skin

• redness of the skin
• irritation
• itching
• skin rash
• swelling (edema)
• formation of blisters on the skin The possible side effects reported above generally occur in the treated skin area and disappear if the application of the cream is stopped
• skin inflammation (allergic contact dermatitis)
• redness of the skin with the appearance of wheals and itching (urticaria)
• widespread skin swelling

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor. You can also report side effects directly through the national reporting system at:
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 Antinfiammatorio locale

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

6. Contents of the pack and other information

What Brufen Antinfiammatorio locale contains

• the active ingredient is etofenamate (1 g of gel contains 50 mg of etofenamate)
• the other ingredients are: oleyl cetyl alcohol polyglycol ether, macrogol 400, carbomer, isopropyl alcohol, sodium hydroxide, purified water

Description of the appearance of Brufen Antinfiammatorio locale and contents of the pack
Brufen Antinfiammatorio locale 5 % gel is presented in a 40 g tube.

Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer