AIRTAL DIFUCREM 15 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Airtal Difucrem 15 mg/g cream

aceclofenac

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Airtal Difucrem and what is it used for
2. What you need to know before you use Airtal Difucrem
3. How to use Airtal Difucrem
4. Possible side effects
5. Storage of Airtal Difucrem
6. Contents of the pack and other information

1. What is Airtal Difucrem and what is it used for

Airtal Difucrem contains aceclofenac, which has analgesic, anti-inflammatory, and antirheumatic properties.

Your doctor will prescribe this medicine for the treatment of local painful and inflammatory conditions such as tendinitis, tenosynovitis, sprains, dislocations, joint pain, lumbago, and torticollis.

2. What you need to know before you use Airtal Difucrem

Do not use Airtal Difucrem

• If you are in the third trimester of pregnancy.
• If you are allergic to aceclofenac, other anti-inflammatory medicines, or any of the other ingredients of this medicine (listed in section 6).
• If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have caused you asthma, rhinitis, urticaria, or other allergic reactions.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine:

• It must not be used in the eyes, on mucous membranes, or on open wounds.
• It must not be used if the area to be treated is irritated.
• The treated areas must not be exposed to the sun (even if cloudy) or to ultraviolet lamps (UVA).
• It must not be used with tight bandages or those that do not allow the area to breathe.
• If you notice redness or any lesions in the treated area, stop the treatment immediately and consult your doctor.
• Reactions of hypersensitivity and very rarely, severe allergic reactions may occur (see section 4. Possible side effects). The risk is greater during the first month of treatment. Stop the treatment immediately if you experience the first symptoms of skin rash, mucosal lesions, or other signs of hypersensitivity.
• In case of chickenpox, the use of this medicine should be avoided because in rare cases, severe skin infections related to its use may occur.

Other medicines and Airtal Difucrem

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This is especially important if you are taking lithium, digoxin, diuretics, anticoagulants, and pain medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Oral formulations (e.g., tablets) of aceclofenac may cause adverse effects in the fetus. It is not known if Airtal Difucrem carries the same risk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Airtal Difucrem if you are in the third trimester of pregnancy. You should not use this medicine during the first and second trimester of pregnancy, unless clearly necessary and your doctor has recommended it. If you need treatment during this period, the dose and duration should be reduced as much as possible.

Driving and using machines

No effects on the ability to drive vehicles and use machines have been described when aceclofenac is used externally on the skin.

Airtal Difucrem contains propyl hydroxybenzoate (E-216), methyl hydroxybenzoate (E-218), andcetostearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains propyl hydroxybenzoate (E-216) and methyl hydroxybenzoate (E-218).

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.

3. How to use Airtal Difucrem

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the number of applications, frequency, and duration of treatment. Generally, 1.5 to 2 grams of cream (approximately 5 to 7 cm) will be applied three times a day by gently massaging the affected area.

Use in children

Not recommended.

If you use more Airtal Difucrem than you should

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service. Telephone 915 620 420.

If you forget to use Airtal Difucrem

Do not use a double dose to make up for forgotten doses, continue with the usual treatment as soon as possible.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Exceptionally, severe skin infections have been observed during chickenpox.

In rare cases (may affect up to 1 in 100 people), allergic reactions to sunlight exposure on treated skin areas without adequate protection, irritation accompanied by redness and itching in the application area, which disappears with the interruption of treatment, have been observed.

In very rare cases (may affect up to 1 in 10,000 people), severe blistering skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been observed.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Airtal Difucrem

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Airtal Difucrem

The active substance is aceclofenac. Each 100 grams of cream contains 1.5 grams of aceclofenac.

The other ingredients are sorbitan palmitate polyoxyethylene, cetostearyl alcohol, liquid paraffin, methyl hydroxybenzoate (E-218), propyl hydroxybenzoate (E-216), and purified water.

Appearance of Airtal Difucrem and contents of the pack

White cream. It comes in a 60-gram pack.

Marketing authorisation holder

Almirall, S.A. General Mitre, 151 08022 – Barcelona (Spain)

Manufacturer

Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek (Germany)

or

Manufacturer

Industrias Farmacéuticas Almirall, S.A. Ctra. de Martorell, 41-61 08740 Sant Andreu de la Barca – Barcelona (Spain)

Date of last revision of this leaflet: March 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)