Product Information for the User

Airtal Difucrem 15 mg/g Cream

aceclofenac

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

Product Information Contents:

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

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

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

Do not use Airtal Difucrem

• If you are in the third trimester of pregnancy.
• If you are allergic to aceclofenac, other anti-inflammatory medications, or any of the other components of this medication (listed in section 6).
• If the acetylsalicylic acid or other nonsteroidal anti-inflammatory medications have caused asthma, rhinitis, urticaria, or other allergic reactions.

Warnings and precautions

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

• It should not be used on the eyes, mucous membranes, or open wounds.
• It should not be used if the area to be treated is irritated.
• The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet (UVA) lamps.
• It should not be used with tight bandages or those that do not allow air circulation to the area.
• If you observe redness or any lesions on the treated area, discontinue use immediately and consult your doctor.
• Reactions of hypersensitivity may occur, and very rarely, severe allergic reactions may occur (see section 4. Possible adverse effects). The risk is higher during the first month of treatment. Discontinue use immediately at the first signs of skin rash, mucous membrane lesions, or other signs of hypersensitivity.
• In case of chickenpox, use of this medication should be avoided because in rare cases, severe skin infections related to its use may occur.

Other medications and Airtal Difucrem

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Oral formulations (e.g., tablets) of aceclofenac may cause adverse effects in the fetus. It is unknown if Airtal Difucrem carries the same risk.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not use Airtal Difucrem if you are in the third trimester of pregnancy. Do not use this medication during the first and second trimesters of pregnancy, unless it is 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 operating machinery

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 parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), andcetoestearic alcohol.

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of 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 through a gentle massage of 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 Toxicological Information Service. Phone 915 620 420.

If you forgot to use Airtal Difucrem

Do not use a double dose to compensate for the missed doses, continue with the usual treatment as soon as possible.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Exceptionally, severe skin infections have been observed during chickenpox.

In casesinfrequently (may affectup to1 in 100 people),allergic reactions have been observed when exposed to intense sunlight on treated skin areas without adequate protection, accompanied by redness and itching in the application area, which disappears with treatment interruption.

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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse even if it is about possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://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 30°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.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Airtal Difucrem

The active ingredient isaceclofenac. Each 100 grams of cream contains 1.5 g of aceclofenac.

The other components are sorbitan polioxietilenated palmitoestearate, cetoestearilic alcohol, liquid paraffin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) and purified water.

Appearance of Airtal Difucrem and content of the packaging

White cream. It is presented in a 60-gram container.

Holder of the marketing authorization

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

Responsible for manufacturing

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

or

Responsible for manufacturing

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

Last review date of this leaflet: March 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)