Airtal Difucrem 15 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Airtal Difucrem 15 mg/g cream

aceclofenac

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

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

Package leaflet contents:

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

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

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

Your doctor has prescribed 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 using Airtal Difucrem

Do not use Airtal Difucrem

• If you are in the third trimester of pregnancy.
• If you are allergic to aceclofenac, to other anti-inflammatory medicines, or to 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 reaction.

Warnings and precautions

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

• Must not be used in the eyes, on mucous membranes, or on open wounds.
• Must not be used if the area to be treated is irritated.
• Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet (UVA) lamps.
• Must not be used with tight bandages or dressings that do not allow air circulation to the area.
• If redness or any lesion appears on the treated area, stop treatment immediately and consult your doctor.
• Hypersensitivity reactions may occur and, very rarely, severe allergic reactions may develop (see section 4. Possible adverse effects). The risk is higher during the first month of treatment. Discontinue treatment immediately at the first signs of skin rash, mucosal lesions, or other signs of hypersensitivity.
• In case of chickenpox, the use of this medicine should be avoided, as severe skin infections related to its use may rarely occur.

Other medicines and Airtal Difucrem

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is especially important if you are taking lithium, digoxine, diuretics, anticoagulants, or pain medications.

Pregnancy and lactation

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.

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

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. 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 trimesters of pregnancy unless clearly necessary and specifically recommended by your doctor. If treatment is needed during this period, the dose and duration should be kept as low as possible.

Driving and use of machines

No effects on the ability to drive vehicles or operate machinery have been reported when aceclofenac is used topically on the skin.

Airtal Difucrem contains propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), and cetearyl alcohol.

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

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

3. How to use Airtal Difucrem

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

Your doctor will determine the number of applications, frequency, and duration of treatment. Generally, between 1.5 and 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, immediately go 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 missed doses; continue with your regular treatment as soon as possible.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

Rarely, severe skin infections have been observed during chickenpox.

In uncommon cases (may affect up to 1 in 100 people), allergic reactions have been observed when treated areas of skin are exposed to strong sunlight without adequate protection, and irritation accompanied by redness and itching at the application site, which resolves upon discontinuation of treatment.

In very rare cases (may affect up to 1 in 10,000 people), severe blistering skin reactions have been observed, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 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 Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. 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 g of aceclofenac.

The other components are polyoxyethylene sorbitan palmitostearate, cetyl stearyl alcohol, liquid paraffin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and purified water.

Appearance of Airtal Difucrem and contents of the package

White-colored cream. It is supplied in a 60-gram tube.

Marketing Authorization 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 most recent review of this leaflet: March 2024

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