ARTICALM 50 mg/g GEL

2. What you need to know before starting to use Articalm

Do not use Articalm

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).

• if you have a sunburn in the affected area.

• if you have experienced allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, itching, or other) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

• if you are in the last 3 months of pregnancy.

Warnings and precautions

• It should not be used on mucous membranes or on skin with wounds or eczema.

• If you are asthmatic or allergic to any colorant used in food or medication (such as yellow-orange tartrazine, etc.), you should consult your doctor before using this medication.

• You should avoid eye contact.

• Do not expose the treated area to the sun, nor use with bandages or on extensive areas.

• Do not apply Articalm simultaneously in the same area where other medications have been applied.

• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Articalm treatment and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Skin reactions

Severe skin reactions have been reported in association with Articalm. Stop taking Articalm and go to the doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Children

Do not use this medication in children under 12 years of age.

Using Articalm with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, especially analgesics, including those purchased without a prescription.

Pregnancy andBreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medication.

Do not use Articalm if you are in the last 3 months of pregnancy. Do not use Articalm during the first 6 months of pregnancy unless it is clearly necessary and advised by your doctor. If you need treatment during this period, use the lowest dose for the shortest possible time.

Oral forms (e.g., tablets) of ibuprofen may cause adverse reactions in the fetus. It is unknown if the same risk applies to Articalm when used on the skin.

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described when used externally on the skin.

3. How to use Articalm

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Articalm is a medication for external use only (on the skin).

The recommended dose is:

Adults and adolescents (over 12 years): apply a thin layer of the product to the painful area 3 to 4 times a day and perform a gentle massage to facilitate penetration.

Wash your hands after each application.

Do not use for more than 7 consecutive days.

If symptoms worsen or persist after 7 days of treatment, you should consult a doctor.

If you use more Articalm than you should

Due to its external use, it is unlikely that cases of intoxication will occur. In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915.620.420), indicating the medication and the amount ingested, as it can cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

• Uncommon (in less than 1 in 100 patients but in more than 1 in 1000): redness, itching, and burning sensation on the skin in the application area, which disappear when treatment is discontinued.

• Rare (in less than 1 in 1000 patients): dermatitis (skin inflammation) caused by the sun.

• Frequency not known (cannot be estimated from available data): generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop taking Articalm if you present these symptoms and seek immediate medical attention. See also section 2.

Discontinue ibuprofen treatment and seek immediate medical attention if you notice any of the following symptoms:

• Reddish, non-elevated spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Articalm

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Articalm

• The active ingredient is ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
• The other components (excipients) are sodium hydroxide, isopropyl alcohol, hyetelosa, benzyl alcohol, herbal perfume, and purified water.

Appearance of the product and package contents

This medication is a transparent, colorless gel for cutaneous use (on the skin).

It is available in packages containing 30 g and 60 g of gel.

Marketing authorization holder and manufacturer

Marketing authorization holder:

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

c/ Laguna 66-68-70. Pol. Ind. Urtinsa II.

28923 Alcorcón (Madrid)

MADAUS, S.A.

Foc, 68-82

Barcelona 08038 Spain

Date of the last revision of this prospectus: January 2024

Other sources of information

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