Articalm 50 mg/g gel

Patient Information

Articalm 50 mg/g Gel

Ibuprofen

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those given by your doctor, pharmacist, or nurse.

-Keep this leaflet, as you may need to read it again.

-For advice on any side effects, talk to your pharmacist.

-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.

-You must see a doctor if your symptoms worsen or do not improve after 7 days.

1.What Articalm is and what it is used for

2.What you need to know before using Articalm

3.How to use Articalm

4.Possible side effects

5.Storage of Articalm

6.Contents of the pack and additional information

The ibuprofen, active ingredient of this medication, acts as a local analgesic and anti-inflammatory.

Articalm is indicated to relieve locally mild and occasional pain and inflammation caused by: small contusions, blows, strains, torticollis or other contractures, low back pain and mild sprains caused by a twist in adults and adolescents 12 years of age and older.

No 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 on the affected area.

- If you have had allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, pruritus, or others) caused by acetylsalicylic acid or other nonsteroidal 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 coloring agents used in food or medications (such as yellow-orange tartrazine, etc.), you should consult your doctor before using this medication.

- You should avoid contact with the eyes.

- Do not expose the treated area to the sun, or use it with bandages or on large 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), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue Articalm treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Severe Skin Reactions

Severe skin reactions have been reported associated with Articalm treatment. Stop taking Articalm and see a doctor immediately if you present any skin rash, mucous membrane lesions, 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 old.

Use of Articalm with Other Medications

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

Pregnancy andLactation

If you are pregnant or breastfeeding, or 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 your doctor advises it. If you need treatment during this period, use the lowest dose for the shortest time possible.

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

Driving and Operating Machinery

No effects on the ability to drive vehicles and use machinery have been described when using Articalm externally on the skin.

Follow exactly the medication administration instructions contained in this leaflet or those 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 must consult a doctor.

If you use more Articalm than you should

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

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

- Infrequent (in fewer than 1 in 100 patients but more than 1 in 1,000): redness, itching, and a burning sensation on the skin at the application site, which disappear when treatment is suspended.

- Rare (in fewer than 1 in 1,000 patients): dermatitis (skin inflammation) caused by the sun.

- Unknown frequency (cannot be estimated from available data): generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (generalized acute pustular exanthema). The skin becomes sensitive to light. Stop taking Articalm if you experience these symptoms and seek medical attention immediately. See section 2.

Interrupt treatment with ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin eruption, 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 (generalized acute pustular exanthema).

Reporting Adverse Effects

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

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Articalm

- The active principle 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 content of the packaging

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

It is presented in containers containing 30 g and 60 g of gel.

Holder of the marketing authorization and Responsible for the manufacture

Holder of the marketing authorization:

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 rEUS (Tarragona)

Responsible for the manufacture:

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 España

Last review date of this leaflet: January 2024

Other sources of information

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