Articalm 50 mg/g gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Articalm 50 mg/g gel
Ibuprofen
Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Articalm is and what it is used for
- What you need to know before using Articalm
- How to use Articalm
- Possible adverse effects
- How to store Articalm
- Contents of the pack and other information
1. What Articalm is and what it is used for
Ibuprofen, the active ingredient in this medicine, acts as a local analgesic and anti-inflammatory.
Articalm is indicated for the local relief of mild and occasional pain and inflammation caused by minor bruises, blows, sprains, torticollis or other muscle spasms, lumbago, and mild sprains resulting from twisting injuries in adults and adolescents aged 12 years and older.
2. What you need to know before using Articalm
Do not use Articalm
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if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
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if you have sunburn in the affected area.
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if you have previously experienced allergic reactions (rhinitis, breathing difficulties or asthma, urticaria, pruritus or other) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
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if you are in the last 3 months of pregnancy.
Warnings and precautions
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This medicine must not be used on mucous membranes or on wounded skin or skin with eczema.
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If you suffer from asthma or are allergic to food or medicine colourings (for example: tartrazine orange-yellow, etc.), you should consult your doctor before using this medicine.
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Avoid contact with the eyes.
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Do not expose the treated area to sunlight, and do not use bandages or apply to large skin areas.
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Do not apply Articalm simultaneously to the same area where other medicines have been applied.
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Serious skin reactions have been reported with ibuprofen treatment, 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). Discontinue treatment with Articalm and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.
Skin reactions
Serious skin reactions have been reported with Articalm treatment. Stop using Articalm and contact your doctor immediately if you develop any skin rash, lesions of mucous membranes, blisters or other signs of allergy, as these may be the first signs of a serious skin reaction. See section 4.
Children
Do not use this medicine in children under 12 years of age.
Using Articalm with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, especially analgesics, even those obtained without a prescription.
Pregnancy and breastfeeding
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 medicine.
Do not use Articalm if you are in the last 3 months of pregnancy. You should not use Articalm during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.
Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the fetus. It is unknown whether the same risk applies to Articalm when used on the skin.
Driving and using machines
No effects on the ability to drive or use machinery have been reported with external use on the skin.
3. How to use Articalm
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Articalm is a medicine intended for topical, external use only (on the skin).
The recommended dose is:
Adults and adolescents (over 12 years of age): apply a thin layer of the product to the affected area 3 to 4 times daily and gently massage to enhance 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, consult your doctor.
If you use more Articalm than you should
Due to its external use, poisoning is unlikely. In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915.620.420), indicating the medicine and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, somnolence, dizziness, spasms, and decreased blood pressure.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
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Uncommon (in less than 1 in 100 patients but more than 1 in 1000): redness, itching, and burning sensation of the skin at the application site, which disappear when treatment is stopped.
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Rare (in less than 1 in 1000 patients): sun-induced dermatitis (skin inflammation).
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Frequency not known (cannot be estimated from available data): widespread red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop taking Articalm if you experience these symptoms and seek immediate medical attention. See also section 2.
Discontinue treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:
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Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
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Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
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Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Articalm
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container. 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 containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Articalm
- The active substance is ibuprofen. Each gram of gel contains 50 mg of ibuprofen.
- The other components (excipients) are sodium hydroxide, isopropyl alcohol, hyetelose, benzyl alcohol, herbal perfume, and purified water.
Appearance of the medicinal product and contents of the pack
This medicine is a transparent, colourless gel for cutaneous use (on the skin).
It is available in containers 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 most recent revision of this leaflet: January 2024
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/