Artrocol Gel 25 mg/g, 45 g tube

Artrocol – Nonsteroidal Anti-Inflammatory Drug for Topical Use

Indications for Use

• Relief of acute painful conditions of the musculoskeletal system caused by injury, such as sports injuries, dislocations, sprains, and contusions.
• Pain associated with mild arthritis.

Composition

• Active substance: ketoprofen;
• 1 g of gel contains ketoprofen 25 mg;
• Excipients: carbomer 980, triethanolamine, ethanol 96%, methylparaben (E218), purified water.

Contraindications

• Known hypersensitivity reactions, such as symptoms of bronchial asthma or allergic rhinitis, occurring with the use of ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other NSAIDs.
• Hypersensitivity to any component of the medicinal product.
• Any history of photosensitivity reactions.
• History of cutaneous allergic reactions when using dexketoprofen, ketoprofen, tiaprofenic acid, fenofibrate, ultraviolet (UV) blockers, or perfumery products.
• Exposure to sunlight (even diffused light) or UV radiation in solariums during treatment and for 2 weeks after discontinuation.
• Use on pathological skin changes such as eczema or acne.
• Application to infected skin, open wounds, mucous membranes, anal or genital areas, eyes, or under occlusive dressings.
• Use during the third trimester of pregnancy.

Adverse Reactions

Immune system: frequency unknown – hypersensitivity reactions, including anaphylactic shock and angioedema.

Skin and subcutaneous tissues: uncommon – local skin reactions such as erythema, eczema, itching, burning sensation; rare – photosensitivity reactions, urticaria; very rare – bullous and phlyctenular eczema that may spread and become generalized; frequency unknown – Stevens–Johnson syndrome.

Renal and urinary system: very rare – exacerbation of existing renal insufficiency.

Method of Administration

The medicinal product is intended for topical (cutaneous) use.

Apply a thin layer of gel to the affected area 2–4 times daily and gently rub until fully absorbed. The usual recommended dose is 15 g of gel (14 cm of gel corresponds to 7.5 g). The duration of treatment is 7 days.

Elderly Patients

No specific dosage recommendations are required.

Special Precautions

Use During Pregnancy or Breastfeeding

First and second trimesters of pregnancy: No embryotoxic effects were observed in animal studies. Epidemiological data confirm the safety of ketoprofen during human pregnancy; however, use during the first and second trimesters should be avoided.

Third trimester of pregnancy: Use is contraindicated.

Breastfeeding: Ketoprofen passes into breast milk in minimal amounts. The medicinal product should not be used during breastfeeding.

Children

The medicinal product should not be used in children.

Effect on Ability to Drive Vehicles and Operate Machinery

No data are available regarding the effect of topical ketoprofen on the ability to drive vehicles or operate machinery.

Overdose

Overdose is unlikely with topical application.

In case of accidental ingestion, systemic adverse reactions may occur depending on the amount ingested. Supportive and symptomatic treatment should be provided if such reactions develop.

Interaction with Other Medicinal Products

Systemic absorption of ketoprofen when applied topically is very low; therefore, interactions are unlikely.

No reports of interactions with other medicinal products have been received; however, the following interactions have been identified with oral ketoprofen or other NSAIDs.

Serious interactions have been reported with concomitant systemic use of NSAIDs, including ketoprofen, and methotrexate.

Storage Conditions

Store at a temperature not exceeding 25 °C, out of reach of children.