ACTION AND MECHANISM

Piketoprofen is a non-steroidal anti-inflammatory and analgesic that acts by preventing the synthesis of prostaglandins and other prostanoids, through the inhibition of cyclooxygenase involved in inflammatory processes.

SPECIAL WARNINGS

- If symptoms persist for more than 7 days or irritation or worsening occurs, the patient's clinical condition should be evaluated. - Sun exposure of the treated area may cause photosensitivity.

PATIENT ADVICE

- Avoid contact with eyes and mucous membranes. - Do not use with occlusive dressings or apply simultaneously to the same area as other topical preparations. - Do not use for prolonged periods or on large areas. - Use only on intact skin, not on open wounds, mucous membranes, or eczematous skin. - Do not expose the treated area to sunlight. - Wash hands after each application.

CONTRAINDICATIONS

- Hypersensitivity to piketoprofen or any of the components of this medicine.- [NSAID ALLERGY], [SALICYLATE ALLERGY]: Although local administration minimizes the risks derived from its systemic use, topical application to large areas of skin, open wounds, mucous membranes or eczematous skin, for prolonged periods and with the use of occlusive dressings, may cause systemic effects. Therefore, it is important to remember that its use is not recommended in patients who have experienced allergic reactions (rhinitis, asthma, pruritus, angioedema, urticaria, shock or others) caused by acetylsalicylic acid or other NSAIDs due to the possibility of cross-hypersensitivity.

PREGNANCY

Although systemic absorption through skin use is very small, the preparation should not be used during pregnancy except under medical supervision, since NSAIDs, especially during the third trimester, can cause dystocia, delay labor and cause adverse effects on the fetal cardiovascular system, such as premature closure of the ductus arteriosus.

INDICATIONS

- Local symptomatic relief of painful or inflammatory conditions of traumatic or degenerative origin of the joints, tendons, ligaments and muscles ([ARTHRITIS], periarthritis, [CAPSULITIS], arthrosynovitis, [TENOSYNOVITIS], sprains, meniscal injuries of the knee, [CONTRACTURE], [TENDINITIS], [BURSITIS], [CONTUSION], [SPRAIN], [LUMBALGIA], [TORTICOLLIS], [DISLOCATION]).

INTERACTIONS

They have not been described in cutaneous use, since very low systemic concentrations of the drug are reached, but it will be assessed whether it should be used in conjunction with other topical analgesics.

LACTATION

Although systemic absorption through skin use is very small, the preparation should not be used during breastfeeding except under medical supervision.

GUIDELINES FOR PROPER ADMINISTRATION

- Hold the container upright at a distance of 10-15 cm and apply a thin layer of the product to the affected area. - Wash your hands after each application. - Do not apply occlusive dressings.

POSOLOGY

DOSAGE: - For external cutaneous use only. - Adults and children over 12 years: PIKETROPROFANO: 3 to 4 times a day. - Do not apply for more than 7 consecutive days without consulting a doctor.

ADVERSE REACTIONS

- Moderate local erythema (0.1%-1%), dermatitis, skin irritation, pruritus (0.1%-1%), and a sensation of skin irritation may occur at the application site, which disappear upon discontinuation of treatment. - Photosensitivity reactions may occur (0.01%-0.1%). - If symptoms appear for which no justification can be found, treatment should be discontinued and the patient's clinical condition reassessed. - Prolonged topical administration to large areas of skin, open wounds, mucous membranes, or eczematous skin, as well as the use of occlusive dressings, may cause the appearance of systemic adverse reactions typical of NSAIDs.

OVERDOSE

- Symptoms: Due to its external use, poisoning is unlikely. In case of accidental ingestion, overdose symptoms will be systemic adverse reactions that will depend on the dose ingested and the time elapsed since ingestion. - Treatment: If accidental ingestion occurs, gastric lavage and symptomatic therapy will be administered.

COMPOSITION

PIKETOPROFENE (TOPICO): 33.28 MILLIGRAMS