Aertal cream 1.5% 60.0 #1

Aertal Cream 1.5%
Composition:

1.0 g of cream contains:

• Active ingredient: Micronized aceclofenac – 0.0150 g

• Excipients: Emulsifying wax, liquid paraffin, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), purified water.

Therapeutic Indications:

For the local treatment of all types of pain and inflammation caused by musculoskeletal injuries, including sports injuries.
The product can be used to relieve inflammation of tendons, ligaments, muscles, and joints in cases of strain, overexertion, or contusion. It is also used in the treatment of lumbago (lower back pain), torticollis, and periarthritis.

Contraindications:

• Hypersensitivity to aceclofenac or any excipients listed in the composition.

• Not to be used in patients with a history of hypersensitivity to other NSAIDs (non-steroidal anti-inflammatory drugs).

• Although cross-reactivity with diclofenac has not been confirmed, Aertal is not recommended in patients with known sensitivity to diclofenac.

• Like other NSAIDs, aceclofenac is contraindicated in patients who have experienced asthma attacks, urticaria, or acute rhinitis caused by acetylsalicylic acid or other NSAIDs.

Use During Pregnancy and Lactation:

• Pregnancy: Animal studies did not show harmful effects on pregnancy or fetal development. However, due to the lack of sufficient human data, use during pregnancy is contraindicated.

• Lactation: There is no data on whether aceclofenac is excreted in breast milk, so its use is not recommended during breastfeeding.

Dosage and Administration:

• Dosing Regimen: Apply the cream to the affected area three times daily with gentle massage.

• The dose depends on the size of the affected area: 1.5–2 g of cream (approximately a 5–7 cm strip of cream).

• Without medical supervision, use should not exceed 2 weeks for muscular or joint injuries (strains, sprains, contusions) or tendonitis.

• For arthritis, the duration should not exceed 3 weeks.

• If symptoms worsen or do not improve within 7 days, consult a doctor.

• Children: Not recommended due to lack of data.

• Elderly (65+): Use the same dose as for adults.

Instructions for Use:

• For external use only.

• Do not apply under occlusive dressings.

• Wash hands after application, unless hands are being treated.

• Avoid contact with eyes and mouth.

• Apply only to intact skin.

Effects on Driving and Machinery Use:

Aertal cream does not affect the ability to drive or operate machinery.

Storage Conditions:

• Store at a temperature not exceeding 25ºC.

• Keep out of reach of children.