Doloxen fast

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DOLOXEN FAST (DOLOXEN FAST)

Composition:

Active substance: methyl salicylate;

1 g of ointment contains methyl salicylate 61.1 mg;

Excipients: turpentine oil, racemic camphor, menthol (levomenthol), white soft paraffin, lanolin.

Pharmaceutical form. Ointment.

Main physicochemical properties: oily, yellowish, homogeneous ointment with a characteristic odor and oily to the touch.

Pharmacotherapeutic group.

Topically applied agents for joint and muscular pain. Agents containing derivatives of salicylic acid. ATC code M02AC.

Pharmacological Properties

Doloxene Fast is a counterirritant and is used for temporary relief of deep pain.

Local application of the ointment containing methyl salicylate to painful joints affected by arthritis contributes to significant reduction of muscle tension.

After topical application, methyl salicylate penetrates through intact skin and exerts a systemic effect; the amount of absorbed drug is sufficient to provide a pronounced analgesic effect.

Clinical characteristics.

Indications.

As part of combination therapy for:

• mild and moderate muscle pain;
• contusions;
• mild and moderate pain associated with osteoarthrosis and osteoarthritis;
• mild and moderate joint pain;
• moderate inflammatory processes of the musculoskeletal system.

Contraindications.

• Hypersensitivity to salicylates or any other component of the medicinal product;
• concomitant use of warfarin;
• pregnancy and breastfeeding.

Special precautions.

The product is intended for topical use only.

Prior to application, the medicinal product should first be applied to a small area of skin to prevent possible allergic reactions. Avoid application on sensitive or damaged skin, as well as over large areas. Lanolin contained in the ointment may cause skin reactions (contact dermatitis). The packaging contains a latex seal which may cause allergic reactions in sensitive individuals. Absorption is enhanced by heat or physical exertion (e.g., during sports activities). Do not use under tight or warming bandages, or together with electric heating pads. The application site may only be lightly covered. Some patients, especially those with sensitive skin, may experience discomfort when using in hot weather or after bathing. Do not use with occlusive dressings.

In case of accidental contact with eyes, rinse thoroughly with water and seek immediate medical advice.

Hands should always be washed after application of Doloxen Fast, unless the hands themselves are the treated area.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of this medicinal product with oral warfarin enhances the effect of the latter, leading to hematological changes.

Although adequate controlled interaction studies have not been conducted, excessive use of topically applied salicylates may potentially increase the effect of coumarin anticoagulants and antiplatelet medicinal products. Therefore, caution should be exercised in patients receiving coumarin anticoagulants or antiplatelet agents, including aspirin.

Special precautions for use.

Salicylates may enhance the effect of anticoagulants and antiplatelet drugs. The use of salicylates has been associated with the development of Reye's syndrome.

Use during pregnancy or breastfeeding.

Contraindicated during these periods due to insufficient observational data.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Dosage and Administration.

Apply approximately 1–2 g of the ointment to the affected area three times daily.

The treatment duration should not exceed 2 weeks.

Children.

The medicinal product is not intended for use in children due to insufficient experience with its use.

Overdose.

Overdose is practically impossible with topical application, as the amount of drug in one package does not pose a risk of overdose.

In case of accidental ingestion, nausea, vomiting, colic, headache, dizziness, sensation of heat, delirium, muscle contractions, seizures, and nervous system depression up to coma are possible.

Treatment: gastric lavage, administration of saline laxatives (sodium sulfate 30 g/250 ml), and large fluid volumes to help prevent kidney dysfunction.

In case of overdose, seek medical advice. Treatment is symptomatic.

Side effects.

Allergic reactions and hypersensitivity to the drug are rare. The most common are local adverse reactions: rash, burning, pain, redness, itching, urticaria. Possible burns at the site of application.

Immune system: angioneurotic edema.

Respiratory system, thorax and mediastinum: dyspnea.

If any adverse effects occur, the use of the medicinal product must be discontinued and medical advice must be sought immediately.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Store in a place protected from light and moisture, in a tightly closed tube.

Keep out of reach of children.

Packaging. 20 g or 50 g in a tube. 1 tube per cardboard box.

Availability category. Over-the-counter.

Manufacturer. Laboratorios Bassi - Indústria Farmacêutica, S.A.

Manufacturer's address and location of business operations.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16, Mortágua,
3450-232, Portugal.