Theraflex^® M (Cream) Instructions for Use

ATC Code

M09AX (Other drugs for the treatment of musculoskeletal system diseases)

Clinical-Pharmacological Group

Drug with cartilage tissue regeneration improving and anti-inflammatory action for external use

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

A combined agent, the action of which is determined by the properties of its constituent components. It improves the regeneration of cartilage tissue and has an anti-inflammatory effect.

Chondroitin sulfate is a high-molecular-weight mucopolysaccharide that participates in the building of cartilage tissue. It reduces the activity of enzymes that destroy articular cartilage and stimulates its regeneration. In the early stages of the inflammatory process, Chondroitin sulfate reduces its activity and thus slows down the degeneration of cartilage tissue. It helps to reduce the intensity of the pain syndrome, improve joint function, and reduces the need for NSAIDs.

Glucosamine hydrochloride has chondroprotective properties, reduces the deficiency of glycosaminoglycans in the body, and participates in the biosynthesis of proteoglycans and hyaluronic acid. Glucosamine hydrochloride selectively acts on the articular cartilage, is a specific substrate and stimulator of the synthesis of hyaluronic acid and proteoglycans, and inhibits the formation of superoxide radicals and enzymes that damage cartilage tissue (collagenase and phospholipase).

When applied topically, Camphor irritates the sensitive nerve endings of the skin and subcutaneous tissues, dilates superficial vessels, causes a sensation of warmth, improves the blood supply to the skin and subcutaneous tissues, and has a moderate antiseptic effect.

When applied topically, Peppermint oil has a moderate antiseptic, anti-inflammatory, anesthetic, and distracting effect.

Indications

Apply for the symptomatic treatment of degenerative and dystrophic diseases affecting the joints and the vertebral column.

• Use for conditions such as osteoarthritis and spinal osteochondrosis to help manage pain and improve joint mobility.
• Employ as part of a comprehensive management plan to address the underlying cartilage degradation and associated inflammation.

ICD codes

Dosage Regimen

Apply a measured amount of cream to the affected area with a frequency of two to three times per day for optimal therapeutic effect.

Use a strip of cream approximately 2 to 3 centimeters in length for each application. Rub the preparation gently onto the skin over the painful joint or spinal area until it is fully absorbed. Ensure consistent application to maintain the desired local concentration of active ingredients.

Cream

A 2-3 cm strip of cream is applied to the skin over the affected area 2-3 times/day and rubbed in until completely absorbed.

Adverse Reactions

Monitor the application site for any signs of localized skin reactions following treatment. The most frequently reported adverse effects are dermatological in nature.

Allergic reactions, including skin rash, pruritus, erythema, or urticaria, are possible. Discontinue use immediately if any of these symptoms occur and seek medical advice if the reaction is severe or persistent.

Contraindications

Do not apply under any circumstances if there is a known history of hypersensitivity to any constituent of the formulation.

• Avoid use on skin that is broken, abraded, infected, or shows any signs of damage, including eczema or dermatitis.
• Do not use on areas with compromised skin integrity, as this increases the risk of systemic absorption and local irritation.

Drug Interactions

Be aware of potential interactions when applying this topical agent concurrently with other medicinal products. No specific pharmacokinetic drug interactions have been formally established.

Exercise caution when using other topical preparations (e.g., creams, ointments, gels) on the same area of skin, as this may alter the absorption of either product or cause local skin reactions. Maintain a time interval between applications of different topical agents if concurrent use is necessary.

Overdose

Manage topical overdose by immediately removing any excess cream from the skin using a gentle cleanser. Systemic overdose via topical application is unlikely due to low absorption; however, excessive application may lead to intensified local adverse effects.

Treat symptoms supportively. In case of accidental ingestion, which may cause gastrointestinal irritation, seek medical attention. Provide symptomatic care as there is no specific antidote.

Use in Pregnancy and Lactation

There are no clinical data on the efficacy and safety of use during pregnancy and breastfeeding.

Pediatric Use

Use with caution in children.

Special Precautions

The product should not be applied to damaged areas of the skin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.