Theraflex^® Chondrocream Forte (Cream) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Nizhpharm JSC (Russia)

Contact Information

BAYER AG (Germany)

ATC Code

M02AX10 (Other drugs)

Active Substances

Meloxicam (Rec.INN registered by WHO)

Chondroitin sulfate sodium (Ph.Eur. European Pharmacopoeia)

Dosage Form

Theraflex® Chondrocream Forte

Cream for external use 10 mg+50 mg/1 g: tubes 50 g or 100 g

Dosage Form, Packaging, and Composition

Cream for external use from light yellow with a greenish tint to yellow with a greenish tint, homogeneous, with the smell of dimethyl sulfoxide.

Excipients : dimethyl sulfoxide – 100 mg, propylene glycol – 100 mg, macrogol cetostearyl ether – 12 mg, cetostearyl alcohol [cetyl alcohol not more than 60%, stearyl alcohol not less than 40%] – 42 mg, liquid paraffin – 100 mg, petrolatum – 80 mg, imidurea – 3 mg, sodium disulfite – 0.5 mg, purified water – up to 1 g.

50 g – aluminum tubes (1) – cardboard boxes.
100 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Tissue repair stimulant in combination with NSAIDs

Pharmacotherapeutic Group

Tissue regeneration stimulant + NSAID

Pharmacological Action

Theraflex^® Chondrocream Forte has a combined action: it slows down the progression of osteoarthritis and osteochondrosis, has an analgesic effect, helps to increase the range of motion of the joints (in the area of cream application), has an anti-inflammatory effect, and reduces joint swelling. Due to the optimal combination of the cream components, a mutual enhancement of their analgesic and anti-inflammatory effects is noted.

Chondroitin sulfate is a high molecular weight mucopolysaccharide, which is a natural component of cartilage tissue. Chondroitin sulfate improves phosphorus-calcium metabolism in cartilage tissue, inhibits enzymes that cause cartilage tissue damage, slows down the processes of cartilage tissue degeneration (destruction), stimulates the synthesis of glycosaminoglycans, promotes the regeneration (restoration) of joint cartilage surfaces, accelerates their repair processes, and prevents the collapse of connective tissue. This leads to a reduction in pain and an increase in mobility of the affected joints.

Meloxicam is an NSAID with anti-inflammatory and analgesic action. Meloxicam selectively inhibits COX-2, disrupts arachidonic acid metabolism, and reduces the amount of prostaglandins (mediators of pain and inflammation) at the site of inflammation. Meloxicam is a chondroneutral drug, does not have a negative effect on cartilage tissue, and does not affect the synthesis of proteoglycan by chondrocytes of articular cartilage.

Indications

The drug is recommended for use as part of the complex therapy of degenerative-dystrophic diseases of the musculoskeletal system

• Osteoarthritis, spinal osteochondrosis;
• Other joint diseases accompanied by pain syndrome.

ICD codes

Dosage Regimen

Apply the cream externally to intact skin only.

Gently rub a 1 to 5 cm long strip of cream onto the affected area.

Apply the cream 2 to 3 times per day.

Adjust the amount used based on the size of the painful area.

Thoroughly wash your hands after each application.

Treatment duration depends on the indication and clinical response.

Consult a physician after two weeks of use to assess the need for continued therapy.

Discontinue use and seek medical advice if skin irritation or allergic reactions occur.

Avoid contact with eyes, mucous membranes, and open wounds.

Adverse Reactions

Possible allergic skin reactions (itching, redness, skin rash).

If any side effects occur, it is necessary to stop using the cream and consult a doctor.

Contraindications

• Hypersensitivity to the components of the drug (as well as to other NSAIDs);
• Violation of the integrity of the skin in the intended areas of application;
• Children under 12 years of age.

With caution : in case of impaired renal and liver function; in case of severe gastrointestinal pathology (peptic ulcer in the acute phase); in case of severe pathology of the blood system; elderly age.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in case of impaired liver function.

Use in Renal Impairment

Use with caution in case of impaired renal function.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

Use with caution in the elderly.

Special Precautions

The drug should be applied only to intact skin, avoiding contact with open wounds. Avoid getting the drug into the eyes and mucous membranes.

You should consult a doctor before using Theraflex^® Chondrocream Forte concomitantly with other NSAIDs, as well as if it is necessary to use the drug for more than 2 weeks.

Effect on the ability to drive vehicles and machinery

The drug does not cause a sedative effect, psychomotor impairments and does not affect the patient’s ability to engage in potentially hazardous activities requiring increased attention and speed of mental and motor reactions.

Overdose

Extremely low systemic absorption of the active components of the drug with external use makes overdose practically impossible.

Drug Interactions

Cases of interaction or incompatibility with other drugs have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is available without a prescription.

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.