Mataren^® Plus (Cream) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

M02AX (Other drugs for topical application for joint and muscle pain)

Active Substances

Meloxicam (Rec.INN registered by WHO)

Capsicum (Rec.INN registered by WHO)

Dosage Form

Mataren® Plus

Cream for external use 30 mg+100 mg/1 g: 10 g, 15 g, 20 g, 30 g, 40 g, 50 g or 100 g tubes

Dosage Form, Packaging, and Composition

Cream for external use from light yellow to dark yellow in color; a reddish-brown tint is allowed.

Excipients: dimethyl sulfoxide, coriander oil, lavender oil, liquid paraffin, propylene glycol, stearic acid 50, distilled monoglycerides (Dimodan HP), emulsifying wax, glycerol, poloxamer (Emuxol-268), carbomer, sodium hydroxide, imidurea, water.

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
10 g – polyethylene tubes (1) – cardboard packs.
15 g – polyethylene tubes (1) – cardboard packs.
20 g – polyethylene tubes (1) – cardboard packs.
30 g – polyethylene tubes (1) – cardboard packs.
40 g – polyethylene tubes (1) – cardboard packs.
50 g – polyethylene tubes (1) – cardboard packs.
100 g – polyethylene tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory, analgesic, and locally irritant action

Pharmacotherapeutic Group

NSAID

Pharmacological Action

Mataren^® Plus has anti-inflammatory, analgesic, and anti-edema effects, and may cause mild local skin hyperemia without having a pronounced irritating effect on the skin.

Mataren^® Plus reduces joint pain (including in the spine) and muscle pain at rest and during movement, and helps to increase the range of motion of the joints (in the area of cream application). It reduces morning stiffness and joint swelling.

Meloxicam selectively inhibits cyclooxygenase 2, disrupts arachidonic acid metabolism, and reduces the amount of prostaglandins (mediators of pain and inflammation) at the site of inflammation.

The Capsicum tincture contains capsaicin, which has an irritating effect on the sensitive receptors of the skin, leading to a local analgesic effect, improved blood circulation in the skin and subcutaneous tissue, and a warming effect. The improvement in local blood flow is accompanied by enhanced circulation in the underlying tissues, which helps remove the substrate of inflammation from the pathological focus.

When acting together, the active components of Mataren^® Plus cream have a greater effect due to synergy, compared to the individual effect of each of these components.

Due to the optimal combination of the cream components, a mutual enhancement of their analgesic and anti-inflammatory effects is noted.

Indications

• Inflammatory and degenerative diseases of the musculoskeletal system;
• Rheumatic soft tissue lesions;
• Pain syndrome: bursitis, tendinitis, lumbago, sciatica, neuralgia, myalgia, arthralgia, radiculitis, post-traumatic pain syndrome (traumatic contusions, dislocations, sprains of ligaments, muscles and tendons, muscle tears without violating the integrity of the skin), muscle and joint soreness caused by heavy physical exertion.

ICD codes

Dosage Regimen

Apply the cream externally only. Use a strip of cream measuring 1 to 5 cm in length. Gently rub the cream into the affected area until fully absorbed.

Apply the cream 1 to 3 times per day. The exact frequency depends on the severity of symptoms and individual patient response.

Adjust the amount of cream and application frequency based on the size of the application area. For larger areas, use a longer strip of cream.

To enhance the therapeutic effect, apply a dry warming bandage over the area after application.

Do not apply the cream to damaged skin, open wounds, or mucous membranes. Avoid contact with eyes.

If the cream accidentally gets into eyes or on mucous membranes, remove it immediately with a cotton swab soaked in vegetable oil or petroleum jelly.

Wash hands thoroughly with soap and water after each application.

The duration of continuous use should not exceed 10 days without consulting a physician.

Discontinue use and seek medical advice if skin irritation, severe redness, itching, or a rash occurs.

Adverse Reactions

Occurring side effects depend on individual sensitivity.

Allergic reactions from the skin (itching, skin rash), skin peeling, hyperemia are possible.

If any side effects occur, the patient should stop using the cream and consult a doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Children under 12 years of age;
• Violation of the integrity of the skin and inflammatory skin diseases at the site of the intended application of the drug;

With caution

In case of impaired renal and liver function, severe gastrointestinal pathology (peptic ulcer of the stomach and duodenum in the acute phase), severe pathology of the blood system, in children aged 12 to 18 years.

The patient should consult a doctor before concomitant use of Mataren^® Plus cream with other NSAIDs, as well as if it is necessary to use the drug for more than 10 days.

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

The drug should be prescribed with caution in case of impaired liver function.

Use in Renal Impairment

The drug should be prescribed with caution in case of impaired renal function.

Pediatric Use

Contraindicated in children under 12 years of age.

The drug should be prescribed with caution in adolescents aged 12 to 18 years.

Special Precautions

Avoid getting the drug on damaged skin surfaces, in the eyes, and on mucous membranes. If Mataren^® Plus cream gets on these areas, it should be removed with a cotton swab soaked in petroleum jelly or vegetable oil.

After using the drug, wash your hands thoroughly.

Effect on ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to drive vehicles and mechanisms.

Overdose

Cases of overdose with Mataren^® Plus are unknown.

Drug Interactions

There are currently no data on the interaction of Mataren^® Plus with other medicinal products.

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 dispensed 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.