Rumalaya cream (Cream) Instructions for Use

Marketing Authorization Holder

Himalaya Drug, Co. (India)

ATC Code

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

Dosage Form

Rumalaya cream

Cream for external use: tube 30 g

Dosage Form, Packaging, and Composition

Cream for external use from white with a creamy tint to light yellow in color with a camphor odor.

* treated with a liquid aqueous extract obtained from a mixture of plant materials: Nardostachys jatamansi rhizomes, Picrorhiza kurrooa roots, Celastrus paniculatus fruits, Vitex negundo leaves, Ocimum sanctum leaves, Acorus calamus rhizomes, Hyoscyamus niger seeds, Anacyclus pyrethrum roots, Calotropis gigantea root bark, Datura metel leaves, Vanda roxburghii aerial roots, Piper nigrum fruits, Cedrus deodara wood, Berberis aristata roots, Ricinus communis seeds, Rubia cordifolia roots, Plumbago zeylanica roots, Nerium oleander roots, Dashamula mixture of roots, and Shorea robusta resin (ratio of plant material : extract – 1 : 5).

Excipients: methylparahydroxybenzoate – 0.075 g, propylparahydroxybenzoate – 0.015 g, cetomacrogol 1000 – 0.9 g, cetearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 3.6 g, sodium alginate – 0.6 g, lemongrass oil – 0.75 g, purified water – 10.71 g.

30 g – laminated tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with anti-inflammatory action

Pharmacotherapeutic Group

Herbal anti-inflammatory agent

Pharmacological Action

Herbal medicinal product. Rumalaya cream in the dosage form of a cream has anti-inflammatory, decongestant, counterirritant, and microcirculation-improving effects.

The use of Rumalaya cream helps to reduce swelling, alleviate pain, relieve muscle spasm, and increase the range of motion in the joints.

The sum of terpenoids in the composition of the preparation helps to improve microcirculation and normalize metabolic processes in the joints and muscles.

Pharmacokinetics

Data on the pharmacokinetics of the multicomponent herbal preparation Rumalaya cream in the dosage form of a cream are not available.

The activity of the preparation is due to the mutually reinforcing combined action of its components, which is characteristic of herbal medicinal products.

Since the activity of the preparation cannot be fully attributed to any single compound, pharmacokinetic studies of multicomponent herbal preparations, including Rumalaya cream, are not feasible.

Indications

• Osteoarthritis;
• Rheumatoid arthritis.

ICD codes

Dosage Regimen

Apply the cream externally only to intact skin.

Administer a 1-2 cm long strip of cream to the skin overlying the affected joint.

Rub the cream into the skin using intensive massage movements until fully absorbed.

Apply the cream twice daily, typically in the morning and evening.

Maintain a daily application schedule for the full treatment course of 4 weeks.

Keep the treated areas warm following application to enhance therapeutic effect.

Thoroughly wash hands with soap and water after each application.

Initiate a repeated course of treatment only upon the recommendation of a physician.

Discontinue use and consult a doctor if skin irritation, redness, or allergic reactions occur.

Avoid contact with eyes, mucous membranes, and open wounds; if contact occurs, rinse immediately with copious water.

Adverse Reactions

Allergic reactions are possible.

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, inform your doctor.

Contraindications

• Diseases and damage to the skin at the site of the intended application of the preparation;
• Children under 18 years of age;
• Hypersensitivity to individual components of the preparation.

Use in Pregnancy and Lactation

The preparation is contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

For external use only.

If allergic reactions occur, the use of the preparation should be discontinued.

If the cream gets into the eyes, rinse them with water.

Effect on the ability to drive vehicles and mechanisms

The preparation does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

To date, no cases of overdose with the use of the preparation have been reported.

Drug Interactions

The preparation Rumalaya cream is compatible with other NSAIDs.

Rumalaya in the tablet dosage form helps to enhance the therapeutic effect.

Storage Conditions

In a dry place at a temperature from 10°C (50°F) to 30°C (86°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Do not use after the expiration date.

Dispensing Status

The preparation is dispensed by 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.