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Rumalaya (Tablets) Instructions for Use

Marketing Authorization Holder

Himalaya Wellness Company (India)

ATC Code

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

Dosage Form

Bottle Rx Icon Rumalaya Tablets: 60 pcs.

Dosage Form, Packaging, and Composition

Tablets uncoated, greenish-brown in color with inclusions of lighter and darker shades, round, biconvex.

1 tab.
Powders
   Mahayogaraj guggulu 324 mg
   Mumiyo 32 mg
   Swarna Makshika Bhasma 10 mg
   Shankha bhasma 130 mg
   Abelmoschus moschatus seeds 20 mg
Aqueous liquid extract from a mixture of herbal raw materials
   Maharasnadi kwath 130 mg
   Leaves and seeds of Moringa oleifera 32 mg
   Indian madder roots 38 mg
   Tinospora cordifolia stems 20 mg
   Tribulus terrestris fruits 32 mg
Steam-processed extracts from: Vitex negundo leaves, Tinospora cordifolia stems, Ocimum sanctum whole plant, Eclipta alba whole plant, Withania somnifera roots, Zingiber officinale rhizome, Dashamula mixture of roots.

Excipients: magnesium stearate 3 mg, microcrystalline cellulose 65.5 mg, sodium carboxymethylcellulose 19.5 mg, colloidal silicon dioxide 3 mg, crospovidone 31 mg.

60 pcs. – plastic bottles (1) made of high-density polyethylene – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with anti-inflammatory action

Pharmacotherapeutic Group

Anti-inflammatory agent

Pharmacological Action

A herbal medicinal product. Rumalaya tablets exert anti-inflammatory, anti-edema, and microcirculation-improving effects.

The use of Rumalaya promotes a reduction in swelling, alleviation of pain, relief of muscle spasm, and an increase in the range of motion in the joints. The sum of bioflavonoids contributes to the improvement of microcirculation and normalization of metabolic processes in the joints and muscles.

Pharmacokinetics

Pharmacokinetic data for the multi-component herbal preparation Rumalaya in the tablet dosage form are not available. The activity of the drug is due to the mutually enhancing combined action of its components, which is characteristic of herbal medicinal products. Since the activity of the drug cannot be fully attributed to any single compound, pharmacokinetic studies of multi-component herbal preparations, including Rumalaya tablets, are not feasible.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system

  • Rheumatoid arthritis;
  • Osteoarthritis.

ICD codes

ICD-10 code Indication
M05 Seropositive rheumatoid arthritis
M15 Polyosteoarthritis
ICD-11 code Indication
FA05 Polyosteoarthritis
FA20.0 Seropositive rheumatoid arthritis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally.

The standard dosage for adults is 2 tablets three times daily.

Take tablets after meals to minimize potential gastrointestinal discomfort.

Continue this regimen for the full prescribed course, typically lasting 4 weeks.

If dyspeptic symptoms such as nausea or bitter taste occur, reduce the dose to 1 tablet three times daily.

Do not discontinue therapy prematurely without consulting a physician.

Subsequent treatment courses may be initiated only upon a doctor’s recommendation.

Do not exceed the recommended daily dose.

Adverse Reactions

Allergic reactions (skin itching, urticaria) are possible. Dyspeptic phenomena (nausea, diarrhea, bitter taste in the mouth), transient increase in the activity of “liver” transaminases 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

  • Hypersensitivity to individual components of the drug;
  • Children under 18 years of age.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

No reports of a “withdrawal” syndrome upon discontinuation of Rumalaya in the tablet dosage form have been received. No special measures are required if one or several doses of the drug are missed. If the patient misses one or more doses of the medication, they should continue taking the drug according to the regimen recommended in the instructions, without doubling the dose.

No special precautions for the disposal of unused medicinal product are required.

Effect on the ability to drive vehicles, machinery.

There are no data on the effect of the drug on 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 drug have been reported. Treatment in case of overdose: symptomatic.

Drug Interactions

Rumalaya tablets are compatible with other non-steroidal anti-inflammatory drugs. Combined use with Rumalaya cream in the dosage form of cream for external use promotes enhancement of the therapeutic effect.

Storage Conditions

Store the drug out of the reach of children, in a dry place at a temperature from 10°C (50°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.

Medical Disclaimer

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