Rumalaya tablets Rumalaya tablets

INSTRUCTION
FOR MEDICAL USE
Rumalaya

REGISTRATION NUMBER:

ЛП-001182

COMMERCIAL NAME

Rumalaya

PHARMACEUTICAL DOSAGE FORM

Tablets

PREPARATION FORMULA

Each tablet contains
Active ingredients:

Powders:  
Mahayograj guggul 324,0 mg
Silajit 32,0 mg
Swarna Makshik Bhasma 10,0 mg
Sankha Bhasma 130,0 mg
Hibiscus abelmoschus seeds 20,0 mg
Liquid aqueous extract from a mixture of plant raw materials:  
Maharasnadi Kwath 130,0 mg
Moringa pterygosperma leaves and seeds 32,0 mg
Indian madder roots 38,0 mg
Tinospora cordifolia culms 20,0 mg
Tribulus terrestris fruits 32,0 mg

Over-steamed extract from: Vitex negundo leaves, Tinospora cordifolia culms, Ocimum Sanctum intact plant, Eclipta alba intact plant, Withania Somnifera roots, Zingiber officinale rootstock, Dashamool root mixture.

Names of producing plants (as part of active ingredients) in Latin:

Hibiscus abelmoschus L., сем. Malvaceae, Moringa pterygosperma Lam., сем. Moringaceae, Rubia cordifolia L.s.l., сем. Rubiaceae, Tinospora cordifolia L, сем. Menispermaceae, Tribulus terrestris L., сем. Zygophyllaceae, Vitex negundo L., сем.Verbenaceae, Ocimum sanctum L., сем. Lamiaceae, Eclipta alba Hassk., сем. Asteraceae, Withania somnifera L., сем. Solanaceae, Zingiber officinale Roscoe, сем. Zingiberaceae.

Excipients: magnesium stearate 3.0 mg, microcrystalline cellulose 65.5 mg, sodium carmellose 19.5 mg, colloidal silicon dioxide 3.0 mg, crospovidone 31.0 mg.

DESCRIPTION:

Round biconvex uncoated tablets of greenish brown color interspersed with lighter and darker color spots.

PHARMACOTHERAPEUTIC GROUP:

Anti-inflammatory agent.

ATC Code:

М09АХ.

PHARMACODYNAMICS:

The medicinal product of plant origin Rumalaya tablets has an anti-inflammatory, anti-edematous, microcirculation-improving effect. The intake of Rumalaya helps to reduce swelling, relieve pain, relieve muscle spasm, and increase the range of joint motions. The combination of bioflavonoids improves microcirculation and normalizes metabolic processes in joints and muscles.

PHARMACOKINETICS:

There are no data on the pharmacokinetics of the multicomponent agent of plant origin Rumalaya in the tablet pharmaceutical form. The agent activity is stipulated by the mutually reinforcing combined action of its components, which is typical for the plant medicines. As far as it is impossible to designate the agent activity to any single compound in full, the pharmacokinetic studies of multicomponent agents of plant origin, including Rumalaya tablets, are unrealizable.

RECOMMENDED INDICATIONS

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, osteoarthritis.

CONTRAINDICATIONS

Hypersensitivity to the separate agent components.

Children under the age of 18.

The intake during the pregnancy and lactation period.

The agent intake during pregnancy and lactation period is contraindicated.

DOSAGE AND INTAKE METHODS

Peroral. 2 tablets TID after meals for 4 weeks. In case of dyspeptic symptoms, the agent dose can be reduced to 1 tablet TID.

The repeated therapy courses are possible on the doctor's recommendation.

SIDE EFFECTS

The allergic reactions (pruritus, urticaria) are possible. The dyspeptic symptoms (nausea, diarrhea, a feeling of bitterness in the mouth), a transient increase in the activity of "hepatic" transaminases are possible.

If any of the listed in the instructions side effects are aggravated, or you notice any other unlisted in the instructions side effects, please inform your doctor.

OVERDOSE

There have been no reports of overdose cases during the agent intake till the present moment. The treatment in case of overdose is symptomatic.

Interaction with other medicinal products
Rumalaya agent is compatible with other non-steroidal anti-inflammatory medicines.

SPECIAL WARNINGS

By the discontinuation of Rumalaya tablets the withdrawal effect was not observed. The special measures are not required when one or more doses are missed. In case the patient misses one or more doses, the agent should be continued according to the prescribed in the instruction regimen without doubling the dose.
No special precautions are required when disposing of unused medicine.
To enhance the therapeutic effect, it is possible to use with Rumalaya cream in the form of a cream for external use simultaneously.

Effects on ability to drive and use machines.
There are no data on the agent effect on the ability to drive vehicles and works in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

PHARMACEUTICAL FORM

Tablets. 60 tablets in a high density polyethylene plastic vial with a screw cap. The vial neck is additionally tightened with aluminum foil applied by the company's trademark. Each vial with instructions for use is placed in a cardboard box.

RECOMMENDATIONS FOR STORAGE

In a dry place at a temperature of 10°C to 30°C.
Keep out of the reach of children.

EXPIRATION DATE

3 years.
Do not use after the expiration date.

DISPENSING RULES

Available with a prescription.

Name and address of the manufacturing site of the medicinу manufacturer:
Himalaya Drug Co., Makali, Bengaluru 562 162, India.

Name, address of the organization authorized by the holder or owner of the product registration certificate for medical use to accept claims from the consumer/exclusive distributor:
ZAO TRANSATLANTIC INTERNATIONAL, Russia.
119590, Moscow, 1 Olof Palme st.
Tel. (495) 775-39-38; Fax: (495) 514-10-54/67.

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