Septilin Plus Septilin Plus

INSTRUCTION FOR MEDICAL USE OF SEPTILIN® PLUS

REGISTRATION NUMBER:

ЛП-001295

COMMERCIAL NAME

SEPTILIN® PLUS

International non-proprietary or generic name

PHARMACEUTICAL DOSAGE FORM

Tablets

PREPARATION FORMULA

Each tablet contains:

Active ingredients:  
Powders:  
Commiphora mukul (mixture of oil, gum and resin) 324,0 mg
Shankha bhasma (ash) 64,0 mg
Dry extract from the collection of plant materials*: 368,0 mg
Maharasnadi kwath** (multicomponent herbal mixture) 35 %;
tinospora cordifolia culms 27 %;
indian madder roots 17 %;
Emblica officinalis fruits   9 %;
Moringa Pterygosperma leaves   9 %;
Spanish licorice roots   3 %.
EXCIPIENTS:

microcrystalline cellulose 57.0 mg; crospovidone 43.0 mg; carmellose sodium 11.0 mg; colloidal silicon dioxide 5.0 mg; magnesium stearate 3.0 mg.

NOTES:

* The water is used as an extractant for the extract preparation from the collection of plant materials. Ratio (collection:dry extract - 5:1)

** The composition of the multicomponent herbal mixture Maharasnadi kwath includes: Terminalia chebula Retz. (Combretaceae); Terminalia bellerica L. (Combretaceae); Emblica officinalis Gaertn. (Euphorbiaceae); Fagonia cretica L. (Zygophyllaceae); Sida cordifolia L. (Malvaceae); Ricinus communis L. (Euphorbiaceae); Cedrus deodara (Roxb.ex Lamb.) G.Don (Pinaceae); Hedychium spicatum Ham.ex.Sm. (Zingiberaceae); Adhatoda vasica Nees. (Acanthaceae); Zingiber officinale Roscoe (Zingiberaceae); Piper chaba L. (Piperaceae); Cyperus rotundus L. (Cyperaceae); Boerhaavia diffusa L. (Nyctaginaceae); Tinospora cordifolia Miers. (Menispermaceae); Ipomoea digitata L. (Convolvulaceae); Anethum sowa Roxb. ex Flem. (Apiaceae); Tribulus terrestris L. (Zygophyllaceae); Withania somnifera L. Dunal. (Solanaceae); Cassia fistula L. (Fabaceae); Asparagus racemosus Willd. (Liliaceae); Piper longum L. (Piperaceae); Barleria prionitis L. (Acanthaceae); Coriandrum sativum L. (Apiaceae); Solanum xanthocarpum Schrad.et Wendl. (Solanaceae); Solanum indicum L. (Solanaceae).

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

Tinospora cordifolia Miers. (Menispermaceae); Rubia cordifolia L. (Menyanthaceae); Emblica officinalis Gaertn. (Euphorbiaceae); Moringa pterygosperma Gaertn. (Moringaceae), Glycyrrhiza glabra L. (Fabaceae).

DESCRIPTION

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

PHARMACOTHERAPEUTIC GROUP

Agent of plant origin.

PHARMACODYNAMICS

SEPTILIN® PLUS has an anti-inflammatory effect. The active herbal substances (bioflavonoids and tannins) included in the agent help to reduce the inflammatory process manifestations, reduce capillary permeability, and exhibit an antiexudative action. The presence of polysaccharides in the agent promotes the stimulation of phagocytosis by increasing the phagocytic activity of granulocytes and macrophages, as well as by accelerating the chemotaxis of polymorphonuclear leukocytes in the infection focus. SEPTILIN® PLUS agent enhances the humoral immune response, promotes an increase in the nonspecific body resistance. The agent intake contributes to the relief of clinical signs of acute inflammation of the upper respiratory tract. The agent has an anti-inflammatory effect simultaneously on the mucous membrane of the nasopharynx, pharynx and palatine tonsils.

PHARMACOKINETICS

The data on the pharmacokinetics of the multicomponent agent of plant origin SEPTILIN® PLUS in the tablet pharmaceutical form are absent. 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 Cyston® tablets, are unrealizable.

RECOMMENDED INDICATIONS

Rhinosinusitis (acute, chronic exacerbation).

Exacerbation of chronic tonsillopharyngitis.

CONTRAINDICATIONS

Hypersensitivity to the separate agent components. Age under 18.
Use with caution in patients with diseases of the gastrointestinal tract.

INTAKE DURING PREGNANCY AND LACTATION

The agent intake during pregnancy and lactation period is contraindicated. If it is necessary to use the agent during lactation, the latter should be discontinued.

DOSAGE AND INTAKE METHODS

Peroral. 2 tablets BID for 10-14 days. In case of incomplete supression of disease symptoms, the treatment can be continued up to 4 weeks at a dose of 1 tablet BID or at the doctor's discretion.
In case of adverse events from the gastrointestinal tract the agent dose can be reduced to 1 tablet BID. If the dose reduction does not result in the symptom reduce, it is recommended to discontinue the agent.

SIDE EFFECTS

The allergic reactions, a feeling of dry mouth, dyspeptic symptoms (nausea, diarrhea, flatulence), abdominal pain, a transient increase in the activity of "hepatic" transaminases are possible.
If you experience the side effects that are not described in this instruction, please, inform your doctor.

OVERDOSE

The information about the overdoses are absent. The treatment in case of overdose is symptomatic.

Interaction with other medicinal products
The agent intake does not exclude the co-administration possibility of other medicines, including antibacterial ones.

SPECIAL WARNINGS

By the discontinuation of SEPTILIN® PLUS 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.

Effects on ability to drive and use machines.
The agent use does not affect the ability to perform potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions (driving, works with moving mechanisms, the dispatcher/operator work).

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 15°C to 25°C.
Keep out of the reach of children.

EXPIRATION DATE

3 years. Please do not use after the expiration date.

DISPENSING RULES

By 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.

ЕАЭС Экологическая марка Употребимо в пищу

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