Tizol^® (Gel) Instructions for Use

Marketing Authorization Holder

Olimp, LLC (Russia)

Manufactured By

Olimp, LLC (Russia)

Labeled By

OLIMP, LLC (Russia)

Or

ZELENAYA DUBRAVA, CJSC (Russia)

Quality Control Release

OLIMP, LLC (Russia)

ATC Code

M02AX10 (Other drugs)

Dosage Form

Tizol®

Gel for topical and external use: tubes 10 g or 30 g

Dosage Form, Packaging, and Composition

Gel for topical and external use in the form of a thick, opaque, non-flowing mass of white color with a grayish tint, with a weak specific odor.

10 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory, antimicrobial, and tissue regeneration-improving action

Pharmacotherapeutic Group

Topical anti-inflammatory agent

Pharmacological Action

Tizol^® – titanium glycerosolvate aquacomplex, is a metal-complex compound.

As a metal-complex compound, Tizol^® is sterile and possesses anti-inflammatory and antimicrobial action.

Tizol^® accelerates reparative processes in the skin and reduces inflammatory phenomena (erythema, swelling, infiltration), promotes the disappearance of itching.

The presence of bound glycerol molecules and a titanium atom in the Tizol molecule provides protective and dehydrating, anti-edematous, local analgesic action.

In the Tizol molecule, the titanium atom, chemically bound to glycerol, is the complex-forming center for the fragments constituting the drug molecule: glycerol and water.

This interaction determines the gel structure of Tizol, ensuring its conductivity through biological tissues and its pharmacological properties.

Tizol^® promotes the conduction of medicinal substances through the skin and mucous membranes.

Pharmacokinetics

When applied externally, Tizol^® is rapidly absorbed, distributing in the skin, subcutaneous tissue, and underlying tissues.

It is not metabolized.

It is excreted unchanged by the kidneys 42%, through the intestine 48%, by sweat glands 6.2%, through the mucous membranes of the respiratory tract 3.8%.

The elimination rate of the drug is 20-24 hours.

It does not accumulate in the body.

Indications

• Bursitis, arthritis, tendinitis, tenosynovitis;
• Psoriasis, neurodermatitis, seborrheic eczema, dermatitis, scleroderma, lichen planus;
• As a local radioprotector during radiotherapy;
• As a conductor of medicinal substances.

ICD codes

Dosage Regimen

Topically and externally.

Apply a thin layer to the affected areas of the skin and mucous membranes 1-3 times a day.

The course of treatment is individual, depends on the severity of the disease, localization, and acuity of the process.

The effect of the drug application occurs within the first week of treatment.

Repeated courses of treatment and long-term use for 2-3 months are possible.

When using the drug as a local radioprotective agent for protection against radiation injuries, Tizol^® is applied in a thin layer to the irradiation area before the session and 12 hours after it.

After application, contact with clothing must be avoided, and occlusive dressings should not be used.

In the presence of a local radiation reaction, the drug is used until it disappears.

Adverse Reactions

Rarely, in the first minutes after application to the skin or mucous membranes, tingling, pinching, a feeling of tightness are possible, which disappear on their own and do not require discontinuation of the drug.

In case of individual sensitivity, local allergic reactions are possible.

In this case, the use of Tizol is discontinued.

Contraindications

• Increased sensitivity to Tizol;
• Acute inflammatory diseases of the skin and mucous membranes;
• Purulent wounds with pronounced exudation phenomena.

Use in Pregnancy and Lactation

Insufficient data on the use of the drug during pregnancy and lactation.

Special Precautions

Tizol^®, being a gel complex-forming system, is compatible with many medicinal substances of various chemical compositions and structures and can be used as a base for the preparation of soft dosage forms.

Overdose

Not registered.

Drug Interactions

Not registered.

Storage Conditions

In a place protected from light, at a temperature from 5 to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.