Tazalok™

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TAZALOKTM

Composition:

Active substances:

10 ml of the preparation contains an extract of a mixture of medicinal plant raw materials (1:10): roots of Filipendula vulgaris Moench – 0.28 g, fresh roots of curly parsley (Petroselini radix) – 0.225 g, fresh roots of celery (Apiumi radix) – 0.17 g, herb of Galium verum (Galii herba) – 0.135 g, herb of common toadflax (Linariae herba) – 0.11 g, marigold flowers (Flores Calendulae) – 0.08 g (extraction agent – 40% ethanol).

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: clear liquid, light brown to brown in color, with a characteristic odor.

Sediment formation may occur during storage.

Pharmacotherapeutic group. Agents used in gynecology. ATC code G02CX.

Pharmacological properties.

Pharmacodynamics.

A herbal non-hormonal medication with complex action due to synergistic effects of components contained in the drug, which exhibit hormone-regulating, anti-proliferative, anti-inflammatory, sedative, and general strengthening properties. The flavonoids, biologically active substances of the Tazalok™ preparation, are structurally similar to endogenous estrogens, but do not demonstrate estrogen-like activity. They are capable of competitively binding to estrogen (androgen) receptors in the presence of excess estrogens (androgens) or their receptors in target organs, and modulate the activity of enzymes of the aromatase system, thereby inhibiting the conversion of androgens into estrogens. Thus, Tazalok™ exhibits selective anti-estrogenic activity, promotes rhythmic production and normalization of the ratio of gonadotropic hormones, reduces prolactin levels, and increases progesterone levels. It eliminates the imbalance between estradiol and progesterone and normalizes the second phase of the menstrual cycle. The drug exerts a pronounced effect on glandular tissue and stromal elements of the mammary glands, ovaries, and uterus, demonstrating anti-proliferative and anti-inflammatory properties, and prevents the development of dysplastic processes in these tissues. In polycystic ovarian disease, it promotes softening of the cyst capsule, reduces its tension due to resorptive action, and enhances the function of the unaffected part of the ovary. It facilitates active resorption of cyst contents, dissolution of painless solid nodules in mammary glands, and reduces mammary gland sensitivity to phases of the menstrual cycle. It exhibits spasmolytic, analgesic, and calming effects. Biologically active molecules of Tazalok™ are capable of inducing and enhancing apoptosis, blocking the action of growth factors, and inhibiting angiogenesis.

Pharmacokinetics.

Data on pharmacokinetics are not available.

Clinical characteristics.

Indications.

Menstrual cycle disorders; premenstrual syndrome; algodysmenorrhea; dysmenorrhea; fibrocystic mastopathy; ovarian retention cysts. Used as part of combination therapy in endometrial hyperplasia, uterine fibroids, endometriosis; polycystic ovary syndrome.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interactions.

If it is necessary to take any other medicinal products, inform your doctor.

Instructions for use.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

Has no effect.

Method of Administration and Dosage.

Dilute 30–40 drops of the preparation in ½ cup of boiled room-temperature water. Take 30 minutes before meals, 3 times daily. Tazalok™ should be taken continuously for at least 3 months without interruption during menstruation. The daily dose may be divided into 2 doses. If symptoms recur after discontinuation, treatment should be continued following consultation with a physician.

Children.

The preparation should not be used in children, as the efficacy and safety of the drug have not been established.

Overdose.

Cases of overdose are unlikely. However, adverse effects on the cardiovascular system may occur. Treatment: gastric lavage, activated charcoal, symptomatic therapy.

Side effects.

Allergic reactions, including skin rashes, hyperemia, itching, skin swelling, and infiltrated hyperemic patches, may occasionally occur affecting the skin.

If any adverse reactions occur, discontinue use of the product immediately and consult a physician without delay.

Shelf life.

2.5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

50 ml in a bottle. One bottle per cardboard box.

100 ml in a bottle. One bottle per cardboard box. Two or three bottles per cardboard box with a partition insert.

Classification.

Over-the-counter (without prescription).

Manufacturer.

Dr. Gustav Klein GmbH & Co. KG.

Dr. Gustav Klein GmbH & Cо. KG.

Manufacturer's address and place of business.

Steinenfeld 3, 77736 Zell am Harmersbach, Germany.

Steinenfeld 3, 77736, Zell am Harmersbach, Germany.

Marketing Authorization Holder.

LLC "UNIVERSAL AGENCY "PRO-PHARMA".