Vagical

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VAGIKAL

Composition:

Active substance: Calendula officinalis;

1 suppository contains Calendula officinalis Ø 150 mg;

Excipients: macrogol 400, macrogol 1500, macrogol 4000.

Pharmaceutical form. Vaginal suppositories.

Main physicochemical properties: cylindrical-conical white suppositories with a yellowish tint. Presence of an air-containing porous core and a funnel-shaped depression on the cross-section is permissible.

Pharmacotherapeutic group.

Medicinal products used in gynecology. ATC code G02C C.

Pharmacological properties.

Calendula officinalis (marigold) contains flavonoids, saponins, carotenoids, and triterpenoid alcohols. Their pharmacological effects are mutually complementary, providing anti-inflammatory action, accelerating the processes of granulation and epithelialization, exerting fungistatic and cytotoxic effects, as well as producing protective, antibiotic, and immunostimulatory actions.

Clinical characteristics.

Indications.

Inflammatory diseases of the vagina accompanied by discharge, itching, burning, and redness.

Contraindications.

Hypersensitivity to any component of the medicinal product. Hypersensitivity to plants of the Asteraceae family (compositae), such as chamomile, echinacea, arnica (cross-reactivity is possible).

Interaction with other medicinal products and other forms of interaction.

Not studied.

If simultaneous use of any other medicinal products is necessary, consult a physician.

Special precautions for use.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of the medicinal product during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

No effect.

Method of administration and dosage.

Suppositories are administered intravaginally 2–3 times daily. Before use, the suppository should be moistened with boiled, cooled water.

The duration of treatment is determined individually by a physician. If symptoms do not resolve or if there is worsening of condition within 3–4 days after starting treatment, medical advice must be sought.

Children.

Not applicable.

Overdose.

No reports available.

Side effects.

The medicinal product is generally well tolerated; however, allergic reactions may occur in individuals with increased sensitivity.

Irritation of the vaginal mucosa and labia may occur during use of the product.

If any adverse reactions occur, discontinue use of the product and consult a physician.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 suppositories per strip; 2 strips in a cardboard package.

Supply category. Over-the-counter.

Manufacturer.

FARMINA Ltd.

Manufacturer's name and address.

Lipska St. 44, 30-721 Kraków, Poland.