Fitodent®
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FİTODENT® (PHYTODENT)
Composition:
Active substances: 100 ml of the preparation contains tincture of a mixture of herbal raw materials "Fitodent®" (1:10) (extraction agent – ethanol 40%): Calamus rhizomes (calami rhizomata) – 2 g; Marigold flowers (calendulae officinalis flores) – 1.5 g; Nettle leaves (urticae dioicae folia) – 1 g; Chamomile flowers (chamomillae recutitae flores) – 1 g; Japanese sophora fruits (sophorae japonicae fructus) – 2 g; Celandine herb (chelidonii herba) – 1.5 g; Rosehip fruits (rosae fructus) – 1 g.
Excipients: None, except the extraction agent.
Pharmaceutical form. Tincture.
Main physicochemical properties: Transparent reddish-brown liquid with an aromatic odor. Sedimentation may occur.
Pharmacotherapeutic group. Agents used in dentistry.
Other agents for local application in dentistry.
ATC code A01AD11.
Pharmacological properties.
Fitodent® exerts anti-inflammatory, analgesic, disinfecting, and fungicidal effects, and is well absorbed by the oral mucosa and periodontal tissues.
In addition, tannins and flavonoids contained in the preparation possess wound-healing, hemostatic, and general strengthening properties. Due to the presence of physiologically active substances derived from chamomile, sophora, and celandine, the preparation provides pain-relieving action.
Clinical characteristics.
Indications.
Local treatment of inflammatory diseases of the oral mucosa: catarrhal stomatitis; recurrent chronic aphthous stomatitis; localized periodontitis (chronic or acute exacerbation) stage I; catarrhal gingivitis.
As a mouthwash in infectious-inflammatory conditions of the mucous membrane of the pharynx and larynx.
Contraindications.
Hypersensitivity to any component of the drug.
Children under 12 years of age.
Interaction with other medicinal products and other forms of interaction.
The drug enhances the effect of anti-inflammatory and analgesic agents.
Instructions for use.
Fitodent® should be used after removal of food residues and dental deposits. The product must be used only in diluted form. Shake well before use.
Use during pregnancy or breastfeeding.
The product may be used during pregnancy and breastfeeding.
Ability to affect reaction rate while driving or operating machinery.
Has no effect.
Method of Administration and Dosage
Dilute the preparation with water in varying proportions (1 part of the preparation to 1 or 2 parts of water, or 1 teaspoon of the preparation to ¼ cup of water), depending on individual sensitivity, and use for rinsing, irrigation, and spraying (3–5 times daily for 5 minutes); as well as for oral baths (3–5 times daily for 2–3 minutes).
Treatment of periodontal diseases should be carried out by inserting pledgets thoroughly moistened with diluted solution of Phytodent**®** (1 part of the preparation to 1 part of water) into gingival pockets and interdental spaces (1–2 times daily for 15–20 minutes); and by applying compresses with diluted solution of Phytodent**®** (1 part of the preparation to 1 part of water) (2–3 times daily for 15–20 minutes).
The treatment course is determined by a physician depending on the nature of the disease; usually the duration of treatment is 12–14 days.
Children.
Do not use the preparation in children under 12 years of age.
Overdose.
When using the undiluted preparation, a burning sensation may occur.
Side effects.
Allergic reactions may occur in case of hypersensitivity to the components of the drug, including skin itching, redness, skin rash, angioneurotic edema.
Shelf life. 2 years.
Do not use after the expiry date.
Storage conditions.
Keep out of reach of children.
Store in the original packaging at a temperature not exceeding 25 ºC.
Packaging.
100 ml in a bottle or jar. 1 bottle or jar in a cardboard box.
Supply category.
Over-the-counter.
Manufacturer.
PJSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA"".
Manufacturer's address and location of business activity.
1 Gordienkovskaya Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.