Propolis tincture

Instructions for Medical Use of the Medicinal Product PROPOLIS Tincture

Composition:

Active substance: propolis tincture (propolis tinctura);

1 vial contains propolis tincture (propolis tinctura) (1:10) (extractant – 80% ethanol) 25 ml;

Excipients: apart from the extractant, none present.

Pharmaceutical form. Tincture.

Main physico-chemical properties: liquid of yellowish-brown to red-brown color, with a specific odor. During storage, sedimentation may occur.

Pharmacotherapeutic group.

Agents for treatment of wounds and ulcerative lesions. Preparations promoting wound healing. ATC code D03AX.

Pharmacological properties.

Pharmacodynamics. Propolis (bee glue) is a product of bee vital activity containing various biogenic substances: essential oils, a mixture of resins, wax, flavonoids, flavones, and derivatives of cinnamic acid. It exhibits antimicrobial and anti-inflammatory activity and accelerates regeneration processes (recovery of damaged tissues).

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Minor injuries and superficial skin and mucous membrane lesions, otitis, pharyngitis, tonsillitis, sinusitis, periodontitis.

Contraindications.

Hypersensitivity to propolis or individual intolerance, especially in patients with liver or kidney diseases, eczema, allergic reactions (particularly to beekeeping products), bleeding from affected areas of skin and mucous membranes.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with other antiseptic agents or beekeeping products is not recommended. If simultaneous use with any other medicinal products is necessary, consult a physician.

Special precautions for use.

Before using the medicinal product, consult a physician.

Complications may occur during administration of the drug; therefore, the patient should be warned about the possibility of their occurrence. Symptoms of propolis intolerance may appear immediately after its application or several hours, and even days later. In individual patients, such symptoms may occur only during repeated courses of treatment.

Use during pregnancy or breastfeeding.

The medicinal product is not recommended for use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Has no effect.

Method of Administration and Dosage

Propolis tincture is intended for topical use in adults and children aged 3 years and older, applied as compresses, rinses, irrigations, and inhalations. In cases of minor skin injuries and purulent skin diseases, apply the propolis tincture with a swab to the affected area 1–3 times daily. For treatment of external suppurative otitis media, after cleaning the ear canal, insert a tampon moistened with propolis tincture into the ear (for 1–2 minutes, 2–3 times daily), or instill 1–2 drops of propolis tincture 3–4 times daily. In chronic tonsillitis and pharyngitis, lubricate the mucous membrane 1–2 times daily for 8–15 days. Additionally, in tonsillitis, use propolis tincture to prepare an inhalation alcoholic-aqueous solution in a ratio of 1 : 20.

Perform 1–2 inhalations daily; treatment course lasts 7–10 days. In chronic sinusitis, irrigate the maxillary sinuses with a solution prepared from propolis tincture and 0.9% sodium chloride solution (in a ratio of 1 : 10) twice daily for 2 weeks. In periodontitis, insert propolis tincture on pledgets into periodontal pockets for 5 minutes. In superficial erosions and lesions of the oral mucosa, use a rinse prepared from 15 ml of propolis tincture in 1/2 cup of warm water, 4–5 times daily for 3–4 days.

The duration of treatment course is determined individually by a physician.

Children

For use in children aged 3 years and older.

Overdose

Symptoms: loss of appetite, decreased general body tone, lethargy, appearance of skin rashes.

Treatment: treat with antihistamine agents.

Adverse reactions.

The drug is not toxic at usual therapeutic doses and is well tolerated. Adverse reactions occur rarely.

Possible adverse reactions:

• Skin and subcutaneous tissue disorders: urticaria, local skin itching, local swelling, skin redness, blisters, vesicular rashes, dryness and skin fissures, especially on palms and other parts of the body that contact the drug;
• Nervous system disorders: dizziness;
• Immune system disorders: allergic reactions, including allergic dermatitis, hyperemia, skin itching, rash, laryngospasm, dyspnea, angioedema, increased body temperature;
• Gastrointestinal disorders: nausea;
• Respiratory system disorders: dyspnea.

Local reactions are possible, including a sensation of tongue burning and dry mouth.

In case of any adverse reactions, discontinue use of the drug and consult a physician immediately.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 ml in dropper bottles (without carton or in a carton).

Availability.

Over-the-counter.

Manufacturer/Marketing authorization holder.

LLC "Ternopharm".

Manufacturer's address and location of its business activities / Marketing authorization holder's address.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua.