Chamomile flowers

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHAMOMILE FLOWERS (MATRICARIAE FLOS)

Composition:

Active substance: chamomile flowers (Matricariae flos);

One pack contains chamomile flowers (Matricariae flos) – 40 g or 50 g; one filter bag contains chamomile flowers (Matricariae flos) – 1.5 g.

Pharmaceutical form. Flowers.

Main physicochemical properties:

Bulk raw material: whole flower heads or partially shed flower heads, hemispherical or conical in shape, without flower stalks or with remnants not longer than 3 cm. The flower head consists of marginal ligulate pistillate flowers and central bisexual tubular flowers. The receptacle is glabrous, finely pitted, hollow inside, hemispherical at the beginning of flowering, conical at the end. The involucre of the flower head is imbricate, multiseriate, composed of numerous elongated bracts with blunt tips and broad membranous margins. Diameter of the flower head (excluding ligulate flowers) – 4–8 mm. Color of ligulate flowers is white, tubular flowers – yellow, involucre – yellowish-green. Odor is strong, pleasant. Taste is aromatic, bitter, slightly mucilaginous;

Coarse powder: a mixture of fragments of ligulate and tubular flowers, flower head involucres, and remnants of flower stalks of various shapes. Color of ligulate flowers is white, tubular flowers – yellow, involucre – yellowish-green. Odor is strong, pleasant. Taste is aromatic, bitter, slightly mucilaginous.

Pharmacotherapeutic group.

Agents affecting the digestive system and metabolic processes. ATC code A16A X.

Pharmacological Properties.

Pharmacodynamics.

The biologically active substances of the drug exert spasmolytic, analgesic, anti-inflammatory, antiseptic, diaphoretic, and choleretic effects; reduce allergic reactions, enhance regenerative processes, increase secretory activity of the digestive glands, stimulate appetite, relieve intestinal spasms, and reduce fermentation processes.

Clinical characteristics.

Indications.

For oral administration in gastritis, inflammatory diseases of the liver and gallbladder, enterocolitis, meteorism, and respiratory infections. For external use—in inflammatory conditions of the mouth and throat.

Contraindications.

Hypersensitivity to the biologically active substances of the drug.

Interaction with other medicinal products and other forms of interaction. Unknown.

Special precautions for use.

Use during pregnancy or breastfeeding. Upon prescription by a physician, if the benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving vehicles or operating machinery. No effect.

Method of Administration and Dosage

Place 3 tablespoons of flowers into an enameled container, pour 200 ml of hot boiled water, cover with a lid, and steep in a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, and squeeze the residue. Add boiled water to the strained infusion to make up the volume to 200 ml.

Administer warm, 3 times daily after meals:

• Adults and children aged 14 years and older: ⅓ cup
• Children aged 12–14 years: ¼ cup
• Children aged 7–12 years: 2 tablespoons
• Children aged 3–7 years: 1 tablespoon
• Children aged 1–3 years: 1 dessert spoon
• Children aged 6 months–1 year: ½–1 teaspoon

Externally, use the infusion for rinsing 3–4 times daily. Shake the infusion before use.

Place 2 filter packets into a glass or enameled container, pour 200 ml of boiling water, cover, and steep for 15 minutes. Administer warm, 3 times daily after meals:

• Adults and children aged 14 years and older: 1 cup
• Children aged 12–14 years: ⅔ cup
• Children aged 7–12 years: ½ cup
• Children aged 3–7 years: ¼ cup
• Children aged 1–3 years: 2 tablespoons
• Children aged 6 months–1 year: 1 dessert spoon

Externally, use the infusion for rinsing 3–4 times daily.

The duration of treatment is determined individually by a physician.

Children

May be used in children aged 6 months and older under medical supervision.

Overdose

No reports of overdose have been reported.

Adverse reactions.

Allergic reactions are possible (including hyperemia, rash, itching, and skin swelling). If adverse reactions occur, discontinue use of the product.

Shelf life. 1 year 6 months.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children. Prepared infusion should be stored at a temperature from 8 °C to 15 °C for no more than 2 days.

Packaging. 40 g or 50 g in cartons with inner pouch; 1.5 g in tea bags, 10 or 20 tea bags per carton.

Category of release. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

69050, Ukraine, Zaporizhzhia, Skladska St., 4.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of marketing authorization holder.

69063, Ukraine, Zaporizhzhia, Amosova Akademyka St., 75.