Gastritol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Gastritol (Gastritol®)

Composition:

100 ml of the preparation contains:

liquid extract of goosegrass herb (Anserinae herba) (1 : 1.7–2.2) [extraction solvent: ethanol 40 % (v/v)] — 35 ml;
liquid extract of chamomile flowers (Matricariae flos) (1 : 1.7–2.2) [extraction solvent: ethanol 45 % (v/v)] — 20 ml;
liquid extract of licorice root (Liquiritiae radix) (1 : 1.7–2.2) [extraction solvent: ethanol 40 % (v/v)] — 15 ml;
liquid extract of angelica root (Angelicae radix) (1 : 1.7–2.2) [extraction solvent: ethanol 40 % (v/v)] — 5 ml;
liquid extract of blessed thistle herb (Cnici ben. herba) (1 : 1.7–2.2) [extraction solvent: ethanol 40 % (v/v)] — 5 ml;
liquid extract of common wormwood herb (Absinthii herba) (1 : 1.7–2.2) [extraction solvent: ethanol 40 % (v/v)] — 5 ml;

Excipients: ethanol 96 %, purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: brown-colored liquid.

Pharmacotherapeutic group.

Agents used in functional gastrointestinal disorders.

ATC code A03AX.

Pharmacological properties.

Pharmacodynamics. The medicinal product contains active substances that act both locally in the gastrointestinal tract and exert a central effect on the secretory and motor functions of the stomach.

Herba Polygoni avicularis exerts a spasmolytic effect on the musculature of the gastrointestinal tract.

Licorice root contains glycyrrhizic acid, which has pronounced anti-inflammatory activity, stimulates the formation of granulation tissue, and also reduces the tone and motility of the gastrointestinal tract (spasmolytic effect). Vascularization of the gastric mucosa is increased.

Chamomile flowers exert anti-inflammatory, antiallergic, and regenerative effects. Chamazulene rapidly and deeply penetrates the mucous membrane. Activation of the hypophyseo-adrenal system leads to enhanced release of corticotropin and cortisone. Anti-inflammatory and antiallergic effects are also exhibited by β-farnesene and α-bisabolol.

Herb of blessed thistle contains the bitter glycoside cnicin, which, like other bitter substances present in the root of angelica, improves blood supply to the organs of the gastrointestinal tract, thereby accelerating the healing of ulcers and lesions of the gastric mucosa.

The bitter substance of Artemisia absinthium herb increases the tone of the abomasum and alleviates symptoms of gastrocardiac syndrome.

Pharmacokinetics. The pharmacokinetic properties of the medicinal product have not been studied.

Clinical characteristics.

Indications.

Functional dyspepsia, meteorism, gastritis, including chronic hyperacid gastritis, as well as part of complex treatment of gastric and duodenal ulcer disease.

Contraindications.

History of pelvic organ bleeding, anemia, epilepsy, hypertensive disease (stage III), cholelithiasis, pregnancy and breastfeeding.

Hypersensitivity to active substances, plants of the Asteraceae family, or other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Administration of a preparation containing Artemisia absinthium may affect the action of other medicinal products acting via GABA (gamma-aminobutyric acid) receptors; therefore, concomitant use with benzodiazepines and their derivatives is not recommended.

Special precautions for use.

The medicinal product contains 40% (v/v) ethanol.

One drop of the preparation contains 0.016 g of ethanol.

Caution should be exercised when administering to patients with liver disease, central nervous system disorders, or alcoholism, as each dose of the medicinal product may pose a health risk for these patients.

Due to the presence of angelica root extract in the medicinal product, prolonged exposure to sunlight should be avoided.

Formation of flakes or turbidity, which may be observed in liquid formulations based on herbal ingredients, does not cause adverse effects and does not reduce the efficacy of the medicinal product.

Use during pregnancy or breastfeeding. Due to insufficient experience of use, the medicinal product is contraindicated in women during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery. The use of the medicinal product within the therapeutic dose range does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

In the absence of other instructions, the adult dose is 30 drops, diluted in a small amount of liquid, taken 3 times daily during or after meals.

30 drops correspond to 1.3 mL.

The duration of treatment is 3–4 weeks. If necessary, the treatment course may be repeated after 2 months.

The medicinal product should be shaken well before use.

Children. Due to insufficient experience with use in pediatric patients (under 18 years of age), the medicinal product should not be administered to this patient group.

Overdose. In case of overdose, symptoms such as bitter taste in the mouth and discomfort in the liver area may occur.

Side effects.

Very rarely, skin reactions resembling sunburn may occur in patients with high photosensitivity, developing under the influence of intense solar radiation.

Allergic reactions are possible, including swelling, redness of the skin, rash, itching. Gastrointestinal reactions are also possible, including nausea, vomiting, stomach pain, and water-electrolyte imbalance.

Reporting of side effects

Reporting of adverse reactions following registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

After first opening of the bottle – 3 months.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

20 ml, 50 ml, or 100 ml in a bottle with dropper; 1 bottle per cardboard box.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

Dr. Gustav Klein GmbH & Co. KG

Manufacturer's address and location of operations.

Steinenfeld 3, 77736 Zell am Harmersbach, Germany