Gastric drops

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SHLUNKOVI KRAPLY

Composition:

Active substances: 1 ml of the preparation contains: valerian tincture (valerianae tinctura) (1:5) (extractant – 70 % ethanol) – 0.4 ml, wormwood tincture (Absinthii tinctura) (1:5) (extractant – 70 % ethanol) – 0.3 ml, peppermint tincture (Menthae piperitae tinctura) (1:20) (extractant – 90 % ethanol) – 0.2 ml, belladonna tincture (Belladonnae tinctura) (1:10) (extractant – 40 % ethanol) – 0.1 ml.

Pharmaceutical form. Oral drops.

Main physico-chemical properties: red-brown liquid with a characteristic odour. Sediment may form during storage.

Pharmacotherapeutic group.

Agents used for functional gastrointestinal disorders.

ATC code A03B.

Pharmacological properties.

Pharmacodynamics. The analgesic effect of the drops in gastric pain is due to the combined action of alkaloids from Belladonna (Atropa belladonna). The drug exerts a moderate spasmolytic effect and has a sedative effect due to the presence of valerian and peppermint in its composition. Wormwood tincture normalizes gastric functions and reflexively enhances gastric juice secretion, thereby improving the digestive process.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Gastralgia, non-ulcer dyspepsia, chronic gastritis with reduced gastric secretory function, hyperkinetic-type biliary dyskinesia.

Contraindications.

Hypersensitivity to the components of the drug.

Gastrointestinal disorders accompanied by obstruction, increased gastric secretion, peptic ulcer of the stomach and duodenum, reflux esophagitis. Cholelithiasis. Urinary retention or predisposition to it.

Cardiovascular disorders in which increased heart rate is undesirable: atrial fibrillation; tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension. Glaucoma.

Epilepsy, depression, and other disorders accompanied by suppression of central nervous system activity.

Bronchial asthma. Spasmophilia. Myasthenia gravis. Hyperthermic syndrome. Thyrotoxicosis. Acute bleeding. History of pelvic organ bleeding. Anemia.

Interaction with other medicinal products and other types of interactions.

Valerian, which is a component of the medicinal product, may potentiate the effects of sedatives, hypnotics, analgesics, spasmolytics, and cardiac agents.

Alkaloids of Hyoscyamus niger reduce or abolish the action of M-cholinomimetics and anticholinesterase agents; potentiate the arrhythmogenic effect of monoamine oxidase inhibitors, cardiac glycosides, and clonidine; enhance the cholinolytic properties of quinidine and procainamide; and intensify the effects of barbiturates, adrenomimetics, antihistamines, and tranquilizers. The preparation forms precipitates with lead acetate, calcium salts, tannin, and Convallaria majalis tincture.

Special precautions for use.

Patients with gastroesophageal reflux (heartburn) should avoid using the drug, as heartburn may increase.

Failure to follow the recommendations for use of the medicinal product may harm health.

The effect of the drug is reduced in individuals who smoke and consume spicy or hot food.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

During treatment, patients should refrain from driving vehicles and performing tasks that require heightened attention and quick reaction time.

Method of Administration and Dosage.

For adults and children aged 12 years and older, administer 15–30 drops internally with a small amount of boiled water, 3–4 times daily, 30 minutes before meals. The duration of treatment is determined by the physician depending on the therapeutic effect achieved and the patient's tolerance to the drug.

Children.

The drug is contraindicated in children under 12 years of age.

Overdose.

Symptoms: intensified adverse reactions, headache, dizziness, general weakness, nausea, vomiting, abdominal pain, tachycardia, decreased arterial blood pressure, excitement, irritability, tremor, insomnia, hyperthermia, depression of the central nervous system, decreased hearing and visual acuity, depression of respiratory and vasomotor centers, loss of consciousness.

Treatment. Immediately discontinue the drug. Gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Symptomatic treatment.

Side effects.

In case of individual hypersensitivity to the components of the drug, local allergic reactions (rash, itching, hyperemia and swelling of the skin) are possible.

Central nervous system: drowsiness, suppression of emotional responses, mental depression.

Gastrointestinal tract: dry mouth, sensation of thirst, taste disturbances, dysphagia, decreased intestinal motility up to atony, reduced tone of bile ducts and gallbladder, nausea, vomiting, spasmodic abdominal pain.

Kidneys and urinary tract: difficulty and retention of urination.

Cardiac disorders: palpitations; arrhythmia, including extrasystoles; myocardial ischemia.

Vascular disorders: facial flushing, sensation of hot flushes.

Neurological disorders: headache, dizziness, dysarthria. Prolonged use may lead to so-called "polynous epilepsy".

Eyes: mydriasis, photophobia, accommodation paralysis, increased intraocular pressure.

Respiratory system and mediastinal organs: reduced secretory activity and bronchial tone, leading to formation of viscous sputum that is difficult to cough up.

Skin and subcutaneous tissue: urticaria, exfoliative dermatitis, hyperemia.

Immune system: anaphylactic reactions, angioneurotic edema, anaphylactic shock.

Other: decreased sweating, dry skin, reduced work capacity, weakness.

If any adverse effects occur, consult a physician.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

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

Availability category. Over-the-counter.

Manufacturer/Marketing authorization holder.

LLC "Ternopharm".

Address of manufacturer and location of its business activity / address of the marketing authorization holder.

LLC "Ternopharm".

4 Fabrychna St., Ternopil, 46010, Ukraine.