Entoban
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENTOBAN (ENTOBAN)
Composition:
Active ingredients: 5 ml of syrup contain:
Extract of Holarrhena antidysenterica bark (dense extract 4–5:1) (extractant: purified water) – 25 mg;
Extract of Myrtus communis fruits (dense extract 4–5:1) (extractant: purified water) – 100 mg;
Extract of Berberis aristata fruits (dense extract 4–5:1) (extractant: purified water) – 15 mg;
Extract of Aegle marmelos fruits (dense extract 4–5:1) (extractant: purified water) – 50 mg;
Extract of Quercus infectoria fruits (dense extract 4–5:1) (extractant: purified water) – 25 mg;
Extract of Butea frondosa stems (dense extract 4–5:1) (extractant: purified water) – 10 mg.
Excipients: sucrose, glycerin, sodium chloride, anhydrous citric acid, methylparaben (E 218), propylparaben (E 216), Tutti-Frutti flavor, peppermint oil, propylene glycol, purified water.
Pharmaceutical form. Syrup.
Main physicochemical properties: brown syrup-like liquid with a characteristic odor. Formation of a sediment is permissible, which dissolves upon shaking.
Pharmacotherapeutic group. Agents used in intestinal infections. ATC code A07AX.
Pharmacological properties.
Pharmacodynamics.
The pharmacological properties of the medicinal product are determined by the combined action of plant-derived components contained in its composition.
Entoban protects the mucous membrane of the gastrointestinal tract, reduces increased gastric acidity, and regulates intestinal peristalsis; it also has calming and bactericidal effects.
It produces antidiarrheal, antimicrobial, and antiprotozoal effects in diarrhea of various etiologies and exhibits spasmolytic activity.
Holarrhena pubescens has amoebicidal activity. It is used as an astringent, anthelmintic, antipyretic, and diuretic agent, including in cases of hemorrhage, colic, and dyspepsia.
Myrtus communis has bactericidal, anti-inflammatory, spasmolytic, antipyretic, antibacterial, antidiarrheal, and astringent properties. It reduces capillary permeability.
Berberis vulgaris normalizes liver function and is also used as a tonic, astringent, and antipyretic agent.
Cydonia oblonga. Has bactericidal, anti-inflammatory, and antidiabetic effects.
Quercus infectoria. Has astringent and bactericidal effects.
Butea monosperma. Exerts an astringent effect in diarrhea of microbial origin.
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
As part of complex therapy for acute intestinal infections accompanied by diarrhea.
Contraindications.
Hypersensitivity to any component of the medicinal product.
Pregnancy or breastfeeding period.
Contraindicated in children with a history of seizures (febrile or otherwise).
Interaction with other medicinal products and other forms of interaction.
Not studied.
Special precautions for use.
This medicinal product should be used with caution in patients with a history of congestive heart failure and edema, as well as in those with arterial hypertension, eclampsia, and hyperaldosteronism. It should also be used cautiously in patients with gastrointestinal ulcers or bronchial asthma.
If there is no clinical improvement within 48 hours, the medication should be discontinued and medical advice sought.
This medicinal product should be administered to children aged 4–12 years under constant medical supervision.
In patients with elevated body temperature or presence of blood in stools, the cause of diarrhea should be established before initiating treatment. During therapy, etiological and rehydration treatment should be administered concomitantly, with replacement of fluid and electrolyte losses.
The syrup contains sucrose, which should be taken into account in patients with diabetes mellitus or those on a low-calorie diet. Also, due to the presence of sucrose in the formulation, the product should not be administered to patients with rare hereditary conditions such as fructose intolerance or sucrase-isomaltase deficiency.
The medicinal product contains 2.32 mmol of sodium per daily dose, which should be considered in patients on a salt-free diet.
Due to the presence of methylparaben (E 218) and propylparaben (E 216), the product may cause allergic reactions (possibly delayed).
Use during pregnancy or breastfeeding.
Use during pregnancy is contraindicated due to the presence of Chelidonium majus in the formulation, which may lead to pregnancy loss.
The medicinal product should not be used during breastfeeding.
Ability to influence reaction rate when driving or operating machinery.
The effect on the ability to drive or operate machinery has not been studied.
Dosage and Administration.
For adults and children aged 12 years and older: take 3–4 teaspoons of syrup every 4 hours. For children aged 7 to 11 years: 1–2 teaspoons of syrup every 4 hours. For children aged 4 to 6 years: 1 teaspoon (5 ml) of syrup every 4 hours.
The duration of treatment is determined individually by a physician; on average, the treatment course lasts from 3 to 5 days.
Children.
This medicinal product must not be used in children under 4 years of age.
Overdose.
No cases of overdose have been reported. In case of overdose – gastric lavage and symptomatic therapy. High doses of Aegle marmelos may cause constipation. Prolonged use of high doses of Buttea superba may lead to kidney disease and anemia. High-dose use of Berberis may be fatal.
Side effects.
In isolated cases, allergic reactions to the components of the medicinal product may occur (urticaria, itching), nausea, vomiting, belching, flatulence, headache, bradycardia, dyspepsia, ataxia, tremor, anaphylactic shock.
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. 90 ml, 120 ml, or 150 ml in a bottle No. 1 in a cardboard box.
Supply category. Over-the-counter.
Manufacturer. Herbion Pakistan Private Limited, Pakistan.
Manufacturer's address and place of business.
Plot No. 30, Sector 28, Korangi Industrial Area, Karachi, Pakistan /
Plot No. 30, Sector 28, Korangi Industrial Area, Karachi, Pakistan.