Altan
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALTAN (ALTAN)
Composition:
Active ingredient: altan;
1 tablet contains 10 mg of altan (calculated as dry substance with 60% ellagitannin content);
Excipients: lactose monohydrate, corn starch, calcium stearate;
Film coating: polyvinyl alcohol – partially hydrolyzed, macrogol (PEG 3350), talc, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), iron oxide black (E 172).
Pharmaceutical form. Film-coated tablets.
Main physicochemical properties: round, biconvex tablets coated with a brown film coating.
Pharmacotherapeutic group. Agents for the treatment of acid-related disorders.
ATC Code A02X.
Pharmacological Properties
Pharmacodynamics
A complex preparation containing polyphenolic substances – ellagitannin derivatives (ellagic and gallic acids, ethyl gallate, alnitanins) obtained from the cones of black alder – Alnus glutinosa (L.) Gaertn. and grey alder – Alnus incana (L.) Moench of the birch family – Betulaceae, which exhibit gastroprotective and anti-ulcer effects. The presence of hydrolysable tannins (ellagic and gallic acids) in the preparation provides antimicrobial activity against Staphylococcus aureus, Salmonella enteritidis, Enterobacter aerogenes, Citrobacter diversus. Anti-inflammatory activity of the preparation is due to flavonoids content, which have antioxidant properties, prevent lipid peroxidation and block the formation of bioreactive oxygen species. Inhibition of enzyme activity in the arachidonic acid cascade leads to reduced synthesis of inflammatory mediators. The reparative properties of the preparation are provided by flavonoids (quercetin, rutin, catechin, leucoanthocyanins), which stimulate protein synthesis and improve local blood supply. The preparation does not affect gastric secretory function.
Pharmacokinetics
Not studied.
Clinical characteristics.
Indications.
In complex treatment of:
- gastritis – regardless of the nature of gastric acid secretion disorders;
- chronic gastroduodenitis;
- peptic ulcer of the stomach and duodenum;
- colitis and enterocolitis.
Contraindications.
- Hypersensitivity to altan and/or other components of the drug;
- individual sensitivity to tannin-containing medicinal agents.
Interaction with other medicinal products and other types of interactions.
Due to the polyphenolic base, Altan tablets form complexes with metal salts (such as aluminum, bismuth, iron), leading to loss of the drug's pharmacological activity.
Usage Notes.
The product contains lactose; therefore, patients with rare hereditary disorders of carbohydrate intolerance, such as galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency, should not use this medicine.
Altan must not be administered concomitantly with aluminum-magnesium antacids, bismuth preparations, iron-containing drugs, or other medicinal products containing metal ions.
Use during pregnancy or breastfeeding.
Altan belongs to practically non-toxic drugs; however, its use during pregnancy and breastfeeding is possible only when, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus/child.
Ability to influence reaction rate when driving or operating machinery.
There is no data available regarding the ability of Altan to affect reaction speed when driving vehicles or operating machinery.
Dosage and Administration.
Take Altana tablets orally, 15–20 minutes before meals.
For adults: take 1 tablet 2–3 times daily.
For children and adolescents aged 9 years and older: take 1 tablet twice daily.
The duration of treatment is determined by the physician, taking into account the nature, severity, and course characteristics of the disease, stability of the achieved therapeutic effect, and drug tolerability. Usually, the treatment course lasts 1 month.
Children.
Clinical data on the use of the drug in children under 9 years of age are lacking.
Overdose.
Possible manifestations of increased sensitivity to the drug in the form of allergic reactions.
Treatment. Discontinue the drug. Induce vomiting or perform gastric lavage. Symptomatic treatment is indicated.
Adverse reactions.
Possible development of allergic reactions, including rashes and itching.
Shelf life. 3 years.
Storage conditions. In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging. 20 tablets per blister, 5 blisters per carton.
Prescription status. Over-the-counter.
Manufacturer. Public joint-stock company "Scientific and Production Center "Borshchagovskiy Chemical and Pharmaceutical Plant".
Location of manufacturer and address of its business activity.
17, Miru Street, Kyiv, 03134, Ukraine.
INSTRUCTION
for medical use of medicinal product
ALTAN
(ALTAN)
Composition:
Active ingredient: altan;
1 tablet contains 10 mg of altan (calculated on dry substance and elagotannin content of 60%);
Excipients: lactose monohydrate, corn starch, calcium stearate; film coating: polyvinyl alcohol – partially hydrolyzed, macrogol (PEG 3350), talc, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), iron oxide black (E 172).
Pharmaceutical form. Film-coated tablets.
Main physicochemical properties: round, biconvex tablets coated with a brown film coating.
Pharmacotherapeutic group. Drugs for the treatment of acid-related disorders.
ATC code: A02X.
Pharmacological properties.
Pharmacodynamics.
A complex preparation of polyphenolic substances – derivatives of elagotannins (ellagic and gallic acids, ethyl gallate, alnitannins) obtained from the cones of black alder – Alnus glutinosa (L.) Gaertn. and grey alder – Alnus incana (L.) Moench of the family Betulaceae. The drug exhibits gastroprotective and anti-ulcer effects. The presence of hydrolysable tannins (ellagic and gallic acids) in the formulation provides antimicrobial activity against Staphylococcus aureus, Salmonella enteridis, Enterobacter aerogenes, Citrobacter diversus. The anti-inflammatory activity of the drug is due to flavonoids, which have antioxidant properties, prevent lipid peroxidation and block the formation of bioreactive oxygen species. Inhibition of enzyme activity in the arachidonic acid cascade leads to reduced synthesis of inflammatory mediators. The reparative properties of the drug are provided by flavonoids (quercetin, rutin, catechin, leucoanthocyanin), which stimulate protein synthesis and improve local blood supply. The drug does not affect gastric secretory function.
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
For use in combination therapy:
- Gastritis – regardless of the nature of disturbances in gastric acid secretion;
- Chronic gastroduodenitis;
- Peptic ulcer disease of the stomach and duodenum;
- Colitis and enterocolitis.
Contraindications.
- Hypersensitivity to altan and/or other components of the drug;
- Individual sensitivity to tannin-containing medicinal products.
Interaction with other medicinal products and other types of interactions.
Due to its polyphenolic base, Altan tablets form complexes with metal salts (such as aluminum, bismuth, iron), leading to loss of the drug's pharmacological activity.
Special precautions.
The drug contains lactose; therefore, patients with rare hereditary disorders of carbohydrate intolerance, such as congenital galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency, should not take this drug.
Altan must not be administered concomitantly with almagel, bismuth preparations, iron supplements, or other medicinal products containing metal ions.
Use during pregnancy or breastfeeding.
Altan belongs to the group of practically non-toxic drugs; however, its use during pregnancy and breastfeeding is possible only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus/child.
Ability to affect reaction rate when driving or operating machinery.
There are no data on the ability of Altan to affect reaction speed during driving or operating machinery.
Method of administration and dosage.
Altan tablets should be taken orally, 15–20 minutes before meals.
Adults: 1 tablet 2–3 times daily.
Children and adolescents aged 9 years and older: 1 tablet twice daily.
Treatment duration is determined by the physician, depending on the nature, severity, and course of the disease, stability of the achieved therapeutic effect, and drug tolerability. Typically, treatment lasts 1 month.
Children.
Clinical data on the use of the drug in children under 9 years of age are lacking.
Overdose.
Symptoms of hypersensitivity to the drug may occur, such as allergic reactions.
Treatment. Discontinue the drug. Induce vomiting or perform gastric lavage. Symptomatic treatment is recommended.
Adverse effects.
Possible development of allergic reactions, including skin eruptions and itching.
Shelf life. 3 years.
Storage conditions. In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging. 20 tablets per blister, 5 blisters per carton.
Prescription status. Over-the-counter.
Manufacturer. Public joint-stock company "Scientific and Production Center "Borshchagovskiy Chemical and Pharmaceutical Plant".
Location of manufacturer and address of its business activity. 17, Miru Street, Kyiv, 03134, Ukraine.