Hilak forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HYLAK® FORTE (HYLAK FORTE)

Composition:

Active substances: 100 ml of drops contain aqueous substrate of metabolites: Escherichia coli, DSM 4087 – 24.9481 g, Enterococcus faecalis, DSM 4086 – 12.4741 g, Lactobacillus acidophilus, DSM 4149 – 12.4741 g, and aqueous concentrate of metabolites: Lactobacillus helveticus, DSM 4183 – 49.8960 g;

Excipients: sodium hydrogen phosphate heptahydrate, potassium hydrogen phosphate, lactic acid, concentrated phosphoric acid, potassium sorbate, citric acid monohydrate.

Lactose is present in the formulation as a product of bacterial metabolism.

Pharmaceutical form. Oral drops, solution.

Main physicochemical properties: Clear, yellowish-brown solution with a characteristic caramel-like sour odor. During the storage period, suspended brown particles may appear.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Antidiarrheal agents; drugs used for the treatment of infectious and inflammatory intestinal diseases. Antidiarrheal microbial agents. ATC code A07FA.

Pharmacological properties.

Hilak Forte drops are a medicinal product that normalizes intestinal flora, pH, and water-electrolyte balance within the intestinal lumen, and stimulates the synthesis of epithelial cells of the intestinal wall.

The natural physiological intestinal flora can be significantly disturbed due to external factors such as antibiotic therapy, radiation, gastrointestinal surgeries (e.g., Billroth II operation), as well as due to dietary disturbances, which may sometimes promote excessive growth of pathogenic microorganisms. As a result, symptoms such as a feeling of heaviness, flatulence, diarrhea, or constipation may occur.

The numerous metabolic products of physiological intestinal bacteria contained in Hilak Forte (lactic acid producers, as well as gram-positive and gram-negative symbionts of the small and large intestine) support the maintenance of physiological function of the intestinal mucosa and promote restoration of its normal flora.

Due to the presence of biosynthetic lactic acid and its buffer salts, Hilak Forte normalizes intestinal acidity.

The volatile fatty acids contained in Hilak Forte drops not only help prevent but also restore the damaged intestinal environment in infectious gastrointestinal diseases; they also promote absorption of water and electrolytes (sodium, chloride).

Hilak Forte is not absorbed into the bloodstream and is excreted via the gastrointestinal tract.

Clinical characteristics.

Indications.

• Digestive disorders, such as flatulence, diarrhea, constipation;
• during and after therapy with antibiotics and sulfonamides, as well as radiotherapy;
• disorders of hepatic metabolism;
• gastrointestinal disorders due to reduced gastric acidity;
• chronic atrophic gastroenteritis ("senile intestine");
• gastrointestinal disturbances associated with climate change (e.g., travel to warm countries);
• symptoms related to chronic intestinal intoxication, such as nausea, circulatory disturbances, tendency to rapid fatigue, etc.

The use of this medicinal product is only a supportive measure. It should be used only in combination with other effective therapeutic measures. In particular, in patients with diarrhea, the use of Hilak Forte drops does not replace rehydration therapy or other necessary interventions, such as temporary avoidance of solid food ("tea break").

Contraindications.

Hypersensitivity to the components of the preparation. Acute diarrhea accompanied by high fever and presence of blood in stool.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with antacids should be avoided.

The preparation has a pH value corresponding to an acidic environment and may therefore cause coagulation of milk. For this reason, Hilak Forte should not be taken with milk.

Special precautions for use.

Hilak Forte must not be used without prior dilution (it can be diluted with water, tea, or orange juice). 1 ml of Hilak Forte medication contains 20 drops.

Consult a physician if serious symptoms occur, such as acute diarrhea accompanied by high fever or blood in the stool, if diarrhea lasts more than 2 days, or if other persistent or unexplained gastrointestinal symptoms appear.

In cases of diarrhea, especially in children and elderly patients, replacement of fluid and electrolyte losses is mandatory during treatment.

Hilak Forte should be prescribed with caution to patients with increased gastric acidity in the presence of reflux esophagitis. The daily dose for such patients should not exceed 6 ml, which should be taken in at least 3 divided doses.

Hilak Forte contains lactose. Therefore, the medication should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding.

There are insufficient epidemiological data on the potential risk of using the drug during pregnancy or breastfeeding. Before using Hilak Forte during pregnancy or breastfeeding, the benefit-risk ratio should be carefully evaluated.

Ability to influence reaction speed while driving or operating machinery.

The drug does not affect reaction speed while driving or operating machinery.

Method of administration and dosage.

Hilak Forte is taken orally, before or during meals, diluted in a small amount of liquid (except milk).

Hilak Forte is prescribed during the first few days of illness 3 times daily:

for adults and children aged 12 years and older – 40–60 drops per dose;

for children aged 2 to 12 years – 20–40 drops per dose.

After improvement of condition, the daily dose may be halved.

For patients with increased gastric acidity and heartburn, which is often associated with this condition, the daily dose should be divided into at least 3 doses.

Duration of treatment is determined individually.

Children.

Not recommended for children under 2 years of age.

Overdose.

No cases of overdose have been reported.

Side effects.

The adverse effects are categorized by frequency as follows: rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000).

Immune system side effects. Rare: hypersensitivity reactions presenting as skin reactions and mucosal reactions.

Gastrointestinal side effects. Very rare: mild abdominal discomfort.

Shelf life. 5 years.

After opening the bottle – 12 months.

Storage conditions.

Keep out of reach of children. No special storage conditions required for this medicinal product.

Packaging.

30 ml or 100 ml of solution in a bottle with dropper cap; 1 bottle per carton.

Prescription status.

Over-the-counter.

Manufacturer.

Merkle GmbH.

Manufacturer's address and location of business operations.

Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany.