SOLIZYM FORTE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLIZYM FORTE (SOLIZYM FORTE)

Composition:

Active substance: 1 tablet contains microbial lipase with enzymatic activity of 3000 F.I.P. IU;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone 25, sodium croscarmellose, magnesium stearate, methacrylic acid copolymer dispersion, talc, titanium dioxide (E 171), propylene glycol, Yellow Sunset FCF (E 110).

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties: round, enteric-coated tablets of light orange to orange color, with convex upper and lower surfaces. When examined under a magnifying glass, the cross-section reveals a core surrounded by a single continuous layer.

Pharmacotherapeutic group. Drugs affecting the digestive system and metabolism. Enzyme preparations.

ATC code A09AA.

Pharmacological Properties.

Pharmacodynamics.

Solizym Forte replenishes pancreatic enzyme deficiency. The lipase contained in the preparation hydrolyzes fats (into glycerol and fatty acids), promoting more complete absorption of nutrients in the small intestine. When the drug is administered, the digestion process is normalized and the functional state of the gastrointestinal tract is improved.

Pharmacokinetics.

The tablets have a protective coating that is insoluble in the acidic environment of the stomach, thus preventing enzyme degradation by gastric juice pH. The coating dissolves and the enzymes are released in the duodenum.

Clinical characteristics.

Indications.

Dyspepsia, consumption of hard-to-digest fatty foods, flatulence associated with the aforementioned disorders, functional acceleration of intestinal transit.

Contraindications.

Hypersensitivity to the components of the drug. Acute pancreatitis or chronic pancreatitis in the stage of exacerbation.

Interaction with other medicinal products and other types of interactions.

The drug should not be taken simultaneously with antacids containing aluminium, magnesium, or calcium ions, or with iron-containing preparations.

Special precautions for use.

The drug contains lactose; therefore, Solizym Forte should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

The medicinal product contains Sunset Yellow FCF (E 110), which may cause allergic reactions when administered orally.

Use during pregnancy or breastfeeding.

Solizym Forte may be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Ability to affect reaction speed when driving or operating machinery.

There are no data regarding negative effects of the drug on the ability to drive or operate machinery.

Dosage and Administration.

Take tablets orally during or immediately after a meal. Swallow tablets whole, without chewing, with a small amount of liquid.

Recommended dose: 1–2 tablets three times daily. Take the drug as needed for digestive disorders.

The dosage and duration of Solizym Forte treatment are determined individually by a physician depending on the nature and course of the disease, pancreatic function, severity of digestive impairment, and dietary composition.

Children.

There is no experience with the use of the drug in children.

Overdose.

May result in an increase in adverse effects. Treatment is symptomatic.

Adverse Reactions.

Gastrointestinal system: in individual cases, nausea may occur or intensify; diarrheal syndrome may develop.

Immune system: allergic reactions, including itching and urticaria.

Shelf Life. 2 years.

Storage Conditions.

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

Keep out of reach of children.

Packaging.

10 tablets per blister; 2 blisters per cardboard box.

Availability Category. Over-the-counter.

Manufacturer.

JSC "Tekhnoloh".

Manufacturer's Location and Address of Business Activity.

8 Stara Prorizna Street, Uman, Cherkasy Oblast, Ukraine, 20300.

INSTRUCTION
FOR MEDICINAL USE OF THE MEDICINAL PRODUCT

SOLIZYM FORTE

(SOLIZYM FORTE)

Composition:

Active ingredient: 1 tablet contains microbial lipase with enzymatic activity of 3000 F.I.P. units;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone 25, sodium croscarmellose, magnesium stearate, methacrylate copolymer dispersion, talc, titanium dioxide (E 171), propylene glycol, sunset yellow FCF (E 110).

Pharmaceutical Form. Enteric-coated tablets.

Main physicochemical properties: round tablets with a coating ranging from light orange to orange, with convex upper and lower surfaces. When broken and examined under a magnifying glass, a core surrounded by a single continuous layer is visible.

Pharmacotherapeutic Group. Drugs affecting the digestive system and metabolism. Enzyme preparations.

ATC Code: A09AA.

Pharmacological Properties.

Pharmacodynamics.

Solizym Forte compensates for the deficiency of pancreatic enzymes. The lipase contained in the drug hydrolyzes fats (into glycerol and fatty acids), promoting more complete absorption of nutrients in the small intestine. When administered, digestion is normalized and the functional state of the gastrointestinal tract improves.

Pharmacokinetics.
The tablets have a protective coating insoluble in the acidic environment of the stomach, which protects the enzyme from degradation by gastric juice pH. Dissolution of the coating and release of enzymes begins in the duodenum.

Clinical Characteristics.

Indications.

Dyspepsia, consumption of hard-to-digest fatty foods, flatulence associated with the above disorders, functional acceleration of intestinal transit.

Contraindications.

Hypersensitivity to the components of the drug. Acute pancreatitis or chronic pancreatitis in the exacerbation phase.

Interaction with Other Medicinal Products and Other Types of Interactions.

The drug should not be taken simultaneously with antacids containing aluminum, magnesium, or calcium ions, or with iron-containing preparations.

Special Precautions.

The drug contains lactose; therefore, Solizym Forte should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

The medicinal product contains sunset yellow FCF (E 110), which may cause allergic reactions when taken orally.

Use During Pregnancy or Breastfeeding.

Solizym Forte may be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus/child.

Effect on Ability to Drive or Operate Machinery.

There is no data on negative effects of the drug on the ability to drive or operate machinery.

Method of Administration and Dosage.

Take tablets orally during or immediately after meals. Swallow tablets whole, without chewing, with a small amount of liquid.

Recommended dose: 1–2 tablets three times daily. Use the drug as needed in cases of digestive disturbances.

Dosage and duration of Solizym Forte treatment should be individually determined by a physician based on the nature and course of the disease, pancreatic function, degree of digestive impairment, and dietary composition.

Children.

Experience of use in children is lacking.

Overdose.

May result in increased adverse effects. Treatment is symptomatic.

Adverse Reactions.

Gastrointestinal system: in individual cases, nausea may occur or intensify; diarrheal syndrome may develop.

Immune system: allergic reactions, including itching and urticaria.

Shelf Life. 2 years.

Storage Conditions.

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

Keep out of reach of children.

Packaging.

10 tablets per blister; 2 blisters per cardboard box.

Availability Category. Over-the-counter.

Manufacturer.

JSC "Tekhnoloh".

Manufacturer's Location and Address of Business Activity.

8 Stara Prorizna Street, Uman, Cherkasy Oblast, Ukraine, 20300.