Defenorm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEFENORM (DEFENORM)

Composition:

Active substance: 1 capsule contains 500 mg of Plantago Psyllium L. (Psyllium husk);

Excipients: calcium stearate, talc, colloidal anhydrous silicon dioxide;

Composition of the hard gelatin capsule: gelatin, black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), yellow azo dye FCF (E 110).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: hard gelatin capsules with a brown body and an orange cap. The capsule contents – a light brown powder with brown specks.

Pharmacotherapeutic group. Laxatives. Intestinal volume-increasing agents. Preparations containing psyllium seed husk. ATC code A06AC01.

Pharmacological properties.

Pharmacodynamics.

The active substance of the medicinal product absorbs approximately 40 times its own weight in water. As a result, bowel movements become more voluminous, feces remain soft, intestinal peristalsis is stimulated, and passage rate increases.

Pharmacokinetics.

Due to the absence of absorption of the medicinal product from the gastrointestinal tract, pharmacokinetic studies have not been conducted. The seed husks are not broken down in the intestinal tract, thus no absorption occurs. In the colon, plant fibers are partially broken down by intestinal flora into unsaturated fatty acids, which exert a trophic and supportive effect on the intestinal mucosa.

Clinical characteristics.

Indications.

• Chronic constipation;
• conditions where soft, easy bowel movements are desirable, e.g., anal fissures, hemorrhoids, after surgical interventions in the rectal area;
• as an adjunctive agent in the treatment of diarrhea of various origins;
• irritable bowel syndrome.

Contraindications.

• Known hypersensitivity reaction to psyllium (Plantago psyllium L.), as well as increased sensitivity to any component of the medicinal product;
• presence of hard fecal masses (coproliths, clusters of hardened feces in the rectum or sigmoid colon);
• abdominal pain, nausea, and vomiting before medical diagnosis of their cause;
• following any sudden change in bowel function lasting more than 2 weeks;
• after using a laxative without subsequent defecation;
• unexplained rectal bleeding;
• difficulty swallowing or vomiting;
• esophageal stricture, cardiac orifice stricture, or other gastrointestinal tract strictures;
• risk of developing or existing intestinal obstruction (ileus), or megacolon syndrome;
• disturbances in fluid and electrolyte balance;
• conditions associated with restricted fluid intake;
• poorly controlled forms of diabetes mellitus (diabetes mellitus).

Interaction with other medicinal products and other forms of interaction.

A time interval of approximately 30–60 minutes should be maintained between the administration of Defenorm and other medicinal products, as intestinal absorption of other concurrently administered medicinal products—such as minerals (e.g., calcium, iron, lithium, zinc), vitamins (vitamin B12), cardiac glycosides, coumarins, and carbamazepine—may be delayed.

Bulk-forming agents and medicinal products that inhibit natural intestinal peristalsis (e.g., loperamide, opium tincture) must not be used simultaneously with this medicinal product, as intestinal obstruction may develop.

When using Defenorm, blood glucose levels may decrease due to slowed carbohydrate absorption. Therefore, patients with insulin-dependent diabetes mellitus may require a reduction in insulin dosage.

A reduced effect of thyroid hormones is possible, even when administered simultaneously.

Special precautions for use.

When using the medicinal product Defenorm, it is necessary to ensure the intake of sufficient fluid — at least 150 ml of water per single dose. Administration of the medicinal product without sufficient fluid may lead to esophagitis.

Defenorm must not be administered immediately before going to bed.

In diarrhea, the most important aspect of treatment is restoration of fluids and electrolytes.

The medicinal product must not be used in patients with dysphagia.

Weakened patients and elderly patients should be under medical supervision during treatment.

For patients concurrently using thyroid hormones, dose adjustment may be required.

Patients with insulin-dependent diabetes may require a reduced insulin dose due to slowed carbohydrate absorption.

Use during pregnancy or breastfeeding.

There are no contraindications regarding the use of the medicinal product Defenorm during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

No influence on the ability to drive or operate machinery has been observed.

Dosage and Administration.

For adults and children aged 12 years and older, take 1–2 capsules (500–1000 mg) of the medicinal product Defenorm 2–3 times daily, swallowing with sufficient amount of liquid (at least 150 ml per single dose).

If the medicinal product is prescribed as an adjunctive treatment for diarrhea or irritable bowel syndrome, take 1–2 capsules (500–1000 mg), swallowing with sufficient amount of liquid (at least 150 ml per single dose) 2–6 times daily.

If the patient has prolonged constipation and irregular bowel movements lasting more than 1 week, or diarrhea persisting for more than 2 days accompanied by blood in the stool or fever, medical advice must be sought.

To achieve a pronounced therapeutic effect, the patient should drink at least 1.5 liters of liquid per day.

If the patient misses a dose, treatment should be continued according to the recommended dosing regimen; do not double the dose.

Before interrupting or discontinuing treatment, it is advisable to consult a physician.

Children.

Defenorm should not be used in children under 12 years of age due to insufficient experience with the use of the medicinal product in this age group.

Overdose.

Symptoms.

If the medicinal product is taken in a dose exceeding the recommended amount, an intensification of such adverse reactions as abdominal pain, flatulence, and a sensation of intestinal fullness may occur.

Treatment.

First of all, drink sufficient amount of liquid. If necessary, the physician should prescribe symptomatic therapy.

Side effects.

Symptoms such as flatulence and a sensation of intestinal fullness may increase during the first days of treatment; however, they may disappear during continued therapy. In extremely rare cases (less than 1 in 10,000 treated patients), hypersensitivity reactions may occur, sometimes including reactions resembling anaphylaxis. One case of bronchospasm has been reported. In such cases, Defenorm medication must be discontinued and medical advice should be sought immediately.

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.

10 capsules in a blister; 3 blisters per carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.

INSTRUCTION

for medical use of medicinal product

DEFENORM

(DEFENORM)

Composition:

active substance: 1 capsule contains 500 mg of Plantago ovata husk (Plantago Psyllium L.);

excipients: calcium stearate, talc, colloidal anhydrous silicon dioxide;

composition of hard gelatin capsule: gelatin, black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), sunset yellow FCF dye (E 110).

Medicinal form. Hard capsules.

Main physico-chemical properties: hard gelatin capsules with brown body and orange cap. The capsule contents – light brown powder with brown specks.

Pharmacotherapeutic group. Laxatives. Agents increasing intestinal content volume. Plantago seed husk preparations. ATC code A06AC01.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the medicinal product absorbs approximately 40 times its own weight in water. Thus, feces become more voluminous, stools remain soft, intestinal peristalsis is stimulated, and passage rate increases.

Pharmacokinetics.

Due to lack of absorption of the medicinal product from the gastrointestinal tract, pharmacokinetic studies have not been conducted. The seed husk is not broken down in the intestinal tract, thus absorption does not occur. In the large intestine, dietary fibers are partially broken down by intestinal flora into unsaturated fatty acids, which exert trophic and supportive effects on the intestinal mucosa.

Clinical characteristics.

Indications.

• Chronic constipation;
• conditions where soft, easy defecation is desirable, e.g., anal fissures, hemorrhoids, after rectal surgery;
• as an adjunct in the treatment of diarrhea of various origins;
• irritable bowel syndrome.

Contraindications.

• Known hypersensitivity to Plantago (Plantago Psyllium L.) or increased sensitivity to any component of the medicinal product;
• hard stools (fecaloliths, accumulation of hardened feces in rectum or sigmoid colon);
• abdominal pain, nausea, and vomiting before medical diagnosis of their cause;
• after any sudden change in bowel function lasting more than 2 weeks;
• after using a laxative without defecation;
• unexplained rectal bleeding;
• difficulty swallowing or vomiting;
• esophageal stricture, esophageal cardia, or other gastrointestinal tract strictures;
• risk of developing or existing intestinal obstruction (ileus), or megacolon syndrome;
• fluid and electrolyte imbalance;
• conditions associated with restricted fluid intake;
• poorly controlled forms of diabetes mellitus.

Interaction with other medicinal products and other types of interactions.

An interval of approximately 30–60 minutes should be maintained between administration of Defenorm and other medicinal products, as intestinal absorption of other concurrently administered drugs such as minerals (e.g., calcium, iron, lithium, zinc), vitamins (vitamin B12), cardiac glycosides, coumarins, and carbamazepine may be delayed.

Laxatives and medicinal products that inhibit natural intestinal peristalsis (e.g., loperamide, opium tincture) must not be used simultaneously with this medicinal product, as intestinal obstruction may develop.

When using Defenorm, blood glucose levels may decrease due to slowed carbohydrate absorption. Therefore, insulin-dependent diabetic patients may require a reduction in insulin dosage.

A possible reduction in the effect of thyroid hormones may occur, even when administered simultaneously.

Special precautions.

During treatment with Defenorm, sufficient fluid intake must be ensured – at least 150 ml of water per single dose. Administration of the medicinal product without sufficient fluid intake may lead to choking.

Defenorm must not be taken immediately before bedtime.

In diarrhea, the most important aspect of treatment is rehydration and electrolyte replacement.

The medicinal product must not be administered to patients with dysphagia.

Frail patients and elderly patients should be under medical supervision during treatment.

For patients concurrently taking thyroid hormones, dose adjustment may be necessary.

Insulin-dependent diabetic patients may require a reduction in insulin dosage due to slowed carbohydrate resorption.

Use during pregnancy or breastfeeding.

There are no contraindications regarding the use of Defenorm during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

No effect on the ability to drive or operate machinery has been observed.

Method of administration and dosage.

For adults and children aged 12 years and older, take orally 1–2 capsules (500–1000 mg) of Defenorm 2–3 times daily, taken with sufficient fluid (at least 150 ml per single dose).

If the medicinal product is prescribed as an adjunct in diarrhea or irritable bowel syndrome, take 1–2 capsules (500–1000 mg), with sufficient fluid (at least 150 ml per single dose) 2–6 times daily.

If a patient has prolonged constipation and irregular bowel movements lasting more than 1 week, or diarrhea lasting more than 2 days accompanied by blood in stool or fever, medical consultation is necessary.

To achieve a pronounced therapeutic effect, at least 1.5 liters of fluid per day should be consumed.

If a patient forgets to take the dose, continue treatment according to dosing recommendations without increasing the dose.

Before stopping or discontinuing treatment, it is advisable to consult a physician.

Children.

Defenorm should not be used in children under 12 years of age due to insufficient experience with the medicinal product in this age group.

Overdose.

Symptoms.

If the patient takes a dose higher than recommended, side effects such as abdominal pain, flatulence, and sensation of intestinal fullness may intensify.

Treatment.

First of all, drink sufficient fluids. If necessary, the physician should prescribe symptomatic therapy.

Side effects.

Symptoms such as flatulence and sensation of intestinal fullness may increase during the first days of treatment; however, they may disappear during continued treatment. In extremely rare cases (less than 1 in 10,000 treated patients), hypersensitivity reactions may occur, sometimes including anaphylaxis-like reactions. One case of bronchospasm has been reported. In such cases, Defenorm must be discontinued and medical advice sought.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at temperatures not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 capsules in a blister; 3 blisters per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's location and address of business activity.

04073, Ukraine, Kyiv, Kopilovska St., 38.

Website: www.vitamin.com.ua.