Tranzilan

INSTRUCTIONS for medical use of the medicinal product TRANZILAN (TRANSILANE)

Composition:

Active substance: powder of psyllium seed husk Ispaghula (Plantago ovata Forssk.) / powder of Ispaghula husk (Plantago ovata Forssk.);

100 g of oral suspension powder contains powder of psyllium seed husk Ispaghula (Plantago ovata Forssk.) 40.231 g;

1 sachet (7 g) contains powder of psyllium seed husk Ispaghula (Plantago ovata Forssk.) 2.816 g;

Excipients: sucrose, potassium hydrogencarbonate, anhydrous citric acid, sodium saccharin, lemon flavoring.

Pharmaceutical form. Powder for oral suspension.

Main physico-chemical properties: beige-colored powder.

Pharmacotherapeutic group.

Medicinal products for the treatment of constipation. Bulk-forming laxatives. Ispaghula (psylla seeds).

ATC code A06A C01.

Pharmacological Properties

Pharmacodynamics

The active ingredient – psyllium husk powder – is produced from the outer seed coat and adjacent layers removed from the seeds of the plant Plantago ovata Forssk.

Psyllium husk powder is particularly rich in dietary fiber and mucilage, and can absorb an amount of water that exceeds its own weight by up to 40 times. It consists of 85% water-soluble fiber, is partially fermentable, and acts by absorbing water in the intestine.

Psyllium husk powder affects intestinal peristalsis and function through mechanical stimulation of the intestinal wall due to an increase in the volume of intestinal contents upon hydration, resulting also in reduced viscosity of intestinal contents. When taken with sufficient fluid, psyllium husk powder increases the volume and water content of intestinal contents, facilitating defecation; at the same time, the swollen mucilage mass acts as a lubricating layer, easing the passage of intestinal contents.

Onset of action

Psyllium husk powder acts as a laxative within 12–24 hours after a single dose. Sometimes, 2–3 days are required to achieve the maximum effect.

Pharmacokinetics

The partially soluble active ingredient absorbs water and swells, forming a gel.

Polysaccharides contained in certain dietary fibers are hydrolyzed to monosaccharides and absorbed by the intestine.

The xylose residues in the main chain and side chains are linked by β-glycosidic bonds, which cannot be broken down by human digestive enzymes.

Less than 10% of the mucilage is hydrolyzed in the stomach, releasing free arabinose. Intestinal absorption of arabinose is approximately 85–93%.

Dietary fibers are fermented to varying degrees by bacteria in the large intestine, resulting in the formation of carbon dioxide, hydrogen, methane, and short-chain fatty acids, which are absorbed and enter the bloodstream via the portal venous system to the liver. In humans, these fibers reach the colon in a highly polymerized form and are fermented to a certain extent, leading to an increased concentration of short-chain fatty acids in feces.

Clinical Characteristics
Indications

A herbal medicinal product for symptomatic treatment of constipation in adults.

Contraindications

Do not use in patients with gastrointestinal tract stenosis, esophageal or gastric cardia disorders, occult or manifest intestinal obstruction, intestinal paresis, or megacolon.

Do not use Transilane in patients with hypersensitivity to psyllium husk and seeds or to any of the excipients.

Patients with sudden changes in bowel function persisting for more than 2 weeks.

Unexplained rectal bleeding or absence of defecation after use of another laxative.

Inflammatory organic diseases of the colon (ulcerative colitis, Crohn's disease).

Abdominal pain of unknown origin.

Coproliths.

Patients who have difficulty swallowing or suffer from pharyngeal disorders.

Interaction with other medicinal products and other forms of interaction

Combinations requiring precautions

Concomitant use may reduce the rate of intestinal absorption of certain drugs, such as minerals (e.g., lithium), vitamins (B12), cardiac glycosides, coumarin derivatives, and carbamazepine. Therefore, Transilane should not be taken within half an hour to one hour before or after any other medicinal product.

Patients with diabetes mellitus should not take Transilane except under medical supervision, as adjustment of diabetes therapy may be required.

Psyllium husk should not be taken in combination with thyroid hormones except under medical supervision, as dose adjustment of thyroid hormones may be necessary.

Special precautions for use.

This medicinal product contains sucrose. It is not recommended for use in patients suffering from fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase/isomaltase deficiency.

One single dose of Transilane (2 teaspoons or 1 sachet) contains 2.32 g of sucrose, which should be taken into account in the daily diet of patients on a low-sugar diet or those with diabetes.

This medicinal product contains potassium: 273 mg of potassium in 2 teaspoons or 1 sachet. This should be considered in patients with renal impairment or those on a low-potassium diet.

Adequate fluid intake (at least 90 ml per 2 teaspoons or per 1 sachet) must always be maintained.

If Transilane is taken with insufficient fluid, it may cause obstruction of the throat or oesophagus and lead to respiratory shock. Associated symptoms include chest pain, vomiting, and difficulty swallowing or breathing.

Patients with intestinal obstruction, abdominal pain, nausea, or vomiting should consult a physician before using psyllium-based products, as these symptoms may indicate occult or overt intestinal obstruction.

In case of abdominal pain or irregular bowel movements, Transilane should be discontinued and medical advice sought.

Treatment of elderly and debilitated patients should be conducted under medical supervision. It is essential to ensure that elderly patients consume sufficient amounts of water.

To reduce the risk of intestinal obstruction, psyllium husk should not be taken in combination with drugs that inhibit intestinal peristalsis (e.g., opioids), except when used under medical supervision.

This medicinal product should be used with caution in patients with megacolon due to impaired colonic motility and in bedridden patients (risk of fecal impaction).

Prolonged use of the product for constipation treatment is not recommended.

Pharmacological treatment of constipation is only an adjunct to proper diet and adequate personal hygiene:

• Enrichment of the diet with vegetable fiber and fluids,
• Physical activity and exercises are recommended to normalize intestinal function.

For the treatment of children and adolescents, dietary measures are primarily used, and medical advice and physician consultation are necessary.

Laxatives should be prescribed to infants and children under 6 years of age only in exceptional cases: the risk of disruption of normal intestinal and defecation function should be considered.

Warnings regarding risk of hypersensitivity

Allergic reactions may occur in individuals who have prolonged exposure to psyllium husk (e.g., healthcare workers or caregivers) upon inhalation of the powder. This may sometimes cause hypersensitivity reactions (potentially severe).

It is recommended to assess the risk of allergic reactions in such individuals, and, if justified, specific tests for hypersensitivity should be performed.

In case of a hypersensitivity reaction, all contact with the product must be immediately discontinued.

Use during pregnancy or breastfeeding.

Clinical studies have not so far shown any teratogenic or fetotoxic effects associated with the use of Transilane. However, monitoring data in pregnant women who have taken psyllium husk are insufficient (only 300 pregnancies monitored) to exclude all risks.

Animal studies on reproductive toxicity are insufficient.

Therefore, this medicinal product should not be used during pregnancy or breastfeeding except when absolutely necessary and when any dietary modifications have proven ineffective.

Bulk-forming laxatives should be used primarily before any other laxatives.

No effect on fertility was observed in rats after oral administration of the product.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration

For oral use in adults: take 2 full teaspoons or 1 sachet 1–3 times daily.

Empty the powder into a large glass and add room temperature water. Stir and drink immediately.

Avoid inhaling the powder during preparation to reduce the risk of sensitization to psyllium husk. Do not use the medication in dry form!

At the beginning of treatment, the first effect may be observed within 12–24 hours.

Duration of treatment

If symptoms persist after 3 days of treatment, consult a physician or pharmacist.

Children

Transilane is not recommended for children and adolescents under 18 years of age (see section "Special precautions for use").

Overdose

Symptoms of overdose may include: abdominal pain, flatulence, and intestinal obstruction.

Adequate fluid intake should be maintained, and treatment should be symptomatic.

Adverse reactions.

Gastrointestinal disorders

At the beginning of treatment, flatulence, abdominal pain, nausea, and vomiting may occur, which usually disappear during treatment. Frequency unknown.

Abdominal distension and risk of esophageal or intestinal obstruction due to formation of fecal concretions, especially if the medicine is taken with insufficient water. Frequency unknown.

Immune system disorders

Psyllium seed husk contains potent allergens. Exposure to these allergens may occur during oral intake, skin contact, or inhalation of the powder form of the medicine.

In individuals exposed to the medicine, hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm, and occasionally anaphylaxis may develop.

Skin-related symptoms such as exanthema and/or pruritus have also been reported. Particular attention should be paid to individuals who regularly handle the medicine in powder form. Frequency of these effects is unknown.

Shelf life. 3 years.

Do not use the medicine after the expiry date stated on the packaging.

Storage conditions.

Store in a dry place at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

140 g of powder for oral suspension in a bottle, 1 bottle in a cardboard box.

7 g of powder for oral suspension in sachet, 20 sachets in a cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

Innothera Chouzy, France.

Address of manufacturer.

Rue René Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.

Marketing authorization holder.

Laboratoire Innotech International, France.

Address of marketing authorization holder.

22 avenue Aristide Briand, 94110 Arcueil, France.