Casenlax

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KASENLAX (CASENLAX)

Composition:

Active substance: macrogol;

One sachet contains macrogol 4000 – 10 g;

Excipients: sodium saccharin, apple flavoring: natural flavoring, maltodextrin, gum arabic (E 414), sulfur dioxide (E 220), alpha-tocopherol (E 307);

Excipients with known effect:

sulfur dioxide (E 220) 0.002 mg in one sachet and sodium less than 1 mmol in one sachet.

Pharmaceutical form. Powder for oral solution.

Main physicochemical properties: free-flowing powder, white or almost white, with apple odor.

Pharmacotherapeutic group.
Laxatives. Osmotic laxatives. Macrogol. ATC code: A06AD15.

Pharmacological properties.

Pharmacodynamics.

Macrogols with high molecular weight (4000) are long-chain polymers that retain water molecules through hydrogen bonds. After oral administration, macrogol promotes an increase in fluid volume within the intestine. The volume of non-absorbed fluid in the intestine is responsible for the laxative effect of the solution.

Pharmacokinetics.

Pharmacokinetic studies confirm that after oral administration, macrogol 4000 is not absorbed in the gastrointestinal tract and does not undergo biotransformation.

Data from preclinical studies.

Toxicological studies conducted in various animal species have shown no evidence of systemic or gastrointestinal toxicity. Macrogol 4000 does not exhibit teratogenic or mutagenic effects.

Clinical characteristics.

Indications.

Symptomatic treatment of constipation in adults and children aged 8 years and older.

Contraindications.

• Hypersensitivity to macrogol or to any of the other components of the medicinal product;
• severe inflammatory bowel disorders (such as ulcerative colitis, Crohn's disease) or toxic megacolon associated with symptomatic stenosis;
• gastrointestinal perforation or risk of gastrointestinal perforation;
• ileus or suspicion of intestinal obstruction, symptomatic stenoses;
• abdominal pain of unknown origin.

Interaction with other medicinal products and other forms of interaction.

Concomitant administration of other medicinal products with Kaisenlax may result in a temporary delay in their absorption. This is particularly important to consider when using medicinal products with a narrow therapeutic index (e.g., antiepileptic agents, digoxin, and immunosuppressants), as their therapeutic effect may be compromised. It is recommended to administer Kaisenlax separately from other medicinal products, with an interval of at least 2 hours.

Special precautions for use.

Treatment of constipation with any medicinal product is only an auxiliary therapy provided that a healthy lifestyle and diet are maintained, namely: increased fluid and dietary fiber intake, appropriate physical activity, and restoration of normal bowel function.

Kasenlax contains sulfur dioxide, which rarely may cause severe hypersensitivity reactions and bronchospasm.

If diarrhea develops, caution is recommended in patients predisposed to disturbances in water-electrolyte balance (i.e., elderly patients, patients with impaired liver or kidney function, or patients taking diuretics); monitoring of electrolyte balance is advised.

Hypersensitivity reactions (rash, urticaria, pruritus, erythema) have been reported with medicinal products containing macrogol (polyethylene glycol). Anaphylactic shock and angioneurotic edema have also been reported (see section "Adverse reactions").

Kasenlax contains a negligible amount of sugar or polyol and therefore can be administered to patients with diabetes mellitus and to individuals whose diet excludes galactose.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.

Due to the mechanism of action of macrogol, it is recommended to consume adequate fluids during treatment with this medicinal product (see section "Pharmacological properties").

A temporary reduction in the absorption of other medicinal products taken concomitantly with Kasenlax may occur due to macrogol-induced acceleration of gastrointestinal transit (see section "Interaction with other medicinal products and other forms of interaction").

The maximum duration of treatment in children is no more than 3 months.

Persistent symptoms despite the use of the product and adherence to an appropriate diet may indicate other underlying pathologies requiring diagnosis and treatment.

Use during pregnancy or breastfeeding.

Pregnancy

Animal studies do not indicate a direct or indirect toxic effect on reproductive function (see section "Pharmacological properties").

Data on the use of Kasenlax in pregnant women are limited (fewer than 300 pregnancy outcomes).

No adverse effects during pregnancy are expected, as the systemic effect of the Kasenlax medicinal product is negligible. Kasenlax can be used during pregnancy.

Breastfeeding

There are no data on the excretion of Kasenlax into breast milk. No effects on breastfed newborns/infants are anticipated, as the systemic exposure to macrogol 4000 in breastfeeding women is negligible. Kasenlax can be used during breastfeeding.

Fertility

No studies on the effect of Kasenlax on fertility have been conducted. However, since macrogol 4000 is not significantly absorbed, no effect on fertility is expected.

Ability to influence the speed of reactions while driving or operating machinery.

Not established.

Dosage and Administration

The medicinal product is intended for oral administration.

Prior to initiating treatment, organic intestinal disorders should be excluded. Treatment of constipation with the medicinal product Casenlax should be a temporary adjunctive therapy, accompanied by lifestyle modifications and dietary adjustments to relieve constipation. The maximum duration of treatment in children should not exceed 3 months.

For adults: administer 1–2 sachets per day, preferably taken as a single dose in the morning. After each dose, it is recommended to drink 125 mL of fluid (e.g., water).

The first effect of the medicinal product usually occurs within 24–48 hours after administration.

The daily dose should be adjusted according to clinical response and may range from 1 sachet every other day (especially in children) up to 2 sachets per day.

Treatment should be discontinued gradually and may be resumed if constipation recurs.

Children

Dosage: 1 to 2 sachets per day, preferably taken as a single dose in the morning. After each dose, it is recommended to drink 125 mL of fluid (e.g., water).

The duration of treatment in children should not exceed 3 months due to the lack of clinical data on use beyond this period. Restoration of normal bowel function during treatment should be supported by adherence to hygienic and dietary recommendations.

Method of Administration

Immediately before use, dissolve the contents of one sachet in a glass of water (approximately 125 mL) to obtain a clear, colorless, water-like solution.

Children.

The medicinal product may be used in children aged 8 years and older.

Overdose.

Due to the absence of systemic absorption, overdose is unlikely.

Administration of an excessive dose may lead to diarrhea, abdominal pain, and vomiting. These symptoms resolve upon temporary discontinuation of the product or dose reduction.

Excessive fluid loss due to diarrhea or vomiting may require correction of disturbed fluid and electrolyte balance.

Cases of aspiration have been reported following administration of large volumes of macrogol (polyethylene glycol) and electrolytes via nasogastric tube. Children with neurological swallowing dysfunction are particularly susceptible to the risk of aspiration.

Adverse reactions.

Undesirable effects are classified by frequency of occurrence into the following categories:

very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000), not known (cannot be estimated based on available data).

Adults

Adverse effects listed in the table below were reported during clinical studies (involving 600 adults) and during post-marketing use.

In general, adverse reactions were mild and transient and mainly concerned the gastrointestinal system:

Children

The adverse effects listed in the table below were reported during clinical trials involving 147 children aged 6 to 15 years, as well as during post-marketing use. As in the adult population, adverse reactions were generally mild and transient, and primarily involved the gastrointestinal system:

*Diarrhea may cause painful sensations in the perianal area.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the use of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

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

Storage conditions. No special storage conditions required. Keep out of reach and sight of children.

Packaging. 10 or 20 sachets in a cardboard box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

Casen Recordati, S.L. /
Casen Recordati, S.L.

Manufacturer's address and place of business.

Autovia de Logrono, km. 13,300, Utebo, 50180, Zaragoza, Spain.
Autovia de Logrono, km. 13,300, Utebo, 50180, Zaragoza, Spain.