Casenlax 10 g Macrogol 4000 Laxative Powder For Oral Solution 20 Sachets

Macrogol 4000 sachets with powder for oral suspension.

Therapeutic indications

Casenlax is used in the short-term treatment of occasional constipation.

Dosage and Posology

The drug should be taken according to the following doses and methods:

• Adults: 1 to 2 sachets per day, preferably taken as a single dose in the morning. The effect of Casenlax occurs within 24-48 hours after administration. The daily dose should be adapted according to the clinical effects and can vary from one sachet every other day (especially in children) up to 2 sachets per day.
• Pediatric population: 1 to 2 sachets per day, preferably taken as a single dose in the morning. In children, treatment should not exceed 3 months due to lack of clinical data in treatments lasting more than 3 months. Treatment-induced intestinal motility regularization will be maintained by lifestyle and dietary measures.

Each sachet should be dissolved in a glass of water (approximately 125ml) just before use. The resulting solution will be clear and transparent like water.

Overdose

Overdose can lead to diarrhea which disappears when treatment is temporarily stopped or the dosage is reduced. Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances. Cases of aspiration have been reported when large volumes of macrogol (polyethylene glycol) and electrolytes were administered via a nasogastric tube. Neurologically impaired children suffering from oromotor dysfunction are particularly at risk of aspiration.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Serious inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stricture
• Perforation or risk of perforation of the digestive tract;
• Ileus or suspected intestinal obstruction;
• Acute abdominal pain or of unknown origin;
• Nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding;

Side effects

Undesirable effects are listed by frequency using the following categories: Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known (frequency cannot be estimated from the available data).

The undesirable effects listed in the following table have been reported in clinical trials including 600 adult patients and in post-marketing experience. In general, adverse reactions were mild and transient and mainly concerned the gastrointestinal system:

- Disorders of the immune system

• Very rare: Hypersensitivity reactions (pruritus, rash, face edema, Quincke's edema, urticaria, anaphylactic shock)

- Metabolism and nutrition disorders

• Not known: Electrolyte disturbances (hyponatremia, hypokalaemia) and / or dehydration, especially in elderly patients

- Gastrointestinal disorders

• Common: Abdominal pain and / or distension: Diarrhea, Nausea
• Uncommon: Vomiting, Defecatory urgency Faecal incontinence

Pediatric population

The undesirable effects listed in the following table have been reported in clinical trials involving 147 children aged 6 months to 15 years and in post-marketing use. As in the adult population, adverse reactions were generally mild and transient and mainly concerned the gastrointestinal system:

- Disorders of the immune system

• Not known: Hypersensitivity reactions

- Gastrointestinal disorders

• Common: Abdominal pain, Diarrhea *
• Uncommon: Vomiting, Swelling, Nausea

* Diarrhea can cause perianal pain

Pregnancy and breastfeeding

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are limited data from the use of Casenlax in pregnant women (less than 300 exposed pregnancies). Casenlax is not expected to cause effects during pregnancy, since systemic exposure to Casenlax is negligible. Casenlax can be used during pregnancy.

There are no data on the excretion of Casenlax in human milk. Macrogol 4000 is not expected to cause effects on newborns / infants, since systemic exposure to macrogol 4000 of breastfeeding women is negligible. Casenlax can be used during breastfeeding.

Special warnings

The treatment of constipation with any medicine is only an adjuvant to a healthy lifestyle and diet, for example: Increased intake of liquids and dietary fiber, Adequate physical activity and re-education of intestinal motility. Due to the presence of sulfur dioxide Casenlax can rarely cause severe hypersensitivity reactions and bronchospasm.

In the event of diarrhea, caution should be exercised in patients predisposed to fluid and / or electrolyte balance disturbances (e.g. the elderly, patients with hepatic or renal impairment or patients receiving diuretics) and electrolyte control should be considered. Hypersensitivity reactions (rash, urticaria and edema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported. Casenlax contains an insignificant amount of sugar or polyols and can be prescribed to diabetic patients or to patients on a galactose-free diet.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store in the original package in order to protect from moisture.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One sachet of Casenlax Powder contains:

Active principle

Macrogol 4000 g 9.736.

Excipients

Natural flavor, maltodextrin, gum arabic E414, sulfur dioxide E220, alpha tocopherol E307.