CASENLAX OS POLV 20BUST 10G

CASENLAX 10 G POLVER FOR ORAL FUTURE IN BUSTINA

active ingredients

Each bag contains 10 g macrogol 4000. Excipients with known effects: 0.0000018 mg of sulphur dioxide (E220) per sachet and less than 1 mmol (23 mg) sodium per sachet. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium saccharin (E954), apple aroma* *Composition of apple aroma: Natural aroma, maltodextrin, gum arabica E414, sulphur dioxide E220, alpha tocopherol E307.

Therapeutic indications

Symptomatic treatment of stypsis in adults and children aged 8 and over. An organic disorder must be excluded before starting treatment. Casenlax must remain a temporary treatment adjuvant to a lifestyle and a food regime appropriate for stipsi, with a maximum treatment cycle of 3 months in children. If the symptoms persist despite the associated dietary measures, a different underlying cause must be suspected and treated.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Severe intestinal inflammatory disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stenosis. - Perforation of the digestive system or risk of drilling of the digestive system. - Paralytical ileum or suspected of intestinal obstruction. - Dolorous abdominal syndromes of undetermined nature.

Population

Oral use Population From 1 to 2 sachets per day, preferably taken in single dose in the morning. It is recommended to drink 125 ml of liquid (e.g. water) after each dose. The Casenlax effect occurs within 24-48 hours after administration. The daily dose must be adapted according to the clinical effects and may vary from a bag to alternate days (especially in children) up to 2 sachets per day. The treatment must be stopped gradually and resumed if the stipsi is resumed. Pediatric population From 1 to 2 sachets per day, preferably taken in single dose in the morning. It is recommended to drink 125 ml of liquid (e.g. water) after each dose. In children, treatment should not exceed 3 months due to the lack of clinical data in treatments lasting more than 3 months. Regularization of intestinal motility induced by treatment will be maintained by lifestyle and dietary measures. Method of administration Each bag must be dissolved in a glass of water (about 125 ml) just before use. The resulting solution will be clear and transparent as water.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Treatment of stypsis with any medicine is only an adjuvant to a healthy lifestyle and diet, for example: - Increased intake of liquids and food fibers, - Adequate physical activity and re-education of intestinal motility. Due to the presence of Casenlax dioxide sulfur, it can rarely cause serious reactions of hypersensitivity and bronchospasm. In case of diarrhea, care should be taken in patients who are prepared for water and/or electrolytic disorders (e.g. seniors, patients with liver or kidney impairment or patients in treatment with diuretics) and electrolytes should be considered. Hypersensitivity reactions (skin rash, hives and edema) were reported with drugs containing macrogol (polyethyleneglycol). Exceptional cases of anaphylactic shock have been reported. Casenlax contains a non-significant amount of sugar or polyols and can be prescribed to diabetic patients or patients following a galactose-free diet. This medicine contains less than 1 mmol (23 mg) of sodium per bag, i.e. essentially “without sodium”. According to the macrogol action mechanism, it is recommended to take liquids during treatment with this medicine (see paragraph 5.1). The absorption of other medicines could be temporarily reduced due to the increase in gastrointestinal transit speed induced by macrogol (see paragraph 4.5).

Interactions

There is a possibility that the absorption of other medicines can be temporarily reduced during the use of Casenlax. The therapeutic effect of medicinal products can be particularly influenced by a narrow therapeutic index (e.g. antiepileptics, digoxin and immunosuppressant agents).

Effects

Side effects are listed by frequency using the following categories: Very common (≥1/10); common (≥1/100, Adult population: The side effects listed in the following table were reported during clinical studies that included 600 adult patients and post-marketing experience. In general, adverse reactions were mild and transient and mainly concerned the gastrointestinal system:

Systems and organs	Adverse reactions
Immune system disorders
Very rare	Hypersensitivity reactions (pruritus, rash, facial edema, Quincke edema, hives, anaphylactic shock)
Notable	Eritema
Disorders of metabolism and nutrition
Notable	Electrolyte disorders (hyponatriemia, hypokaliemia) and/or dehydration, especially in elderly patients
Gastrointestinal diseases
Town	Abdominal pain and/or distension, Diarrhea, Nausea
Not common	Vomito, Defectory Urgence, Fecal Incontinence

Pediatric population: The side effects listed in the following table were reported during clinical studies that involved 147 children aged between 6 months and 15 years and post-marketing. As in the adult population, adverse reactions were generally mild and transient and mainly concerned the gastrointestinal system:

Systems and organs	Adverse reactions
Immune system disorders
Notable	Hypersensitivity reactions (anaphylactic shock, angioedema, hives, rash, itching)
Gastrointestinal diseases
Town	Abdominal pain, Diarrhea*
Not common	Vomito, Gonfiore, Nausea

* Diarrhea can cause perianal pain Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Overdose can lead to diarrhea, abdominal pain and vomiting that disappears when the treatment is temporarily interrupted or the dosage is reduced. Excessive liquid loss due to diarrhea or vomiting may require correction of electrolytic imbalances. Intake cases were reported when large volumes of macrogol (polyethyleneglycol) and electrolytes were administered with nose-gaster sondin. Neurologically compromised children who suffer from hormonal dysfunction are particularly at risk of aspiration.

Pregnancy

Animal studies show no direct or indirect harmful effects of reproductive toxicity (see paragraph 5.3). The data relating to the use of Casenlax in pregnant women are limited (less than 300 pregnancies exposed). Casenlax is not believed to cause effects during pregnancy, since systemic exposure to Casenlax is negligible. Casenlax can be used during pregnancy.

Food

There is no data on Casenlax's excretion in breast milk. It is not believed that macrogol 4000 can cause effects on infants/ infants, since systemic exposure to macrogol 4000 of nursing women is negligible. Casenlax can be used during breastfeeding.

Fertility

No fertility studies have been conducted with Casenlax; however, since macrogol 4000 is not significantly absorbed, no effects are expected.

Source: Farmadati