Casenlax 10 g 20 sachets powder for oral solution

Casenlax 10 g 20 sachets powder for oral solution is an osmotic laxative based on macrogol 4000 , specifically formulated for the symptomatic treatment of constipation (constipation) in both adults and children aged 8 years and over . Each sachet contains 10 g of active ingredient, ensuring an effective and delicate action to promote intestinal regularity and intestinal well-being.

The powder, with a pleasant apple flavor , dissolves easily in water, forming a clear and transparent solution that facilitates daily intake. Casenlax acts locally in the intestine, retaining water and softening the stool, without being absorbed by the body, thus reducing the risk of systemic effects. It is particularly suitable for those who suffer from intestinal problems such as abdominal swelling and difficulty evacuating, offering valid support to regain natural regularity.

Thanks to its tolerability and the absence of sugars or polyols, Casenlax 10 g is also suitable for diabetic patients or those following a galactose-free diet. The formulation in 20 single-dose sachets makes it practical to use both at home and away, easily integrating into a healthy lifestyle and a balanced diet. Choosing Casenlax means relying on a safe, effective and proven quality product for the treatment of constipation and the maintenance of intestinal health .

ACTIVE INGREDIENTS

Active ingredients contained in Casenlax 10 g 20 sachets powder for oral solution - What is the active ingredient of Casenlax 10 g 20 sachets powder for oral solution?

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

EXCIPIENTS

Composition of Casenlax 10 g 20 sachets powder for oral solution - What does Casenlax 10 g 20 sachets powder for oral solution contain?

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

DIRECTIONS

Therapeutic indications Casenlax 10 g 20 sachets powder for oral solution - Why is Casenlax 10 g 20 sachets powder for oral solution used? What is it used for?

Symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder must be excluded before starting treatment. Casenlax should remain a temporary adjunct to a lifestyle and dietary regimen appropriate for constipation, with a maximum treatment course of 3 months in children. If symptoms persist despite associated dietary measures, a different underlying cause should be suspected and treated.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Casenlax 10 g 20 sachets powder for oral solution - When should Casenlax 10 g 20 sachets powder for oral solution not be used?

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stenosis. - Perforation of the digestive tract or risk of perforation of the digestive tract. - Paralytic ileus or suspicion of intestinal obstruction. - Painful abdominal syndromes of undetermined nature.

DOSAGE

Quantity and method of taking Casenlax 10 g 20 sachets powder for oral solution - How to take Casenlax 10 g 20 sachets powder for oral solution?

Oral use Dosage 1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquid (e.g. water) after each dose. The effect of Casenlax occurs within 24-48 hours after administration. The daily dose should be adjusted according to clinical effects and can vary from one sachet every other day (especially in children) up to 2 sachets per day. Treatment should be discontinued gradually and resumed if constipation recurs. Paediatric population 1 to 2 sachets per day, preferably taken as a 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. The regularisation of intestinal motility induced by treatment will be maintained by lifestyle and dietary measures. Method of administration Each sachet should be dissolved in a glass of water (about 125 ml) just before use. The resulting solution will be clear and transparent like water.

CONSERVATION

Storage Casenlax 10 g 20 sachets powder for oral solution - How do you store Casenlax 10 g 20 sachets powder for oral solution?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Casenlax 10 g 20 sachets powder for oral solution - About Casenlax 10 g 20 sachets powder for oral solution it is important to know that:

Treatment of constipation with any medicine is only an adjunct to a healthy lifestyle and diet, for example: - Increased fluid and dietary fibre intake, - Adequate physical activity and re-education of intestinal motility. Due to the presence of sulphur dioxide Casenlax can rarely cause serious hypersensitivity reactions and bronchospasm. In case of diarrhoea, caution should be exercised in patients predisposed to disturbances of fluid and/or electrolyte balance (e.g. elderly, patients with hepatic or renal impairment or patients treated with diuretics) and monitoring of electrolytes should be considered. Hypersensitivity reactions (skin rash, urticaria and oedema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported. Casenlax contains an insignificant amount of sugars or polyols and can be prescribed to diabetic patients or patients on a galactose-free diet. This medicinal product contains less than 1 mmol sodium (23 mg) per sachet, i.e. essentially “sodium-free”. Based on the mechanism of action of macrogol, fluid intake is recommended during treatment with this medicinal product (see section 5.1). The absorption of other medicinal products may be temporarily reduced due to the increase in gastrointestinal transit rate induced by macrogol (see section 4.5).

INTERACTIONS

Interactions Casenlax 10 g 20 sachets powder for oral solution - Which medicines or foods can modify the effect of Casenlax 10 g 20 sachets powder for oral solution?

There is a possibility that the absorption of other medicinal products may be temporarily reduced during the use of Casenlax. The therapeutic effect of medicinal products with a narrow therapeutic index (e.g. antiepileptics, digoxin and immunosuppressive agents) may be particularly affected.

SIDE EFFECTS

Like all medicines, Casenlax 10 g 20 sachets powder for oral solution can cause side effects - What are the side effects of Casenlax 10 g 20 sachets powder for oral solution?

Undesirable effects are listed under headings of frequency using the following categories: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Adult population : 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 involved the gastrointestinal system:

Systems and organs	Adverse reactions
Immune system disorders
Very rare	Hypersensitivity reactions (pruritus, skin rash, facial edema, Quincke's edema, urticaria, anaphylactic shock)
Not known	Erythema
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, Urgent defecation, Fecal incontinence

Paediatric population: The undesirable effects listed in the following table have been reported during 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 involved the gastrointestinal system:

Systems and organs	Adverse reactions
Immune system disorders
Not known	Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus)
Gastrointestinal disorders
Common	Abdominal pain, Diarrhea*
Uncommon	Vomiting, Bloating, Nausea

* Diarrhea may cause perianal pain Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .

OVERDOSE

Overdose Casenlax 10 g 20 sachets powder for oral solution - What are the risks of Casenlax 10 g 20 sachets powder for oral solution in case of overdose?

Overdose may result in diarrhea, abdominal pain, and vomiting, which resolve when treatment is temporarily stopped or the dosage is reduced. Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances. Aspiration has been reported when large volumes of macrogol (polyethylene glycol) and electrolytes have been administered via nasogastric tube. Neurologically compromised children with oromotor dysfunction are particularly at risk of aspiration.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Casenlax 10 g 20 sachets powder for oral solution.

Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). There are limited data (less than 300 pregnancy outcomes) from the use of Casenlax in pregnant women. Casenlax is not expected to cause any effects during pregnancy, since systemic exposure to Casenlax is negligible. Casenlax can be used during pregnancy. Breast-feeding There are no data on the excretion of Casenlax in human milk. Macrogol 4000 is not expected to cause any effects on the newborn/infant, since the systemic exposure to macrogol 4000 in breast-feeding women is negligible. Casenlax can be used during breast-feeding. Fertility No fertility studies have been conducted with Casenlax; however, since macrogol 4000 is not significantly absorbed, no effects are expected.

DRIVING AND USE OF MACHINERY

Taking Casenlax 10 g 20 sachets powder for oral solution before driving or using machines - Does Casenlax 10 g 20 sachets powder for oral solution affect driving or using machines?

Casenlax does not alter the ability to drive vehicles or use machines.