Paxabel 10 g powder for oral solution - helps with constipation 20 bags

Product Description

Symptomatic treatment of constipation in adults and children over 8 years of age.

Indications

Paxabel 10 g should be considered a temporary adjuvant treatment to be combined with an appropriate lifestyle and dietary regimen for constipation, with a maximum course of therapy of 3 months in children. If symptoms persist despite associated dietary measures, a pre-existing pathology should be suspected and treated.

Composition

Active ingredients

Each sachet contains 10 g of macrogol 4000.

Excipients

Sodium saccharin (E954), artificial flavour (orange-grapefruit).
Composition of the artificial orange-grapefruit flavour: orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethylbutyrate, alpha-terpineol, octanal, beta-gammahexenol, maltodextrin, gum arabic, sorbitol.

Directions for use and Dosage

For oral use. 1-2 sachets per day, preferably taken as a single dose in the morning. Each sachet should be dissolved in a glass of water shortly before use.
The effect of Paxabel occurs within 24-48 hours of administration.
In children, treatment should not exceed 3 months, in the absence of clinical data on the use of the product for periods longer than 3 months.
The regularization of intestinal motility induced by treatment should be maintained with lifestyle and dietary measures.
The daily dose must be adapted based on the clinical effect obtained and can be increased. vary from 1 sachet every other day (especially in children) up to 2 sachets per day.

Warnings

The treatment of constipation with any medicinal product should be considered an adjunct to an appropriate lifestyle and a healthy diet. Patients with hereditary problems of fructose intolerance should not take Paxabel.
In case of diarrhea, special precautions must be taken in patients predisposed to disturbances of fluid and electrolyte balance (i.e. patients with impaired liver and kidney function or patients undergoing treatment with diuretics) and the patient's electrolyte profile must be monitored.

Very rare cases of hypersensitivity reactions (rash, urticaria, edema) have been reported with drugs containing polyethylene glycol.
Exceptional cases of anaphylactic shock have been reported. Paxabel, since it does not contain significant amounts of sugars or polyols, can also be prescribed to diabetic patients or those on a galactose-free diet.

Contraindications

Severe organic inflammatory diseases of the colon (such as ulcerative colitis, Crohn's disease), toxic megacolon associated with symptomatic stenosis. Gastrointestinal perforation or risk of gastrointestinal perforation. Ileus or suspected intestinal obstruction. Abdominal pain of undetermined cause. Known individual hypersensitivity to macrogol (polyethylene glycol) or any of the excipients of the product.

Interactions

Not applicable.

Undesirable effects

During clinical studies in 147 children aged between 6 months and 15 years and from post-marketing experience, undesirable effects have been reported with the frequencies indicated below.
These effects were always minor and transient and were observed in the gastrointestinal system.
The frequency of adverse reactions is classified as follows:

very common (≥1/10);
common (≥1/100 to <1/10);
uncommon (from ≥1/1,000 to <1/100)
rare (from ≥1/10,000 to <1/1,000);
very rare (<1/10,000);
Not known (frequency cannot be estimated from the available data).

*Diarrhea may cause perianal soreness.
In adults, additional adverse reactions have been observed in clinical trials or post-marketing as follows:

Gastrointestinal disorders: Uncommon: urgency to defecate, faecal incontinence.
Metabolism and nutrition disorders:

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

Immune system disorders:

Not known: erythema Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Diarrhoea, abdominal pain and vomiting have been reported.
Diarrhea caused by overdose disappears upon temporary discontinuation of treatment or reduction of the dosage.
Excessive fluid losses due to diarrhea or vomiting may require corrective measures for electrolyte disturbances.

Pregnancy and breastfeeding

Pregnancy: Animal studies have not shown direct or indirect effects on reproductive toxicity.
There are insufficient data on the use of Paxabel in pregnant women (less than 300 pregnancy outcomes are known).
No adverse effects are expected during pregnancy, since systemic exposure to Paxabel is negligible.
Paxabel can be used during pregnancy.
Breastfeeding: There are no data on the excretion of Paxabel in human milk.
No effects on breast-fed newborns or infants are expected, since systemic exposure to macrogol 4000 in breast-feeding women is negligible.
Paxabel can be administered during breast-feeding.
Fertility: Fertility studies have not been conducted with Paxabel, but since macrogol 4000 is not significantly absorbed, no effects on fertility are expected.

Storage

No special storage precautions.

Format

20 sachets of 10 g