Alaxa 5mg 20 gastro-resistant tablets

Alaxa 5mg 20 gastro-resistant tablets is a medicine indicated for the short-term treatment of occasional constipation . Each tablet contains bisacodyl 5 mg as the active ingredient, known for its effectiveness in promoting intestinal transit. The tablets are designed to be gastro-resistant , ensuring that the active ingredient is released into the intestine, where it is most effective. This medicine is formulated with excipients such as lactose monohydrate and sucrose , which contribute to its stability and absorption. Alaxa is a targeted solution for those looking for an effective remedy against constipation, with a rapid and targeted action.

ACTIVE INGREDIENTS

Active ingredients contained in Alaxa 5mg 20 gastro-resistant tablets - What is the active ingredient of Alaxa 5mg 20 gastro-resistant tablets?

Each gastro-resistant tablet contains: Active substance: bisacodyl 5 mg; Excipients with known effect: lactose monohydrate, sucrose, sodium carboxymethylcellulose. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Alaxa 5mg 20 gastro-resistant tablets - What does Alaxa 5mg 20 gastro-resistant tablets contain?

Tablet core : lactose monohydrate , maize starch, magnesium stearate, gelatin. Gastro-resistant film coating : diethyl phthalate, cellulose acetophthalate, talc. Sugar coating : acacia, sucrose , sodium carboxymethylcellulose, macrogol 6000, titanium dioxide, calcium carbonate, talc.

DIRECTIONS

Therapeutic indications Alaxa 5mg 20 gastro-resistant tablets - Why is Alaxa 5mg 20 gastro-resistant tablets used? What is it used for?

Short-term treatment of occasional constipation.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Alaxa 5mg 20 gastro-resistant tablets - When should Alaxa 5mg 20 gastro-resistant tablets not be used?

- Hypersensitivity to the active substance or to other chemically related substances or to any of the excipients listed in section 6.1. - Children under 3 years of age. - Generally contraindicated during pregnancy and breastfeeding (see section 4.6). - Subjects with acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration, acute surgical abdomen, appendicitis, gastroenteritis.

DOSAGE

Quantity and method of taking Alaxa 5mg 20 gastro-resistant tablets - How to take Alaxa 5mg 20 gastro-resistant tablets?

Dosage : 2 tablets per day; in particularly stubborn cases, 3 tablets. Paediatric population . Children aged between 3 and 12 years : 1-2 tablets per day (0.3 mg/kg) under direct medical supervision. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses indicated. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. Method of administration : The tablets should be swallowed whole, without chewing, together with an adequate quantity of water (a large glass). A diet rich in liquids promotes the effect of the medicine. The tablets should preferably be administered after the evening meal, so that the effect of the laxative, which occurs after 10-12 hours, does not disturb sleep. If taken on an empty stomach, the laxative effect occurs within approximately 5 hours. Take ALAXA at ​​least 1 hour after taking milk or antacids and at least two hours after taking other oral medications.

CONSERVATION

Storage Alaxa 5mg 20 gastro-resistant tablets - How to store Alaxa 5mg 20 gastro-resistant tablets?

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

WARNINGS

Warnings Alaxa 5mg 20 gastro-resistant tablets - About Alaxa 5mg 20 gastro-resistant tablets it is important to know that:

Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypokalemia may occur, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can also cause dependence (and therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Frequent or prolonged use of the medicine should be avoided as it can cause addiction and atonic colitis. Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and monitoring during therapy. Caution is recommended if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks; when rectal bleeding is present; when the use of a laxative fails to produce effects or when the patient suffers from diabetes mellitus, hypertension or heart disease. It is also advisable for elderly or unhealthy subjects to consult their doctor before using the medicine. Paediatric population : In children under 12 years of age, the medicine can only be used after consulting your doctor. Important information about some of the excipients: ALAXA contains: - lactose monohydrate: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine; - sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. - sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

INTERACTIONS

Interactions Alaxa 5mg 20 gastro-resistant tablets - Which medicines or foods can modify the effect of Alaxa 5mg 20 gastro-resistant tablets?

Milk or antacids may alter the effect of the medicine; leave an interval of at least one hour before taking the laxative. Concomitant use of diuretics, cardiac glycosides or adrenocorticosteroids may promote electrolyte imbalance. Laxatives may reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid taking laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.

SIDE EFFECTS

Like all medicines, Alaxa 5mg 20 gastro-resistant tablets can cause side effects - What are the side effects of Alaxa 5mg 20 gastro-resistant tablets?

Occasionally: isolated cramping pain or abdominal colic. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Alaxa 5mg 20 gastro-resistant tablets - What are the risks of Alaxa 5mg 20 gastro-resistant tablets in case of overdose?

Excessive doses may cause abdominal pain and diarrhea; the resulting fluid and electrolyte losses must be replaced. Muscle weakness and weight loss may occur. In case of accidental overdose, gastric lavage is indicated. See also paragraph 4.4 regarding laxative abuse.

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 Alaxa 5mg 20 gastro-resistant tablets.

There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or breastfeeding. Therefore, the medicinal product should be used only when necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or the infant.

DRIVING AND USE OF MACHINERY

Taking Alaxa 5mg 20 gastro-resistant tablets before driving or using machines - Does Alaxa 5mg 20 gastro-resistant tablets affect driving or using machines?

There are no restrictions. However, those who perform an activity that requires vigilance should exercise caution.