ALAXA 20CPR GASTR 5MG

ALAXA 5 MG COMPRESENT

active ingredients

Each gastrorexisting tablet contains: Active ingredient: bisacodile 5 mg; Excipients with known effects: lactose monohydrate, sucrose, carbossimetilcellulose soda. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: lactose monohydrate, corn starch, magnesium stearate, jelly. Gastro-resistant coating: diethylphalate, cellulose acetophthalate, talc. Sugar coating: acacia, sucrose, carbossimetilcellulose soda, macrogol 6000, titanium dioxide, calcium carbonate, talc.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

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

Population

Population: 2 tablets per day; in particularly stubborn cases, 3 tablets. Pediatric population. Children between 3 and 12 years: 1-2 tablets per day (0.3 mg/Kg) under direct medical control. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case. Method of administration: The tablets should be swallowed whole, without chewing, along with an adequate amount of water (a plentiful glass). A fluid-rich diet promotes the effect of the medicine. Tablets should preferably be given after the evening meal, so that the effect of laxative, which is produced after 10-12 hours, does not disturb sleep. If the intake occurs on an empty stomach, the laxative effect occurs within about 5 hours. Consumer ALAXA at least 1 hour after taking milk or antacids and at least two hours after taking other medicines by mouth.

Conservation

This medicine does not require any special storage temperature. Store in the original packaging, to protect the medicine from moisture.

Warnings

Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, moreover, especially those of contact, (stimulating laxatives), can cause dependence (and therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). The frequent or prolonged use of the medicinal product must be avoided as it can cause acute and atonic colitis. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. It is recommended caution if the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks; when there is rectal bleeding; when the use of laxative fails to produce effects or when the patient is suffering from diabetes mellitus, hypertension or cardiopathy. You should also consult your doctor before using the medicine. Pediatric population: In children under 12 years, the medicine can only be used after consulting the doctor. Important information about some excipients: ALAXA contains: - lactose monohydrate: patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine; - sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. - sodio: This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’.

Interactions

Milk or antacids may change the effect of the medicinal product; let spend a range of at least an hour before taking the laxative. Concurrent use of diuretics, heart glycosides or adrenocorticosteroids can promote an electrolytic imbalance. Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative.

Effects

Occasionally: isolated crampiform pains or abdominal colics. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes must be replaced. It can manifest muscle weakness and weight loss. In case of accidental overdose the gastric lavender is indicated. See also in paragraph 4.4 about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore, the medicinal product must be used only if necessary, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or the infant.

Source: Farmadati