PURSENNID*30CPR RIV 12MG

004758049
6 Items

- Occasional constipation treatment

- From 10 years of age

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004758049
6 Items

PURSENNID*30CPR RIV 12MG

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

Dosage Adults and children over 12 years of age: 2-4 coated tablets per day. Children between 10 and 12 years: 1-2 coated tablets per day.After a short period of treatment without noticeable results, consult your doctor. The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Pediatric population: Contraindicated in children under 10 years of age. Method of administration: Take preferably in the evening. The action of Pursennid manifests itself after 6-12 hours. Given in the evening, the effect of Pursennid appears the next morning. 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. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Contraindicated if the following medical conditions exist: - Inflammatory diseases of the digestive system (ie Crohn's disease, ulcerative colitis, liver disease, peritonitis and inflammatory bowel diseases). - Irritation or obstruction of the gastrointestinal tract (ie spastic constipation, obstruction of the ileum / preileus, cramps and pains, nausea, vomiting and colic). - Abdominal symptoms which may be due to an undiagnosed underlying condition, such as acute bowel conditions which may require surgery (eg acute diverticulitis, appendicitis and massive diarrhea). - States of severe dehydration, with loss of water and electrolytes, especially hypokalemia. Contraindicated in children under 10 years of age.

Side effects

This medicine can cause mild abdominal discomfort such as abdominal pain, cramps, irritation of the colonic and gastric mucosa. Other effects such as dehydration, hypotension, fatigue, myopathy, stomach pain, hyponatremia, renal disorders, secondary aldosteronism, hypocalcemia and hypomagnesaemia have also been reported. These adverse reactions are usually reversible once the laxative is stopped. Prolonged use or overdose of this drug can cause nausea, diarrhea with excessive loss of electrolytes, especially potassium (hypokalemia). There is also the possibility of developing megacolons. A brownish-yellow (pH-dependent) discoloration of the urine due to metabolites may occur during treatment and is of no clinical significance. Habituation has been reported after prolonged treatment. Adverse reactions are listed below by system organ classes and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, uncommon (≥ 1 / 1,000, rare (≥ 1 / 10,000; very rare (not known (cannot be estimated from the available data)). Table 4-1 Undesirable effects in post-marketing experience.

Frequency of adverse eventAdverse event
Gastrointestinal disorders
Not knownMegacolon
Abdominal pain
Diarrhea
Nausea
Abdominal discomfort
General disorders and administration site conditions
Not knownFatigue Drug tolerance
Musculoskeletal and connective tissue disorders
Not knownMyopathy
Renal and urinary disorders
Not knownKidney problems
Not knownChromaturia
Metabolism and nutrition disorders
Not knownHyperaldosteronism
Hypocalcemia
Hypomagnesemia
Dehydration
Hypokalemia
Hyponatremia
Decrease in blood electrolytes
Vascular pathologies
Not knownHypotension

The adverse events listed above are based on post-marketing spontaneous reports and represent a less accurate estimate of the incidence that would be obtained in clinical trials. Pediatric population: The same frequency, type and severity of adverse events are expected in children and adults. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed on the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

The established dose should not be exceeded. Prolonged indiscriminate use of laxatives can lead to addiction and deterioration of intestinal functions. The lowest effective dosage should be used to restore normal bowel function. If no intestinal improvement has been achieved, the dosage can be increased under medical supervision. Products containing senna and sennosides should only be used if a therapeutic effect cannot be obtained through a change in diet or the administration of bulking agents. The use of these drugs requires medical supervision: - if there are no positive effects following the treatment; - if use is extended beyond one week of treatment; - if symptoms persist or worsen; - after a laparotomy or abdominal surgery; - if there are skin rashes, nausea and vomiting; - in children between 10 and 12 years; - during pregnancy and breastfeeding. Information relating to excipients: - Lactose: Patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine. - Glucose: Patients with rare glucose-galactose malabsorption problems 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.

Pregnancy and breastfeeding

Pregnancy: There are no reports of side effects or harm during pregnancy and the fetus at the recommended dosage regimen. However, following experimental data regarding the genotoxic risk of various anthraquinones, emodin and aloe-emodin, use during pregnancy is not recommended. Feeding time: Use during lactation is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of metabolites (reine) are excreted in breast milk. No laxative effect has been reported on breastfed infants. Fertility: Preclinical studies with sennosides do not indicate particular risks for fertility at therapeutically relevant doses.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Concomitant use of other drugs that induce hypokalaemia (eg diuretics, adrenocorticosteroids and licorice) may increase electrolyte imbalance. Hypokalaemia (resulting from the abuse of laxatives taken for a long time) enhances the action of cardiac glycosides and interferes with antiarrhythmic drugs, with other drugs that induce the return to sinus rhythm (quinidine) and with drugs that induce elongation of the QT interval.

Overdose

Symptoms The most important symptoms related to overdose / overuse are abdominal colic and severe diarrhea resulting in loss of fluids and electrolytes, which must be replaced. Diarrhea especially can cause potassium loss, which can lead to cardiac disorders and muscle weakness, particularly when cardiac glycosides, diuretics, adrenocorticosteroids, or licorice root are administered at the same time. Management Treatment should be supportive with generous amounts of fluids. Electrolytes, especially potassium, need to be monitored. This is particularly important in the elderly. Chronic overdose of anthraquinone drugs can cause toxic hepatitis.

Active principles

One coated tablet contains: - Active ingredient: sennosides A + B (as calcium salts) 12 mg - Excipients with known effects: Lactose monohydrate; anhydrous glucose; sucrose. For the full list of excipients, see section 6.1.

Excipients

Lactose monohydrate; stearic acid; talc; cornstarch; anhydrous glucose; sucrose; Arabic gum; anhydrous colloidal silica; titanium dioxide, cetyl palmitate.

004758049
6 Items

Data sheet

Active component
Sennosides
Problem
Occasional constipation

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