PURSENNID 40CPR RIV 12MG

PURSENNID 12 MG STATEMENTS

active ingredients

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

Excellent

Lactose monohydrate; stearic acid; talc; corn starch; glucose anidro; ; sucrose; arabic rubber; anidra colloidal silica; titanium dioxide; palmite cetile.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Contraindicated if the following medical conditions occur: - Inflammatory diseases of the digestive system (i.e. Crohn's disease, ulcerative rettocolitis, hepatopathies, peritonitis and intestinal inflammatory diseases); - Irritation or obstruction of gastrointestinal tract (i.e. spastic constipation, obstruction of the ileo/preilee, cramps and pains, nausea, vomiting and colic); - Abdominal symptoms that may be due to an undiagnosed underlying condition, such as acute intestinal conditions that may require surgery (i.e. acute diverticulitis, appendicitis and mass diarrhea); - states of severe dehydration, with water loss and electrolytes, especially hypopotassiemia. Contraindicated in children under 10 years of age.

Population

Population Adults and children over 12 years of age: 2-4 tablets coated daily. Children between 10 and 12 years: 1-2 tablets coated with giorno.Dopo short period of treatment without appreciable results consult your doctor. 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. Pediatric population Contraindicated in children under 10 years of age. Method of administration Preferably in the evening. The action of Pursennid is manifested after 6-12 hours. Administered in the evening, the effect of Pursennid appears the next morning. 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. Eating together with an adequate amount of water (a plentiful glass). A fluid-rich diet promotes the effect of the medicine.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The established dose should not be exceeded. Prolonged indiscriminate use of laxatives can lead to the absorption and deterioration of intestinal functions. The lowest effective dosage must be used to restore normal intestinal function. If no intestinal improvement has been achieved, the dosage can be increased under medical supervision. Products containing senna and sennoside should be used only if a therapeutic effect cannot be obtained through a diet change or the administration of mass forming agents. The use of these drugs requires medical supervision: - if there are no positive effects following treatment; - if use extends over a week of treatment;- if symptoms persist or worsen; - after a laparotomy or abdominal surgery; - if there is skin rash, because it can be a signal of hypersensitivity; - if there are nausea and vomiting, because these symptoms may be signs of a potential or existing intestinal block (ileo); - in children between 10 and 12 years. Information about excipients - Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. - Glucose: patients suffering from rare glucose-galactose mal absorption problems should not take this medicine. - Sustained patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Interactions

Concurrent use of other drugs that induce hypopotassiemia (i.e. diuretics, adrenocorticosteroids and licorice) can increase electrolytic imbalance. Hypopotassiemia (derive of 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 the sinus rhythm (chinidine) and with drugs that induce the extension of the Q-T range.

Effects

This medicine can cause mild abdominal discomfort such as abdominal pain, cramps, irritation of the colic and gastric mucosa. Other effects were also reported such as dehydration, hypotension, fatigue, myopathy, stomach pain, hypothremia, kidney disorders, secondary hyperaldosteronism, hypocalcemia and hypomagnesemia. These adverse reactions are usually reversible once the laxative is stopped. Prolonged use or overdosing of this drug can cause nausea, diarrhea with excessive loss of electrolytes, especially potassium (hypopotassiemia). There is also the possibility to develop megacolons. During the treatment, a yellow-brown color (pH-dependent) of urine may occur due to metabolites, which has no clinical meaning. It has been reported to be used after prolonged treatment. Adverse reactions are listed below according to organ system classes and frequency. The frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, not common (≥ 1/1.000, rare (≥ 1/10.000; very rare (not known (frequency cannot be defined on the basis of available data). Table 4-1 Undesirable effects in post-commercialization experience

Frequency of the adverse event	Adverse event
Immune system disorders
Notable	Reactions of hypersensitivity (pruritus, hives, local or generalized exantema)
Gastrointestinal disorders
Notable	Megacolon
	Abdominal pain
	Diarrea
	Nausea
	Abdominal disease
Systemic pathologies and conditions for administration
Notable	Fact
	Tolerance to the drug
Diseases of musculoskeletal system and connective tissue
Notable	Myopathy
Kidney and urinary pathologies
Notable	Renal problems
Notable	Chromatography
Disorders of metabolism and nutrition
Notable	Hyperaldosteronism
	Hypocalcemia
	Ipomagneseemia
	Dehydration
	Hypothalaemia
	Iponatremy
	Decrease of blood electrolytes
Vascular diseases
Notable	Hypotension

The adverse events listed above are based on post-market spontaneous reports and represent a less accurate estimate of the incidence you would gain in clinical studies. Pediatric population The same frequency, type and severity of adverse events in children and adults are foreseen. 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

Synonyms The most important symptoms related to overdose/excess use are abdominal colics and severe diarrhea with consequent fluid and electrolyte losses, which must be replaced. Diarrhea in particular can cause potassium loss, which can lead to heart disorders and muscle axenia, especially when administered at the same time heart glycosides, diuretics, adrenocorticosteroids or licorice root. Management Treatment must be of support with generous quantities of liquids. Electrolytes, especially potassium, must be monitored. This is particularly important in the elderly. A chronic overdose of anthraquinone-based drugs can cause toxic hepatitis. Additional treatment modes must take into account clinical indications or recommendation of the anti-veleni center, where available.

Pregnancy

There are no adequate data on the use of sennosides in pregnant women. Animal studies have not shown reproductive toxicity. The potential risk for man is not known. Pregnant women should consult the doctor before taking this medicine.

Food

Use during breastfeeding is not recommended since there is no sufficient data on the excretion of metabolites in breast milk. Small amounts of metabolites (reina) are excreted in breast milk. No laxative effect has been reported on breast-feededed infants.

Fertility

Preclinical studies with sennosides do not indicate special risks to fertility at therapeutically relevant doses.

Source: Farmadati