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Pursennid 30 tablets minsan 004758049

  • Haleon Italy S.r.l.
  • 004758049

- Occasional constipation treatment

- From 10 years of age

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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 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 event Adverse event
Disorders of the immune system
Not known Hypersensitivity reactions (itching, hives, local or generalized rash)
Gastrointestinal disorders
Not known Megacolon
Abdominal pain
Diarrhea
Nausea
Abdominal discomfort
General disorders and administration site conditions
Not known Fatigue
Tolerance to the drug
Musculoskeletal and connective tissue disorders
Not known Myopathy
Renal and urinary disorders
Not known Kidney problems
Not known Chromaturia
Metabolism and nutrition disorders
Not known Hyperaldosteronism
Hypocalcemia
Hypomagnesemia
Dehydration
Hypokalemia
Hyponatremia
Decrease in blood electrolytes
Vascular pathologies
Not known Hypotension

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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 you have a rash, as it can be a sign of hypersensitivity; - if nausea and vomiting are present, as these symptoms may be signs of a potential or existing intestinal blockage (ileus); - in children between 10 and 12 years.Information relating to excipients. - Lactose: Patients with rare hereditary problems of galactose intolerance, total 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 adequate data on the use of sennosides in pregnant women. Animal studies did not show reproductive toxicity. The potential risk for humans is unknown. Pregnant women should consult their doctor before taking this medicine.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.

Expiration 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

SymptomsThe 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.ManagementTreatment 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. Additional treatment modalities should take into account clinical indications or the recommendation of the poison control center, where available.

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

Data sheet

Packaging
12 mg 30 compresse rivestite
Product Type
HUMAN DRUG
ATC code
A06AB06
ATC description
Senna glycosides
Therapeutic Group
Laxatives
Active principle
senna leaf pure glycosides
Class
C.
Pharmaceutical form
coated tablets
Type of Administration
oral
Container
blister
Quantity
30 coated tablets
Quantity of the Active Ingredient
12MG
Recipe required
OTC - self-medication medicine
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