Pursennid 12 mg - constipation medicine 40 coated tablets

Product Description

Laxative tablets for the treatment of occasional constipation.

Indications

Pursennid 12 mg is a laxative tablet useful for the short-term treatment of occasional constipation.

Ingredients

Active ingredients
One coated tablet contains 12 mg of Sennosides A + B (as calcium salts).

Excipients
Lactose monohydrate; stearic acid; talc; corn starch; anhydrous glucose; sucrose; gum arabic; colloidal anhydrous silica; titanium dioxide, cetyl palmitate.

Directions for use and dosage

• Dosage Adults and children over 12 years of age: 2-4 coated tablets per day.
• Children between 10 and 12 years of age: 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 recommended doses.
When necessary, the dose can then be increased, but never exceed the maximum indicated.
Pediatric population:
Contraindicated in children under 10 years of age.

Method of administration:
Preferably take in the evening.
Pursennid's effect occurs after 6-12 hours.
If administered in the evening, the effect of Pursennid appears the following morning.
Laxatives should be used as infrequently as possible and for no more than seven days.
Use for longer periods requires a doctor's prescription after an appropriate evaluation of the individual case.
Swallow with an adequate amount of water (a large glass).
A diet rich in liquids promotes the effect of the medicine.

Warnings

The established dose should not be exceeded.
Prolonged indiscriminate use of laxatives can lead to habituation and deterioration of intestinal function.
The lowest effective dosage for the restoration of normal intestinal function should be used.
If no improvement in the intestinal function has been achieved, the dosage may be increased. Increased under medical supervision.
Products containing senna and sennosides should be used only if a therapeutic effect cannot be achieved through dietary changes or the administration of bulking agents.
The use of these drugs requires medical supervision:

• if no beneficial effects are achieved following treatment;
• if use is prolonged beyond one week of treatment;
• if symptoms persist or worsen;
• after laparotomy or abdominal surgery;
• if skin rashes, nausea, and vomiting are present;
• in children between 10 and 12 years of age;
• during pregnancy and breastfeeding.

Information about excipients:

• Lactose
  Patients with rare hereditary problems of Patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
• Glucose
  Patients with rare hereditary problems of 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.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Contraindicated in the following medical conditions:

• Inflammatory diseases of the digestive system (i.e., Crohn's disease, ulcerative colitis, liver disease, peritonitis and inflammatory bowel disease).
• Gastrointestinal tract irritation or obstruction (e.g., spastic constipation, obstruction of the ileum/preileum, cramps and pain, nausea, vomiting, and colic).
• Abdominal symptoms that may be due to an undiagnosed underlying condition, such as acute intestinal conditions that may require surgery (e.g., acute diverticulitis, appendicitis, and massive diarrhea).
• Severe dehydration, with loss of water and electrolytes, especially hypokalemia.

Contraindicated in children under 10 years of age.

Interactions

Concomitant use of other drugs that induce hypokalemia (e.g., diuretics, adrenocorticosteroids, and licorice) may increase electrolyte imbalance.
Side Effects

This medicine may cause mild abdominal discomfort such as abdominal pain, cramps, and irritation of the colon and gastric mucosa.
Other effects such as dehydration, hypotension, fatigue, myopathy, stomach pain, hyponatremia, renal disorders, secondary hyperaldosteronism, hypocalcemia, and hypomagnesemia have also been reported.
These adverse reactions are usually reversible once the laxative is discontinued.
Prolonged use or overdose of this medicine may cause nausea, diarrhea with excessive loss of electrolytes, especially potassium. (hypokalaemia).
There is also a possibility of developing megacolon.
During treatment, a yellow-brownish (pH-dependent) discoloration of the urine due to metabolites may occur, which has no clinical significance.
Habituation has been reported after prolonged treatment.
Adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1,000, <1/100); rare (≥ 1/10,000, <1/1,000); very rare (<1/10,000), or not known (frequency cannot be estimated from the available data).

Table 4-1 Undesirable effects from post-marketing experience

The adverse events listed above are based on spontaneous post-marketing reports and represent a less precise estimate of the incidence that would be obtained in clinical trials.
Paediatric population: The same frequency, type, and severity of adverse events are expected in children as in adults.

Overdose

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

Pregnancy and breastfeeding

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

Format

40 coated tablets of 12 mg