STADALAX 5 mg. 30 tablets
STADALAX 5 mg. 30 tablets
Qualitative and quantitative composition
Each gastro-resistant tablet contains 5 mg bisacodyl
For short-term treatment of constipation and in conditions requiring alleviation of defecation.
Dosage and method of administration
For adults and children over 6 years old - 1-2 tablets are equivalent to STADALAX 5-10mg disacodyl.
For optimal treatment results gastro-resistant tablets should be taken at night or in the morning on an empty stomach with plenty of fluid.
When taking the medicine in the evening enhancement of motility occurs after approximately 10 hours. When administered in the morning in the fasted state the effect on motility occurred after about 6 hours.
If the causes of constipation are unclear, the use of laxatives medicines should only be for a short period of time. Continued acceptance of STADALAX often worsens constipation. The etiology of chronic constipation should be clarified by research.
STADALAX should not be taken if:
- Known hypersensitivity to disacodyl or to any of the excipients.
- Ileus, bowel obstruction.
- Appendicitis or other conditions accompanied by acute abdomen.
- Children under 6 years of age.
- Acute infections of the gastrointestinal tract.
- Disorders of fluid and electrolyte balance.
- Severe renal failure.
Special warnings and precautions
Because the lactose content of this product is not suitable for patients with rare hereditary galactose diabetes, congenital lactose malabsorption or glucose-galactose malabsorption.
Because sucrose content this product is not suitable for patients with a rare, congenital fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase with deficits.
STADALAX can increase the loss of potassium ions induced by other drugs (eg. Diuretics).
Because of the loss of potassium ions can be increased susceptibility to cardiovascular active glycosides.
Dairy products and medicines neutralizing stomach acid (antacids) may be taken at least half an hour after taking STADALAX.
Use during pregnancy and lactation
There are no known data negatively effects during pregnancy and lactation, but no controlled clinical trials in this group of patients. STADALAX should not be used at high doses for prolonged periods or during pregnancy. STADALAX should not be used during breastfeeding because the information on the excretion of the drug in breast milk is insufficient.
Effects on ability to drive and use machines
In short-term treatment are rare side effects such as abdominal discomfort, colic, abdominal pain and diarrhea. Are described hypersensitivity reactions including isolated cases of anaphylactic reactions and angioedema. Prolonged use of STADALAX often worsen constipation. Therefore STADALAX should be taken only for a short period of time.
Prolonged use and high doses STADALAX are often associated with loss of water, potassium and other electrolytes. This can lead to disturbances in cardiac function, and muscle weakness, especially when simultaneously diuretics and corticosteroids.
Overdose can cause diarrhea and abdominal cramps. Treatment should be in accordance with the prevailing symptoms. If necessary should be taken to recover the loss of water and electrolytes.
Pharmacotherapeutic group: Contact laxatives
ATC code: A06AB02
Bisacodyl is a laxative medicine of the derivatives Triarylmethane that after biotransformation inhibits water reabsorption and increases the secretion of water and electrolytes. As a result, fecal ointments soften and liquefy, their volume increases, leading to an increase of peristalsis.
Bisacodyl is subjected to hydrolysis under the action of the enzymes in the intestinal mucosa. The resulting deacetylbisacodyl is absorbed and excreted in the bile as glucuronides. Difenolna active form of bisacodyl is obtained thanks to the release of glucuronic acid under the action of the bacterial flora in the colon. Enterohepatic circulation of the drug explains the rapid onset of effect in rectal administration compared to oral administration. Bisacodyl is excreted in the feces, mostly in the form of deacetylbisacodyl. Little honor is eliminated by the kidneys in the form of glucuronides. Nema information available on the plasma concentrations and the extent of binding proteins palzmenite basicodyl.
Preclinical safety data
a) Acute toxicity
The study of acute toxicity in various experimental animals did not show a significant sensitivity to bisacodyl.
b) Chronic Toxicity
The study of chronic toxicity in rats and mice showed no expression of toxic effects.
c) mutagenic and carcinogenic potential
Conducted long-term studies show no evidence of carcinogenic potential
Basicodyl did not show mutagenic potential in vitro studies (test of Ames) and in vivo (micronucleus test in rats).
d) Reproductive Toxicology
Studies in rats indicate a toxic effect on reproductive function at doses above 10 mg / kg daily. No evidence of teratogenic effects.
List of Utilities
Microcrystalline celullose, cellulose acetate phthalate, glucose syrup, glyceryl (momo, di, tri) alkanoate (C14 - C18) potato starch, lactose monohydrate, magnesium stearate (Ph, Eur), maize starch, castor oil, sucrose, colloidal anhydrous silica, talcum, montan glycol wax, titanium dioxide
One gastro-resistant tablet contains 0.4 mg glucose syrup, 51.8mg lactose monohydrate, 14.01mg sucrose.
Do not use after the expiry of shelf life specifications.
Advice for storage
Store in original container.
Not to be stored at temperatures higher than 25 ° C.