Active ingredients: Bisacodyl
DULCOLAX 5 mg coated tablets
DULCOLAX adults 10 mg suppositories
Dulcolax package inserts are available for pack sizes: - DULCOLAX 5 mg coated tablets, DULCOLAX adults 10 mg suppositories
- DULCOLAX children 5 mg suppositories
Why is Dulcolax used? What is it for?
Dulcolax contains bisacodyl. It belongs to a group of medicines called contact laxatives.
Dulcolax works by stimulating the movements of the intestine, accelerating the passage of the contents of the intestine.
Dulcolax is used in adults, children and adolescents aged 2 to 18 years for the short-term treatment of occasional constipation.
Talk to your doctor if you don't feel better or if you feel worse after 7 days
Contraindications When Dulcolax should not be used
Do not take / give your baby Dulcolax
- if you and / or your child are allergic to bisacodyl or any of the other ingredients of this medicine
- if you and / or your child suffer from a stop in the progression of the intestinal contents due to a blockage of the muscles of the intestine (paralytic ileus);
- if you and / or your child suffer from acute abdominal conditions, such as inflammation of the appendix, part of the bowel (appendicitis), and severe stomach pain associated with nausea and vomiting which may be signs of serious illness;
- if you and / or your child suffer from obstruction or narrowing of the bowel (intestinal stricture);
- if you and / or your child suffer from acute inflammation of the stomach and intestines;
- if you and / or your child suffer from rectal bleeding of unknown origin, - if you and / or your child suffer from severe water loss from the body (state of dehydration);
- if you and / or your child suffer from a hereditary disease which may be incompatible with the intake of any of the excipients (see section 2. "Dulcolax contains lactose");
- if your child is under the age of 2;
- if you and / or your child suffer from anal fissures and ulcers do not take / do not give your child suppositories (pain and perianal bleeding may occur).
If you are pregnant or breast-feeding, see section "Pregnancy and breast-feeding".
Precautions for use What you need to know before taking Dulcolax
Talk to your doctor or pharmacist before taking / giving your child Dulcolax.
There have been reports of dizziness and / or fainting (syncope) after taking Dulcolax. The data relating to these cases suggest that the events, rather than a phenomenon related to the intake of Dulcolax, could be interpreted as a manifestation of "fainting (syncope) from defecation" (attributable to the effort of the "act of defecation), or as a reflex response to belly pain related to constipation itself. The use of suppositories can lead to painful sensations and local irritation, in particular, in the presence of fissures and inflammatory disease of the rectum (ulcerative proctitis) (see section "Do not take / do not give your child Dulcolax").
Like all laxatives do not take / do not give your child Dulcolax daily or for prolonged periods without your doctor having first assessed the cause of constipation. The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
In particular, consult your doctor:
- when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects.
- if you are elderly or in poor health.
- if you / your child have diabetes mellitus, high blood pressure (hypertension) or heart disease (heart disease).
Abuse of laxatives
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of fluids (dehydration) or decreased levels of potassium in the blood (hypokalaemia).
In severe cases, the decrease in potassium can cause heart or muscle disorders, especially if you are treated simultaneously with certain heart drugs (cardiac glycosides), with drugs that increase urine production (diuretics) or with those used to treat inflammation (corticosteroids).
Symptoms of intestinal fluid loss (dehydration) can be thirst and decreased urine output (oliguria).
Fluid loss (dehydration) can be dangerous if you / your child have reduced kidney function (kidney failure) or if you are elderly; then stop taking Dulcolax and consult your doctor.
Blood in the stool (haematochezia) may also occur, which is usually mild and goes away on its own.
Avoid frequent or prolonged use of the medicine as it can cause addiction and dependence (i.e. need to gradually increase the dosage and not be able to do without the medicine) as well as chronic constipation and loss of normal bowel functions (intestinal atony).
Children
In children between 2 and 10 years of age, the medicine can only be used after consulting your doctor.
Dulcolax should not be used in children younger than two years of age.
Interactions Which drugs or foods may change the effect of Dulcolax
Tell your doctor or pharmacist if you / your child are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking:
- diuretics (medicines that increase urinary excretion);
- adrenocorticosteroids (medicines to treat inflammation). If you use these medicines and excessive doses of Dulcolax may increase the risk of an imbalance of the elements contained in the blood (electrolytes). This imbalance, in turn, can lead to increased sensitivity to cardiac glycosides (medicines to treat heart conditions);
- antacids (medicines to treat heartburn). They can change the effect of the medicine; leave an interval of at least one hour before taking the laxative.
Laxatives can reduce the time spent in the intestine, and therefore, the absorption of other drugs administered simultaneously orally.
Therefore, avoid taking / giving your child laxatives and other drugs at the same time: after taking / giving your child a medicine, leave an interval of at least two hours before taking the laxative.
Dulcolax with drinks
Milk may change the effect of the medicine; leave an interval of at least one hour before taking / giving your baby the laxative.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate and well-controlled studies on the use of the medicine in pregnancy. Therefore, although no adverse or toxic effects have ever been reported during pregnancy, as with all medicines, if you are pregnant, use Dulcolax, only in case of need. , under the direct supervision of your doctor, after your doctor has assessed the expected benefit for you in relation to the possible risk to the fetus.
Pregnancy
Clinical data show that the active form of bisacodyl and its glucuronic derivatives do not pass into breast milk, however use the medicine only when needed, under the direct supervision of your doctor, after your doctor has assessed the expected benefit for you in relation to the possible risk to the infant.
Fertility
No studies have been conducted to investigate the effects on human fertility.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Due to the reflex response to belly pain due to the consequent constipation itself, eg. to abdominal spasm, dizziness and / or fainting (syncope) may occur. If you / your child experience belly pains (abdominal spasm) you must avoid potentially dangerous activities such as driving or operating machinery.
Dulcolax tablets contain lactose, sucrose and castor oil
Dulcolax tablets contain lactose: if your doctor has diagnosed you / your child with intolerance to some sugars, contact your doctor before taking this medicine.
Dulcolax tablets contain sucrose: if your doctor has diagnosed you / your child with intolerance to some sugars, contact your doctor before taking this medicine.
Dulcolax tablets contain castor oil: you / your child may experience stomach upset and diarrhea.
Dose, Method and Time of Administration How to use Dulcolax: Posology
Always take / give your child this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is as follows:
Coated tablets
Adults
1-2 coated tablets per day.
Use in children and adolescents
Children over 10 years: 1-2 coated tablets per day.
Children aged 2 to 10 years: 1 coated tablet per day.
Children aged 10 years and younger with chronic or persistent constipation should take Dulcolax only after consulting their doctor. Dulcolax should not be used in children younger than two years of age. It is advisable to start with the lowest expected dose.
The dose can then be increased, up to the maximum recommended dose, for regular stool evacuation.
The maximum daily dose should never be exceeded.
Take / give your child the coated tablets preferably in the evening to evacuate the next morning (after approximately 10 hours). When administered in the morning, on an empty stomach, the effect is achieved after approximately five hours.
Do not take / give your baby the coated tablets together with milk, bicarbonate or medicines to treat heartburn (antacids).
The coated tablets should be swallowed whole, together with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
The recommended dose is as follows:
Suppositories
Adults
1 adult suppository (10 mg).
Use in children and adolescents
Children over 10 years: 1 adult suppository (10 mg). Children aged 10 years and younger with chronic or persistent constipation should take Dulcolax only after consulting their doctor.
Dulcolax should not be used in children younger than two years of age.
The maximum daily dose should never be exceeded.
The suppositories must be deprived of the external wrapping and inserted in the rectum from the tip side.
The effect of suppositories usually occurs in about 20 minutes (the onset of the effect can however vary in different subjects, and manifest itself between 10 and 30 minutes).
Duration of treatment
Use laxatives as infrequently as possible and for no longer than 7 days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
As a laxative that acts on the intestine (colon), bisacodyl stimulates the natural process of evacuation. Therefore, bisacodyl does not affect digestion or the absorption of calories or essential nutrients in the intestine.
Overdose What to do if you have taken too much Dulcolax
In case of accidental ingestion / intake of an overdose of Dulcolax, notify your doctor immediately or go to the nearest hospital.
Symptoms
If you take / give your child too much Dulcolax you may experience belly pain and diarrhea and significant losses of substances in the blood (potassium and other electrolytes).
If you / your child chronically abuse Dulcolax, like other laxatives, they may experience chronic diarrhea, belly pain, decreased blood potassium levels (hypokalaemia), increased production of a hormone (aldosterone) by the adrenal gland. , which can lead to a decrease in potassium levels in the blood (secondary aldosteronism) and pebbles in the kidney (kidney stones). You may also experience kidney damage, decreased acidity in the blood (metabolic alkalosis) and muscle weakness caused by low blood potassium levels (hypokalaemia).
See also the information in the section "Warnings and precautions" about the abuse of laxatives.
Treatment
If action is taken within a short time of ingestion of Dulcolax tablets, absorption can be reduced or avoided by induction of vomiting or gastric lavage (emptying of stomach contents to be done in hospital). The doctor will replace the loss of fluids and elements contained in the blood (electrolytes) This is particularly important in elderly patients or children
In addition, your doctor may give you / your child medicines to calm the muscle contractions of the intestine (spasmolytics).
If you forget to take / give your child Dulcolax
Do not take / give your child a double dose to make up for a forgotten tablet or suppository.
If you stop taking Dulcolax
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Dulcolax
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are listed according to frequency:
common (may affect up to 1 in 10 patients)
- abdominal cramps, abdominal pain, diarrhea, nausea
uncommon (may affect up to 1 in 100 patients)
- dizziness (vertigo),
- blood in the stool (haematochezia), vomiting, stomach discomfort, anorectal discomfort
rare (may affect up to 1 in 1,000 patients)
- anaphylactic reactions, swelling of the skin and mucous membranes of the face, lips and throat (angioedema), hypersensitivity,
- fluid loss (dehydration),
- fainting (syncope),
- inflammation of the intestines (colitis).
Reporting of side effects
If you and / or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system on the website of the Italian Medicines Agency: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. help provide more information on the safety of this medicine
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Tablets: This medicine does not require any special storage conditions.
Suppositories: do not store above 30 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
What Dulcolax contains
Coated tablets
- The active ingredient is 5 mg bisacodyl
- The other ingredients are lactose monohydrate, sucrose, castor oil (see section "Dulcolax contains lactose, sucrose and castor oil"), maize starch, soluble starch, glycerol, magnesium stearate, talc, gum arabic, titanium dioxide (E171 ), methacrylic acid / methyl methacrylate copolymer (1: 1), methacrylic acid / methyl methacrylate copolymer (1: 2), macrogol 6000, iron oxide (E172), white wax, carnauba wax, shellac.
Suppositories
- The active ingredient is bisacodyl 10 mg
- The other ingredients are triglycerides of saturated fatty acids.
What Dulcolax looks like and contents of the pack
Coated tablets
Dulcolax 5 mg coated tablets come in the form of coated tablets.
The contents of the pack are 40, 30 or 24 coated tablets.
Suppositories
Dulcolax adult 10 mg suppositories comes in the form of suppositories.
The contents of the package are 6 suppositories.
Not all pack sizes may be marketed.
Health education notes
First of all it must be borne in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they suffer from constipation if they fail to evacuate every day. This is a mistaken belief as this situation is completely normal for a large number of individuals. Consider, instead, that constipation occurs when the bowel movements are reduced compared to your personal habits and are associated with the emission of hard stools. If the episodes of constipation occur repeatedly, the doctor must be consulted.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DULCOLAX
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
COATED TABLETS
One coated tablet contains: 5 mg bisacodyl.
Excipients: lactose, sucrose, castor oil.
ADULTS SUPPOSITORIES
One suppository contains: 10 mg bisacodyl.
CHILDREN SUPPOSITORIES
One suppository contains: 5 mg bisacodyl.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets
Suppositories
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of occasional constipation.
04.2 Posology and method of administration
COATED TABLETS
Adults and children over 10 years: 1-2 coated tablets per day.
Children aged 2 to 10 years: 1 coated tablet per day. Take the coated tablets preferably in the evening to determine an evacuation the following morning (after about 10 hours). With administration in the morning, on an empty stomach, the effect is obtained after about five hours.
The coated tablets should not be given together with products that reduce upper gastrointestinal acidity, such as milk, antacids (eg bicarbonate) or proton pump inhibitors.
The coated tablets should be swallowed whole. Swallow with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
SUPPOSITORIES
- Adults and children over 10 years: 1 adult suppository (10 mg).
- Children aged between 2 and 10 years: 1 child suppository (5 mg).
The effect of suppositories usually occurs in about 20 minutes (range: 10 - 30 minutes).
Do not exceed the recommended dose.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Children aged 10 years and younger with chronic or persistent constipation should take Dulcolax under the supervision of their physician. Dulcolax should not be given to children younger than two years of age.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Dulcolax is also contraindicated in patients with paralytic ileus, acute abdominal conditions, such as appendicitis, and severe abdominal pain associated with nausea and vomiting which may be indicative of serious medical conditions, intestinal obstruction or stricture, acute inflammation of the gastrointestinal tract, bleeding rectal of unknown origin, severe dehydration.
Pregnancy and lactation (see section 4.6).
The use of Dulcolax is contraindicated in case of rare hereditary conditions which may be incompatible with the intake of any of the excipients (see section 4.4 "Special warnings and precautions for use").
Dulcolax is contraindicated in children under 2 years of age.
Suppositories are contraindicated in cases of anal fissures and ulcers (pain and perianal bleeding may occur).
04.4 Special warnings and appropriate precautions for use
Warnings
In case of diabetes mellitus, hypertension or heart disease use only after consulting your doctor.
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors.
In severe cases, the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
Intestinal fluid loss can cause dehydration. Symptoms can be thirst and oliguria. In patients, for whom dehydration can be dangerous (patients with renal insufficiency, elderly patients), treatment with Dulcolax should be stopped and restarted only under medical supervision.
Hematochezia (blood in the stool) may occur in patients, which is usually mild and goes away on its own.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
Cases of dizziness and / or syncope have been reported after taking Dulcolax. The data relating to these cases suggest that the events, rather than a phenomenon related to the intake of Dulcolax, could be interpreted as a manifestation of "defecation syncope" (attributable to the effort of the act of defecation), or as a vasovagal response to the abdominal pain related to constipation itself. The use of suppositories can lead to painful sensations and local irritation, in particular, in the presence of fissures and ulcerative proctitis (see section 4.3 "contraindications").
Important information about some of the ingredients:
Dulcolax tablets contain 33.2 mg of lactose equivalent to 66.42 mg when taking the maximum daily dose, for the treatment of constipation in adults and adolescents over 10 years of age. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take tablets of this medicine.
Dulcolax tablets contain 23.4 mg of sucrose equal to 46.8 mg when taking the maximum daily dose for the treatment of constipation in adults and adolescents over 10 years of age.Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take tablets of this medicine.
Dulcolax tablets can cause stomach upset and diarrhea.
Precautions for use
In children aged 2 to 10 years, the medicine can only be used after consultation with your doctor (see section 4.3).
Like all laxatives it should not be taken daily or for prolonged periods without first evaluating the cause of constipation. The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects.
It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant administration of diuretics or adrenocorticosteroids and excessive doses of Dulcolax may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to an increase in sensitivity to cardiac glycosides.
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally.
Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least two hours before taking the laxative.
Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative.
04.6 Pregnancy and lactation
No studies have been conducted to investigate the effects on human fertility.
There are no adequate and well-controlled studies on the use of the medicine in pregnancy. Therefore, although no toxic effects have ever been reported during pregnancy, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus.
Clinical data show that neither the active form of bisacodyl BHPM, bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), nor its glucuronic derivatives are excreted in breast milk, however the medicinal product should only be used in cases of need, under the direct supervision of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the infant.
04.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that dizziness and / or syncope may occur due to the vasovagal response (consequent eg to abdominal spasm). If patients experience abdominal spasm they should avoid potentially hazardous activities such as driving or operating machinery.
04.8 Undesirable effects
The most commonly reported side effects during treatment with Dulcolax are abdominal pain and diarrhea.
Disorders of the immune system: anaphylactic reactions, angioneurotic edema as well as other hypersensitivity reactions.
Disorders of the nervous system: dizziness, syncope.
The phenomena of dizziness and syncope that occur after taking bisacodyl appear to be attributable to a vasovagal response (resulting, for example, from abdominal pain, or from the evacuation of stools).
Metabolism and nutrition disorders: dehydration.
Gastrointestinal disorders: colitis, abdominal cramps, abdominal pain, diarrhea, vomiting, nausea, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort.
04.9 Overdose
Symptoms
Excessive doses can cause abdominal pain and diarrhea, and significant losses of potassium and other electrolytes.
Chronic overdose of Dulcolax, like other laxatives, can also cause secondary aldosteronism and kidney stones. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described.
See also the information in the section "Special warnings and precautions for use" regarding the abuse of laxatives.
Treatment
If action is taken within a short time of ingestion of the oral form of Dulcolax, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Fluid and electrolyte losses should be replaced.
The administration of spasmolytics may be useful.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: contact laxative, ATC code: A06AB02.
Bisacodyl is a contact laxative with local action, belonging to the group of derivatives of triarylmethane, which, following the metabolic activation by hydrolysis, stimulates the mucous membranes of the large intestine causing an increase in peristalsis in the colon and favoring the " accumulation of water and consequently of electrolytes in the lumen of the colon This stimulates defecation, reduces transit time and makes stool soft.
05.2 Pharmacokinetic properties
Following oral and rectal administration, bisacodyl is rapidly hydrolyzed into its active form, bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), mainly by the esterases of the enteric mucosa. The administration of a coated tablet determines the maximum plasma concentration of BHPM between 4 and 10 hours after administration, while the laxative effect occurs between 6 and 12 hours after administration. suppository, the laxative effect occurs on average about 20 minutes after administration; in some cases 45 minutes after administration. The maximum plasma concentration of BHPM is reached in 0.5-3 hours following the administration of a suppository. Therefore, there is no correlation between the laxative effect and the plasma level of BHPM. Instead, the BHPM acts locally in the lower part of the intestine and there is no relationship between the laxative effect and the plasma levels of the active form. For this reason, bisacodyl coated tablets are formulated to be resistant to stomach and small intestine juices. This results in release of the drug predominantly in the colon, which is the desired site of action.
Following oral and rectal administration, only small amounts of the drug are absorbed and almost completely conjugated as glucuronide in the intestinal wall and liver to produce the inactive form of BHPM. It has been estimated that the glucuronide form of BHPM is cleared from plasma with a half-life of approximately 16.5 hours. Following administration of the bisacodyl coated tablets, on average 51.8% of the dose is recovered in the faeces as free BHPM and on average 10.5% of the dose is recovered in the urine as the BHPM glucuronide. Following administration of a suppository, 3.1% of the average dose is found in the urine as the BHPM glucuronide. Stool contains large amounts of BHPM (90% of total excretion) as well as small amounts of unmodified bisacodyl.
05.3 Preclinical safety data
The acute oral toxicity of bisacodyl in rodents and non-rodents is low and exceeds 2 g / kg. Dogs tolerate doses up to 15 g / kg. The main clinical signs of acute toxicity are diarrhea, decreased motor activity and horripilation.
Chronic toxicity was studied in rats, mini-pigs and rhesus monkeys for up to 26 weeks. The drug caused severe dose-dependent diarrhea (except for the mini-pigs). No evident histo-pathological alterations were observed and in particular no signs of drug-related nephrotoxicity. Bisacodyl caused proliferative lesions of the urinary bladder, evidenced in rats treated for 32 weeks. These proliferations are not attributable to the bisacodyl itself; they are to be considered attributable to the formation of microcalculations secondary to the alterations of urinary electrolytes and, therefore, are not of biological significance for man.
Results of in vitro and in vivo mutagenicity studies did not indicate that bisacodyl is potentially genotoxic. Furthermore, bisacodyl did not cause significant morphological changes in embryonic cells of Syrian hamsters (SHE). In contrast to the phenolphthalein laxative, which has a genotoxic and carcinogenic effect, bisacodyl did not show any mutagenic potential in mutagenicity tests.
No lifetime carcinogenicity studies have been performed with bisacodyl. Given the therapeutic similarities with phenolphthalein, bisacodyl has been studied in the p53 transgenic mouse model for 26 weeks and, up to doses of 8000 mg / kg / day. treatment-related malignancies were not observed.
No teratogenic effects have been shown in rats and rabbits (FDA Pregnancy Risk Category B) up to doses of 1000 mg / kg / day which exceed the maximum recommended human daily dose (MRHDD) (calculated in mg / m2) by at least 800 times.In the rat, maternal and embryonic toxicity was observed at doses 80 times higher than those of MRHDD.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
COATED TABLETS
Lactose monohydrate, corn starch, soluble starch, glycerol, magnesium stearate, sucrose, talc, gum arabic, titanium dioxide (E171), anionic polyacrylates, castor oil, macrogol 6000, iron oxide (E172), white wax, carnauba wax, shellac.
SUPPOSITORIES
Triglycerides of saturated fatty acids.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
COATED TABLETS
3 years
SUPPOSITORIES
5 years
06.4 Special precautions for storage
Coated tablets: This medicinal product does not require any special storage conditions.
Suppositories: store at temperatures no higher than 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
COATED TABLETS
Opaque white / aluminum PVC / PVDC blister, carton of 30 coated tablets and carton of 24 coated tablets.
SUPPOSITORIES
Aluminum / PE strips, box of 6 adult suppositories and box of 6 children's suppositories.
06.6 Instructions for use and handling
Not relevant.
07.0 MARKETING AUTHORIZATION HOLDER
BOEHRINGER INGELHEIM ITALIA S.p.A.
Reggello (Florence) - Loc. Prulli n. 103 / c.
Fher division
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n.
30 coated tablets: 008997013
24 coated tablets: 008997052
6 adults suppositories: 008997025
6 children suppositories: 008997037
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorization:
30 coated tablets: 03.06.54
24 coated tablets: 11.12.89
6 adults suppositories: 20.01.55
6 children suppositories: 22.04.81
Renewal: 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
AIFA resolution of 11 February 2011
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