The instruction for medical use
of DULKOLAKS® medicine
the International unlicensed
name Bisacodyl Dosage Form
of the Tablet, 5 mg covered with a sugar / kishechnorastvorimy cover
One tablet contains
active agent – bisacodyl of 5 mg,
excipients: lactoses the monohydrate, starch which corn is dried up, starch soluble, glycerin of 85%, magnesium stearate,
structure of a cover: magnesium stearate, sucrose, talc, acacia (powder), titan dioxide (E 171), copolymer of methacrylic acid and methylmethacrylate (1: 1) (Eudragit L 100), copolymer of methacrylic acid and methylmethacrylate (1: 2) (Eudragit L 100), castor oil, a macrogoal 6000, ferrous oxide yellow (E 172), wax white, wax of karnaubskiya, shellac, the water purified, ethanol anhydrous, acetone
the Round biconvex tablets covered with a sugar kishechnorastvorimy cover of beige-yellow color with a smooth brilliant surface and a kernel of white color
Contact laxatives. Bisacodyl.
The ATX A06AB02 code
Pharmacokinetics Later properties of use bisacodyl is quickly hydrolyzed in active component an encore – (p-hydroxyphenyl)-pyridyl-2-methane (VNRM), mainly by means of the enzymes which are present at a gut cover mucosal surface. The maximum VNRM – plasma concentration come between 4 – 10 hours after use while the laxative effect occurs on average between 6 – 12 hours after reception. Therefore the laxative effect of bisacodyl is not correlated with the VNRM plasma level. Instead, BHPM works locally in the lower part of intestines and communication between laxative effect and levels of content of active agent in blood plasma is absent. In this regard dulkolaks tablets are executed resistant to effect of juice of a stomach and small intestine. It promotes that effect of drug comes in the desirable scene of action – in a large intestine.
Absorption is small, it is mainly conjugated in walls of intestines and liver, releasing inactive VNRM glyukoronid. Elimination half-life of VNRM of a glyukoronid – about 16.5 hours.
Removal – about 10.5% of VNRM of a glyukoronid through an urinogenital path and about 51.8% of free VNRM – through a GIT.
of Dulkolaks – locally operating depletive from group of derivatives of diphenylmethane. As contact laxative for which the anti-resorptive laxative effect was also described dulkolaks, after hydrolysis in a large intestine, stimulates a vermicular movement of intestines and increases accumulation of liquid and electrolytes in a gleam of a large intestine. It leads to defecation stimulation, reduction of the transit period and softening of a chair.
As the depletive operating in a large intestine dulkolaks in particular stimulates natural process of depletion in the lower part of digestive tract. Thereof, dulkolaks it is inefficient for change of digestion or assimilation of calories and necessary nutrients in a small intestine.
– preparation for tool and X-ray inspections
– purgation in respect of preoperative preparation and postoperative treatment
the Route of administration and doses
To adults and children 10 years on 1-2 tablets (5 – 10 mg) of 1 times a day are more senior.
To children aged from 6 up to 10 years on 1 tablet (5 mg) of 1 times a day.
It is recommended to begin with the smallest dose. The dosage can be adjusted to most recommended daily dose before receiving a regular chair.
Exceeding the maximum daily dosage is not admissible.
At children up to 10 years with chronic and long constipations the use of drug is possible only on doctor’s orders.
IInstruktsiya on use
is recommended to take the Pill for the night for emergence of a chair next morning. Tablets should be swallowed entirely, washing down with enough liquid.
It is not recommended to take a pill together with the products lowering acidity of an upper part of a GIT such as milk, antacids or inhibitors of a proton pomp not to allow premature dissolution of a cover of a tablet.
Preparation for tool and X-ray inspections and preoperative preparation:
For preoperative preparation, postoperative treatment and preparation for tool and X-ray inspections the drug should be taken under medical observation.
To achieve full bowel emptying, the recommended drug dose dulkolaks for adults has to make 2-4 tablets, for the night on the eve of the research, with the subsequent introduction of 1 suppository (10 mg) in the morning before a research.
One coated tablet and one children’s suppository the next morning is for children over 6 years recommended in the evening.
Side effects are defined with the following frequency: very often: ≥ 1/10, it is frequent: ≥ 1/100 & lt, 1/10, infrequently: ≥ 1/1.000 & lt, 1/100, is rare: ≥ 1/10.000 & lt, 1/1.000, is very rare: & lt, 1/10.000, is unknown: it is impossible to estimate on the basis of available data.
– gripes, abdominal pain, diarrhea, nausea
– dizziness, a gematokheziya (presence of blood in a chair), vomiting, discomfort in a stomach, discomfort in anorectal area
– allergic reactions, an angioedema, reactions of hypersensitivity, dehydration, a faint,
– hypersensitivity to bisacodyl or other components of drug
– severe dehydration of an organism
– intestinal impassability, intestinal obstruction, acute inflammatory diseases of abdominal organs, including appendicitis, acute inflammatory bowel diseases, the severe pain in a stomach which is followed by nausea and vomiting that can indicate a serious illness
– hereditary intolerance of fructose, a galactosemia (see. Special instructions)
– children’s age up to 6 years
Combined use of diuretics or adreno-corticosteroids can increase risk of disturbance of water and electrolytic balance when exceeding the recommended drug dose. The electrolytic imbalance can lead to increase in sensitivity to cardiac glycosides.
daily and prolonged use of drug dulkolaks without establishment of the cause of a constipation as prolonged use of drug can lead to disturbance of water and electrolytic balance and a gipokalemiya is not recommended.
Loss of liquids can provoke dehydration which signs can be a thirst and an oliguria. At the patients suffering from loss of liquids where dehydration can be dangerous (a renal failure, elderly patients) the drug use dulkolaks has to be suspended and resumed only under medical observation.
The patients using drug can find the small presence of blood in a chair which is taking place independently.
At the patients accepting bisacodyl the dizziness and/or a faint which are presumably connected with pain at a natuzhivaniye during defecation or the parasympathetic vascular reaction to an abdominal pain connected with a constipation that not necessarily belongs to reception of a dulkolaks was observed.
One tablet, coated, contains 33.2 mg of lactose that gives 66.4 mg of lactose in the maximum daily recommended dose for treatment of a constipation at adults and children 10 years are more senior. For X-ray analysis it gives 132.8 mg in the maximum daily recommended dose at adults. Patients with rare hereditary diseases of intolerance of a galactose, for example, with a galactosemia, should not take this drug.
One tablet, coated, contains 23.4 mg of sucrose that gives 46.8 mg of sucrose in the maximum daily recommended dose for treatment of a constipation at adults and children 10 years are more senior. For X-ray analysis it gives 93.6 mg in the maximum daily recommended dose at adults. Patients with rare hereditary diseases of intolerance of fructose should not take this drug.
Fertility, pregnancy and the period of a lactation
Long experience did not show cases of side effects during pregnancy. However, dulkolaks, as well as all other medicines, during pregnancy it is necessary to appoint with care.
In need of use of drug it is necessary to estimate potential advantage of therapy for mother and possible risk for a fruit.
According to clinical data neither bisacodyl, nor its glyukoronida get into breast milk of the feeding women, respectively dulkolaks can be applied during a lactation.
Researches of influence of drug on fertility of the person were not conducted.
There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms data. Nevertheless, patients have to be informed on possibility of dizziness or faint, in connection with the parasympathetic vascular reaction to an abdominal pain connected with a constipation.
Symptoms: diarrhea, dehydration, spasms in a stomach, disturbance of water and electrolytic balance.
The chronic overdose dulkolaksy, as well as other depletive, can lead to chronic diarrhea, an abdominal pain, a gipokalemiya, a secondary hyper aldosteronism and an urolithiasis.
Also in connection with chronic abuse of depletive, cases of renal canalicular defeats, a metabolic alkalosis and muscle weakness, being secondary to a gipokalemiya were described.
Treatment: symptomatic. Absorption can be lowered or prevented, having caused vomiting, or gastric lavage. Restoration of liquid and a water and electrolytic imbalance can be required that is especially important for patients of advanced age and children. Intake of antispasmodics can represent advantage.
The form of release and packing
On 10 tablets place in blister strip packagings from a film of polyvinylchloride and aluminum foil.
On 1, 2, 3 or 4 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions in the dry place, at a temperature not above 25 °C.
To store out of children’s reach!
not to use a period of storage after the expiry date specified on packing.
Reims Delfarm Producer C. Ampere-second., Reims, France
the Owner of the registration certificate
of Boehringer Ingelcheim International GmbH, Ingelcheim, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality a produktsiipredstavitelstvo “Boehringer Ingelcheim of Pharm Hess mbkh” in RKAdres: Almaty, 050008, the ave of Abay 52, Business center “Innova Tower”, the 7th etazhtet: +7 (727) 250 00 77, fax: +7 (727) 244 51 77 e-mail-mail