for medical use
of DULKOLAKS medicine
the Trade name
the International unlicensed
name Bisacodyl Dosage Form
Suppositories rectal 10 mg
1 suppository contains
active agent – bisacodyl of 10 mg,
excipient: solid fat (Witepsol W 45).
Suppositories of a torpedovidny form with smooth or slightly oily surface, white or slightly yellowish color with funnel in the suppository basis.
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. At rectal use the laxative effect occurs on average in 20 min. after reception, in certain cases through – 45 min. The maximum VNRM – plasma concentration come between 0.5 – 3 hours after use, 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.
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 3.1% of VNRM of a glyukoronid through an urinogenital path and about 90% – through a GIT, with a small amount of invariable bisacodyl.
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 are more senior – on 1 suppository (10 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
the Suppository is entered into a rectum by the pointed end forward, action comes approximately in 20 min. (between 10 and 30 min.).
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.
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
– rare hereditary diseases which can be incompatible with drug excipient
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.
Use of suppositories can lead to painful feelings and local irritation in anorectal area, in particular, at patients with anal fissures and an ulcer proctitis.
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 6 suppositories place in blister strip packagings from a film of polyethylene and aluminum foil.
On 1 planimetric packing together with the instruction for use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
Not to use a period of storage of 5 years after the expiry date specified on packing.
of Proizvoditel Institut de Angueli of S.R. L., Redzhello, Italy
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