Laksigal 25ml drops for oral administration

The instruction for medical use of LAKSIGAL medicine the Trade name of the drug Laksigal Mezhdunarodnoye the unlicensed name of Sodium pikosulfat the Dosage form of the Drop for intake Structure of 1 ml of solution contains active agent: sodium of the pikosulfat of 7.5 mg excipients: sorbitol solution of 70%, sodium ethylparahydroxybenzoate, the acid of chlorohydrogen 35%, water purified. Description Transparent, colourless or slightly yellowish color liquid. Pharmacotherapeutic group Laxatives. Contact laxatives. Sodium pikosulfat. The ATX A06AB08 code the Pharmacological Pharmacokinetics Active Ingredient properties - sodium pikosulfat as hydrophilic substance is poorly adsorbed by lipophilic membranes of intestines. After oral administration takes place in an invariable look through a stomach and a small intestine. In 3 hours about 70% of the accepted amount of drug come to a large intestine. There is a pikosulfat sodium hydrolysis by bacterial microflora. The metabolite is lipophilic gets through biological membranes. In 12 hours in a large intestine there are only 8% of the received dose. 72 hours of 21% of substance later also 72% with a stake, in the form of a pikosulfat sodium metabolite are removed with urine. Pharmacodynamics Laxative drug. Operates on the level of a large intestine: under the influence of intestinal microflora of sodium pikosulfat it is hydrolyzed with formation of an active form – free biphenol. Biphenol stimulates receptors of a mucous membrane of a large intestine and strengthens its vermicular movement. Indications of Laksigal it is applied in acute functional constipations, also drug is shown for periodic reception in a chronic constipation to facilitate defecation. The route of administration and doses Children at the age of 4-10 years of 6-12 drops before going to bed Adults and children are more senior than 10 years of 12-24 drops before going to bed Laksigal's Action comes in 6-12 hours. Laksigal it is possible to use with liquid and without it. Increase or decrease in the recommended dosage it is possible to pick up an optimum dose to reach the required consistence of a chair. It is recommended to begin with a low dose. The dose can be adjusted to the maximum recommended dose for induction of regular movements of intestines. The maximum recommended daily dose should not exceed the specified doses. It is not recommended to use without medical control more than 10 days. In need of prolonged use of drug it is necessary to consult to the doctor. Side effects - nausea, vomiting, gripes, diarrhea and an abdominal pain - dehydration and disturbance of electrolytic balance: loss of potassium and other electrolytes at long reception in much the raised doses. - loss in weight at long use of drug - disturbance of a menstrual cycle - lack of appetite - a depression - changes of a tone of a muscular wall of intestines - dizziness, a faint - reactions of hypersensitivity (skin reactions, a Quincke's disease). At prolonged use the laksativny syndrome (abuse of depletive) can develop: diarrhea, abdominal pain, nausea, vomiting, loss of weight, asthenia, menstrual disorders, anorexia, depression, changes in a muscular wall of a gut, intestines dilatation similar to ulcer colitis and megacolon. Contraindications - hypersensitivity to a pikosulfat and other excipients, parabens - intestinal impassability - acute inflammatory diseases of abdominal organs - gastrointestinal and uterine bleedings - nausea and vomiting of the obscure etiology - the restrained hernia - the profound dehydration of an organism - a state after an abdominal cavity surgery - peritonitis - abdominal pains of not clear genesis - cystitis - spastic constipations - rare hereditary problems of intolerance of fructose - pregnancy І a trimester, the lactation period - children's age up to 4 years Medicinal interactions At simultaneous use with antibacterial drugs of a broad spectrum of activity Laksigal's efficiency decreases. Simultaneous use with diuretics and corticosteroids can promote disturbance of water and electrolytic balance and increase in sensitivity to cardiac glycosides. The special instructions Laksigal should not be used after surgeries on an abdominal cavity. As well as it is not necessary to take any other depletive, the drug Laksigal daily or throughout the long period without establishment of the causes of a constipation. It can lead to disturbance of water and electrolytic balance and also cause a hypopotassemia. Dizziness and/or faints were registered at the patients taking the drugs on the basis of the pikosulfat. The obtained data on these cases allow to assume a possibility of a faint at defecation (or a faint at a natuzhivaniye at defecation), or vazovagalny reaction to an abdominal pain owing to a constipation which can be not connected with intake of sodium of the pikosulfat. Use for children without preliminary consultation of the doctor is not recommended. Patients with rare hereditary problems of intolerance of fructose should not take this drug as it contains sorbite. Children Drug is not intended for use for children up to 4 years. Pregnancy and a lactation Are not present enough data on use of drug for pregnant women and the nursing women therefore it should be applied with care and under medical observation. In need of use of drug it is necessary to estimate potential advantage of therapy for mother and possible risk for a fruit. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Researches about influence on ability of driving of vehicles and control of mechanisms were not conducted. Nevertheless, patients should be warned that owing to the vazovagalny answer (for example, because of a spasm in a stomach), there can be dizzinesses and/or faints. If patients test spasms in an abdominal cavity, then they should avoid potentially dangerous tasks, such as driving of vehicles and control of mechanisms Overdose Symptoms: paroxysmal pain in a stomach, a frequent liquid chair, clinically significant loss of potassium and other electrolytes. Treatment: symptomatic. The form of release and packing On 10 ml and 25 ml of drug place in the bottles of brown glass supplied with a dropper and a cover with control of the first opening. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions in the place protected from light at a temperature from 10 of 0C up to 25 0C. To store out of children's reach! 2 years not to use a period of storage after an expiration date. Prescription status from drugstore Without prescription the Producer packer Teva the Czech Enterprises of neuter about, Ostravsk 29.74779 Opava of Mosquitoes, the Czech Republic. The owner of the registration certificate Teva the Czech Enterprises of neuter about, the Czech Republic the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Ratiopharm Kazakhstan LLP, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, BC Nurly-Tau, 5B, 6 floor. Phone number: (727) 3251615 The address of the organization, in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: Ratiopharm Kazakhstan LLP, 050059 (A15E2P), Almaty, Al-Farabi Ave. 17/1, BC Nurly-Tau, 5B, 6 floor. Phone number: (727) 3251642, mobile +7(701)9240368, e-mail: safety.kazakhstan@tevapharm.com