Пиколакс (tablets)

General characteristics. Structure:

Active ingredient: sodium picosulfate,

1 tablet contains sodium of a pikosulfat in terms of 100% anhydrous substance of 5 mg or 7,5 mg;

excipients: lactoses monohydrate, starch corn, starch prezhelatinizirovanny 1500, silicon dioxide colloid anhydrous, magnesium stearate.

Pharmacological properties:

The contact purgative of triarilmetanovy group, is activated in a large intestine under the influence of bacterial sulphatases; substance which is released at the same time stimulates sensitive nerve terminations of a mucous membrane of intestines, increases its motility, promotes a kumulirovaniye of water and electrolytes in a gleam of a large intestine. Defecation stimulation, reduction of time of transit and mitigation a calla is result of it. Use of drug is not followed by tenesmus and enterospasms.

After intake reaches a large intestine without essential absorption therefore intra hepatic circulation is absent. Under the influence of a bacterial flora it is split with formation of an active form (free biphenol). The laxative effect develops in 6-12 hours after reception, expressiveness of laxative effect does not correlate with the level of active biphenol in a blood plasma. At course treatment of Pikolaks stimulates growth and metabolic activity of normal intestinal microflora.

Indications to use:

The locks or cases demanding defecation simplification.

Route of administration and doses:

Appoint inside, it is desirable for the night.

To adults and children 10 years – on 5-10 mg of 1 times a day are more senior. At heavy and obstipations the adult about 15 mg disposable are recommended to accept.

To children from 4 to 10 years – 2,5-5 mg of 1 times a day.

For children there is effective a single dose of drug. If necessary the course of treatment for the child can be prolonged, but it is preferable to limit it three days. Duration of treatment is established individually, usually it does not exceed 10 days.

Features of use:

To use with care at a hypopotassemia, the increased content of magnesium in blood, to patients with the weakened organism.

Drug contains lactose that should be meant to patients with a hereditary lactose intolerance.

Use during pregnancy or feeding by a breast

Long experience did not reveal side undesirable or harmful effect of Pikolaks at inclusion in pregnancy time.

Proofs concerning Pikolaks's penetration into breast milk are absent.

Despite it, Pikolaks, as well as all other medicines, it is possible to apply during pregnancy or feeding by a breast, only if, according to the doctor, the advantage of use of drug exceeds potential risk for the fruit/child.

Extra care should adhere in the presence of threat of abortion.

Ability to influence speed of response at control of motor transport or  work with other mechanisms

Patients have to mean that in connection with possibility of vazovagalny reaction (a spasm in a stomach), dizziness and/or a faint it is necessary to avoid potentially dangerous types of activity, such as control of motor transport or work with other mechanisms.

Children

Not to use drug to children without consultation of the doctor. Not to apply a tablet on 7,5 mg to children up to 10 years. Not to apply a tablet on 5 mg to children up to 4 years.

Side effects:

At short-term administration of drug side effects are observed seldom.

At prolonged use of drug in much the raised doses disturbances are possible:

from water and electrolytic balance: loss of potassium, sodium and other electrolytes, development of dehydration is possible;

from the alimentary system: seldom – the dispeptic phenomena, vomiting, nausea, spasms and an abdominal pain, diarrhea, a meteorism, pain in a stomach and area of an anus, strengthening of motility of intestines which pass at reduction of a dose of drug;

from immune system: hypersensitivity reactions, including a Quincke's disease, a small tortoiseshell, skin rashes, an itch;

from TsNS: very seldom – a headache, increased fatigue, drowsiness, spasms, dizziness, a faint.

Interaction with other medicines:

The electrolytic imbalance can lead to decrease in tolerance to cardiac glycosides. Diuretics or glucocorticosteroids can increase expressiveness of the hypopotassemia caused by Pikolaks's use in high doses. Simultaneous treatment by antibiotics can reduce laxative effect of drug.

Contraindications:

Hypersensitivity to drug components; intestinal impassability; acute inflammatory diseases of intestines and acute diseases of abdominal organs (including acute appendicitis, nonspecific ulcer colitis, peritonitis); abdominal pains, nausea and vomiting of an unspecified origin; a state after    digestive tract operation; heavy dehydration.

In case of rare hereditary states as a result of which hypersensitivity to drug excipients is possible (see the section "Special Cautions") administration of drug is contraindicated.

Appropriate security measures at use

As well as other purgatives, Pikolaks should not be applied daily or throughout the long period without establishment of the reason of a lock. Prolonged and excessive use can lead to disturbance of water or electrolytic balance, a hypopotassemia. At patients who accepted sodium пикосульфат were observed dizziness and/or a syncope. The available data concerning these cases allow to assume that the phenomena correspond to a defecation syncope (or a syncope, connected with attempt to be emptied) or to the vazovagalny answer to the abdominal pain connected with a lock, but it is not obligatory with reception of sodium of a pikosulfat.

Overdose:

Symptoms. High doses of Pikolaks can cause a liquid chair, spasms (gripes) in a stomach and clinically significant disturbances of water and electrolytic balance (a hypopotassemia, loss of other electrolytes and liquid). There are messages on ischemia of a mucous membrane of a large intestine at use of higher doses of Pikolaks, much above those which are usually recommended at locks. The long overdose leads to development of chronic diarrhea and an abdominal pain, hypopotassemia, secondary hyper aldosteronism, damage of kidneys and development of a nephrolithiasis, a metabolic alkalosis and muscular weakness as a result of a hypopotassemia are possible.

Treatment. Drug withdrawal, calling of vomiting, a gastric lavage, reception of enterosorbents (absorbent carbon), a symptomatic treatment (carrying out correction of water and electrolytic balance that use of spasmolysants is especially important for patients of advanced age and children).

Storage conditions:

Period of validity 2 years. Not to use drug after the termination of the period of validity specified on packaging. To store in the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in the blister.

Tablets on 5 mg. On 1 blister in a pack.

Tablets on 7,5 mg. On 1 or 3 blisters in a pack.