Pikolaks 0.75 ml of 30% drops for oral administration

The instruction for medical use


of PIKOLAKS medicine

the Trade name
of Pikolaks

the International unlicensed name
of Sodium pikosulfat

the Dosage form
of the Drop oral 0.75%

Structure
of 1 ml of drug contains
active agent: pikosulfat sodium in terms of 100% substance - 7.5 mg (20 drops),
excipients: sorbite (E 420), methylparahydroxy-benzoate sodium (E 219), 1 M Acidum hydrochloricum solution to rn from 6.0 to 7.0, water for injections.

Description
Transparent colourless or yellowish color liquid

Pharmacotherapeutic group
Contact depletive. Sodium pikosulfat.
ATH A06A B08 code

the Pharmacological

Pharmacokinetics Later properties of intake reaches a large intestine without significant absorption where under the influence of bacterial flora it is split with formation of an active form (free biphenol). The laxative effect develops in 6-12 hours after reception, the expressiveness of laxative effect does not correlate with the level of active biphenol in blood plasma. At course treatment of Pikolaks stimulates growth and metabolic activity of normal intestinal microflora.
The pharmacodynamics
Contact depletive 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, enhances his motility. Use of drug is not followed by tenesmus and enterospasms.

Indications
- constipations
- the cases demanding defecation simplification

the Route of administration and doses
Drug is dosed by the doser of the producer. To adults and children 10 years of 13-27 drops (5-10 mg) are more senior, children are from 4 to 10 years old of 7-13 drops (2.5-5 mg). More young than 4 years dosing of 250 mkg/kg of body weight or 2 drops on 3 kg of body weight of the child is recommended to children. Children can add drug to food.
Children have effective a single dose of drug. As necessary the course of treatment at the child can be prolonged, but it is preferable to limit it three days.
Pikolaks it is necessary to accept for the night in order that the chair was the next morning.
At the oncological patients receiving high doses of opioids apply to elimination of constipations on doctor's orders.

Side effects
- skin rash
- urticaria
- an itching
- loss of potassium, sodium and other electrolytes
- possible development of dehydration
- 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
- allergic reactions
- a Quincke's disease
- a headache
- increased fatigue
- drowsiness
-

Contraindication spasms
- intestinal impassability
- acute inflammatory bowel diseases
- acute diseases of abdominal organs (including an acute appendicitis, nonspecific ulcer colitis, peritonitis)
- the acute abdominal pain which is followed by nausea and vomiting which can indicate the acute inflammatory diseases stated above
- an abdominal pain of unspecified character
- heavy dehydration
- hypersensitivity to sodium to a pikosulfat and other components of drug.

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

Special instructions
As well as other depletive, Pikolaks it is not necessary to accept daily long time. At daily need of intake of depletive it is necessary to find out the cause of constipations. Prolonged use of depletive can lead to an electrolytic imbalance and a hypopotassemia and also to become the reason of accustoming and constipations owing to effect of ricochet. To use with care to elderly people, at a hypopotassemia, the increased magnesium content in blood, to patients with the weakened organism.
Pikolaks it is effective in elimination of constipations at the oncological patients receiving high doses of opioids. Drug contains sorbite therefore to patients with rare hereditary intolerance of fructose
the Pregnancy is not recommended to accept it and a lactation
the negative effect of the pikosulfat of sodium for a course of pregnancy is not revealed and fetation, however is possible to use drug at pregnancy only if the expected advantage for mother exceeds possible risk for a fruit. Sodium pikosulfat is not emitted with breast milk, but in need of use of the drug Pikolaks in the period of a lactation it is necessary to stop breastfeeding.
Use in pediatrics. Children without consultation of the doctor should not apply Pikolaks.
Features of influence drug on ability to run motor transport and potentially dangerous mechanisms.
In therapeutic doses drug does not affect ability to run vehicles and to work with other mechanisms.

Overdose
Symptoms. High doses of Pikolaks can cause liquid excrements, spasms (gripes) in a stomach and clinically significant disturbances of water and electrolytic balance (hypopotassemia, loss of other electrolytes and liquid), ischemia of a mucous membrane of a large intestine. The long overdose leads ment of chronic diarrhea and an abdominal pain, hypopotassemia, secondary hyper aldosteronism, damage of kidneys and development of a nephrolithiasis, a metabolic alkalosis, a hypopotassemia and muscle weakness as result of a hypopotassemia is possible.
Treatment. Gastric lavage, reception of enterosorbents (activated carbon), symptomatic treatment (carrying out correction of water and electrolytic balance, use of spasmolysants).

A form of release and packing
On 15 ml or 30 ml in bottles polyethylene transparent or opaque with dosers, corked with covers with seals (control of the first opening) or in bottles polyethylene, corked by traffic jams droppers and caps.
On bottles paste labels self-bondings.
Each bottle together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.


To Store storage conditions in the place protected from light at a temperature from 15 of 0C up to 25 0C.
To store out of children's reach!

A period of storage
3 years
it is not necessary to use drug after the expiration date specified on packing.

Prescription status
Without prescription.


PJSC Pharmak producer, Ukraine, 04080, Kiev, st. of Frunze, 63.

The owner of the registration certificate
of PJSC Pharmak, Ukraine

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) the Republic of Kazakhstan, 050009 Almaty, st. of Abay 157, office 5tel/fax: +7 (727) 250 66 23, the e-mail address: Djatlova88@mail.ru