Active substanceMacrogolMacrogol
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  • Dosage form: & nbspPOral solution for oral administration.
    Composition:

    1 sachet contains:

    Active substance: Macrogol-4000 - 10 g;

    Excipients: sodium saccharinate, orange flavor.

    Description:

    A drug - a white or almost white powder with an orange smell.

    5% solution of the drug - a colorless liquid with a sweet orange flavor and an orange smell.

    Pharmacotherapeutic group:laxative
    ATX: & nbsp

    A.06.A.D.15   Macrogol

    Pharmacodynamics:

    Osmotic laxative. A high-molecular substance, which is a long linear polymer, which by means of hydrogen bonds is capable of retaining water molecules. Increases the osmotic pressure and volume of the intestinal fluid, enhancing peristalsis.Increases the volume of chyme, prevents the loss of electrolytes with feces. It restores the reflex of evacuation, does not change the pH of the chyme. The laxative effect occurs 24-48 hours after oral administration. Prevents the violation of water-electrolyte balance.

    Pharmacokinetics:

    It is not absorbed in the gastrointestinal tract and is not metabolized.

    Indications:Constipation (symptomatic treatment in adults and children over 12 years old).
    Contraindications:

    Hypersensitivity to the components of the drug, dehydration, inflammatory and erosive ulcerative lesions of the colon mucosa (including ulcerative colitis, Crohn's disease), intestinal perforation or perforation risk, intestinal obstruction (including spastic, obturation) or suspected intestinal obstruction , abdominal pain of unclear etiology, chronic heart failure, children's age (up to 12 years).

    Carefully:Pregnancy, lactation.
    Dosing and Administration:

    The drug is used inside after dissolving the contents of the sachet in a glass of water.

    The recommended dose is for children over 12 years 1 packet per day, for adults 1-2 bags per day, preferably in one session in the morning.

    The action of Forteza Rhompharm manifests itself 24-48 hours after admission.

    Treatment of children should not exceed 3 months. Restoration of normal bowel activity, achieved through treatment, should be supported by a healthy lifestyle and diet.

    Side effects:

    During clinical trials, mostly minor and transient side effects, mainly associated with the gastrointestinal tract (GI tract), were recorded:

    - often ( 1/100, <1/10): bloating (may occur at the beginning of therapy and usually occurs after dose selection), abdominal pain, nausea, diarrhea;

    - sometimes ( 1/1000, <1/100): allergic reactions.

    - very rarely (<1/10000): itching, hives, face swelling, Quincke's edema, cases of anaphylactic shock.

    Side effects in children are the same as in adults.

    Overdose:

    Symptoms: diarrhea.

    Treatment: cancellation of the drug (diarrhea stops on its own 1-2 days after cancellation). Aspiration cases were recorded with the introduction of a large volume of polyethylene glycols and electrolytes through a gastroscopic probe. The risk of aspiration is increased in children with neurologic disorders of the swallowingfunction.

    Interaction:

    Slows the absorption of concomitant medications.

    In case of simultaneous reception of Forteza Rompharm with other medicines, it is recommended to prescribe the drug 2 hours after their administration.

    Special instructions:

    Before starting treatment with Forteza Rompharm, you need to make sure that there is no organic pathology of the digestive tract.

    In the drug therapy of constipation, the drug should be considered as an addition to general hygiene measures and diet therapy (eating foods rich in plant fibers, a large amount of fluid, a physically active lifestyle and restoring a regular defecation reflex).

    Duration of treatment should not exceed 3 months. If the patient's condition does not improve despite diet therapy, it is necessary to look for another cause of dysfunction.

    Cases of hypersensitivity to medicines containing macrogol (polyethylene glycol). Cases of anaphylactic shock have been reported.

    Fortez Rompharm contains an artificial sweetener (sodium saccharinate), so it can be prescribed to patients with diabetes mellitus, as well as patients whose diet is excluded galactose.

    Form release / dosage:

    Powder for solution for oral administration, 10 g.

    Packaging:

    10.5 g of the preparation in a sachet of paper / aluminum / polyethylene.

    For 10 sachets together with instructions for use in a cardboard bundle.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:3 years.
    Do not use after the expiration date indicated on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007785/09
    Date of registration:05.10.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp08.01.2017
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