Rutatsid® (Rutacid®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrotalciteHydrotalcite
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    Bayer Konsyumer Kare AG     Switzerland
  • Rutatsid®
    pills inwards 
    KRKA, dd, Novo mesto, AO    
    • Dosage form: & nbspchewing tablets
    Composition:1 tablet contains:

    Active substance:

    Hydrotalcite

    500.00 mg

    Excipients:

    Mannitol

    836.00 mg

    Sodium saccharinate

    0.60 mg

    Sodium carboxymethyl starch

    12.00 mg

    Talc

    35.00 mg

    Magnesium stearate

    14.00 mg

    Flavoring mint

    2.40 mg
    Description:

    Round tablets white or almost white, with a bevel, with a slight minty smell.

    Pharmacotherapeutic group:antacid agent
    ATX: & nbsp

    A.02.A.D.04   Hydrotalcite

    Pharmacodynamics:

    The hydrotalcite has a stratified-mesh structure with a low content of aluminum and magnesium. The release of aluminum and magnesium ions occurs gradually depending on the pH of the gastric juice. The drug provides a quick and long-lasting neutralization of hydrochloric acid with maintaining the pH close to normal. Has a protective effect on the mucous membrane of the stomach. Reduces the proteolytic activity of pepsin, binds bile acids.

    Pharmacokinetics:

    The release of magnesium and aluminum ions occurs in the stomach gradually, depending on the pH value. Absorbed hydrotalcite in the small intestine. After ingestion, the content of magnesium and aluminum ions in the blood plasma temporarily increases, but no penetration into the nerve and bone tissue occurs (with normal kidney function).The absorbed part is excreted by the kidneys.

    Indications:

    Hyperacidity of gastric juice, heartburn, gastritis, peptic ulcer and duodenal ulcer, reflux esophagitis.

    Contraindications:

    Individual hypersensitivity to the components of the drug, children's age (up to 6 years).

    Carefully:

    Chronic renal failure, hypophosphatemia.

    Pregnancy and lactation:

    There is no confirmed data on the undesirable effects of hydrotalcite during pregnancy and breastfeeding.

    Use of the drug Rutatsid® during pregnancy is permitted in the event that the potential benefit to the mother exceeds the possible risk to the fetus.

    The drug Rutatsid® does not penetrate into breast milk, so its use is possible during breastfeeding.

    Dosing and Administration:

    Inside, thoroughly chewing.

    Adults and children over 12 years of age: 1-2 tablets 1 hour after meals 3-4 times a day and at bedtime.

    Children from 6 to 12 years: 1 tablet 2 times a day.

    Treatment should be continued for 4 weeks.

    Side effects:

    When using Rutatsid® in recommended doses, undesirable effects are rare.

    Allergic reactions, diarrhea, eructation are possible.

    Overdose:

    No signs of intoxication due to drug overdose have been reported.

    Interaction:

    Like other antacids, Rutatsid® can reduce the absorption of tetracyclines, quinolones (ciprofloxacin, ofloxacin), iron preparations and coumarins, antibiotics.

    Special instructions:

    The interval between the use of the drug Rutatsid® and other drugs should be at least 1-2 hours.

    It is not recommended to use the drug Rutatsid® simultaneously with acid-containing beverages (juices, wine).

    The drug Rutatsid® does not contain sucrose, therefore it can be taken by patients with diabetes mellitus.

    Polyols (mannitol) can cause diarrhea.

    Effect on the ability to drive transp. cf. and fur:

    The drug Rutatsid® does not affect the ability to drive vehicles and other complex technical devices that require concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets are chewable, 500 mg.

    Packaging:

    10 tablets per blister.

    For 2 or 6 blisters are placed in a pack of cardboard along with instructions for use.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012378 / 01
    Date of registration:25.10.2010
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp17.01.2016
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