Active substanceSodium FluorideSodium Fluoride
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  • Sodium Fluoride
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    GRINDEX, JSC     Latvia
  • Dosage form: & nbsp

    absorbable tablets for children

    tablets for resorption for children

    Composition:

    One tablet for resorption for children is orange contains: active substance - sodium fluoride 1.1 mg;

    Excipients: mannitol, aspartame, silicon dioxide, magnesium stearate, corn starch, orange flavor additive, yellow dye "sunset sunset" (E 110).

    One tablet for resorption for children contains: active substance - sodium fluoride 2.2 mg;

    Excipients: lactose monohydrate, calcium stearate, potato starch.

    Description:

    Reducing tablets for children, orange 1.1 mg

    Round flat cylindrical tablets of orange color with darker inclusions, with a facet, with an orange smell.

    Tablets for resorption for children 2.2 mg

    Round flat cylindrical tablets of white color with a bevel.

    Pharmacotherapeutic group:Fluorine preparation
    ATX: & nbsp

    A.01.A.A.01   Sodium Fluoride

    Pharmacodynamics:

    Sodium fluoride is an anti-caries prophylactic drug (especially in children and adolescents). Fluorine ions directly affect the processes of mineralization of hard tooth tissues during their development.Additional introduction of fluorine provides the formation in the tissues of teeth the most stable form of apatite - fluorapatite. In addition, fluoride helps reduce cariogenic activity of plaque. It inhibits the formation of lactic acid from carbohydrates.

    Pharmacokinetics:

    Absorption on intake - 93-97 %. TSmax -4 hours. At any dose, 50% of the fluoride that is received accumulates in the hard tissues of the tooth and bone tissue. Accumulation in organs or soft tissues is not observed. It is excreted by the kidneys (not participating in the process of formation of bone tissue fluoride).

    Indications:

    Prevention of dental caries in children aged 2 to 14 years (if the concentration of fluoride in drinking water does not exceed 0.7 mg / l).

    Contraindications:

    Hypersensitivity, hypothyroidism, gastric and duodenal ulcer (at the stage of exacerbation), hepatic and / or renal insufficiency.

    Pregnancy, lactation.

    Children under 2 years.

    Living in an area with sufficient fluoride content in water (above 0.7 mg / ml). Tablets of sodium fluoride for resorption for children of orange 1.1 mg contain aspartame - A source of phenylalanine. This drug should not be taken in patients with phenylketonuria.

    Sodium fluoride tablets for resorption for children 2.2 mg contain lactose. This drug should not be taken to patients with a rare congenital galactose intolerance, lactase deficiency or malabsorption of glucose-galactose.

    Dosing and Administration:

    Children aged 2 to 6 years - 1 tablet (1.1 mg) 1 time per day.

    Children older than 6 years - 1 tablet (2.2 mg) or 2 tablets (1.1 mg) 1 time per day. It is recommended to take the drug before going to bed after brushing your teeth. The tablet is kept in the mouth until it is completely resorbed. Duration of treatment is at least 250 days per year, annually up to 15 years of age. It is not recommended to simultaneously use medicines containing calcium.

    Side effects:

    Nausea, vomiting, decreased appetite, fatigue, headache, diarrhea, ossification of the attachment sites of tendons and ligaments, hypothyroidism (with prolonged use), allergic reactions, rhinitis, eosinophilia, skin rash, fluorosis (violation of the formation and calcification of the enamel, the appearance of yellow , brown spots, finesse, increased fragility and abrasion of the teeth).

    Overdose:

    Symptoms: lacrimation, hypersalivation, nausea, decreased appetite, vomiting,diarrhea, abdominal pain, pain in the lower extremities, arthralgia, fatigue, miosis, impaired vision, weakness, myasthenia gravis, tremor, convulsions, fever, tachycardia, lowering blood pressure, respiratory failure, respiratory arrest.

    Treatment: the administration of large quantities of liquid and calcium (a solution of calcium gluconate or calcium lactate, milk) to precipitate fluorides; gastric lavage with acidified water or 1% solution of sodium chloride, the appointment of salt laxatives, iv administration of electrolytes (20 ml of 10-20% calcium gluconate solution), vitamins; symptomatic therapy, control of calcium concentration in the blood; hemodialysis.

    Interaction:

    Sodium fluoride absorption reduces antacids (prematurely dissolve the shell); Antacids should be used no earlier than 2 hours before taking sodium fluoride.

    Vitamins A and D contribute to the development of ectopic calcification.

    Special instructions:

    Do not exceed recommended doses and follow the directions of the dentist.

    Ensure that the child does not receive fluoride additionally while taking other drugs or nutritional supplements at the same time.

    Use in children under 6 years of age requires special control.

    In order to avoid the development of fluorosis it is desirable to regularly perform a dental examination of the teeth in a child at least 1-2 times a year.

    Form release / dosage:

    The tablets for resorption for children are orange 1.1 mg.

    Tablets for resorption for children 2.2 mg.

    Packaging:

    The tablets for resorption for children are orange 1.1 mg.

    For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil. 3 contour mesh packages together with instructions for use in a pack of cardboard.

    Tablets for resorption for children 2.2 mg.

    For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil. 3 contour mesh packages together with instructions for use in a pack of cardboard.

    250 tablets in a plastic bottle. 1 bottle with instructions for use in a pack.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    5 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016088 / 01
    Date of registration:29.06.2011 / 13.09.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Information update date: & nbsp14.06.2018
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