Structure and form of release

Structure of 1 capsule

• Active components: dekslansoprazol 30 mg
• Excipients:
  • a sugar krupka - 28.8 mg (including sucrose of 18-26.352 mg, starch of corn 2.448-10.8 mg),
  • magnesium a carbonate - 11.5 mg,
  • sucrose - 41.5 mg,
  • hypro rod low-substituted - 8.64 mg,
  • a hypro rod - 0.34 mg,
  • a gipromelloz of 2910 - 7.54 mg,
  • talc - 16.64 mg,
  • titan dioxide - 5.5 mg,
  • dispersion of methacrylic acid of copolymer - 9.66 mg (including methacrylic acid - 4.4436 mg, ethyl acrylate - 4.2504 mg, sodium lauryl sulfate - 0.2254 mg, polysorbate-80 - 0.7406 mg),
  • a macrogoal of 8000 - 0.96 mg,
  • polysorbate-80 - 0.44 mg,
  • silicon dioxide colloidal - 0.09 mg,
  • methacrylic acid and methylmethacrylate copolymer [1:2] - 15.95 mg,
  • methacrylic acid and methylmethacrylate copolymer [1:1] - 5.32 mg,
  • triethyl citrate - 2.12 mg.
• Structure of a cover of capsules:
  • carrageenan - 0.192-0.624 mg,
  • potassium chloride - 0.144-0.48 mg,
  • titan dioxide - 2.4768 mg,
  • FD & C dye blue No. 2 aluminum varnish - 0.3456 mg,
  • dye ferrous oxide black - 0.0576 mg,
  • a gipromelloz - q.s. up to 48 mg,
  blackened
  • gray cleaned for marking - trace quantities.
Structure blackened
• : dye ferrous oxide red, dye ferrous oxide yellow, FD & C dye blue No. 2 aluminum varnish, wax of karnaubskiya, shellac, glyceryl monooleate.

a release Form

Capsule with the modified release with an opaque blue lid and with the opaque gray body; on a lid dark gray ink applied the TAP logo, on the body - the inscription "30". Contents of capsules - granules from white till almost white color.

Indications

• treatment of an erosive esophagitis of any severity;
• maintenance therapy after treatment of an erosive esophagitis and simplification of manifestations of heartburn;
• symptomatic treatment of a gastroesophageal reflux disease of GERD (i.e. NERB - not erosive reflux disease);

Contraindication

• hypersensitivity to any of medicament components;
• combined use with inhibitors of HIV proteases (atazanavir, nelfinavir);
• age up to 12 years;
• pregnancy, lactation period.

Drug contains sucrose therefore its use is not recommended to patients with hereditary intolerance of fructose, glyukozo-galaktozny malabsorption or sakharazno-izomaltazny insufficiency.

with caution

• to the patients accepting takrolimus;
• to the patients accepting CYP2C19 isoenzyme inhibitors, such as fluvoksamin to the patients accepting warfarin under control of a prothrombin time and MHO;
• to the patients accepting a methotrexate.

Special instructions

Before an initiation of treatment dekslansoprazoly should exclude a possibility of a malignant new growth as medicament can mask symptoms and delay the correct diagnosis.

If symptoms remain, despite adequate treatment, then it is necessary to perform further examination.

At intake of inhibitors of the proton pump which treats dekslansoprazol the risk of gastrointestinal infections, followed by diarrhea which activators are bacteria of the sort Clostridium difficile, especially at the hospitalized patients increases. It needs to be taken into account if at treatment of diarrhea the condition of the patient does not improve.

to Patients in this case is recommended to accept minimum effective dose of a dekslansoprazol at the smallest duration of treatment.

At the patients receiving high doses of medicament or at long therapy by the inhibitors of the proton pump (IPP) within a year and more the risk of osteoporotichesky bone fractures of hips, brushes and a backbone increases. Patients with risk of developing of osteoporotichesky fractures have to adhere to the recommended dosages (see the section "Route of Administration and Doses").

In rare instances at patients observed a symptomatic and symptomless hypomagnesiemia at administration of medicaments of IPN within not less than three months, and in most cases - at reception within a year. Symptoms of a hypomagnesiemia are the tetany, arrhythmia and spasms. Treatment - completion of magnesium and cancellation of administration of medicaments of IPN. At patients who need long treatment or at the same time taking the medicaments IPN with the digoxin or other medicaments capable to cause a hypomagnesiemia (for example, diuretics) it is necessary to control concentration of magnesium in blood serum prior to the beginning of and during treatment.

Dose adjustment

In renal failures: dose adjustment with a renal failure is not required from patients.

In abnormal liver functions: at patients with abnormal liver functions of moderate severity (I Drink class B but Chayld-) the daily dose should not exceed 30 mg of a dekslansoprazol.

Clinical data on administration of medicament at patients with disturbances of heavy degree (class C on Chayld-Pyyu) are absent. with an abnormal liver function of light severity (class A on Chayld-Pyyu) it is not required by

Dose adjustment from patients to p.

Use at advanced age: dose adjustment is not required from elderly patients.

Influence on ability of control of vehicles/mechanisms.

Because of the probability of dizziness and a disorder of vision should refrain from control of the vehicles and other mechanisms requiring special attention.