Sevikar HCT 20mg/5mg/12.5mg 28 tablets — Made in Germany — Free Delivery

(Sevikar HCT)
Sevikar HCT 20mg/5mg/12.5mg 28 tablets — Made in Germany — Free Delivery
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Daiichi Sankyo Europe GmbH Brand: Daiichi Sankyo Europe GmbH
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Description Sevikar HCT 20mg/5mg/12.5mg 28 tablets — Made in Germany — Free Delivery

Product description 

Tablets "Sevikar HCT" are used to treat essential hypertension:
  • adjunctive therapy (prescribed to patients whose blood pressure is not sufficiently controlled by the combination of olmesartan medoxomil and amlodipine as a two-component drug);
  • replacement therapy (prescribed as an alternative therapy in adult patients whose blood pressure is normally controlled using a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide as two-component preparations (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and single-component preparations (hydrochlorothiazide or amlodipine).

Compound

One film-coated tablet contains (active ingredients):
  • olmesartan medoxomil 20 mg;
  • amlodipine besylate - 6.944 mg, equivalent to amlodipine - 5 mg;
  • hydrochlorothiazide 12.5 mg.
  • Excipients: pregelatinized corn starch, microcrystalline siliconized cellulose (contains 98% microcrystalline cellulose (Ph. Eur.) and 2% anhydrous colloidal silicon dioxide (Ph. Eur.)), croscarmellose sodium, magnesium stearate (vegetable origin); the film shell contains: Opadry II 85F24118 or Opadry II 85F32331, or Opadry II 85F25437 (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E 172)).

Contraindications

  • hypersensitivity to active substances, to dihydropyridine derivatives or to sulfanilamide substances (since hydrochlorothiazide is a sulfanilamide preparation) or to any of the excipients;
  • severe renal dysfunction;
  • persistent hypokalemia, hypercalcemia, hyponatremia and clinically significant hyperuricemia;
  • severe liver dysfunction, cholestasis and obstructive diseases of the bile ducts;
  • II and III trimester of pregnancy;
  • the combined use of the preparation  "Sevikar HCT" and preparations containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR < 60 ml / minute / 1.73 m2);
  • due to the content of amlodipine as an active ingredient in the preparation, the preparation "Sevikar HCT" is contraindicated in patients with: shock (including cardiogenic shock), severe hypotension, impaired blood outflow from the left ventricle (for example, severe aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction.

Mode of application

Tablets of the preparation "Sevikar HCT" are taken 1 time per day, regardless of the meal.
The tablet should be taken with a sufficient amount of liquid (for example, a glass of water). The tablet should not be chewed. The preparation should be taken every day at the same time.
Complementary Therapy
The preparation can be used in patients whose blood pressure is not adequately controlled when using olmesartan medoxomil 20 mg and amlodipine 5 mg in a two-component combination.
Before switching to a three-component combination, a gradual dose titration of the individual components is recommended. If clinically appropriate, direct replacement of the two-component combination with the tricomponent combination may be considered.
Replacement therapy
Patients using both stable doses of olmesartan medoxomil, amlodipine and hydrochlorothiazide as a two-component preparation (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single preparation (hydrochlorothiazide or amlodipine) can switch to Sevikar  HCT, which contains the same doses of the components .
The maximum dose of the preparation "Sevikar HCT" is 40 mg / 10 mg / 25 mg per day.

Application features

pregnant
The use of the preparation  "Sevikar HCT" is contraindicated during the II and III trimesters of pregnancy. Taking into account the effect of the active substances in the combined preparation "Sevikar HCT" on pregnancy, the use of the preparation is not recommended during the first trimester of pregnancy.
Since there is no information on the use of the preparation during lactation, Sevikar HCTis not recommended for women who are breastfeeding.
There have been reports of reverse biochemical changes in the head of the spermatozoa in some patients taking calcium channel blockers. Clinical data regarding the potential effect of amlodipine on fertility is not enough. In a study on rats, an undesirable effect on male fertility was found.
Children
"Sevikar HCT" is not recommended for use in children and adolescents (under 18 years of age) due to insufficient data on safety and efficacy.
Drivers
No studies have been conducted on the effect on the reaction rate when driving vehicles or operating other mechanisms. However, it should be kept in mind that patients undergoing antihypertensive therapy may occasionally experience dizziness, headache, nausea, or fatigue, which may impair their response. Caution is advised, especially at the start of treatment.

Overdose

Symptoms
There is no information on the overdose of the preparation "Sevikar HCT" in humans. The most likely effect of an overdose is hypotension.
Treatment
In case of an overdose of Sevikar HCT, treatment is symptomatic and supportive and depends on the time elapsed after administration and the severity of the symptoms. If taken recently, gastric lavage may be considered.

Side effects

During treatment with Sevikar HCT, the most commonly reported adverse reactions are: peripheral edema, headache and dizziness.

Storage conditions

Keep out of the reach of children. Does not require special storage conditions.
Shelf life - 3 years.

Tags: Sevikar

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