Jardiance film-coated tablets 10 mg 3 blisters of 10 pcs.

• active ingredient: empagliflozin;
• 1 tablet contains empagliflozin 10 mg;
• excipients: lactose monohydrate; microcrystalline cellulose; hydroxypropylcellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; Opadry Yellow 02B38190 coating (hypromellose 2910, titanium dioxide (E171), talc, macrogol 400, iron oxide yellow (E172)).

Hypersensitivity to the active substance or to any of the excipients.

Dosage

Type 2 diabetes

The recommended starting dose is 10 mg empagliflozin once daily as monotherapy or in combination with other antidiabetic medicinal products. For patients who tolerate empagliflozin 10 mg once daily and who have an eGFR ≥ 60 mL/min/1.73 m2 and require tighter glycaemic control, the dose may be increased to 25 mg once daily. The maximum daily dose is 25 mg.

Heart failure

The recommended dose is 10 mg of empagliflozin once daily.

All indications (type 2 diabetes and/or heart failure)

When empagliflozin is used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin should be considered to reduce the risk of hypoglycemia.

If a dose is missed, it should be taken as soon as the patient remembers, but a double dose should not be taken on the same day.

The tablets can be taken with or without food, washed down with water, without chewing.

Use during pregnancy or breastfeeding

Pregnancy

There are no data from the use of empagliflozin in pregnant women. As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy.

Breastfeeding period

It is not known whether empagliflozin is excreted in human milk. Jardiance should not be used during breast-feeding.

Reproductive function

Studies on the effect of Jardiance on human fertility have not been conducted.

Children

The safety and efficacy of empagliflozin in children (under 18 years of age) with type 2 diabetes have not been studied and the drug is not used in this category of patients. Empagliflozin has not been used in children for the treatment of heart failure.

Ability to influence reaction speed when driving vehicles or other mechanisms

Jardiance has minor influence on the ability to drive and use machines. However, patients should be informed of the risk of hypoglycemia when Jardiance is used in combination with sulfonylureas and/or insulin.

Symptoms

In controlled clinical studies, single doses of up to 800 mg empagliflozin in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin in patients with type 2 diabetes mellitus were not associated with any toxicity. Empagliflozin increased urinary glucose excretion, resulting in increased urine volume. The observed increase in urine volume was not dose-related and was not clinically relevant. There is no human experience with doses above 800 mg.

Treatment

In the event of overdose, treatment should be initiated according to the patient’s clinical condition. The removal of empagliflozin by hemodialysis has not been studied.

The most common adverse reaction was hypoglycemia when used with a sulfonylurea or insulin.

Store in original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.