Rayenom film-coated tablets 5 mg blister No. 56

Rayen tablets are indicated for the symptomatic treatment of chronic stable angina pectoris.

Composition

active substance: ivabradine (in the form of ivabradine hydrobromide);

1 film-coated tablet contains 5 mg ivabradine, corresponding to 5.863 mg ivabradine hydrobromide, or

1 film-coated tablet contains 7.5 mg of ivabradine, corresponding to 8.795 mg of ivabradine hydrobromide;

excipients: lactose, mannitol (E 421), maltodextrin, croscarmellose sodium, colloidal anhydrous silicon dioxide (E 551), magnesium stearate;

film coating: polyvinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E 171), macrogol/PEG 3350 (E 1521), methacrylate copolymer (1:1), yellow iron oxide (E 172), red iron oxide (E 172), sodium bicarbonate (E 500).

Contraindication

Method of application

Tablets should be taken orally twice a day (morning and evening) with meals.

Application features

Pregnant women

Contraindicated.

Children

Contraindicated.

Drivers

With caution.

Overdose

Overdose may lead to severe and prolonged bradycardia (see section "Adverse reactions"). Severe forms of bradycardia require symptomatic treatment in specialized facilities. In the event of bradycardia with poor hemodynamic tolerance, the use of intravenous β-stimulating agents such as isoprenaline may be considered. If necessary, the temporary use of an electrocardiogram may be considered.

Adverse reactions

The most common adverse reactions of ivabradine – visual phenomena (phosphenes) and bradycardia – are dose-dependent and due to the pharmacological action of the drug.

Interaction

Concomitant use of ivabradine with strong CYP3A4 inhibitors, such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contraindicated (see section "Contraindications"). Strong CYP3A4 inhibitors, such as ketoconazole (200 mg once daily) and josamycin (1 g twice daily), increase the average plasma concentration of ivabradine by 7-8 times.

Storage conditions

Does not require any special storage conditions. Keep out of the reach of children.

Shelf life: 3 years.