Jarina film-coated tablets blister pack 21 pcs

One film-coated tablet contains (active ingredients):

• ethinylestradiol – 0.03 mg;
• drospirenone – 3 mg.

Excipients: lactose monohydrate, corn starch, pregelatinized corn starch, povidone, magnesium stearate, hydroxypropylmethylcellulose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

Combined hormonal contraceptives (CHCs) should not be used if any of the following conditions are present. If any of these conditions appear for the first time during CHC use, the drug should be discontinued immediately.

Presence or risk of venous thromboembolism (VTE):

• Current VTE, particularly due to anticoagulant therapy or a history of it (e.g. deep vein thrombosis (DVT) or pulmonary embolism (PE));
• known hereditary or acquired predisposition to VTE, such as resistance to activated protein C (including factor V Leiden mutation), antithrombin-III deficiency, protein C deficiency, protein S deficiency;
• major surgical interventions with prolonged immobilization;
• high risk of VTE due to the presence of multiple risk factors.

Presence or risk of arterial thromboembolism (ATE):

• the presence of ATO now or in history (for example, myocardial infarction) or the presence of prodromal symptoms (for example, angina);
• current or history of cerebrovascular accident, presence of prodromal symptoms (e.g., transient ischemic attack (TIA));
• known hereditary or acquired predisposition to ATO, such as hyperhomocysteinemia and antiphospholipid antibodies (e.g. anticardiolipin antibodies, lupus anticoagulant);
• migraine with focal neurological symptoms in history;
• high risk of ATO due to the presence of multiple risk factors or due to the presence of one serious risk factor, such as:
  • diabetes mellitus with vascular complications;
  • severe arterial hypertension;
  • severe dyslipoproteinemia.

Presence of severe liver disease, current or history, until liver function tests return to normal.

Severe renal failure or acute renal failure.

Presence of liver tumors now or in history (benign or malignant).

Known or suspected malignant tumors (e.g., of the genital organs or mammary glands) that are dependent on sex hormones.

Vaginal bleeding of unknown etiology.

Hypersensitivity to the active substances or to any of the components of the drug.

Suspected or confirmed pregnancy.

The drug Jarina is contraindicated when used simultaneously with drugs containing ombitasvir / paritaprevir / ritonavir and dasabuvir.

Oral. The tablets should be taken regularly at about the same time, washed down with a small amount of liquid if necessary, in the order indicated on the package. The drug is taken one tablet per day for 21 consecutive days. Taking the tablets from each subsequent package should be started after a 7-day break in taking the drug, during which withdrawal bleeding usually occurs. As a rule, it begins on the 2-3rd day after taking the last tablet and may not end before starting to take the tablets from the next package.

Children

The drug Jarina is indicated for use only after the onset of the first menstruation. Based on epidemiological data collected in more than 2000 adolescents under the age of 18, there is no data showing a difference in safety and efficacy of use in this group of patients compared to women aged 18 years and older.

Drivers

No studies have been conducted on the effects on the ability to drive or use machines. No effects on the ability to drive or use machines have been reported in women taking combined oral contraceptives.

There are no clinical data on overdose of Jarina tablets. As the general experience of using COCs shows, nausea, vomiting and withdrawal bleeding may occur in case of overdose. Withdrawal bleeding may occur in girls even before menarche in case of unintentional/accidental use of the drug. There is no specific antidote, treatment should be symptomatic.

Below are the adverse reactions that were observed most frequently (≥ 1/100 and <1/10) when using the drug Jarina.

Mental disorders: depressed mood.

From the nervous system: headache.

Vascular disorders: migraine.

Gastrointestinal: nausea.

Reproductive system and breast disorders: menstrual disorders, intermenstrual bleeding, breast tenderness, breast engorgement, vaginal discharge, vulvovaginal candidiasis.

Store at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 3 years.