– Thrombosis (venous and arterial) currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
– conditions preceding thrombosis (including transient ischemic attacks, atrial fibrillation, angina) currently or in history:
– identified predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia. antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant);
– migraine with focal neurological symptoms currently or in history;
– diabetes mellitus with diabetic angiopathy;
– multiple or pronounced risk factors for venous or arterial thrombosis (including complicated heart valve defects, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, prolonged immobilization, major surgery, surgical interventions on the lower extremities, pelvic area, neurosurgical operations, extensive trauma, smoking over the age of 35 years, obesity with a body mass index of more than 30 kg/m2; severe dyslipoproteinemia; air travel lasting more than 4 hours);
– pancreatitis with severe hypertriglyceridemia currently or in history;
– liver failure and severe liver diseases (before normalization of liver function tests and within three months after these indicators return to normal);
– liver tumors (benign or malignant) currently or in history;
– severe renal failure and/or acute renal failure:
– identified or suspected hormone-dependent malignant diseases (including genital organs or mammary glands):
– bleeding from the vagina of unknown origin;
– pregnancy or suspicion of it;
– period of breastfeeding;
– hypersensitivity to the components of the drug;
– hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Side Effects

Organ class system

Frequency of adverse reactions

Often

(≥1/100 and <1/10)

Uncommon

(≥1/1000 and <1/100)

Rare(≥1/10000 and <1/1000)

Immune system disorders

Hypersensitivity reactions, bronchial asthma

Mental disorders

Depressive states

Change in libido

Nervous system disorders

Headache, migraine

Hearing and labyrinth disorders

Hearing loss

Vascular disorders

Increased blood pressure, decreased blood pressure

Venous or arterial thromboembolism*

Gastrointestinal disorders

Nausea

Vomiting, diarrhea

Skin and subcutaneous tissue disorders

Acne, eczema, itching, alopecia

Erythema nodosum, erythema multiforme

Disorders of the reproductive system and mammary glands

Menstrual irregularities, acyclic bleeding, pain in the mammary glands, tenderness of the mammary glands, leucorrhoea, vaginal candidiasis

Breast enlargement, vaginitis

Discharge from the mammary glands

General and administration site disorders

Fluid retention, weight change

* Venous or arterial thromboembolism includes the following nosological forms: peripheral deep vein occlusion, thrombosis and thromboembolism/pulmonary vascular occlusion, thrombosis, thromboembolism and infarction/myocardial infarction/cerebral infarction and stroke.

The following adverse reactions have been reported in women using COCs, with a very rare incidence or delayed symptoms, which are thought to be related to COC use:

– breast cancer (see section “Special instructions”);

– liver tumors (benign and malignant);

– increased blood pressure:

– pancreatitis in women with hypertriglyceridemia;

– the appearance or worsening of conditions, the connection of which with the use of COCs has not been definitively established: porphyria. epilepsy, uterine fibroids, systemic lupus erythematosus (SLE), herpes during pregnancy, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice and/or itching associated with cholestasis: cholelithiasis; otosclerosis with hearing loss;

– liver dysfunction;

– changes in glucose tolerance and development of insulin resistance:

– chloasma;

– Crohn’s disease, ulcerative colitis.

In women with hereditary angioedema, estrogen may cause or worsen symptoms.

Interaction

Interaction of COCs with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to Delsia or choose another method of contraception.

Overdose

No serious adverse events have been reported following overdose.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

2 years.

Manufacturer

Sun Pharmaceutical Industries Ltd, India

Additional information

Shelf life	2 years.
Conditions of storage	At a temperature not exceeding 25 ° C. Keep out of reach of children.
Manufacturer	Sun Pharmaceutical Industries Ltd, India
Medication form	pills
Brand	Sun Pharmaceutical Industries Ltd