Incassia is a progestin-only contraceptive which contains norethisterone (norethindrone), which is used to prevent pregnancy.
Contents:
Indications for use
- Prevention of pregnancy.
Mechanism of action
Norethindrone prevents pregnancy by making vaginal fluid thicker, preventing fertilization and changing the lining of the uterus. As a result, the attachment of a fertilized egg does not occur. The drug also stops ovulation in about half of a woman’s menstrual cycles.
Dosage and mode of application
Take the tablets orally as directed by your doctor (usually 1 tablet per day) at the same time each day (preferably at bedtime).
Begin taking the tablets on the first day of your menstrual period. If you begin taking them on another day, you should use additional non-hormonal birth control methods for the first 2 days.
After taking the last tablet, start a new pack without interruption. The package does not contain any tablets (without hormones). You may also have spotting between menstrual periods. In this case, you should not stop taking the drug.
Side effects
In some cases, Incassia tablets can cause the following side effects:
- Nervous system and sensory organs: headache, paresthesia, migraine, dizziness, mood swings, increased nervous excitability, depression, increased fatigue;
- Cardiovascular system and blood (hemostasis, hematopoiesis): peripheral edema, hypercoagulation, thrombosis, thromboembolism;
- Digestive system: dyspepsia, nausea, vomiting, weight gain, weight changes, abdominal pain, diarrhea, constipation, jaundice, impaired hepatic functional tests, increased hepatic enzyme activity;
- Genitourinary system: acyclic spotting, metrorrhagia, intermenstrual bleeding, irregular menstruation, amenorrhea, vaginal discharge, cervical discharge, soreness in the mammary glands, mastalgia, mammary gland strain, breast engorgement, increased libido, decreased libido, peripheral edema;
- Metabolism and nutrition: weight gain, fluid retention, decreased glucose tolerance, impaired lipid performance;
- Skin and subcutaneous tissues: chloasma, melasma, increased sweating, itching, acne, hives, hirsutism, seborrhea, rash;
- Allergic reactions: hypersensitivity, skin rash, itching.
Contraindications
Incassia contraindications include:
- hypersensitivity to norethisterone or other components of the drug;
- puberty;
- malignant tumors of female genital organs;
- breast cancer (including suspected);
- diagnosed or suspected hormone-dependent malignant tumors;
- pregnancy (including suspected pregnancy);
- an ectopic pregnancy in history;
- acute liver diseases (including benign and malignant neoplasms of the liver);
- congenital hyperbilirubinemia (Dubin-Johnson syndrome, Gilbert syndrome (including history);
- severe liver function;
- liver cirrhosis;
- hepatitis;
- renal dysfunction;
- hyperbilirubinemia;
- acute thrombophlebitis;
- acute thromboembolism;
- a propensity to thrombosis;
- bleeding from the urinary tract of unknown origin;
- bleeding from the genital tract of unknown origin;
- metrorrhagia of unknown origin;
- otosclerosis (including in the anamnesis);
- hearing loss;
- porphyria;
- obesity;
- congenital disorders of cholesterol metabolism;
- cholestitis icteric jaundice during a previous pregnancy;
- pruritus in history;
- herpes;
- breastfeeding;
- lactose intolerance;
- lactase deficiency;
- glucose-galactose malabsorption.
With caution:
- bronchial asthma;
- epilepsy;
- chronic heart failure;
- arterial hypertension;
- renal failure;
- migraine;
- convulsions;
- diabetes mellitus;
- dysfunction of the central nervous system (including history);
- hyperlipidemia;
- history of thrombophlebitis;
- liver disease (including history);
- thromboembolism in anamnesis.
Interactions
Norethisterone can interact with some drugs, so it’s recommended to avoid the use of Incassia with the following drugs:
- anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), anti-infective drugs (eg rifabutin, rifampicin, efavirenz, nevirapine), barbiturates, aminoglutethimide, hydantoins;
- nelfinavir and ritonavir;
- herbal preparations, including St. John’s wort;
- inhibitors of microsomal liver enzymes (cimetidine and others);
- hypoglycemic drugs, glucocorticosteroids, oral anticoagulants;
- insulin;
- phenytoin, barbiturates, cimetidine, rifampicin and other drugs that affect microsomal oxidation in the liver;
- activated carbon and laxative drugs;
- theophylline, cyclosporine, troleandomycin and beta-blockers;
- macrolides.
Pregnancy and breastfeeding
Incassia tablets are contraindicated in pregnancy and lactation. If you get pregnant, stop taking birth control pills immediately. The use of the drug during breastfeeding reduces the secretion of milk and changes its quality. Breastfeeding should be stopped if you decide to take norethisterone tablets.
What if I miss a pill?
Missing a tablet can increase the risk of pregnancy so try not to miss it. If you missed 1 pill, take it as soon as possible and continue taking the drug at the regular time. In addition, you should use a barrier contraception method for the next 2 days). If you missed more than 1 pill, use a barrier contraception method for the rest of the pack until you have menstruation. Consult your gynecologist if you missed more than 1 pill.
Precautions
Before using the drug, you need to undergo a general medical examination and gynecological examination to exclude endometrial hyperplasia.
In case of prolonged treatment, you need to undergo a gynecological examination every 6 months.
Liver function, blood pressure, urinalysis, blood lipid levels should be regularly monitored in women taking this contraceptive.
Stop taking the pills immediately if you notice symptoms of phlebitis, deep vein thrombosis, thromboembolic diseases, a significant increase in blood pressure, jaundice, liver tumor, sudden migraine headaches, sudden vision impairment, prolonged immobilization, epilepsy, pregnancy.
Prolonged therapy with Incassia (more than 1 year) increases the risk of hyperplasia and endometrial cancer.
If you have an irregular bleeding during the use of birth control pills, a histological examination of the endometrial smear should be performed. If intermenstrual bleeding persists for more than 3 months, diagnostic scraping should be performed to exclude malignant neoplasms of the uterus.
Long-term use of norethisterone tablets (5 years or more) may increase the risk of breast cancer in women who are in menopause.
Patients with otosclerosis, multiple sclerosis, systemic lupus erythematosus, porphyria, melanoma, epilepsy, migraine or bronchial asthma should be examined regularly and thoroughly.
The drug may aggravate the symptoms of endometriosis.
Patients with cardiovascular diseases or impaired renal function should be carefully monitored since the drug contributes to the retention of water and sodium in the body.
Patients with hypertension should monitor blood pressure.
Patients with diabetes taking Incassia require careful monitoring because of a possible decrease in glucose tolerance.
The use of norethisterone increases the risk of gallbladder disease.
Norethisterone can affect the results of certain laboratory parameters: the functions of the liver, kidneys, adrenals, thyroid gland.
Stop taking birth control pills 6 weeks before the planned surgical interventions.