Aranelle is a birth control pill used to prevent pregnancy. The drug contains 2 female hormones, ethinyl estradiol and norethindrone, which are hormonal contraceptives.
Indications for use
Mechanism of action
The drug has a depressing effect on the gonadotropic function (effect on the ovaries) of the pituitary gland (a gland of internal secretion located in the brain): norethisterone acetate reduces the release of the luteinizing (causing the formation of the ovary’s yellow body) hormone. Ethinyl estradiol is a foldiculostimulating (hormone-stimulating hormone) hormone that inhibits ovulation (the exit of a mature egg from the ovary).
Dosage and mode of application
Aranelle is intended for oral administration. The pack contains 21 active tablets (ethinyl estradiol and norethindrone) and 7 inert tablets (no hormones).
Take 1 tablet per day for 28 days without interruption, approximately at the same time of a day, with a small amount of water, in the order indicated on the blister pack. Begin a new pack the day after taking the last tablet from the previous package.
In some cases, Aranelle can cause the following side effects:
- infectious and parasitic diseases: candidiasis of the oral mucosa, vaginal candidiasis, herpes simplex;
- immune system: allergic reactions, bronchial asthma, hypersensitivity reactions;
- blood and lymphatic system: anemia, thrombocytopenia;
- mental disorders: emotional lability, depression, nervousness, sleep disorder, anorgasmia;
- nervous system: headache, paresthesia, dizziness, migraine, tremor;
- impaired vision: conjunctivitis, dry eye syndrome, visual impairment;
- hearing disorders and labyrinthine disturbances: hearing loss;
- heart disorders: extrasystoles, tachycardia;
- vascular disorders: thromboembolism of the pulmonary artery, increased blood pressure, lower blood pressure, varicose veins, arterial and venous thromboembolism, fainting;
- respiratory system, chest and mediastinum: pharyngitis;
- gastrointestinal tract: nausea, vomiting, gastroenteritis, diarrhea, constipation, abdominal pain, bloating;
- liver and biliary tract: cholecystitis;
- skin and subcutaneous tissues: skin itching, rash, seborrhea, acne, alopecia, dry skin, eczema, photodermatitis, acneiform dermatosis, hypertrichosis, striae, nodal erythema, erythema multiforme;
- musculoskeletal and connective tissue: pain in the neck, pain in the extremities, lumbar region; muscle cramps;
- kidneys and urinary tract: cystitis;
- genitals and breast: breast pain, breast tenderness, metrorrhagia, lack of menstrual-like bleeding, tumors of breast, galactorrhoea, ovarian cyst, “tides”, whites, dry mucous membranes of the vagina, pelvic pain, changes smear results, decreased libido, increased mammary glands, painful menstrual bleeding, irregular menstrual-like spotting, fibrocystic mastopathy, vaginitis, cervical neoplasia, endometrial atrophy, profuse menstrual bleeding, dyspareunia, postcoital bleeding, , enlargement of the uterus;
- endocrine system: changes in glucose tolerance or influence on insulin resistance;
- general disorders: weight gain, increased appetite, weight loss, anorexia, edema, asthenia, excessive thirst, sweating;
- laboratory and instrumental data: hyperkalemia, hyponatremia.
Aranelle tablets are contraindicated in the presence of any of the conditions listed below:
- venous and arterial thrombosis and thromboembolism (current or in the anamnesis), cerebrovascular disorders (current or in the anamnesis);
- conditions preceding thrombosis (current or in the anamnesis);
- a hereditary or acquired predisposition to venous or arterial thromboses, such as resistance to activated protein C deficiency of antithrombin III, deficiency of protein C, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
- migraine with focal neurologic symptoms (current or in the anamnesis);
- multiple or expressed risk factors for venous or arterial thrombosis, including complicated cardiac valve disease, atrial fibrillation, diseases of the vessels of the brain or coronary arteries; uncontrolled arterial hypertension; severe dyslipoproteinemia, diabetes mellitus with vascular complications, serious surgical intervention with prolonged immobilization; smoking over the age of 35; obesity with a body mass index of more than 30 kg / m2; extensive trauma;
- liver failure, severe liver disease (before the normalization of liver function);
- benign or malignant liver tumors (current or in the anamnesis);
- severe renal failure, acute renal failure;
- adrenal insufficiency;
- pancreatitis associated with severe triglyceridemia (current or in the anamnesis);
- identified hormone-dependent malignant diseases (including genital organs or mammary glands);
- bleeding from the vagina of unspecified etiology;
- the period of breastfeeding;
- hypersensitivity to ethinyl estradiol and norethindrone or other components of the drug;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
If you have any of the conditions/risk factors listed below, use Aranelle contraceptive with caution:
- risk factors for thrombosis and thromboembolism: smoking, thrombosis (current or in the anamnesis), predisposition to myocardial infarction or cerebrovascular disorders, obesity with a BMI of less than 30 kg / m2; dyslipoproteinemia; controlled arterial hypertension; migraine without focal neurological symptoms; heart valve disease without complications; heart rhythm disorder;
- diseases that may be accompanied by violations of peripheral circulation: diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome;
- Crohn’s disease and ulcerative colitis; sickle-cell anemia; phlebitis of superficial veins;
- hereditary angioedema;
- liver disease;
- diseases that first appeared or worsened during pregnancy or against the background of the previous intake of oral contraceptives (jaundice, cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham’s chorea);
- the postpartum period.
The interaction of oral contraceptives with other drugs can lead to “breakthrough” bleeding and / or a decrease in contraceptive reliability. Women taking these drugs should temporarily use additional methods of contraception.
Possible Aranelle interactions include:
- drugs that induce microsomal liver enzymes: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate,
- griseofulvin and preparations containing St. John’s wort;
- HIV proteases (ritonavir) and non-nucleoside reverse transcriptase inhibitors (nevirapine) and their combinations;
- some antibiotics (penicillins and tetracycline);
- drugs affecting microsomal enzymes;
- cyclosporine, lamotrigine;
- omeprazole, simvastatin and midazolam;
- ACE inhibitors, angiotensin II receptor antagonists, some non-steroidal anti-inflammatory drugs, potassium-sparing diuretics and aldosterone antagonists.
Pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. When a pregnancy occurs against the background of taking this contraceptive, you must immediately stop taking it. The available data on the use of Aranelle during pregnancy are too limited and do not allow to draw a conclusion about its negative effect on pregnancy or on the health of the fetus or newborn.
Aranelle is contraindicated during breastfeeding. Ethinyl estradiol and norethindrone can reduce the amount of breastmilk and change its quality. A small amount of sex hormones can penetrate into breast milk and affect the baby.
What if I miss a pill?
- If you missed 1 active pill of Aranelle during week 1, 2 or 3, take the missed pill as soon as you remember;
- If you missed 2 active pills in a row during week 1 or 2, take 2 pills the day you remember about it and 2 pills the next day. After that, continue taking the drug according to your usual schedule until you finish the pack. Use an additional contraceptive method for 7 days, starting from the day you remember about your mistake;
- If you missed 2 active pills in a row during week 3: throw out the rest of the pack the day you realize your mistake and start a new one. For the next seven days, use a backup birth control method;
- If you missed 3 pills in a row during week 1, 2 or 3, discard the rest of the tablets and start a new one. For the next 7 days, use an additional contraception method;
- If you missed 1 or more inactive pills during week 4, discard them and continue to take 1 pill a day.
In some cases, you may not have a menstruation after the period in which you missed active pills. However, if you have no menstruation for 2 months in a row, you should exclude pregnancy.
If you have any questions about your schedule, consult your doctor.
Before taking the tablets and every 6 months during treatment, it’s recommended to undergo a general medical and gynecological examination (including gynecological control, breast examination, liver function, blood pressure control and cholesterol concentration in the blood, urine analysis, cytological smear analysis).
The use of Aranelle after childbirth is recommended only after the first normal cycle.
The drug should be discontinued immediately in the following cases:
- the onset of pregnancy;
- 3 months before the planned pregnancy;
- unusual headaches;
- pain and feelings of tightness in the chest;
- an increase in blood pressure;
- early signs of phlebitis or phlebothrombosis (unusual pain or bloating of the veins on the legs);
- visual impairment;
- cerebrovascular disorders;
- stitching pain of unclear etiology when breathing or coughing;
- 6 weeks before the planned surgery followed by a prolonged immobilization.
The efficiency of the contraceptive effect decreases with regular excessive intake of ethanol.
Moderate spotting during the contraception course does not require discontinuation of Aranell. If you have a severe bleeding, stop taking birth control pills and undergo a gynecological examination.
Diarrhea and vomiting can reduce a contraceptive effect of the drug. In this case, you need to use additional non-hormonal birth control methods).
Smoking women have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depends on the number of cigarettes smoked per day (especially in women over 35 years of age).
Ethinyl estradiol and norethindrone may change the results of skin allergic tests, decrease the concentration of LH and FSH.