Volnea is a birth control pill containing 2 female hormones known as progestin (desogestrel) and estrogen (ethinyl estradiol).
Contents:
Indications for use
- Contraception.
Mechanism of action
Ethinyl estradiol / desogestrel strengthens the central and peripheral effects of cyproterone acetate on ovulation, retains a high viscosity of the cervical mucus, making it difficult for spermatozoa to penetrate into the uterine cavity and contributing to a reliable contraceptive effect.
The drug makes periods more regular, less painful, less intensive.
Dosage and mode of application
Each Volnea pack contains 21 active pills and 7 inert pills. Take 1 tablet daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days. Take tablets from the next package when the previous one is empty. The “withdrawal” bleeding usually occurs 2-3 days after the start of taking inert tablets and does not necessarily end at the start of the next package.
Side effects
Volnea contraceptive may cause the following side effects:
- candidiasis;
- anemia, thrombocytopenia;
- allergic reactions;
- increase in body weight;
- increased appetite;
- anorexia;
- disease of body weight;
- emotional lability;
- depression;
- reduced libido;
- nervousness;
- drowsiness;
- anorgasmia;
- insomnia;
- headache;
- dizziness;
- paresthesia;
- vertigo;
- conjunctivitis;
- sight impairment;
- migraine;
- phlebeurysm;
- increase of blood pressure;
- tachycardia;
- the damage of blood vessels;
- nose bleeding;
- nausea, vomiting;
- abdominal pain;
- diarrhea;
- cholecystitis;
- acne;
- itching;
- eczema;
- alopecia (baldness);
- dry skin;
- contact dermatitis;
- photodermatitis;
- backache;
- muscle cramps;
- chest pain;
- the lack of bleeding “cancellation”;
- vaginal candidiasis;
- an increase of mammary glands;
- spotting from the vagina;
- high tides of blood;
- vaginitis;
- acyclic spotting;
- painful menstrual bleeding;
- dry vaginal mucosa;
- painful intercourse;
- vulvovaginitis;
- postcoital hemorrhage;
- cyst of the breast;
- hyperplasia of the breast;
- mammary cancer;
- atrophy of the endometrium;
- ovarian cyst;
- an increase of the uterus;
- asthenia;
- sweating;
- a feeling of discomfort;
- venous thromboembolic diseases;
- liver tumors.
Contraindications
Volnea tablets are contraindicated for use in the following conditions (present or in the history):
- simultaneous use with another hormonal contraceptive;
- thrombosis (venous and arterial) or thromboembolism;
- conditions preceding thrombosis (including angina pectoris, transient ischemic attacks);
- multiple or expressed risk factors for venous or arterial thrombosis (complicated heart valve apparatus defects, atrial fibrillation, cerebrovascular or coronary artery disease, uncontrolled arterial hypertension, prolonged immobilization, surgical interventions on lower extremities, neurosurgical operations, extensive injuries, smoking over the age of 35, obesity);
- predisposition to venous or arterial thrombosis;
- diabetes mellitus with diabetic angiopathy;
- severe liver disease or violations of liver function;
- liver tumors (benign and malignant);
- hormone-dependent malignant tumors;
- bleeding from the vagina of an unclear etiology;
- pancreatitis with severe hypertriglyceridemia;
- a migraine, which was accompanied by focal neurological symptoms;
- the period of breastfeeding;
- pregnancy;
- congenital hyperbilirubinemia;
- age over 40 years;
- hyperprolactinemia;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- hypersensitivity to ethinyl estradiol/desogestrel or other components of the drug.
If any of these conditions occur against the background of taking Volnea contraceptive, the drug should be immediately withdrawn.
The drug is not intended for use in men.
With caution: epilepsy, depression, ulcerative colitis, liver and gallbladder diseases, uterine myomas, mastopathy, chorea, tetany, porphyria, multiple sclerosis, varicose veins, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles), dyslipoproteinemia, sickle-cell anemia, idiopathic jaundice or itching during previous pregnancy, otosclerosis during previous pregnancy.
Interactions
Volnea can interact with inducers of microsomal hepatic enzymes (hydantoins, barbiturates, primidone, carbamazepine and rifampicin, oxcarbazepine, topiramate, felbamate and griseofulvin), ampicillin, rifampicin and tetracyclines. This interaction can lead to breakthrough uterine bleeding or decrease the contraceptive reliability of the drug.
Pregnancy and breastfeeding
Volnea drug is contraindicated during pregnancy.
If the pregnancy occurred during the use of birth control pills, stop using them immediately. According to preclinical research, it is impossible to exclude unwanted effects on the fetus due to the hormonal action of the active components.
Ethinyl estradiol/desogestrel can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and their metabolites can be excreted with milk. This can affect the baby. The use of Volnea during breastfeeding is contraindicated.
What if I miss a pill?
Missing inactive tablets can be ignored. Nevertheless, you should discard the missed inactive tablets so as not to accidentally prolong the period of taking inactive tablets.
If a delay is less than 12 hours: take the pill right as soon as you remember, even if you have to take two tablets in one day. Take the rest of the tablets at the usual time.
If a delay is more than 12 hours: take the last of the missed tablets as soon as you remember. Check which of the tablets you missed:
- If you missed the tablet on day 1-7. Take the pill at the usual time, but use an additional method of contraception the next 7 days – your protection has decreased. If you have had sexual intercourse within a week before missing the pill, the probability of pregnancy increases. Consult a doctor immediately;
- If you missed the tablet on day 8-14. Take the pill at the usual time, additional precautions are not needed if you missed no tablets before. However, if you missed tablets before or you missed more than one pill, use an additional contraceptive method for 7 days;
- If you missed the tablet on day 15-24. There are 2 options: you should either take the pill at the usual time, discard 4 inactive tablets and start a new package without interruption; or stop taking the pills from the current package. Take a break in taking the tablets lasting no more than 4 days, including those days when the tablets were missed, and continue taking the tablets from the next package.
Precautions
Before you start taking birth control pills a woman should consult a specialist.
If you have any conditions/risk factors mentioned below, the benefits of taking the drug should be evaluated individually for each woman and discussed with a doctor.
Circulatory disorders
Taking any combined oral contraceptive increases the risk of venous thromboembolism. The increased risk of venous thromboembolism is most pronounced in the first year.
The risk of venous thromboembolism associated with the use of Volnea is not established.
Epidemiological studies have also revealed a link between ethinyl estradiol/desogestrel intake and an increased risk of arterial thromboembolism.
In rare cases, women taking oral contraceptives experienced thrombosis of blood vessels. There is no data on the connection between these phenomena and the use of hormonal contraceptives.
Symptoms of venous or arterial thrombotic/thromboembolic conditions or acute disorders of cerebral circulation:
- unusual unilateral leg pain and/or swelling;
- sudden severe pain in the chest with possible irradiation in the left arm;
- sudden shortness of breath;
- sudden coughing;
- any unusual, severe prolonged headache;
- sudden partial or complete loss of vision;
- diplopia;
- slurred speech or aphasia;
- dizziness;
- fainting;
- sudden weakness;
- numbness on one side of the body;
- movement disorders;
- “acute abdomen.”
Risk factors for venous thrombosis and embolism:
- age;
- predisposition to venous thrombosis and embolism;
- long-term immobilization, extensive surgical intervention, any operation on the lower limbs or a serious injury;
- obesity;
- thrombophlebitis of superficial veins and varicose veins.
Risk factors for arterial thrombosis:
- age;
- smoking (the risk increases with intensive smoking, especially in women older than 35 years);
- dislipoproteinemia;
- obesity;
- arterial hypertension;
- migraine;
- heart valve flaw;
- atrial fibrillation;
- predisposition to arterial thrombosis.
The presence of one serious risk factor for venous disease or several risk factors for artery disease can also be a contraindication. You should also consider the possibility of anticoagulant therapy. Women who use oral contraceptives should be properly instructed about the need to inform the doctor in case of suspicion of symptoms of thrombosis. In the event that thrombosis is suspected or confirmed, the use of birth control pills should be discontinued.
Other conditions that were accompanied by undesirable vascular disorders:
- diabetes;
- systemic lupus erythematosus;
- hemolytic uremic syndrome;
- inflammatory bowel disease;
- Crohn’s disease;
- ulcerative colitis;
- sickle-cell anemia.
An increase in the frequency or severity of a migraine during Volnea intake may be an indication for the immediate withdrawal of combined oral contraceptives.
Tumors
The most significant risk factor for developing cervical cancer is a persistent infection caused by the human papillomavirus (HPV). In epidemiological studies, long-term use of combined contraceptives containing ethinylestradiol has been shown to increase this risk, but it remains unclear to what extent this effect is related to other factors.
In epidemiological studies, women who took ethinylestradiol-containing combined oral contraceptives had a slight increase in the relative risk of developing breast cancer (relative risk = 1.24). The increased risk gradually disappears within 10 years after discontinuation of combined oral contraceptives. Breast cancer rarely develops in women under the age of 40.
In rare cases, women who took combined oral contraceptives observed the development of benign liver tumors and even less often – malignant. In some cases, these tumors led to life-threatening intra-abdominal bleeding. If you have intense pain in the upper abdomen, an increase in the liver or symptoms of intra-abdominal bleeding, it is necessary to exclude liver tumor.
Other conditions
The progestogen component of Volnea is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in the potassium content is not expected. However, in a clinical study, some patients observed an increase in the serum potassium content. Therefore, it is recommended to monitor the serum potassium content during the first treatment cycle in patients with renal insufficiency.
In women with hypertriglyceridemia or a corresponding family history, the risk of developing pancreatitis when taking combined oral contraceptives is increased.
In many women receiving combined oral contraceptives, a small increase in blood pressure was noted, although clinically significant BP increase was rare. The relationship between the intake of combined oral contraceptives and the development of hypertension has not been established.
In rare cases, combined oral contraceptives caused or aggravated the following conditions:
- jaundice and/or itching associated with cholestasis;
- the formation of stones in the gallbladder;
- porphyria;
- systemic lupus erythematosus;
- hemolytic uremic syndrome;
- gestational herpes;
- hearing loss associated with otosclerosis;
- hereditary edema.
In women with hereditary angioedema, exogenous estrogens can induce or enhance symptoms of edema.
In acute and chronic violations of liver function, it may be necessary to cancel combined oral contraceptives until the liver function is normalized.
Birth control pills may affect peripheral insulin resistance and glucose tolerance.
In rare cases, women taking ethinyl estradiol/desogestrel contraceptives complained of chloasma. Women who are prone to chloasma should avoid exposure to sun and ultraviolet light while taking combined oral contraceptives.
Volnea tablets contain lactose monohydrate and anhydrous lactose. Patients with rare hereditary diseases, such as galactose intolerance, lactase deficiency, or glucose-galactose absorption impairment who follow a lactose-free diet, should not take this drug.
Allergic reactions may occur in women who are allergic to soy lecithin.
Medical examinations / consultations
Before taking Volnea drug, you should exclude pregnancy and contraindications for use.
It is necessary to measure blood pressure and, in the presence of indications, conduct a physical examination taking into account contraindications and cautions. The interval between the control medical examinations is determined in each case individually, but not less than once in 6 months.
Women should be informed that combined oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Decreased efficiency
The effectiveness of the contraceptive may be reduced in the case of missing tablets, gastrointestinal disorders or undesirable drug interactions.
Insufficient period control
A woman may have acyclic bleeding, especially in the first months of admission. Therefore, any irregular bleeding should be assessed after a three-month adaptation period.
If acyclic bleeding recurs or begins after several regular periods, one should take into account the possibility of developing non-hormonal disorders and take measures to exclude pregnancy or cancer, including therapeutic and diagnostic curettage of the uterine cavity.
In some women, menstruation does not occur during the placebo phase. If Volnea was taken in accordance with the instructions for use, it is unlikely that a woman is pregnant. However, if the admission rules were violated before the first missed menstrual-like “withdrawal” bleeding, or if two bleedings are missed, pregnancy should be excluded before continuing hormonal contraception.
Use in pediatrics
The effectiveness and safety of Volnea contraceptive were studied in women of reproductive age. It is assumed that the effectiveness and safety of the drug in the post-pubertal period up to 18 years are similar to those in women after 18 years of age. The use of the drug before the menarche is unknown.
Use in liver function violations
Contraindications:
- severe liver diseases;
- liver tumors (malignant or benign).
Use in renal dysfunction
Contraindications:
- severe chronic or acute renal failure.
Influence on the ability to drive vehicles and manage mechanisms
Volnea does not affect the ability to drive vehicles and work with mechanisms.