Belara: composition and pharmaceutical form
One film-coated Belara tablet contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate. This is a combined hormonal contraceptive intended for 21 days of use followed by a seven-day break.
The tablets are pressed out of the blister from the cell marked with the corresponding day of the week and swallowed whole, with a small amount of liquid if needed. They are taken once a day, following the order shown by the arrow on the pack.
How Belara works
Continuous use of the medicine for 21 days suppresses the release by the pituitary of follicle-stimulating and luteinising hormone and thereby blocks ovulation. At the same time the proliferation and secretory activity of the endometrium change, and the mucus of the cervix takes on a different consistency — this hinders the passage of spermatozoa through the cervical canal and alters their motility.
The minimum daily dose of chlormadinone acetate needed for the complete suppression of ovulation is 1.7 mg, and the dose that brings about the complete transformation of the lining of the uterus is 25 mg per cycle. Chlormadinone acetate belongs to the antiandrogenic progestogens: it is able to displace androgens from their receptor sites.
Indications
Belara is used for hormonal contraception.
The decision to prescribe it is taken on the basis of an individual assessment of the risk factors in the particular woman, above all of the risk of venous thromboembolism — both her own and that associated with this medicine specifically, compared with other combined hormonal contraceptives.
Method of use and dosage
One tablet is taken a day at the same time, better in the evening, for 21 days in a row, after which a seven-day break is made. Two to four days after the last tablet a withdrawal bleed resembling a period should begin.
The next pack is started exactly after the seven days of the break, regardless of whether the bleeding has ended or is still continuing. The detailed scheme for starting, for switching from another contraceptive method and for what to do about a missed tablet is set by the doctor.
Contraindications
Combined hormonal contraceptives are not used in the cases listed; if any of these conditions appears for the first time during use, the medicine is withdrawn immediately:
- venous thromboembolism now or in the past — deep vein thrombosis, pulmonary embolism — and a known hereditary or acquired tendency to it: activated protein C resistance, including factor V Leiden, deficiency of antithrombin III, of protein C or of protein S;
- major surgery with prolonged immobilisation and a high risk of venous thromboembolism from a combination of several factors;
- arterial thromboembolic disorders — active, for example myocardial infarction, or their warning signs, for example angina pectoris; an active or past stroke and transient ischaemic attack; a hereditary or acquired tendency to arterial thrombosis, including hyperhomocysteinaemia and antiphospholipid antibodies;
- migraine with focal neurological symptoms in the history;
- a high risk of arterial thrombosis from several factors or from one severe one — diabetes with vascular complications, severe arterial hypertension, severe dyslipoproteinaemia;
- insufficiently controlled diabetes mellitus, uncontrolled arterial hypertension or a persistent rise in blood pressure above 140/90 mm Hg;
- hepatitis, jaundice, impaired liver function — until the liver values have normalised;
- generalised itching and cholestasis, especially if they have occurred before.
Special warnings and precautions
As with all combined hormonal contraceptives, the main subject of the warnings is thrombosis. Taking such medicines raises the risk of venous thromboembolism compared with using no hormonal contraception, and the risk is greatest in the first year of use and also on resuming after a break of four weeks or more. Before prescribing and on resuming, the doctor takes a detailed history, including the family history, measures the blood pressure and performs an examination, and then repeats the check periodically.
- the risk of thrombosis is increased by age over 35, smoking, obesity, arterial hypertension, dyslipoproteinaemia, migraine, heart valve defects and rhythm disturbances;
- thrombosis in a parent, brother or sister at a young age is a reason to refer the woman to a specialist before she starts;
- before a planned operation, with prolonged immobility and after severe trauma the medicine is stopped in advance and resumed only once mobility has returned;
- sudden pain or swelling in one leg, sharp chest pain, sudden breathlessness or cough, an unusually severe headache, a disturbance of vision or speech, and weakness or numbness of one half of the body require immediate help;
- migraine becoming more frequent or more severe during use may herald a disturbance of the cerebral circulation and is a reason to stop the medicine at once;
- a persistent rise in blood pressure and the appearance of jaundice, hepatitis or generalised itching are grounds for withdrawing the medicine;
- with a tendency to chloasma, sun and ultraviolet exposure should be avoided: pigmentation disorders with this medicine are uncommon but possible;
- hormonal contraception does not protect against HIV or other sexually transmitted infections.
The reliability of the method deserves separate attention. Missed tablets, vomiting and diarrhoea soon after a dose, and also concurrent treatment with medicines that speed up the metabolism of the hormones, reduce the contraceptive effect — in these situations an additional barrier method is needed, and it is worth discussing in advance with the doctor what to do.
Drug interactions
Contraceptive efficacy is reduced by inducers of the liver enzymes: barbiturates, carbamazepine, phenytoin, primidone, rifampicin and, probably, also oxcarbazepine, topiramate, felbamate, griseofulvin, preparations containing St John's wort and a number of anti-HIV medicines. Their effect develops over a few days and persists for about four weeks after withdrawal, so for the duration of such treatment and for another 28 days a barrier method is used and, with prolonged therapy with inducers, one switches to non-hormonal contraception.
Strong enzyme inhibitors, on the contrary, raise the plasma concentrations of the hormones. The contraceptives themselves are capable of changing the metabolism of other medicines: the concentration of ciclosporin may rise, that of lamotrigine may fall. In addition, steroid contraceptives affect the results of laboratory tests — liver, kidney and hormone tests, the parameters of lipid and carbohydrate metabolism, blood clotting — although the values usually stay within the normal range.
Pregnancy and breastfeeding
In pregnancy the medicine is not used, and if a pregnancy occurs during use it is withdrawn immediately. Large epidemiological studies have found no increase in the frequency of congenital malformations in the children of women who took combined contraceptives before conception, and no teratogenic effect from accidental use in the early stages.
Combined hormonal contraceptives can reduce the amount of breast milk and change its composition, and small amounts of the hormones pass into the milk, so until breastfeeding has ended such medicines are usually not prescribed. When resuming after childbirth, the doctor takes into account the increased risk of venous thromboembolism in the postpartum period.
Adverse effects
In the clinical studies the most frequent — in more than 20% of the women — were intermenstrual bleeding, spotting, headache and discomfort in the breasts. Irregular bleeding, as a rule, stops as use continues.
- very common — nausea, vaginal discharge, painful periods, absence of periods;
- common — vomiting, pain in the lower abdomen, a feeling of heaviness;
- common — lowered mood, nervousness, irritability, dizziness, migraine or its worsening, visual disturbances, acne;
- uncommon — vaginal candidiasis, fibroadenomas of the breasts, hypersensitivity reactions, including allergic skin reactions;
- uncommon — changes in the blood lipids, including hypertriglyceridaemia, reduced libido, abdominal pain, bloating, diarrhoea, back pain;
- uncommon — pigmentation disorders, chloasma, hair loss, dry skin, increased sweating;
- rare — inflammation of the vagina and vulva, conjunctivitis, contact lens intolerance, sudden hearing loss, tinnitus, increased appetite;
- rare — a rise or fall in blood pressure, cardiovascular collapse, varicose veins, venous thrombosis, venous and arterial thromboembolism, urticaria, eczema, erythema, itching, worsening of psoriasis, excessive hair growth; very rare — erythema nodosum.
Overdose
There is no information about severe harmful consequences of an overdose. Nausea, vomiting and slight vaginal bleeding are possible, especially in young girls.
There is no antidote and treatment is symptomatic. In rare cases monitoring of the water and electrolyte balance and of liver function may be needed.
How to get a prescription for Belara online
Combined contraceptives are dispensed on prescription: before prescribing, the doctor takes a history, including the family history, assesses the risk factors for thrombosis and measures the blood pressure.
During the online consultation the doctor will discuss with you the contraindications, the rules of use and what to do about a missed tablet and, if there are no restrictions, will issue an electronic prescription — the medicine can be collected from a pharmacy using its code.
