Ovulastan Forte: composition and form
One tablet contains 0.15 mg of desogestrel and either 0.02 or 0.03 mg of ethinylestradiol: the progestogen dose is the same in both versions, only the oestrogen part differs. It is a combined oral contraceptive, and the pack holds 21 tablets — the cycle of taking and the break are written into the presentation itself.
The tablets are taken in the order shown on the pack, every day and at roughly the same time. The order is not decorative: it sets the continuity of ovarian suppression, and a fixed hour is the protection against a missed tablet, which is where the effectiveness is lost.
How Ovulastan Forte works
The contraceptive action of combined oral contraceptives arises from several factors, the most important being inhibition of ovulation and a change in cervical secretion. Two barriers therefore work at once: the egg does not come out, and the mucus becomes impassable to sperm. How reliable that is was shown by the largest multicentre study, covering 23 258 cycles: the uncorrected Pearl index was 0.1, with a confidence interval from 0.0 to 0.3.
Besides protection from pregnancy, medicines of this group have properties that are also weighed when choosing a method: the cycle becomes more regular, menstruation is often less painful and bleeding less heavy, and as a result iron deficiency develops less often. The other side is in the same figures: after six cycles, 4.5% of women reported no withdrawal bleeding and 9.2% reported irregular bleeding.
Indications
There is exactly one indication and it fits into two words: oral contraception. No additional ones — for painful periods, acne or endometriosis — are claimed by the product information, though lighter and more regular periods are mentioned in the section on action as a property that accompanies the whole class.
The limits of use are set not by the indication but by the data: safety and efficacy in adolescents under 18 have not been established. And one more limitation is repeated separately, because it is not about pregnancy: combined oral contraceptives protect neither against HIV infection nor against other sexually transmitted diseases.
Administration and dosage
The regimen is 21 days of one tablet a day and a seven-day break, during which withdrawal bleeding resembling a period begins: usually on the second or third day after the last tablet, and it may not be over by the start of the next pack. Where you begin depends on what came before. If no hormonal contraception was used in the previous month, you start on the first day of menstrual bleeding; you may also start between the second and fifth day of the cycle, but then a barrier method is needed for the first seven days. When switching from another combined product, the first tablet is taken the day after the last active tablet of the previous one, at the latest the day after the usual break or after the last placebo tablet; from a ring or a patch, on the day it is removed. From progestogen-only tablets the switch can be made on any day, from an implant or an intrauterine system on the day of removal, from an injection on the day the next one would be due; in all these cases a barrier method is needed for the first seven days. After a first-trimester miscarriage the tablets are started at once and without extra protection; after childbirth or a second-trimester miscarriage, on days 21 to 28.
A missed tablet is handled by the time elapsed and by the week of the cycle. If less than 12 hours have passed, protection is retained: the missed tablet is taken at once and the rest as usual. If more than 12 hours have passed, two rules apply: the break must not exceed seven days, and adequate suppression of the hypothalamic-pituitary-ovarian axis is given by seven days of continuous use. In the first week the last missed tablet is taken, even if that means two at once, and a barrier method is used for seven days; if intercourse occurred in the preceding seven days, pregnancy is possible. In the second week no extra protection is needed provided the previous seven days were taken correctly. In the third week the risk is higher because of the approaching break, and there are two ways out: take the missed tablet and start the next pack at once, with no break, or stop the current pack, wait seven days including the days missed, and start a new one. Vomiting or severe diarrhoea within 3-4 hours of taking a tablet mean it may not have been fully absorbed, and then one acts as for a missed tablet.
Contraindications
The prohibitions here are built differently from usual: they apply not only before starting. If any of the listed conditions appears for the first time during treatment, the medicine is withdrawn at once, without waiting for the pack to finish. The first group is vascular: venous thrombosis now or in the past, that is deep vein thrombosis and pulmonary embolism; arterial thrombosis or its prodromes — cerebrovascular disorders, infarction, angina, transient ischaemic attacks; here too belong severe or multiple risk factors: diabetes with vascular damage, severe hypertension, severe dyslipoproteinaemia. Separately stands a predisposition to thrombosis — resistance to activated protein C, deficiency of antithrombin III, protein C or protein S, hyperhomocysteinaemia, antiphospholipid antibodies.
The second group concerns the liver and tumours: severe liver disease now or in the past, until liver function tests return to normal; liver tumours, benign or malignant; the presence or suspicion of a malignant sex-hormone-dependent tumour, of the genital organs or the breast for instance. The third group is the rest: pancreatitis now or in the history if associated with severe hypertriglyceridaemia; vaginal bleeding of unknown cause; migraine with focal neurological symptoms; hypersensitivity to the active substances or excipients.
Special warnings and precautions
The central theme of the warnings is venous thromboembolism, and here the product information speaks in figures rather than generalities. The risk is highest in the first year of use in women who had not taken combined contraceptives before. For preparations with desogestrel or gestodene and 30 µg of ethinylestradiol the relative risk is estimated at 1.5-2.0 compared with those containing levonorgestrel, and the data do not say that the 20 µg oestrogen version is safer than the 30 µg one. In absolute numbers the picture is this.
| Group | Cases per 100 000 woman-years |
| Women using no contraception | 5-10 |
| Any low-oestrogen combined contraceptive | 20-40, depending on the progestogen |
| Preparations with levonorgestrel | about 20 |
| This medicine | 30-40, that is 10-20 additional cases |
| Pregnancy | about 60 per 100 000 pregnancies |
Venous thromboembolism ends in death in 1-2% of cases, so the symptoms should be known in advance: one-sided pain or swelling of the leg, sudden chest pain, breathlessness or an unusual cough, an unusually severe headache, loss of vision, double vision, disturbed speech, weakness or numbness of one side of the body, an "acute" abdomen. If thrombosis is suspected the medicine is withdrawn. The risk is raised by age, family history, obesity with a body mass index above 30, prolonged immobility and surgery: before a planned operation the tablets are stopped 4 weeks in advance and resumed no earlier than 2 weeks after full mobility returns. For arterial complications smoking is added — beyond the age of 35 giving it up is strongly advised — along with hypertension, migraine, valvular disease and atrial fibrillation. An increase in the frequency or severity of migraine while taking it may herald a vascular event and calls for withdrawal to be considered. A meta-analysis of 54 studies showed a slight increase in the relative risk of a breast cancer diagnosis, which disappears within 10 years of stopping; benign and, more rarely still, malignant liver tumours have been described rarely. Irregular bleeding in the first months is ordinary, and assessing it makes sense only after an adaptation period of about three cycles. The medicine contains lactose.
Interactions with other medicines
There is one main mechanism: induction of liver enzymes speeds up the clearance of sex hormones, and the consequence is intermenstrual bleeding and loss of contraceptive effect. This is confirmed for hydantoin derivatives, barbiturates, primidone, carbamazepine and rifampicin, and probably also for oxcarbazepine, topiramate, felbamate and nevirapine. Maximum enzyme activation comes only after 2-3 weeks of taking such medicines, but it persists for at least 4 weeks after they are stopped — hence the back-up rules. On a short course, of up to a week, a barrier method is used throughout and for 7 days afterwards; with rifampicin, throughout the course and for 28 days after. If the tablets run out during such treatment, the new pack is begun at once, with no break. St John's wort must not be used alongside: intermenstrual bleeding and unplanned pregnancy have been described, and the inducing effect lasts at least 2 weeks after the herb is stopped.
Separately stand the interactions unrelated to induction. Loss of contraceptive action was also seen with ampicillin and tetracyclines, though the mechanism has not been explained. Ritonavir reduced the area under the ethinylestradiol curve by 41% — reason to consider either higher doses or another method of contraception. Flunarizine increases the sensitivity of breast tissue to prolactin and creates a risk of galactorrhoea; troleandomycin raises the risk of intrahepatic cholestasis. In the other direction the medicine affects the metabolism of other substances: concentrations may rise, as with ciclosporin, or fall, as with lamotrigine. Finally, contraceptive steroids distort a range of laboratory parameters — liver, thyroid, adrenal and renal, transport proteins, coagulation — though the shifts usually stay within normal limits.
Pregnancy and breastfeeding
In pregnancy the medicine is not indicated, and if pregnancy occurs the tablets are stopped at once. This is no reason for alarm in retrospect: extensive epidemiological studies found neither an increased risk of congenital defects in children of mothers who took combined contraceptives before conception, nor a teratogenic effect from unintentional use in early pregnancy.
With breastfeeding it is different, and the reason is not malformations but the milk itself: combined contraceptives can reduce its quantity and change its composition, so they are not recommended to nursing mothers until the child is weaned. Small amounts of contraceptive steroids and their metabolites do pass into the milk and may affect the child.
Adverse reactions
The list begins with what applies to everyone: in women taking a combined contraceptive the risk of venous thromboembolic disease rises. Very often there is irregular bleeding and weight gain. Commonly: fluid retention, reduced libido, lowered and changeable mood, headache, dizziness, nervousness, migraine and raised blood pressure, nausea and vomiting, acne, rash, urticaria and, on the genital side, absence of menstruation, breast tenderness and enlargement, uterine bleeding. Rarely recorded are vaginal candidiasis, hypersensitivity, increased libido, intolerance of contact lenses, otosclerosis, thromboembolic disease, erythema nodosum and multiforme, itching, hair loss, and vaginal and nipple discharge.
A separate list holds the serious reactions: venous and arterial thromboembolic disease, hypertension, liver tumours. And a third holds conditions whose link with use is not established but which are mentioned in this context: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uraemic syndrome, cholestatic jaundice and melasma. The last is worth singling out: it appears more often in women who had it during a previous pregnancy, and they are advised to avoid sun and ultraviolet light.
Overdose
This section is short, and that in itself is information: no serious harmful effects of overdose have been reported. The possible manifestations are limited to nausea, vomiting and slight bleeding from the genital tract in young girls.
There is no specific antidote and further treatment is symptomatic. The practical conclusion is simple: an extra tablet taken by accident calls for no urgent measures, but neither does it cancel the ordinary rules — the schedule is not "shifted", it is continued as the product information says.
How to get a prescription for Ovulastan Forte online
Before a first prescription and before repeating one, the product information requires a full medical history, including the family history, exclusion of pregnancy, a blood pressure measurement and a physical examination. That is exactly what the questionnaire collects. At e-zdrowie.com you fill it in, the doctor examines the answers and, if the medicine is suitable, issues an electronic prescription: the code arrives by message, and with it any Polish pharmacy will hand over the pack.
In the questionnaire state any thrombosis, pulmonary embolism, heart attack or stroke in yourself and in close relatives at a young age, known clotting disorders, diabetes, hypertension, liver disease, pancreatitis, breast tumours, and migraine too — and separately, whether it comes with focal neurological symptoms. Report whether you smoke and how old you are: past 35 the combination of smoking and a contraceptive changes the calculation. Give your weight and height, any recent birth or miscarriage, and planned operations. And list your medicines — antiepileptics, rifampicin, antibiotics, HIV drugs and St John's wort: they are not forbidden, but they require a barrier method and exact timing.
