Yasmin - (IR): composition and pharmaceutical form
One film-coated tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol. This is a monophasic combined contraceptive: all the tablets in the pack are identical in composition.
The pack is intended for 21 days of use, after which comes a seven-day break. The tablets are taken in the order shown on the pack, with a small amount of liquid if needed.
How Yasmin - (IR) works
The composition includes two hormones: the oestrogen ethinylestradiol and the progestogen drospirenone. The contraceptive effect is provided by several mechanisms at once, the main ones being the suppression of ovulation and changes in the lining of the uterus. Drospirenone at therapeutic doses has an antiandrogenic and a weak antimineralocorticoid action and shows no oestrogenic, glucocorticoid or antiglucocorticoid activity, so in its pharmacological profile it is closest to natural progesterone.
The reliability of the method is described by the Pearl index: for the method itself it is 0.09, and taking errors in use into account, 0.57. In general, with correct use combined oral contraceptives give about 1% of failures a year, and missed tablets and a broken routine increase that figure. A reduction in the risk of cancer of the endometrium and the ovary has been shown for preparations with a higher hormone dose — 0.05 mg of ethinylestradiol — and for low-dose products it is not confirmed.
Indications
The medicine is intended for oral contraception.
Prescription is preceded by an individual assessment of the risk factors. The main thing the doctor weighs is the particular woman's risk of venous thromboembolism and how that risk for this medicine compares with other combined hormonal contraceptives.
Method of use and dosage
The scheme is the same for every cycle: one tablet a day, at roughly the same time, for 21 days in a row, then 7 days without tablets.
| Stage | What happens |
|---|---|
| Days 1–21 | One tablet a day in the order shown on the pack |
| Days 22–28 | The break: no tablets are taken and a withdrawal bleed usually occurs |
| Start of the withdrawal bleed | As a rule, on the second or third day after the last tablet |
| Start of the new pack | Strictly after the seven-day break, even if the bleeding continues |
The scheme for starting, for switching from another contraceptive method and for what to do about a missed tablet is chosen by the doctor: they depend on what was used before and on the day of the cycle on which use begins.
Contraindications
The medicine is not used in the conditions listed below; if any of them appears for the first time during use, it is stopped immediately:
- hypersensitivity to the active substances or to the excipients;
- venous thromboembolism now or in the past, including deep vein thrombosis and pulmonary embolism, and also a hereditary or acquired tendency to it — activated protein C resistance, deficiency of antithrombin III, of protein C or of protein S;
- major surgery with prolonged immobilisation, and also a combination of several risk factors for venous thrombosis;
- arterial thromboembolic disorders, their warning signs, a past stroke or transient ischaemic attack, and a hereditary or acquired tendency to arterial thrombosis;
- migraine with focal neurological symptoms in the history;
- diabetes mellitus with vascular complications, severe arterial hypertension, severe dyslipoproteinaemia;
- severe liver disease now or in the past, liver tumours, severe or acute renal failure;
- hormone-dependent tumours, genital bleeding of unclear nature, pregnancy or a suspicion of it.
Special warnings and precautions
The main theme of the warnings is thrombosis. Taking any combined hormonal contraceptive raises the risk of venous thromboembolism, and with preparations containing drospirenone it is roughly twice as high as with products containing levonorgestrel, norgestimate or norethisterone. Over a year venous thromboembolism develops in about 2 out of 10,000 women who take no hormonal contraception and are not pregnant, in 9–12 out of 10,000 on drospirenone preparations and in about 6 out of 10,000 on levonorgestrel preparations; during pregnancy and after childbirth the risk is higher still. It is greatest in the first year of use and on resuming after a break of four weeks or more, and in 1–2% of cases venous thromboembolism proves fatal. That is precisely why the prescription is discussed with the woman, making sure she understands both the general risk and the contribution of her own factors.
What raises the risk and which symptoms need help
The risk grows with an age over 35, smoking, obesity with a body mass index above 30 kg/m², arterial hypertension, dyslipoproteinaemia, migraine, heart valve defects and atrial fibrillation, and also with diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, inflammatory bowel disease and sickle cell anaemia. The family history matters too: 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. Immediate help is needed for pain or swelling in one leg, sudden severe chest pain, sudden breathlessness or cough, an unusually severe headache, a sudden disturbance of vision or speech, and weakness or numbness of one half of the body. Migraine becoming more frequent and more severe during use may herald a stroke and calls for immediate withdrawal, as does a persistent rise in blood pressure, while severe pain in the upper abdomen with enlargement of the liver makes it necessary to rule out a liver tumour. Hormonal contraception does not protect against sexually transmitted infections.
Drug interactions
Contraceptive efficacy is reduced by inducers of the liver enzymes: barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, ritonavir, nevirapine, efavirenz and, probably, also felbamate, griseofulvin, oxcarbazepine, topiramate and St John's wort. The effect of the induction develops over a few days, reaches its maximum in weeks and persists for about four weeks after withdrawal, so during such treatment and for another 28 days afterwards a barrier method is needed and, with prolonged use of inducers, it is better to switch to non-hormonal contraception.
Strong CYP3A4 inhibitors act the other way round — they raise the plasma concentrations of the hormones. The contraceptives, in their turn, change the metabolism of other medicines: the level of ciclosporin may rise, that of lamotrigine may fall. Because of the antimineralocorticoid properties of drospirenone, when combined with aldosterone antagonists and potassium-sparing diuretics the potassium is monitored, especially if kidney function is impaired. Finally, steroid contraceptives affect the results of a number of laboratory tests — liver and kidney tests, hormones, lipids, the parameters of carbohydrate metabolism and of clotting — although the values usually stay within normal limits.
Pregnancy and breastfeeding
The medicine is not prescribed to pregnant women, and if a pregnancy occurs its use is stopped. Large-scale epidemiological studies have shown 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. In animal experiments undesirable effects were noted during pregnancy and lactation, and the influence of the hormonal activity of the active substances cannot be entirely ruled out; however, the clinical experience of using such medicines in pregnancy does not point to real adverse consequences in humans.
The data on this particular medicine in pregnancy are too scarce for independent conclusions. When deciding to resume use after childbirth, the doctor takes into account the increased risk of venous thromboembolism in the postpartum period. Combined contraceptives are capable of reducing the amount of milk and changing its composition, and the hormones themselves pass into the milk in small amounts, so until breastfeeding has ended they are usually not recommended.
Adverse effects
What women encounter most often are reactions of the reproductive system, of digestion and of mood.
- common — headache and migraine;
- common — lowered mood and mood swings;
- common — nausea, abdominal pain, weight gain;
- common — cycle disturbances, bleeding outside the cycle, pain and increased sensitivity of the breasts, candidiasis of the vagina and vulva;
- uncommon — vomiting, diarrhoea, a rise or fall in blood pressure, migraine-type headaches, inflammation of the vagina, breast enlargement;
- uncommon — changes in libido, fluid retention, fluctuations in weight, acne, eczema, itching, hair loss, rash, urticaria;
- rare — venous and arterial thromboembolism, a rise in blood pressure, liver tumours;
- rare — contact lens intolerance, hearing loss, hypersensitivity and asthma, erythema nodosum and multiforme, discharge from the vagina and from the breasts.
The data on whether combined contraceptives influence the course of Crohn's disease, ulcerative colitis, epilepsy, migraine, uterine fibroids, porphyria and systemic lupus erythematosus remain contradictory.
Overdose
No undesirable reactions have been reported after an overdose of this particular medicine. From the general experience of using combined oral contraceptives, taking an excessive number of tablets may cause nausea and vomiting and, in young girls, slight genital bleeding.
There is no antidote and treatment is symptomatic. If more tablets than needed have been taken by accident, it is worth contacting a doctor to establish how to continue and whether additional contraception is required.
How to get a prescription for Yasmin - (IR) online
Combined contraceptives are dispensed on prescription: the doctor takes a history, including the family history, assesses the risk factors for thrombosis, measures the blood pressure and performs an examination.
During the online consultation the doctor will discuss with you the contraindications, the scheme 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.
