Yasmin® - leaflet, price, method of use and contraindications of the medicine

Yasmin®: composition and pharmaceutical form

Yasmin® is a combined oral contraceptive in film-coated tablets. One tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol. The pack holds 21 tablets, intended for one cycle of use followed by a seven-day break.

All the tablets in the pack have the same composition, which means the medicine is monophasic: they do not need to be swapped around, but they should be taken in the order shown on the pack.

How Yasmin® works

The contraceptive effect is made up of several mechanisms, the most important of which are the suppression of ovulation and changes in the endometrium. The medicine contains the oestrogen ethinylestradiol and the progestogen drospirenone. At therapeutic doses drospirenone has an antiandrogenic and a weak antimineralocorticoid action, while showing no oestrogenic, glucocorticoid or antiglucocorticoid activity — in its pharmacological profile it is close to natural progesterone.

With correct use the failure rate of combined oral contraceptives is about 1% a year, and with missed tablets or a broken routine it rises. For this medicine the Pearl index for failure of the method itself is 0.09, and the overall index, which also takes the users' errors into account, is 0.57. It is worth noting separately that preparations with a higher hormone dose (0.05 mg of ethinylestradiol) reduce the risk of cancer of the endometrium and the ovary, but there is no confirmation that low-dose contraceptives act in the same way.

Indications

Yasmin® is used for oral contraception — the prevention of an unwanted pregnancy.

The decision to prescribe it is taken after an individual assessment of the risk factors in the particular woman. Special attention is paid to the risk of venous thromboembolism: both the woman's own risk and how that risk with this particular medicine compares with other combined hormonal contraceptives.

Method of use and dosage

The tablets are taken daily, at roughly the same time, in the order shown on the pack, with a small amount of liquid if needed. The scheme is simple: one tablet a day for 21 days in a row, then a 7-day break, during which no tablets are taken and a withdrawal bleed usually occurs.

The withdrawal bleed usually starts on the second or third day after the last tablet and may continue once the new pack has been started — that is normal. The new pack is started strictly after the seven-day break, even if the bleeding has not yet finished. 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 below and, if any of these conditions appears for the first time during use, the medicine is withdrawn immediately:

• hypersensitivity to the active substances or to the excipients;
• venous thromboembolism now or in the past — deep vein thrombosis, pulmonary embolism — and also a known hereditary or acquired predisposition 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 prodromal, 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;
• severe liver disease now or in the past until the liver tests have normalised, benign and malignant liver tumours, severe or acute renal failure;
• hormone-dependent tumours, confirmed or suspected, genital bleeding of unclear origin, pregnancy or a suspicion of it.

Special warnings and precautions

Any combined hormonal contraceptive raises the risk of venous thromboembolism compared with using no hormonal contraception. The lowest risk is associated with preparations containing levonorgestrel, norgestimate or norethisterone; for those with drospirenone it may be roughly twice as high. In figures: 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 taking contraceptives with drospirenone and in about 6 out of 10,000 taking preparations with levonorgestrel. During pregnancy and in the postpartum period this frequency is higher than in any of these groups. The risk is greatest in the first year of use and on resuming after a break of 4 weeks or more; in 1–2% of cases venous thromboembolism ends in death. That is why prescribing a medicine that is not in the lowest-risk group is possible only after a conversation in which the woman understands both the risk itself and how her personal factors affect it.

• the risk is raised by age over 35, smoking, obesity with a body mass index above 30 kg/m², arterial hypertension, dyslipoproteinaemia, migraine, heart valve defects and atrial fibrillation;
• venous or arterial thrombosis in a parent, brother or sister, especially at a young age, is a reason to refer the woman to a specialist before she starts;
• prolonged immobility, major surgery, an operation on the lower limbs and severe trauma require the medicine to be stopped in advance and not resumed until mobility has returned;
• concomitant illnesses — diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, inflammatory bowel disease, sickle cell anaemia — increase the risk further;
• migraine becoming more frequent or more severe during use may herald a disturbance of the cerebral circulation and calls for immediate withdrawal;
• if thrombosis is suspected the medicine is withdrawn; if anticoagulant therapy has been started, another contraceptive method is needed — coumarin derivatives have a teratogenic effect;
• a persistent rise in blood pressure, and also liver tumours, whose signs are severe pain in the upper abdomen, enlargement of the liver or intra-abdominal bleeding, mean the medicine must be stopped;
• hormonal contraception does not protect against HIV or other sexually transmitted infections.

Warning signs are pain or swelling in one leg, sudden severe chest pain, sudden breathlessness or cough, an unusually severe and prolonged headache, a sudden partial or complete loss of vision, double vision, a speech disturbance, dizziness, weakness or numbness of one half of the body — with these symptoms immediate help is needed. Before starting 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.

Drug interactions

Inducers of the liver microsomal enzymes speed up the elimination of the sex hormones and can lead to intermenstrual bleeding and to loss of contraceptive protection. They include barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, ritonavir, nevirapine and efavirenz, and probably also felbamate, griseofulvin, oxcarbazepine, topiramate and St John's wort preparations. Enzyme induction develops over a few days, reaches its maximum in a few weeks and persists for about 4 weeks after such a medicine is stopped, so for the duration of the treatment and for another 28 days a barrier method is needed and, with prolonged use of inducers, non-hormonal contraception.

Strong CYP3A4 inhibitors, on the contrary, raise the plasma concentrations of the oestrogen and the progestogen, and the clinical significance of this can in individual cases be considerable. The contraceptives themselves affect the metabolism of other medicines: the concentration of ciclosporin may rise, that of lamotrigine may fall. Because of the antimineralocorticoid properties of drospirenone, potassium requires separate attention: combination with aldosterone antagonists and potassium-sparing diuretics calls for monitoring of its level, especially in renal failure. Steroid contraceptives are capable of altering the results of laboratory tests — liver, kidney and hormone tests, the lipid profile and the parameters of carbohydrate metabolism and of clotting — although the values usually stay within the normal range.

Pregnancy and breastfeeding

In pregnancy the medicine is not recommended; if a pregnancy occurs during use, it is stopped. Large epidemiological studies have found neither an increase in the frequency of congenital malformations in the children of women who took combined contraceptives before pregnancy, nor a teratogenic effect from accidental use in the early stages. In animal studies 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 extensive clinical experience of the use of combined contraceptives in pregnancy does not point to real adverse consequences in people.

The data on the use of this particular medicine in pregnancy are too scarce for independent conclusions. When resuming after childbirth, the doctor takes into account the increased risk of venous thromboembolism in the postpartum period. Combined contraceptives can reduce the amount of breast milk and change its composition, and small amounts of the hormones pass into the milk, so they are usually not prescribed until breastfeeding has ended.

Adverse effects

Most of the undesirable reactions concern the reproductive system, digestion and mood; serious complications are rare.

• common — headache, migraine, lowered mood and mood swings;
• common — nausea, abdominal pain, weight gain;
• common — disturbances of the menstrual cycle, 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;
• uncommon — a decrease or increase in libido, breast enlargement, inflammation of the vagina, fluid retention, changes in weight;
• uncommon — acne, eczema, itching, hair loss, rash, urticaria;
• rare — venous and arterial thromboembolism, contact lens intolerance, hearing loss, hypersensitivity reactions and asthma;
• rare — erythema nodosum and erythema multiforme, discharge from the vagina and from the breasts.

Separately one must remember the serious, though rare, complications: venous and arterial thromboses ending in myocardial infarction, stroke, transient ischaemic attack, deep vein thrombosis and pulmonary embolism, a persistent rise in blood pressure and liver tumours. The data on the influence of combined contraceptives on the course of Crohn's disease, ulcerative colitis, epilepsy, migraine, uterine fibroids, porphyria and systemic lupus erythematosus are contradictory.

Overdose

There are no reports of undesirable reactions after an overdose of this medicine. Judging by the general experience of using combined oral contraceptives, taking an excessive number of tablets may cause nausea, vomiting and, in young girls, slight genital bleeding.

There is no antidote and treatment is symptomatic. If several tablets have been taken by accident, it is worth contacting a doctor to establish the subsequent scheme and whether additional contraception is needed.

How to get a prescription for Yasmin® 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.