Jeanine®: composition and pharmaceutical form
One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of micronised dienogest. The pack holds 21 tablets — all active — and the scheme runs with a seven-day break.
That amount of hormones places the medicine among the low-dose oral contraceptives, often called micro-tablets. It also matters that the progestogen component here is dienogest: it is precisely dienogest that the medicine's second indication relates to, besides preventing pregnancy.
How Jeanine® works
Jeanine® is a monophasic oral contraceptive: the hormone dose is the same in every tablet of the cycle. The active substances are dienogest as the progestogen and ethinylestradiol as the oestrogen.
Besides the contraceptive effect the medicine brings predictable side benefits. The bleeding corresponding to menstruation usually becomes shorter and lighter, which lowers the risk of iron-deficiency anaemia. Menstrual pain as a rule eases or disappears altogether.
Indications
The first indication is oral contraception. The second is the treatment of moderate acne in women who have decided to use an oral contraceptive, after correctly conducted topical treatment or oral antibiotic therapy has produced no result.
The decision to prescribe is based on an individual assessment of a particular woman's risk factors — above all the risk of venous thromboembolism, including the risk tied to this very medicine compared 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 little liquid if needed. One tablet a day for 21 days in a row, then a seven-day break, during which withdrawal bleeding usually begins — as a rule on the second or third day after the last tablet — and it may continue after the new pack has been started.
| Situation | How to start |
|---|---|
| No hormonal contraception was taken in the previous month | from day 1 of the cycle; if starting on days 2–5, a barrier method is needed for the first 7 days |
| Switching from another combined contraceptive | the day after the last active tablet, no later than the day following the usual break |
| Switching from a progestogen-only product | from the mini-pill, any day; from an implant or device, the day it is removed; from injections, the day of the next injection; a barrier method is needed for the first 7 days |
| After a miscarriage in the first trimester | immediately, no additional contraception is needed |
| After childbirth or a miscarriage in the second trimester | on days 21–28; if starting later, a barrier method is needed for the first 7 days |
| In the treatment of acne | noticeable improvement usually comes no earlier than 3 months and further improvement by 6; the need to continue is assessed at 3–6 months and then periodically |
The medicine can be stopped at any moment. If it is withdrawn in order to conceive, it is worth waiting for a natural period: that will help to establish the expected date of delivery more precisely.
Contraindications
Most of the prohibitions relate to thrombosis; the rest to the liver and hormone-dependent tumours.
- hypersensitivity to the active substances or to any excipient;
- venous or arterial thrombosis and thromboembolism, current or past — deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke;
- prodromes of thrombosis, current or in the history: transient ischaemic attack, angina pectoris;
- migraine with focal neurological symptoms in the past;
- diabetes mellitus with vascular complications, and also a serious thrombosis risk factor or a combination of several factors;
- severe liver disease, current or past — until liver tests normalise — as well as benign and malignant liver tumours;
- hormone-dependent tumours or suspicion of them, including tumours of the genital organs and the breast;
- genital bleeding of unknown origin, pregnancy or suspected pregnancy.
Special warnings and precautions
Epidemiological studies point to a link between taking combined oral contraceptives and an increased risk of arterial and venous thrombosis and thromboembolism — myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism. They occur rarely, and the risk is highest in the first year of use. In numbers it looks like this: in women on contraceptives with a low oestrogen dose venous thromboembolism develops in about 4 per 10,000 a year against 0.5–3 per 10,000 in those not taking them; during pregnancy the figure is 6 per 10,000.
What raises the risk
- age and smoking — the risk grows with the number of cigarettes and especially after 35;
- thrombosis in parents or siblings at a young age: where an inherited predisposition is suspected, a specialist should be consulted before prescribing;
- obesity with a body mass index above 30 kg/m²;
- dyslipoproteinaemia, arterial hypertension, migraine;
- heart valve defects, atrial fibrillation;
- prolonged immobilisation, major surgery, any operation on the lower limbs;
- very rarely thromboses of unusual sites have been described — hepatic, mesenteric, renal and cerebral vessels and those of the retina;
- a combination of several factors is more dangerous than each one separately.
Symptoms at which the medicine is stopped immediately
One-sided pain or swelling of a leg; sudden severe chest pain, whether or not radiating to the left arm; sudden breathlessness; a cough of abrupt onset; any atypical, severe and persistent headache; sudden partial or total loss of vision; double vision; disturbed speech or aphasia; dizziness; collapse with or without a convulsive seizure; sudden weakness or marked numbness of half the body or part of it; movement disorders; acute abdominal pain.
Drug interactions
Agents that induce hepatic microsomal enzymes speed up the elimination of sex hormones and reduce the reliability of protection. These include phenytoin, barbiturates, primidone, carbamazepine, rifampicin and, probably, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products with St John's wort; HIV protease inhibitors together with non-nucleoside reverse transcriptase inhibitors can also increase hepatic metabolism. Antibiotics are a separate story: penicillins and tetracyclines may disturb the enterohepatic circulation of oestrogens and lower the concentration of ethinylestradiol.
Hence the practical rules. While enzyme inducers are being taken and for 28 days afterwards a barrier method is needed; with antibiotics, apart from rifampicin and griseofulvin, for up to 7 days after the course ends. If that period runs beyond the current pack, the next one is started at once, without the seven-day break. CYP3A4 inhibitors work the other way: dienogest is a substrate of that enzyme, so azole antifungals such as ketoconazole, cimetidine, verapamil, macrolides, diltiazem, some antidepressants and grapefruit juice raise its concentration. The medicine itself can change the levels of other drugs — ciclosporin upwards, lamotrigine downwards — and influence laboratory results, though usually leaving them within the normal range.
Pregnancy and breastfeeding
During pregnancy the medicine is contraindicated. If pregnancy occurs while it is being taken, it is stopped. It is worth noting that large epidemiological studies have found neither an increased risk of congenital malformations in children of women who took combined contraceptives before conception, nor a teratogenic effect from accidental use in early pregnancy; for this particular medicine, however, such studies have not been carried out.
Combined contraceptives affect lactation: they reduce the amount of milk and change its composition. Small amounts of the steroid contraceptive substances and their metabolites pass into breast milk. For that reason, until breastfeeding has ended, such medicines are as a rule not recommended.
Adverse effects
What women most often report are headache and breast tenderness. A considerable share of the reactions concerns the genital sphere and the cycle.
- common: headache, breast pain;
- uncommon: dizziness, migraine, low mood, increased appetite, nausea, vomiting, abdominal pain, diarrhoea, acne, rash, itching, hair loss;
- uncommon in the cycle: atypical withdrawal bleeding, intermenstrual bleeding, breast enlargement and swelling, painful periods, vaginal discharge, ovarian cyst, pelvic pain;
- uncommon, other: vaginitis and vulvovaginitis, vaginal candidiasis, a rise or fall in blood pressure;
- rare but serious: stroke and cerebrovascular disturbances, thrombosis or pulmonary embolism, thrombophlebitis, sudden hearing loss;
- rare: anaemia, hypersensitivity, depression, insomnia, aggression, tachycardia, asthma, gastritis, enteritis, cervical dysplasia, cysts of the adnexa and the breast, pain during intercourse;
- rare in the skin: allergic and atopic dermatitis, eczema, psoriasis, chloasma, pigmentation disorders, seborrhoea, hirsutism, increased sweating;
- frequency not known: mood changes, decreased or increased libido, contact lens intolerance, urticaria, erythema nodosum and multiforme.
A separate group is the rare reports of virilisation and of uterine leiomyoma. Any of the signs of thrombosis listed above calls not for observation but for stopping the medicine at once and seeing a doctor.
Overdose
There are no reports of severe adverse reactions after taking several tablets at once. Nausea, vomiting or genital bleeding are possible.
There is no antidote and treatment is symptomatic. Such a situation usually needs no separate intervention, but it is worth telling the doctor about it, if only to establish whether protection against pregnancy has been maintained in the current cycle.
How to get a prescription for Jeanine® online
Jeanine® is a prescription-only medicine and is prescribed after an assessment of individual risk factors, above all thrombotic ones. During the online consultation the doctor will go through your history, concomitant illnesses, smoking and the medicines you take and decide whether this product suits you or whether a contraceptive from another group makes more sense.
If there are no contraindications, the doctor will issue an electronic prescription and explain how to start taking it in your situation and what to do after a missed tablet and, in acne treatment, when to assess the result and whether the course is worth continuing.
