Eloine Plus Film-Coated Tablets

• ELOINE PLUS is used to prevent pregnancy and to improve the folate status in women who decide to use oral contraception.

• ELOINE PLUS is used for the treatment of moderate acne vulgaris in women seeking oral contraception.

• ELOINE PLUS is also used for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptive as their method of birth control. The efficacy of ELOINE PLUS for PMDD was not assessed beyond 3 cycles.

• Each of the 24 pink film-coated tablets contains a small amount of the female hormones ethinyl o estradiol and drospirenone and the vitamin levomefolate calcium (which is also contained in the 4 light orange hormone-free film-coated tablets).

• Contraceptive pills that contain two hormones are called ‘combined pills’ or ‘combined oral contraceptives’.

Do not use ELOINE PLUS if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use ELOINE PLUS. Your doctor may advise you to use a different type of pill or an entirely different (non-hormonal) method of birth control.

Do not take ELOINE PLUS:

• if you are allergic (hypersensitive) to ethinyl o estradiol, drospirenone, levomefolate calcium or any of the other ingredients in ELOINE PLUS. This may cause, for example, itching, rash or swelling
• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other parts of the body
• if you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• if you have (or have ever had) a disease that can be an indicator (i) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic attack)
• if you have (or have ever had) a certain kind of migraine accompanied by e.g. visual symptoms, speech disability, or weakness or numbness in any part of your body
• if you have diabetes mellitus with damaged blood vessels
• if you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin or itching over the whole body) and your liver is still not working normally
• if you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
• if you have a severe kidney insufficiency or acute kidney failure
• if you have (or have ever had) a benign or malignant tumour of the liver
• if you have any unexplained bleeding from the vagina
• if you are pregnant or think you might be pregnant

Do not share medicines prescribed for you with others. The ELOINE PLUS pack contains 28 tablets. Take your tablet at about the same time each day, with some liquid if necessary. Follow the direction of the arrows until all 28 tablets have been taken.

Usually a period will start on day 2 to 3 after the last hormone-containing pink ELOINE PLUS tablet (i.e. while you are taking the last 4 hormone-free light orange tablets).

Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days every month.

When taken correctly, combined oral contraceptives, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

When can you start with the first pack?

If you have not used a contraceptive with hormones during the previous month: Start taking ELOINE PLUS on the first day of the cycle (that is, the first day of your period). Then follow the days in order. ELOINE PLUS will work immediately, it is not necessary to use an additional contraceptive method.

If you take more ELOINE PLUS than you should: There are no reports of serious harmful effects of taking too many ELOINE PLUS tablets. If you take several hormone-containing tablets at once, you may feel sick or vomit. Young girls may have bleeding from the vagina. If you have taken too many ELOINE PLUS tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take ELOINE PLUS: Missed hormone-free light orange film-coated tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the hormone-free light orange tablet phase.

The following advice only refers to missed hormone-containing pink film-coated tablets: If the user is less than 12 hours late in taking any hormone-containing tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time. If she is more than 12 hours late in taking any hormone-containing tablet, contraceptive protection may be reduced.

The management of missed hormone-containing tablets can be guided by the following two basic rules: 1. Active tablet-taking must never be discontinued for longer than 4 days; 2. 7 days of uninterrupted hormone-containing tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

What to do if you vomit or have severe diarrhoea: If you vomit or have severe diarrhoea after taking any of the pink tablets, the active ingredients in that tablet may not have been completely absorbed. If you vomit within 3 to 4 hours after taking your tablet, this is like missing a tablet. Therefore, follow the advice under ‘If you forget to take ELOINE PLUS’.

If you have severe diarrhoea, please contact your doctor. Vomiting or diarrhoea while taking the 4 hormone-free light orange film-coated tablets at the end of your blister does not have an influence on the contraceptive reliability.

If you want to stop taking ELOINE PLUS: You can stop taking ELOINE PLUS at any time. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking ELOINE PLUS and wait for a menstrual period before starting to try to become pregnant.

Not all side effects reported for ELOINE PLUS are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor if you notice any side effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by the Pill.

ELOINE PLUS can cause side effects. Serious side effects: See also section “Take special care with ELOINE PLUS”, “ELOINE PLUS and blood clots” and “ELOINE PLUS and cancer” for side effects, including serious reactions, associated with the use of ELOINE PLUS. Please read these sections carefully and consult your doctor at once where appropriate.

The following side effects were reported in studies with Yasmin and are also regarded as being representative for ELOINE PLUS:

Frequent side effects: depressive mood, headache, migraine, nausea, breast pain including breast tenderness, leukorrhoea (vaginal discharge), vaginal moniliasis (fungal infection), menstrual disorder, intermenstrual bleeding (bleeding irregularities usually subside during continued treatment).

Less frequent side effects: body weight changes, fluid retention, changes in interest in sex, high blood pressure, low blood pressure, vomiting, acne, eczema, itching, vaginitis (vaginal inflammation), hypacusia (hearing impairment), thromboembolism (blood clots including embolism), asthma, breast discharge.

Other side effects that have been reported are: allergic reactions (hypersensitivity), altered mood, contact lens intolerance, abdominal pain, diarrhoea, rash, urticaria (hives), skin disorders such as erythema nodosum or multiforme, breast enlargement.

If you have hereditary angioedema (swelling which involves lips, eyes or tongue) medicines containing certain female sex hormones (oestrogens) may induce or worsen the symptoms of angioedema (see section “When to take special care with ELOINE PLUS”). If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Store at or below 30 °C. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Keep the blister strip in the pouch, in the original carton until required for use. Do not use after expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).