Eloine Tablets

ELOINE is a combined oral contraceptive (“the combined Pill”) consisting of 24 pink tablets with active ingredients and 4 white inactive tablets (bottom row of the blister pack). Each active tablet contains a small amount of two different female hormones. These are drospirenone (a progestogen) and ethinylestradiol (an oestrogen). Because of the small amounts of hormones, ELOINE is considered a low-dose oral contraceptive. As all active tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.

• ELOINE is used to prevent pregnancy.
• ELOINE is used for the treatment of moderate acne vulgaris in women seeking oral contraception.
• ELOINE is also used for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of ELOINE for PMDD was not assessed beyond 3 cycles.
• Each of the 24 light pink film-coated tablets contains an amount of the female hormones ethinylestradiol and drospirenone.
• Contraceptive pills that contain two hormones are called ‘combined pills’ or ‘combined oral contraceptives’.

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

Do not use ELOINE:

• If you are hypersensitive (allergic) to ethinylestradiol or drospirenone or any of the other ingredients of ELOINE tablets.
• If you have, or have ever had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), or other parts of the body. (See also the section later in this leaflet called “ELOINE and thrombosis”.)
• If you have or have had a stroke (caused by a blood clot or a rupture of a blood vessel in the brain).
• If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
• If you have a history 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 blood vessel damage.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have 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 an acute failure of your kidney.
• If you have or have had a benign or malignant liver tumour.
• If you have any unexplained vaginal bleeding.
• If you are pregnant or think you might be pregnant.

If any of these conditions appear for the first time while using ELOINE, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

See also “General notes” in the next section.

General notes: In this leaflet, several situations are described where you should stop taking ELOINE, or where the reliability of ELOINE may be decreased. In such situations you should not have sexual intercourse or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use the rhythm or temperature methods. These methods can be unreliable because ELOINE alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle. Women should be advised that ELOINE does not protect against HIV infections (AIDS) and other sexually transmitted diseases (STDs). Women should be advised that additional barrier contraceptive measures are needed to prevent transmission of STDs and HIV infection.

Take special care with ELOINE: If used in the presence of any of the conditions listed below; you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use ELOINE.

• you smoke;
• you have diabetes;
• you are overweight;
• you have high blood pressure;
• you have a heart valve disorder or a certain heart rhythm disorder;
• you have an inflammation of your veins (superficial phlebitis);
• you have varicose veins;
• anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
• you suffer from migraine;
• you suffer from epilepsy;
• you have an increased potassium blood level (e.g. due to problems with your kidneys) and also use diuretics that may increase the potassium in your blood (ask your doctor);
• you or someone in your immediate family has or has had high blood levels of cholesterol or triglycerides (fatty substances);
• anyone in your immediate family has had breast cancer;
• you have liver or gallbladder disease;
• you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus erythematosus (SLE, a disease affecting the skin all over the body);
• you have haemolytic uraemic syndrome (HUS, a disorder of blood coagulation causing failure of the kidneys);
• you have sickle cell disease (for example, sickle cell anaemia, or other sickle cell conditions);
• you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham’s chorea);
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation;
• you have hereditary angioedema: exogenous oestrogens may induce or exacerbate symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing.

If any of the above conditions appear for the first time, recur or worsen while using ELOINE, you should contact your doctor.

When and how to take the tablets: The ELOINE pack contains 28 tablets (24 active tablets and 4 inactive tablets). The first course of ELOINE is started on the first day of the menstrual period (day 1 of the cycle) from the white section of the pack by selecting the appropriate tablet for that day of the week (e.g. “MO” for Monday). The tablet is swallowed whole with some liquid. Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once you have selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 or 3 after starting the inactive tablets and may not have finished before the next pack is started. Each subsequent pack is started in the white section the day after the last tablet of the current pack. If you start ELOINE during the latter part of the week, the very first cycle may be slightly shortened.

Starting your first pack of ELOINE:

• When no hormonal contraceptive has been used in the past month: Start taking ELOINE on the first day of your cycle, i.e. the first day of menstrual bleeding. Take the tablet marked with that day of the week from the white section of the pack. For example, if your period starts on a Friday, take the tablet marked “FR”. Then take 1 tablet every day following the directions shown by the arrows. During the first cycle an additional barrier method is recommended for the first 7 days of tablet-taking.
• When changing from another combined pill, vaginal ring or transdermal (contraceptive) patch: You should start with ELOINE preferably on the day after the last active tablets of your previous combined oral contraceptive, but at the latest on the day following the usual tablet-free or inactive tablet interval of your previous combined oral contraceptive. In case you have used a vaginal ring or transdermal patch, you should start using ELOINE preferably on the day of removal, but at the latest when the next application would have been due. If you follow these instructions, it is not necessary to use an additional contraceptive method.
• When changing from a progestogen-only method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): You may switch any day from the minipill, from an implant or the IUS on the day of its removal, and from an injectable when the next injection would be due, but in all these cases you are advised to use an additional barrier method for the first 7 days of tablet-taking.
• After having a baby: If you are breastfeeding and want to take ELOINE, you should discuss this first with your doctor, who will advise you. After a miscarriage or an abortion: Your doctor will advise you.

If you take more ELOINE than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken ELOINE, ask your doctor for advice. Taking the white tablets from the bottom row of the blister is harmless because they do not contain active ingredients.

If you forget to take ELOINE:

• If you are less than 12 hours late in taking an active tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablet at the usual time.
• If you are more than 12 hours late in taking any active tablet, the reliability of the Pill may be reduced. The more consecutive active tablets you have missed, the higher the risk that the contraceptive effect is decreased. There is a particularly high risk of becoming pregnant if you miss tablets in the week before or in the week after the inactive tablets. Therefore, you should follow the rules given below.

ELOINE can have side effects. Not all side effects reported for ELOINE 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.

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).

Rare side effects: Thromboembolism (blood clots including embolism), asthma, breast discharge, hypacusia (hearing impairment). 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 involve lips, eyes or tongue) medicines containing certain female sex hormones (oestrogens) may induce or worsen the symptoms of angioedema. If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Store at or below 30 ºC. Do not use after expiry date stated on the carton. Keep the blister strips in the original carton until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).