Meliane (Gestodene, Enthinylestradiol) – 21 tablets

Meliane is a contraceptive pill and is used to prevent pregnancy. Each of 21 coated tablets contains a small amount of the female hormones ethinylestradiol and gestodene. Contraceptive pills that contain two hormones are called “combined pills” or “combined oral contraceptives”.

Indications: oral contraceptive

Side effects: emotional lability (mood swings), depression and depressive mood, migraine, nausea, breast pain, unscheduled uterine bleeding (bleeding between periods), genital tract bleeding (vaginal bleeding). Less common is decrease and loss of libido (reduced or loss of sexual drive). Rare side effects are venouse and arterial thromboembolic events. If you notice any side effects not mentioned, please inform your doctor.

Contraindications: do not take Meliane:

• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart at tack or a stroke
• if you have (or have ever had) a disease that can be an indicator of a heart attackin the future (for example, angina pectoris which causes severe pain in the chest) or of a stroke (for example, a passing slight stroke with no residual effects)
• if you have a disease that may increase the risk of a blood clot in the arteries
• diabetes with damaged blood vessels
• very high blood pressure
• a very high level of fat in the blood (cholesterol or trigylcerides)
• if you have a disturbance of blood clotting (for example, protein C deficiency)
• if you have (or have ever had) a certain form of migraine (with so – called focal neurological  symptoms)
• if you have (or have ever had) a liver disease and your liver function is still not normal
• if your kidneys are not working well (renal failure)
• if you have (or have ever had) a tumour in the liver
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs
• if you have any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol or gestodene, or any of the other ingredients of this medicine. This may cause itching, rash or swelling.

If anything on the above list applies to you, tell your doctor before starting to use Meliane.

Important information: you may need to be kept under close observation of doctor if:

• you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• you have syst emic lupus erythematosus (SLE – a disease affecting your natural defence system)
• you have haemolytic uraemic syndrome (HUS – a disorder of blood clotting causing failure of the kidneys)
• you have sickle cell anaemia (an inherited disease of the red blood cells)
• you have inflammation of the pancreas (pancreatitis)
• you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Yasmin
• you have an inflammation in the veins under the skin (superficial thrombophlebitis)
• you have varicose veins
• you smoke
• you have diabetes
• you are overweight
• you or your close family have ever had problems with your heart, or circulation such as high blood pressure
• you or your close family have ever had problems with blood clotting
• you or someone in your close family has had a thrombosis, a heart attack or a stroke
• you suffer from migraine
• you suffer from epilepsy
• you or someone in your close family have or have had high cholesterol or triglycerides
• you or someone in your close family have or have had a breast cancer
• you have a liver or gallbladder disease
• you have an operation, or if your ability to move around is limited for a long period of time

If any of above conditions appear for the first time, come back or get worse while using the Meliane, you should contact your doctor.

Use and dosage: take one tablet of Meliane every day arround the same time, with some liquid if necessary. The blister contains 21 tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. Follow the direction of the arrow untill all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually it will start on day 2-3 after the last Meliane tablet. Start taking your next pack on the 8th day (the day after your 7-day tablet-free break) 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, each month. If you use Meliane in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.

Missed dose:  follow the below instructions if you have missed the dose

• if you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
• if you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant. The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip.

Package Contents: each box of Meliane contains 1 blister of Meliane with 21 tablets. Each tablet contains 0.075 mg of gestodene and 0.020 mg of ethinylestradiol.

Active ingredient: each tablet contains gestodene 0.075 mg and ethinylestradiol 0.020 mg

Manufacturer: Bayer Pharma AG, Berlin, Germany or Delpharm Lille S.A.S., Lys Lez Lannoy, France

Storage: keep Meliane in its calender blister until used. Store at room temperature below 30°C, keep away from direct sunlight and do not refrigerate.

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Download the Meliane leaflet here.