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What Ethinylestradiol, Norelgestromin is and what it is used for This medicine contains two types of sex hormones, a progestogen called norelgestromin and an oestrogen called ethinyl estradiol. Because it contains two hormones, it is called a ‘combined hormonal contraceptive’. It is used to prevent pregnancy What you need to know before you use Ethinylestradiol, Norelgestromin Do not use Ethinylestradiol, Norelgestromin Tell your doctor if you: • if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs; • if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies; • if you need an operation or if you are off your feet for a long time • if you have ever had a heart attack or stroke; • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack [TIA -temporary stroke symptoms]); • if you have any of the following diseases that may increase your risk of a clot in the arteries: o severe diabetes with blood vessel damage, o very high blood pressure, o a very high level of fat in the blood (cholesterol or triglycerides), o a condition known as hyperhomocysteinaemia; • if you have (or have ever had) a type of migraine called ‘migraine with aura’; • if you have or have recently had a severe liver disease; • if you have ever had a liver tumour; • if you have or have had a pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood; • known or suspected pregnancy; • if you have cancer affected by sex hormones – such as some cancers of the breast, womb lining or ovary; • if you have vaginal bleeding that has not been explained by your doctor; • if you are allergic (hypersensitive) to any of the ingredients in Ethinylestradiol, Norelgestromin . • if you have hepatitis C and are taking medicinal products containing ombitasvir/ paritaprevir/ ritonavir and dasabuvir Warnings and precautions You should let your doctor know: • if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease); • if you have SLE (systemic lupus erythematosus; a disease affecting your natural defence system); • if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys); • if you have sickle cell anaemia (an inherited disease of the red blood cells); • if 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); • if you need an operation, or you are off your feet for a long time; • if you have just given birth you are at an increased risk of blood clots • if you have an inflammation in the veins under the skin (superficial thrombophlebitis); • if you have varicose veins Other medicines and Ethinylestradiol, Norelgestromin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Certain medicines and herbal therapies may stop this pill from working properly. If this happens you could get pregnant, or may experience unexpected bleeding. These include medicines used for the treatment of: • some antiretroviral medicines used to treat HIV/AIDS and Hepatitis C virus infections (socalled protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) • medicines for infection (such as rifampicin and griseofulvin) • anti-seizure medicines (such as barbiturates, topiramate, phenytoin, carbamazepine, primidone, oxcarbazepine, and felbamate) • bosentan (a medicine for high blood pressure in the blood vessels in the lungs) • St. John’s wort (an herbal therapy used for depression) This pill may make some other medicines less effective, such as: • medicines containing ciclosporin • lamotrigine used for epilepsy [This can increase the risk of fits (seizures)] How to use Ethinylestradiol, Norelgestromin To prevent pregnancy, always take this medicine exactly as described in this leaflet or as your doctor, family planning nurse or pharmacist has told you. Check with your doctor, family planning nurse or pharmacist if you are not sure. How many patches to use • Weeks 1, 2 & 3: Put on one patch and leave it on for exactly seven days. • Week 4: Do not put on a patch this week. If you have not used a hormonal contraceptive during your previous cycle • You may start this medicine on the first day of your next period. • If one or more days have elapsed since the start of your period, talk to your doctor about temporarily using a non-hormonal contraceptive. If you switch from the oral contraceptive pill to transdermal patch • If you are switching from an oral contraceptive pill to this medicine: • Wait until you get your menstrual period. • Put on your first patch during the first 24 hours of your period. If the patch is applied after Day 1 of your period, you should: • Use a non-hormonal contraceptive until Day 8 when you change your patch. • If you do not get your period within 5 days of taking the last contraceptive pill, check with your doctor before starting this medicine. Possible side effects Stop using the product and seek immediate medical attention if you have noticed: • Signs of deep vein thrombosis: swelling of one leg or along a vein in the leg or foot especially when accompanied by pain or tenderness in the leg which may be felt only when standing or walking; increased warmth in the affected leg; change in colour of the skin on the leg e.g. turning pale, red or blue. • Signs of a pulmonary embolism: sudden unexplained breathlessness or rapid breathing; sudden cough without an obvious cause, which may bring up blood; sharp chest pain which may increase with deep breathing; severe light headedness or dizziness; rapid or irregular heartbeat; severe pain in your stomach. • Signs of retinal vein thrombosis (blood clot in the eye): symptoms most commonly occur in one eye: immediate loss of vision or painless blurring of vision which can progress to loss of vision. • Signs of heart attack: chest pain, discomfort, pressure, heaviness; sensation of squeezing or fullness in the chest, arm or below the breastbone; • Signs of a stroke: sudden weakness or numbness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure. • Signs of blood clots blocking other blood vessels: swelling and slight blue discolouration of an extremity; severe pain in your stomach (acute abdomen). • Signs of a severe allergic reaction: swelling of the face, lips, mouth, tongue or throat. • Signs of breast cancer: dimpling of the skin; changes in the nipple; any lumps you can see or feel. • Signs of cancer of the cervix: vaginal discharge that smells and contains blood; unusual vaginal bleeding; pelvic pain; painful sex. • Signs of severe liver problems: severe pain in your upper abdomen; yellow skin or eyes (jaundice). How to store Ethinylestradiol, Norelgestromin • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date, which is stated on the label after “EXP”. The expiry date refers to the last day of that month. • Store in the original container to protect from light and moisture. Do not refrigerate or freeze. • Used patches still contain some active hormones. To protect the environment, the patches should be disposed of with care.
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