Nuvaring 1 Vaginal Ring

1. What this product is and what it is used for NuvaRing is a contraceptive vaginal ring used to prevent pregnancy. Each ring contains a small amount of two female sex hormones – etonogestrel and ethinylestradiol. The ring slowly releases these hormones into the blood circulation. Because of the low amount of hormones that is released, NuvaRing is considered a low-dose hormonal contraceptive. Since NuvaRing releases two different types of hormones it is a so-called combined hormonal contraceptive. NuvaRing works just like a combined contraceptive pill (the Pill) but instead of taking a pill every day, the ring is used for 3 weeks in a row. NuvaRing releases two female sex hormones that prevent the release of an egg cell from the ovaries. If no egg cell is released you cannot become pregnant. 2. What you need to know before you use this product 2. What you need to know before you use NuvaRing General notes Before you start using NuvaRing you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see section 2 “Blood clots”. In this leaflet, several situations are described where you should stop using NuvaRing, or where NuvaRing may be less reliable. In such situations you should not have intercourse or you should take extra non-hormonal contraceptive precautions – such as using a male condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because NuvaRing alters the monthly changes of the body temperature and of the cervical mucus. NuvaRing, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease. 2.1 When you should not use NuvaRing You should not use NuvaRing if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate. • 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 (see section ‘Blood clots’); • if you have ever had a heart attack, or a 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: – severe diabetes with blood vessel damage – very high blood pressure – a very high level of fat in the blood (cholesterol or triglycerides) – a condition known as hyperhomocysteinaemia • if you have (or have ever had) a type of migraine called ‘migraine with aura’; • if you have (had) inflammation of the pancreas (pancreatitis) associated with high levels of fat in your blood. • if you have (had) severe liver disease and your liver is not yet working normally. • if you have (had) a benign or malignant tumour in the liver. • if you have (had), or if you may have, cancer of the breast or the genital organs. • if you have any unexplained vaginal bleeding. • if you are allergic to ethinylestradiol or etonogestrel, or any of the other ingredients of this medicine (listed in section 6). If any of these conditions appear for the first time while using NuvaRing, remove the ring immediately and contact your doctor. In the meantime, use non-hormonal contraceptive measures. Do not use NuvaRing if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section 2.4 ‘Other medicines and NuvaRing’). 2.2 Warnings and precautions Tell your doctor if any of the following conditions apply to you. If the condition develops, or gets worse while you are using NuvaRing, you should also tell your doctor. • if a close relative has or has ever had breast cancer; • if you have epilepsy (see section 2.4: ‘Other medicines and NuvaRing’); • if you have liver disease (for instance jaundice) or gallbladder disease (for instance gallstones); • if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease); • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defense 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 (see in section 2 ‘Blood clots’); • if 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 using NuvaRing; • if you have an inflammation in the veins under the skin (superficial thrombophlebitis); • if you have varicose veins; • if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a disease of the blood], herpes gestationis [skin rash with vesicles during pregnancy], Sydenham’s chorea [a disease of the nerves in which sudden movements of the body occur], hereditary angioedema [you should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing]; • if you have (or have ever had) chloasma (yellowish-brown pigment patches, so called ‘pregnancy patches’, particularly on the face). If so, avoid too much exposure to the sun or ultraviolet light; • if you have a medical condition that makes it difficult to use NuvaRing – for example, if you are constipated, have a prolapse of the uterine cervix or have pain during intercourse. • if you have an urgent, frequent, burning, and/or painful urination, and cannot locate the ring in the vagina. These symptoms may indicate accidental placement of NuvaRing into the urinary bladder. When should you contact your doctor? Seek urgent medical attention – if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clots’ section below). For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”. BLOOD CLOTS Using a combined hormonal contraceptive such as NuvaRing increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems. Blood clots can develop • in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE); • in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE). Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal. It is important to remember that the overall risk of a harmful blood clot due to NuvaRing is small. HOW TO RECOGNISE A BLOOD CLOT Seek urgent medical attention if you notice any of the following signs or symptoms. Are you experiencing any of these signs? What are you possibly suffering from? • 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 Deep vein thrombosis • 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; If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’). Pulmonary embolism Symptoms most commonly occur in one eye: • immediate loss of vision or • painless blurring of vision which can progress to loss of vision Retinal vein thrombosis (blood clot in the eye) • chest pain, discomfort, pressure, heaviness • sensation of squeezing or fullness in the chest, arm or below the breastbone; • fullness, indigestion or choking feeling; • upper body discomfort radiating to the back, jaw, throat, arm and stomach; • sweating, nausea, vomiting or dizziness; • extreme weakness, anxiety, or shortness of breath; Heart attack • rapid or irregular heartbeats • 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. Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke. Stroke • swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen). Blood clots blocking other blood vessels BLOOD CLOTS IN A VEIN What can happen if a blood clot forms in a vein? • The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive. • If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT). • If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism. • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis). When is the risk of developing a blood clot in a vein highest? The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more. After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive. When you stop using NuvaRing your risk of a blood clot returns to normal within a few weeks. What is the risk of developing a blood clot? The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking. The overall risk of a blood clot in the leg or lung (DVT or PE) with NuvaRing is small. • Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year. • Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year. • Out of 10,000 women who are using a combined hormonal contraceptive that contains norelgestromin, or etonogestrel such as NuvaRing, between about 6 and 12 women will develop a blood clot in a year. • The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below). Risk of developing a blood clot in a year Women who are not using a combined hormonal pill/patch/ring About 2 out of 10,000 women and are not pregnant Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate About 5-7 out of 10,000 women Women using NuvaRing About 6-12 out of 10,000 women Factors that increase your risk of a blood clot in a vein The risk of a blood clot with NuvaRing is small but some conditions will increase the risk. Your risk is higher: • if you are very overweight (body mass index or BMI over 30 kg/m2); • if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder; • if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of NuvaRing may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop using NuvaRing ask your doctor when you can start using it again; • as you get older (particularly above about 35 years); • if you gave birth less than a few weeks ago. The risk of developing a blood clot increases the more conditions you have. Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed. It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that NuvaRing needs to be stopped. If any of the above conditions change while you are using NuvaRing, for example a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor. BLOOD CLOTS IN AN ARTERY What can happen if a blood clot forms in an artery? Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke. Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using NuvaRing is very small but can increase: • with increasing age (beyond about 35 years); • if you smoke. When using a combined hormonal contraceptive like NuvaRing you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive; • if you are overweight; • if you have high blood pressure; • if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke; • if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides); • if you get migraines, especially migraines with aura; • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation); • if you have diabetes. If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased even more. If any of the above conditions change while you are using NuvaRing, for example, you start smoking, a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor. Cancer The information given below was obtained in studies with combined oral contraceptives and it may also apply to NuvaRing. Information about vaginal administration of contraceptive hormones (as in NuvaRing) is not available. Breast cancer has been found slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often. The increased occurrence of breast cancer becomes gradually less after stopping the combined pill. It is important to regularly check your breasts and you should contact your doctor if you feel any lump. You should also tell your doctor if a close relative has, or ever had breast cancer (see section 2.2 ‘Warnings and precautions’). In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusual severe abdominal pain. For users of the combined Pill it has been reported that cancer of the endometrium (the lining of the womb) and cancer of the ovaries occur less frequently. This may also be the case for NuvaRing but this has not been confirmed. 2.3 Children and adolescents The safety and efficacy of NuvaRing in adolescents under the age of 18 have not been studied. 2.4 Other medicines and NuvaRing Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist (or the pharmacist) who prescribes another medicine that you use NuvaRing. They can tell you if you need to take additional contraceptive precautions (for example, male condoms) and if so, for how long, or, whether the use of another medicine you need must be changed. Some medicines – can have an influence on the blood levels of NuvaRing; – can make it less effective in preventing pregnancy; – can cause unexpected bleeding. These include medicines used for the treatment of: • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); • tuberculosis (e.g. rifampicin); • HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz); • Hepatitis C virus infection (e.g. boceprevir, telaprevir); • other infectious diseases (e.g. griseofulvin); • high blood pressure in the blood vessels of the lungs (bosentan); • depressive moods (the herbal remedy St. John’s wort). If you are taking medicines or herbal products that might make NuvaRing less effective, a barrier contraceptive method should also be used (for example, a male condom). Since the effect of another medicine on NuvaRing may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long. Note: Do not use NuvaRing with a diaphragm, cervical cap, or female condom. NuvaRing may influence the effect of other medicines, e.g. - medicines containing ciclosporin - the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures) Do not use NuvaRing if you have Hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to the start of treatment with these medicinal products. NuvaRing can be restarted approximately 2 weeks after completion of this treatment. See section 2.1 ‘When you should not use NuvaRing’. Ask your doctor or pharmacist for advice before taking any medicine. You can use tampons while using NuvaRing. Insert NuvaRing before inserting a tampon. You should be careful when removing a tampon to be sure that the ring is not accidentally pulled out. If the ring does come out, simply rinse the ring in cool to lukewarm water and immediately reinsert it. Ring breakage has occurred when also using a vaginal product such as a lubricant or treatment for infection (see section 3.4 ‘What to do if…Your ring breaks’). Using spermicides or vaginal yeast products will not reduce the contraceptive efficacy of NuvaRing. Laboratory tests If you are having any blood or urinary test, tell your health care professional that you are using NuvaRing as it may affect the results of some tests. 2.5 Pregnancy and breast-feeding NuvaRing must not be used by women who are pregnant, or who think they may be pregnant. If you get pregnant while using NuvaRing you should remove the ring and contact your doctor. If you want to stop NuvaRing because you want to get pregnant, see section 3.5 ‘When you want to stop using NuvaRing’. NuvaRing is not usually recommended for use during breast-feeding. If you wish to use NuvaRing while breast-feeding, please seek the advice of your doctor. 2.6 Driving and using machines NuvaRing is unlikely to affect your ability to drive or use machines.