NuvaRing vaginal delivery system

Description NuvaRing is a contraceptive vaginal ring inserted into the vagina that lasts for 3 weeks. It contains both oestrogen and progesterone and works in a similar way to the combined contraceptive pill. You need a prescription from a doctor to use a NuvaRing. With NuvaRing, you can be up to 98% protected from pregnancy without worrying about applications or remembering to take pills. It's easy to insert and won't affect sex or tampons. Description Directions Most women choose to wear the ring for 3 weeks, then take a 1-week break. Exactly 1 week after the day of removal, insert a new ring. Make a note of the day and time you removed it – try to insert the new one at the same time, on the same day, 1 week later. To insert the ring, press the opposite sides together, making an oval. Push the ring into the vagina until it feels comfortable. Remove the ring by hooking a finger under the ring and pulling it out. Nuvaring can also be used as follows: • Extended use: 1 ring every 3 weeks for 9 weeks (3 rings in total) then no ring for the next 4 or 7 days. • Continuous use: 1 ring every 3 weeks with no break. Directions Warnings Like all medicines, NuvaRing can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe or persistent, or have any change to your health that you think may be due to NuvaRing, please talk to your doctor. An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives. If you are allergic to one of the ingredients of NuvaRing (hypersensitivity) you may experience the following symptoms (frequency unknown): angioedema and/or anaphylaxis (swollen face, lips, tongue and/or throat and/or difficulty swallowing) or hives potentially with difficulty breathing. If this happens, remove the NuvaRing and contact your doctor immediately. Users of NuvaRing have reported the following side effects. Common (may affect up to 1 in 10 women): • Abdominal pain, feeling sick (nausea) • Yeast infection of the vagina (such as ‘thrush’) • Discomfort in the vagina due to the ring • Genital itching • Secretion from the vagina • Headache or migraine • Depressive moods • Lower sex drive • Breast pain • Pelvic pain • Painful menstrual periods • Acne • Weight gain • The ring falling out Uncommon (may affect up to 1 in 100 women): • Disturbed vision • Dizziness • Swollen abdomen • Vomiting, diarrhoea or constipation • Feeling tired, unwell or irritable • Mood changes or mood swings • Extra fluid in the body (oedema) • Bladder or urinary tract infection • Difficulty or pain when passing urine, strong desire or need to pass urine or passing urine more often • Problems during intercourse, including pain, bleeding or partner feeling the ring • Increased blood pressure • Increased appetite • Back pain • Muscle spasms • Pain in legs or arms • Less sensitive skin • Sore or larger breasts • Fibrocystic breast disease (cysts in the breasts which may become swollen or painful) • Inflammation of the cervix • Cervical polyps (growths in the cervix) • Rolling outward of the margin of the cervix (ectropion) • Changes to menstrual periods (e.g. periods can be heavy, long, irregular or stop altogether) • Pelvic discomfort • Premenstrual syndrome or spasm of the uterus • Vaginal infection (fungal and bacterial) • Burning feeling, smell, pain, discomfort or dryness in the vagina or vulva • Hair loss, eczema, itching, rash or hot flushes • Hives Rare: may affect up to 1 in 1,000 women • Harmful blood clots in a vein or artery, for example: o In a leg or foot (i.e. DVT) o In a lung (i.e. PE) o Heart attack o Stroke o Mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA) o Blood clots in the liver, stomach/intestine, kidneys or eye. The chance of having a blood clot may be higher if you have any other conditions that increase this risk: • Breast discharge Not known (cannot be estimated from the available data): • Chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) • Penis discomfort of the partner (such as irritation, rash, itching) • Inability to remove ring without medical assistance (e.g., because of adherence to vaginal wall) • Vaginal injury associated with ring breakage Breast cancer and liver tumours have been reported in users of combined hormonal contraceptives. Very rarely, the NuvaRing may break. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed here. You can also report side effects directly . By reporting side effects, you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA