PACKAGE LEAFLET: INFORMATION FOR THE USER. Angeliq 1 mg / 2 mg film-coated tablets. Oestradiol / Drospirenone

Transcription

1 Version 1.3, 12/2008 PACKAGE LEAFLET: INFORMATION FOR THE USER Angeliq 1 mg / 2 mg film-coated tablets Oestradiol / Drospirenone Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1 1. WHAT ANGELIQ IS AND WHAT IT IS USED FOR BEFORE YOU TAKE ANGELIQ... 8 Medical history and regular check-ups... 8 Do not take Angeliq if you have:... 9 Take special care with Angeliq Angeliq and blood clots Angeliq and cancer Angeliq and heart disease Angeliq and stroke Angeliq and memory loss Other conditions Using other medicines Pregnancy and breast-feeding Driving or using machines Important information about some of the ingredients of Angeliq HOW TO TAKE ANGELIQ If you take more Angeliq than you should If you forget to take Angeliq If you stop taking Angeliq If you need to have surgery POSSIBLE SIDE EFFECTS HOW TO STORE ANGELIQ FURTHER INFORMATION Note: This table of content only applies to the booklet version of the Angeliq package insert. For the leaflet version of the Angeliq package insert the table of content contains only the major headings 1 to 6: 1. WHAT ANGELIQ IS AND WHAT IT IS USED FOR BEFORE YOU TAKE ANGELIQ HOW TO TAKE ANGELIQ POSSIBLE SIDE EFFECTS HOW TO STORE ANGELIQ FURTHER INFORMATION

2 1. WHAT ANGELIQ IS AND WHAT IT IS USED FOR What Angeliq is Angeliq is a Hormone Replacement Therapy (HRT). It contains two types of female hormone, an oestrogen and a progestogen. Your ovaries no longer make these hormones after the menopause. What Angeliq is used for Angeliq is used for the treatment of symptoms of the menopause such as hot flushes or vaginal dryness in postmenopausal women with at least 12 months since their last natural period. Angeliq is also used for prevention of osteoporosis in postmenopausal women who have a high risk of fractures and who cannot be given other osteoporosis treatments. There is only limited experience of treating women older than 65 years. 2. BEFORE YOU TAKE ANGELIQ Medical history and regular check-ups Before you start (or restart) Angeliq your doctor will ask you about your own and your family s medical history. Your doctor may decide to examine your breasts and/or your abdomen and may carry out an internal examination. Once you have started on Angeliq you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss the benefits and risks of continuing with Angeliq. Go for regular breast screening and cervical smear tests, as directed by your doctor. Do not take Angeliq if you have: breast cancer, suspected or confirmed; or if you have had it in the past cancer that depends on oestrogen to grow (e.g. cancer of the lining of the womb) any unexplained vaginal bleeding untreated thickening of the lining of the womb (endometrial hyperplasia) a blood clot in a vein (thrombosis) such as deep vein thrombosis or a lung embolus, now or in the past a heart attack, stroke or angina had liver disease, and you have been told by your doctor that your liver function tests have not yet returned to normal porphyria (a rare, inherited blood pigment disorder) severe kidney disease or acute kidney failure an allergy to oestrogens, progestogens or to any other ingredient in Angeliq If any of the above conditions appear for the first time while taking Angeliq, stop taking it at once and consult your doctor immediately. Take special care with Angeliq If you have ever had (e.g. during pregnancy or previous hormone treatment) any of the following, you may be closely supervised by your doctor because Angeliq may worsen these conditions or cause them to return: fibroids of the womb or any tissue of the lining of the womb at inappropriate places (endometriosis) a history of, or risk factors for, blood clotting (see below under "Angeliq and blood clots") an increased risk for breast cancer (mother, sister or grandmother who has had breast cancer), or other tumours that depend on oestrogen to grow high blood pressure 2

3 any disorder of the liver diabetes gallstones migraine or severe headaches systemic lupus erythematosus (SLE; a chronic inflammatory disease which can affect many parts of the body) a history of thickening of the lining of the womb (endometrial hyperplasia) epilepsy asthma hearing loss due to otosclerosis (excessive growth of the bones in the middle ear) heart or kidney problems elevated triglycerides (a type of blood fat) Angeliq is not an oral contraceptive. If you are still capable of becoming pregnant you must not use any hormone replacement therapy Angeliq and blood clots HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis) especially during the first year of taking it. These blood clots are not always serious but if one travels to the lungs it can cause chest pain, sudden breathlessness, collapse or even death. This condition is called pulmonary embolism. The risk of getting a blood clot increases if: you or any of your close relatives have ever had a blood clot in the leg, lung or an other organ you are seriously overweight you have systemic lupus erythematosus you have any blood clotting problem that needs treatment with a medicine such as warfarin you have had repeated miscarriages you are unable to walk or stand for a long time because of major surgery, injury or illness. If any of the above applies to you, talk to your doctor before taking Angeliq. Stop taking Angeliq and contact your doctor immediately if you notice possible signs of a blood clot, such as: painful swelling in one of your legs sudden severe chest pain difficulty breathing Angeliq and cancer Breast cancer Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT for several years slightly increases the risk of breast cancer. In oestrogen-progestogen combined products, this risk seems to be higher than in oestrogen-only products. For all types of HRT, the extra risk of breast cancer increases the longer you take it, but returns to normal within a few years after the end of treatment (at most 5 years). Regularly check your breasts. Make an appointment to see your doctor if you notice any changes such as: dimpling of the skin changes in the nipple 3

4 any lumps you can see or feel Cancer of the lining of the womb (endometrial cancer) Taking oestrogen-only HRT for a long time can increase the risk of developing cancer of the lining of the womb (the endometrium). Taking an oestrogen together with a progestogen, as in Angeliq, helps to significantly lower the extra risk. If you get light or menstruation-likebleeding this is usually nothing to worry about, especially during the first few months of taking Angeliq. Make an appointment to see your doctor if the light or menstruation-like bleeding: carries on for more than the first few months starts after you have been taking Angeliq for a while carries on after you have stopped taking Angeliq Ovarian cancer Ovarian cancer is very rare, but it is serious. It can be difficult to diagnose because there are often no obvious symptoms of the disease. Taking oestrogen-only HRT (used by women without a womb) for more than 5 years may increase the risk of ovarian cancer. It is not known if this also applies to other types of HRT, such as Angeliq.Angeliq and heart disease HRT does not prevent heart disease. Do not take Angeliq if you have had a heart attack or angina. Contact your doctor immediately and do not take any more HRT if you get: A pain in your chest that spreads to your arm or neck. This pain could be a sign of heart disease. Women taking one type of HRT (containing conjugated oestrogen plus the progestogen medroxyprogesterone acetate) may be slightly more likely to develop heart disease during the first year of taking the medication. It is not known if this also applies to other types of HRT, such as Angeliq. Angeliq and stroke Do not take Angeliq if you have had a stroke. Recent research suggests that HRT slightly increases the risk of having a stroke. Other factors that can increase the risk of stroke include: getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat Contact your doctor immediately and do not take any more HRT if you experience any of the following: blurring or decreased vision in one or both eyes sudden, severe headache weakness, numbness, or paralysis of the face, arm, or leg dizziness, loss of balance or coordination These may be early warning signs of a stroke Angeliq and memory loss HRT will not prevent memory loss (dementia). 4

5 Women who started using one type of HRT (containing conjugated oestrogen plus the progestogen medroxyprogesterone acetate) after the age of 65 showed a small increase in their risk of developing dementia. It is not known if this also applies to other types of HRT, such as Angeliq, or to younger women. Other conditions If you have a kidney disorder and have high serum potassium levels, particularly if you are taking other medications that increase serum potassium, your doctor may check the potassium levels in your blood during the first month of treatment. If you have high blood pressure, treatment with Angeliq may decrease it. Angeliq should not be used to treat high blood pressure. If you have a tendency to develop blotchy brown patches (chloasma) on the face you should avoid exposure to the sun or ultraviolet light whilst using Angeliq. Using other medicines Tell your doctor or pharmacist if you are using or have recently used any other medicines, including ones obtained without prescription. The following may reduce the effects of Angeliq and may cause irregular bleeding: medicines used for the treatment of: epilepsy (e.g. phenobarbital, phenytoin, carbamazepine) HIV infections (e.g. nevirapine, efavirenz, nelfinavir and ritonavir) bacterial infections (e.g. rifampicin and rifabutin) the herbal remedy St. John s wort (Hypericum perforatum) The following may cause small increases in serum potassium: medicines used for the treatment of: inflammation or pain (e.g. aspirin, ibuprofen) certain types of heart disease or high blood pressure (e.g. diuretics (water tablets), ACE inhibitors (e.g. enalapril), angiotensin II receptor antagonists (e.g. losartan). If you are having treatment for high blood pressure and take Angeliq there may be an additional decrease in blood pressure. Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy and breast-feeding Angeliq is for use in post-menopausal women. Do not take Angeliq if you are pregnant or breast-feeding. If you become pregnant, stop taking Angeliq immediately and tell your doctor. Driving and using machines There is nothing to suggest that the use of Angeliq affects driving and use of machines. Important information about some of the ingredients of Angeliq Angeliq contains lactose (a type of sugar). If you have an intolerance to some sugars, check with your doctor before taking Angeliq. 3. HOW TO TAKE ANGELIQ Always take Angeliq exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide how long you should take Angeliq for. 5

6 Take one tablet a day, preferably at the same time. Swallow the tablet whole with a drink of water. You can take Angeliq with or without food. Start your next calendar pack of tablets the day after you finish your current pack. Do not take a break between packs. If you have been taking other HRT preparations: carry on until you have finished your current pack and have taken all the tablets for that month. Take your first Angeliq tablet the next day. Do not leave a break between your old tablets and the Angeliq tablets. If this is your first HRT treatment: you can start your Angeliq tablets any day. If you take more Angeliq than you should If you have taken too many Angeliq tablets by mistake, you may feel sick, vomit or have some menstruationlike bleeding. No specific treatment is necessary but you should consult your doctor or pharmacist if you are worried. If you forget to take Angeliq If you forget to take a tablet at your usual time and you are less than 24 hours late, take it as soon as possible. Take the next tablet at the usual time. If you are more than 24 hours late, leave the forgotten tablet in the pack. Continue to take the rest of the tablets at the usual time every day. Do not take a double dose to make up for a forgotten tablet. If you forget to take your tablet for several days you may experience irregular bleeding. If you stop taking Angeliq You may begin to feel the usual symptoms of menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. You will also start to lose bone mass when you stop taking Angeliq. Consult your doctor or pharmacist if you want to stop taking Angeliq tablets. If you need to have surgery If you are going to have surgery, tell the surgeon that you are taking Angeliq. You may need to stop taking Angeliq about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see also section 2 "Angeliq and blood clots"). Ask your doctor when you can start taking Angeliq again. 4. POSSIBLE SIDE EFFECTS Like all medicines, Angeliq can cause side effects, although not everybody gets them. Serious side effects associated with Hormone Replacement Therapy: blood clots in the veins cancer of the lining of the womb breast cancer ovarian cancer heart disease stroke dementia For more information about these side effects see section 2. The following is a list of side effects that have been linked to the use of Angeliq. Most frequent side effects (affecting more than 1 patient in every 10 patients): unexpected menstruation-like bleeding (see also section 2 "Angeliq and cancer/ cancer of the lining of the womb") 6

7 breast tenderness breast pains Unexpected menstruation-like bleeding occurs during the first few months of treatment with Angeliq. It is usually temporary and normally disappears with continued treatment. If it does not, contact your doctor. Common side effects (affecting between 1 and 10 in every 100 patients): depression, mood changes, nervousness headache stomach ache, nausea, stomach enlargement lumpy breast (benign breast neoplasm), swollen breasts increase in size of uterine fibroids non-cancerous growth of cells at the neck of the womb (benign cervical growth) irregularities in your vaginal bleeding vaginal discharge loss of energy, localised fluid retention. Uncommon side effects (affecting between 1 and 10 in every 1000 patients): weight increase or decrease, loss or increase of appetite for food, increase blood fats sleep problems, anxiety, decrease in sex drive burning or pricking sensation, decreased concentration, dizziness eye problems (e.g. red eyes), visual disturbance (e.g. blurred vision) palpitations blood clot, venous thrombosis (also see section 2 "Angeliq and blood clots"), high blood pressure, migraine, inflammation of the veins, varicose veins breathlessness stomach disorder, diarrhoea, constipation, vomiting, dry mouth, wind, altered sense of taste altered liver enzymes (will show up in blood tests) skin problems, acne, hair loss, itchy skin, excessive hair backache, joint pain, pain in limbs, muscle cramps urinary tract disorders and infections breast cancer, thickening of the lining of the womb, benign unusual growth in the uterus, thrush, vaginal dryness and itchiness of the vagina lumpy breast (fibrocystic breast), disorders of the ovaries, cervix and uterus, pelvic pain generalised fluid retention, chest pain, feeling generally unwell, increase in sweating Rare side effects (affecting between 1 and 10 in every 10,000 patients): anaemia giddiness ringing in the ears gall stones muscle pain inflammation of the fallopian tubes milky discharge from the nipples chills The following side effects have occurred in clinical trials of women with high blood pressure: high potassium levels (hyperkalaemia) sometimes causing muscle cramps, diarrhoea, nausea, dizziness or headache heart failure, enlargement of the heart, heart flutter, effects on heart rhythm increase in blood aldosterone. The following side effects have been reported with other HRTs: a variety of skin disorders (erythema nodosum, erythema multiforme and haemorrhagic dermatitis) If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 7

8 5. HOW TO STORE ANGELIQ Keep out of the reach and sight of children. Do not use Angliq after the expiry date which is printed on carton box and blister after "EXP". The expiry date refers to the last day of the month stated. Angeliq does not require any special storage conditions. Medicines should not be disposed via the waste water or the household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Angeliq contains The active substances are oestradiol (as oestradiol hemihydrate) and drospirenone; each tablet contains 1 mg oestradiol and 2 mg drospirenone.. The other ingredients are lactose monohydrate, maize starch, pregelatinized maize starch, povidone and magnesium stearate (E470b). The ingredients of the tablet coating are hypromellose (E464), macrogol 6000, talc (E553b), titanium dioxide (E171) and ferric oxide (E172). What Angeliq looks like and contents of the pack Angeliq tablets are red round convex coated tablets. One side is marked with the letters DL in a regular hexagon. They are supplied in a blister pack containing 28 tablets with the days of the week printed on the blister. Boxes containing one or three blisters packs are available. Marketing Authorisation Holder {Name and address} {tel} {fax} { } Manufacturer Bayer Schering Pharma AG Müllerstrasse D Berlin This medicinal product is authorised in the Member States of the EEA under the following names: Angeliq Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, France, Ireland, Italy, Lithuania, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Slovakia, Spain, United Kingdom Angemin Denmark, Iceland, Sweden This leaflet was last approved in {MM/YYYY}. [To be completed nationally] 8