BAYER MIDDLE EAST. Breast cancer, whether suspected or discovered; What is Angeliq. Tumours whose growth is stimulated by a sup-

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1 08-15 Angeliq 1 mg/2 mg Film Coated Tablets BAYER MIDDLE EAST 1. What is ANGELIQ and what is it used for? Angeliq may not be taken in the presence of: What is Angeliq Breast cancer, whether suspected or discovered; Angeliq is a preparation for hormone replacement or if it has occurred previously therapy (HRT). It contains two types of female sexual hormones, one oestrogen and one gestagen. ply of oestrogens (e.g. cancer of the uterine Tumours whose growth is stimulated by a sup- Your ovaries no longer produce these hormones mucosa) after menopause. Any incidence of unexplained bleeding from the vagina whatsoever What is Angeliq used for Untreated thickening of the uterine mucosa Angeliq is used to treat menopause symptoms (endometrial hyperplasia) such as hot flashes or vaginal dryness in women Blood clots (thrombosis) in a vein, e.g. deep after menopause whose last natural menstrual flow phlebothrombosis of the leg or pulmonary embolism, one presently existing or previously occurring was at least 1 year ago (postmenopausal). Angeliq is also used to prevent osteoporosis (bone loss) Heart attack, cerebral stroke or attack-like among postmenopausal women (for whom the last chest pain with feelings of tightness in the natural menstrual flow was at least 1 year ago) chest (angina pectoris) who are at high risk for bone fractures and who are Previous history of liver disorder, and your physician has informed you that the liver function val- unable to use other drugs available for treating this condition. ues have not yet returned to normal Only limited experience is available for women over Rare metabolic diseases with disorders in the formation of red haemoglobin (porphyria) 65 years of age. 2. WHAT DO YOU NEED TO BE AWARE OFF Severe renal disease or acute renal failure BEFORE TAKING ANGELIQ? Oversensitivity (allergy) to oestrogens, gestates or Previous illness case history and regular checkup examinations. Should you experience one of the above-men- one of the other excipients of Angeliq Before beginning (or resuming) a therapy with tioned illnesses for the first time during administration of Angeliq, discontinue the treatment Angeliq, your physician will question you about your previous illness case history and also about immediately and inform your physician without your close relatives. Your physician may need to delay. perform an examination of your breasts and/or Special caution is required when taking Angeliq, your pelvis, as well as possibly an examination of if you have ever experienced the following (e.g. your internal genitalia. during a pregnancy or a previous hormone treatment), your physician should monitor you closely, Regular check-up examinations should be performed once you have begun taking Angeliq (at because these illnesses could worsen or reappear while undergoing a therapy with Angeliq: least once per year). During these check-up examinations, your physician can explain to you the Benign uterine tumour (myoma) or appearance advantages and risks of continuing a therapy with of uterine mucosa growths outside of the uterus Angeliq. (endometriosis) Have your breasts examined at regular intervals Blood clots occurring in the vessels (thromboembolisms) in the past or corresponding risk factors and have a cervical smear performed in accordance with the instructions of your physician. for this (cf. under Angeliq and blood clots ) BAYER-ANGELIQ 1 mg/2 mg Film Coated Tablets - p.1/6

2 BAYER-ANGELIQ 1 mg/2 mg Film Coated Tablets - p.2/6 Increased risk of breast cancer (mother, sister or grandmother who became ill with breast cancer) or other tumours whose growth is stimulated by the supplying of oestrogens High blood pressure Any liver disorders Sugar diabetes (Diabetes mellitus) Gallstone illnesses Migraine or unusually severe headache Lupus (SLE, systemic lupus erythematodes, a chronic inflammatory disease which can affect many parts of the body) Excessive growth of the uterine mucosa (endometrial hyperplasia) in the case history Seizures (epilepsy) Asthma Hearing loss due to otosclerosis (a special form of advanced middle ear deafness with hardening of the connection between the ear bones) Problems with the heart or kidneys Elevated triglyceride levels (a form of blood lipid) Angeliq is not a contraceptive. You should not use any hormone replacement therapy if you are still in your childbearing years. Angeliq and blood clots HRT can increase the risk of the formation of blood clots in the veins (also referred to as deep venous thrombosis), particularly during the first years of intake. These blood clots are not always grave, but if a clot migrates into the lung, it could result in chest pain, sudden shortness of breath, collapse or even death. This event is referred to as a pulmonary embolism. The risk of blood clots occurring is increased if You or a near relative of yours has ever had a blood clot in the leg, in the lung or in another organ You are considerably overweight You suffer from lupus, i.e. as systemic lupus erythematodes You have a problem with blood clotting severe enough to require medication therapy, e.g. one with Warfarin You have had repeated miscarriages You are unable to walk or stand for prolonged periods due to major surgery, an injury or a disease. if you have one of the above-named diseases, or if one of the above-named situations applies to you, then please consult your physician before taking Angeliq. Discontinue the intake of Angeliq and inform your physician without delay if you notice possible indications of a blood clot, e.g.: Painful swelling in one of your legs Sudden, severe pain in the chest Breathing difficulties Angeliq and cancer Breast cancer No HRT should be administered to women who have breast cancer or who have had it in the past. The application of HRT over a period of several years increases the risk of breast cancer slightly. The risk appears to be greater in the case of oestrogen-gestagen combination preparations, than it does in the case of preparations which contain only oestrogen. As a general rule for all types of HRT, the additional risk of breast cancer increases, the longer the HRT is administered, although it then returns to normal within a few years (no later than after a maximum of 5 years) following the end of the application. Examine your breasts at regular intervals. Arrange for an examination appointment with your physician if you notice any changes at all, e.g.: Tightening of the skin Changes in the nipples Any nodes that you can see or feel Cancer of the uterine mucosa (endometrial carcinoma) HRT applications over an extended period of time involving preparations which contain only oestrogen could increase the risk of emergence of cancer of the uterine mucosa (endometrial carcinoma). Taking oestrogens together with gestagens, as is the case with Angeliq, helps minimise the additional risk considerably. If you experience incidents of mild or menstruation-like bleeding, this will normally not be a cause for concern, particularly if they occur during the first couple of months after starting to take Angeliq.

3 BAYER-ANGELIQ 1 mg/2 mg Film Coated Tablets - p.3/6 Arrange for an examination appointment with your physician if the incidents of mild or menstruation-like bleeding: persist for longer than the first couple of months appear after you have already been taking Angeliq for some time persist after you have discontinued taking Angeliq Ovarian cancer Ovarian cancer is a very rare but grave illness. It can be difficult to make a diagnosis, because the disease often has no apparent symptoms. The risk of ovarian cancer can increase when HRT preparations which contain oestrogen only (for application with women who have no uterus) are administered for more than 5 years. It is not known whether or not this also applies to other forms of HRT, e.g. Angeliq. Angeliq and cardiac disease HRT does not prevent cardiac disease. Do not take Angeliq if you have experienced a heart attack or a painful feeling of constriction in the chest. Inform your physician without delay and do not use HRT any longer if one of the following events occurs: Pain in the chest which extends into the arm or neck. This pain could be an indication of cardiac disease. Women who take a form of HRT consisting of conjugated oestrogens and the gestagen medroxyprogesterone acetate are slightly more at risk of developing cardiac disease during the first year of administration. It is not known whether or not this also applies to other forms of HRT, e.g. Angeliq. Angeliq and cerebral stroke Do not take Angeliq if you have had a cerebral stroke. Latest research indicates that the administration of HRT preparations slightly increases the risk of having a cerebral stroke. Other factors which increase the risk of cerebral stroke include: Increasing age High blood pressure Smoking Drinking alcohol to excess Irregular heartbeat Inform your physician without delay and do not take any more HRT preparations if you notice the following complaints: Reduced vision or sharpness of vision in one or both eyes Sudden, severe headache Weakness, numbness or paralysis of face, arm or leg Stupor, disruption of the equilibrium or of the coordination These could be early warning signs of a cerebral stroke. Angeliq and loss of memory HRT preparations are not able to prevent loss of memory (dementia). Women who have begun taking an HRT consisting of conjugated oestrogen and the gestagen medroxyprogesterone acetate after the age of 65 have been shown to be slightly more at risk for developing dementia. It is not known whether or not these findings are also applicable for other forms of HRT, e.g. Angeliq, or for younger women. Other diseases If you suffer from a renal function disorder and also have a high serum potassium level, then you should have your potassium blood levels checked during the initial months of therapy, particularly if you are taking other drugs which increase your serum potassium. If you have high blood pressure, a therapy with Angeliq may cause it to be lowered. Angeliq should not be used for treating high blood pressure. If you have a tendency to develop brownish spots in the face (chloasma), then you should avoid sunlight or UV light while you are taking Angeliq. If you are taking other drugs Please inform your physician or your pharmacist if you are taking or applying other medicinal products and/or have taken or applied them recently, even it they were ones that you received without a prescription. The following drugs could reduce the effect of Angeliq and influence the pattern of bleeding:

4 BAYER-ANGELIQ 1 mg/2 mg Film Coated Tablets - p.4/6 Drugs which are used to treat: - Epilepsy (z.e.g. Phenobarbital, phenytoin, carbamazepine) - HIV infections (e.g. nevirapine, efavirenz, nelfinavir and ritonavir) - Bacterial Infections (e.g. rifampicin, rifabutin) The herbal remedy St. John s Wort (Hypericum perforatum) The following drugs could cause slight elevations in serum potassium: Drugs which are used to treat: Inflammation or pain (e.g. aspirin, ibuprofen) Certain forms of heart disease or high blood pressure (e.g. diuretics (water tablets)), ACE inhibitors (e.g. enelapril), angiotensin II receptor antagonists (e.g. losartan). If you are taking drugs for the treatment of high blood pressure together with Angeliq, then this can lead to an additional (additive) lowering of your blood pressure. Consult your doctor or pharmacist for advice before taking any drugs. Pregnancy and lactation Angeliq is intended to be taken by women who are in postmenopause. You should not take Angeliq if you are pregnant or breast-feeding. If you become pregnant, then you must discontinue taking Angeliq immediately and inform your physician. Driving ability and the operation of machinery There are no indications that the taking of Angeliq has any influence upon the ability to drive or to operate machinery. Important information concerning certain excipients of Angeliq Angeliq contains lactose (a particular form of sugar). If you suffer from intolerance to certain sugars, then you should not take Angeliq until after you have consulted your physician. 3. HOW IS ANGELIQ TO BE TAKEN? Always take Angeliq precisely in accordance with your doctor s instructions. Please consult your physician or pharmacist if you are not completely sure. Your physician will decide how long you should take Angeliq. Take one tablet daily, at the same time of day if at all possible. Swallow the tablet with a little water and without chewing it. Angeliq can be taken without regard to your mealtime schedule. Begin using your next monthly pack on the day after you have finished your current pack. Do not observe any tablet-free intervals between the packs. If you have taken other HRT preparations: Continue with your intake of the preparation until you have finished your current pack and have taken all of the tablets for the respective month. Take your first Angeliq tablet on the following day. Do not observe any tablet-free intervals between your previous tablets and the Angeliq tablets. If this is your first HRT treatment: You can begin treatment with Angeliq tablets on any day you choose. If you have taken a larger amount of Angeliq than you should have If you have accidentally taken too many Angeliq tablets, you may experience a feeling of sickness, vomiting or menstruation-like bleeding. No special treatment is necessary, but consult your physician or pharmacist for advice if your are worried. If you have forgotten to take Angeliq If you have forgotten to take a tablet at the usual time, and if fewer than 24 hours have passed since the time you would normally have taken it, simply take the tablet as soon as possible. The next tablet in the therapy sequence should then be taken at the usual time. If more than 24 hours have passed since the time you forgot to take the tablet, leave the tablet that was forgotten in the pack. Resume the therapy by taking the subsequent tablets at the usual time. Do not take a double dosage in order to make up for the tablet that was forgotten. If you have forgotten to take the tablets for several days, this may cause you to experience intermenstrual bleeding. If you discontinue taking Angeliq You could once again experience symptoms resembling those of menopause, e.g. hot flashes, sleep disorders, nervousness, stupor or vaginal dryness. A loss of bone mass could occur. Consult your physician or pharmacist for advice if you wish to discontinue taking Angeliq tablets.

5 BAYER-ANGELIQ 1 mg/2 mg Film Coated Tablets - p.5/6 If you need to undergo surgery If you need to undergo surgery, inform your physician that you are taking Angeliq. It may be necessary to discontinue taking Angeliq approximately 4 to 6 weeks before the operation in order to reduce the risk of a developing a blood clot (see also Section 2 Angeliq and blood clots ). Ask your physician when you can begin taking Angeliq again. 4. WHAT ARE THE POTENTIAL SIDE EFFECTS? Like all medicines, Angeliq can cause side effects which will however not necessarily occur to every patient. Grave side effects which are associated with hormone replacement therapy: Blood clots in the veins Cancer of the uterine mucosa (endometrial carcinoma) Breast cancer Ovarian cancer Heart disease Cerebral stroke Loss of memory (dementia) Further information concerning these side effects can be found in Section 2. The following list is comprised of side effects which have been linked with the administration of Angeliq. Very common side effects (more than 1 out of 10 users could be affected): Unexpected menstruation-like bleeding (see also Section 2 Angeliq and cancer / cancer of the uterine mucosa (endometrial carcinoma) ) Breast tension Chest pain Unexpected incidents of menstruation-like bleeding will occur during the first few months of treatment with Angeliq. They usually occur for only a limited period and then disappear again with continued. If they do not, please contact your physician. Common side effects (1 to 10 out of every 100 patients could be affected): Depression, mood swings, nervousness Headache Stomach-ache, queasiness, meteorism Benign neoplasms (neoplasias) of the breast, enlargement of the breast Enlargement of uterine leiomyomas Benign neoplasms of the cervix Bleeding irregularities Vaginal discharge Lack of energy, localised fluid retention (oedema) Occasional side effects (1 to 10 out of every 1000 patients could be affected): Weight gain or weight loss, loss of appetite, increased appetite, elevated blood lipids (hyperlipidaemia) Sleep disorders, anxiety, lessening of sexual drive Sensibility disorders, e.g. prickling of the skin (paraesthesia), limited powers of concentration, stupor Ophthalmopathies (e.g. reddened eyes), vision disorders (e.g. unsharp vision) Heart palpitations Blood clot, venous thrombosis (see also Section 2 Angeliq and blood clots ), high blood pressure, migraine, phlebitis, varicose veins Shortness of breath Gastrointestinal disorders, diarrhoea, constipation, vomiting, dry mouth, flatulence, disorders of the sense of taste Changed liver function values (evident in the blood test) Skin problems, acne, hair loss, itching, excessive hair growth Back pain, joint pain, pain in the extremities, muscle cramps Urinary tract illnesses and infections Breast cancer, thickening of the uterine mucosa (endometrial hyperplasia), benign enlargement of the uterus, fungal infection of the vagina, vaginal dryness, vaginal itching Changes in the breast (node-like, cysts); ovarian, cervical or uterine changes; pelvic pain Water retention in tissue (oedemas), chest pain, general discomfort, increased perspiration Rare side effects (1 to 10 out of every 10,000 patients could be affected): Anaemia Vertigo Ringing or buzzing in the ears

6 BAYER-ANGELIQ 1 mg/2 mg Film Coated Tablets - p.6/6 Gallstones Muscle pain Fallopian tube inflammation Milky discharge from the nipples Chills The following undesirable effects have been recorded in clinical studies among women with high blood pressure: High potassium values in the blood (hyperkalaemia), which can on occasion lead to muscle cramps, diarrhoea, queasiness, stupor or headache Cardiac insufficiency, cardiac enlargement, atrial flutter, effect on the heartbeat Increase in the level of the hormone aldosterone in the blood. The following undesirable effects have been reported in connection with other HRT preparations: Various types of skin diseases (erythema nodosum, erythema multiforme and haemorrhagic dermatitis) Please inform your doctor or pharmacist If one of the side effects listed is considerably inhibiting for you or if you notice other side effects that are not specified in these Instructions for Use. 5. HOW IS ANGELIQ TO BE STORED? Keep drugs out of the reach of children. Do not use Angeliq after the expiration date specified on the outer packaging and blister pack with Use before. The expiration date refers to the last day of the respective month. Do not store above 30 C. Drugs may not be disposed of in the sewage system nor with household refuse. Ask your pharmacist how the drug should be disposed of if you no longer require it. This measure helps protect the environment. 6. FURTHER INFORMATION What Angeliq contains: Its active ingredients are: Estradiol (as estradiol hemihydrate) and drospirenone; Each tablet contains 1 mg estradiol (as estradiol hemihydrate) and 2 mg drospirenone. The other constituents are: lactose monohydrate, maize starch, preagglutinated maize starch, povidone and magnesium stearate (E470b). The constituents of the tablet coating are: hypromellose (E464), macrogol 6000, talcum (E553b), titanium dioxide (E171), iron(iii) oxide (E172). Appearance of Angeliq and package contents: Angeliq tablets are red, round film coated tablets with convex surfaces, stamped on one side with the letters DL in a regular six-sided shape (hexagon). Angeliq is supplied in blister strips containing 28 tablets along with the days of the week printed on the blister. Packs with 1 blister (N1) or 3 blisters (N2) are available. Manufacturer Bayer Schering Pharma AG Mu llerstraße D Berlin Germany. These Instructions for Use were last approved in 03/2009.