Angeliq 1 mg/2 mg Film-Coated Tablets

ANGELIQ is for hormone replacement therapy. ANGELIQ provides hormone replacement therapy for the treatment of climacteric complaints in postmenopausal women, such as hot flushes and sweating attacks, sleep disorders, depressed moods, nervousness and signs of involution of the bladder and genital organs. It is also used for treating complaints that are due to greatly decreased activity of the sexual organs (hypogonadism), following the removal of the ovaries or when the ovaries do not work (primary ovarian failure). ANGELIQ is suitable for women who still have a womb (intact uterus). Some women are more likely than others to develop osteoporosis in later life depending on their medical history and lifestyle. If it is appropriate you may be prescribed ANGELIQ to prevent osteoporosis. Your doctor will be able to advise you further.

Your doctor will carry out gyn a ecological, breast, blood pressure and other examinations as appropriate. If you are known to have any liver disease, your doctor will arrange for your liver function to be checked periodically.

ANGELIQ is not an oral contraceptive. If you still have the ability to become pregnant, ANGELIQ is unlikely to alter it. On the other hand, if your doctor has already advised you that you need no longer use any contraceptive, you need not do so while taking ANGELIQ.

Do not take ANGELIQ

Do not take ANGELIQ if you have, or have ever had any of the conditions listed below. If any of these apply to you, tell your doctor who will be able to advise you further.

• if you are hypersensitive (allergic) to estradiol or drospirenone or any of the other ingredients of ANGELIQ (listed in section 6).
• if you have unspecified vaginal bleeding.
• if you have or if there is a suspicion of cancer of the breast.
• if you have a family history of breast cancer.
• if you have or if there is a suspicion of other malignancies influenced by sex hormones.
• if you have or have had liver tumours (benign or malignant).
• if you have or have had severe liver disease and your laboratory values for liver function have not returned to normal.
• if you have or have had severe kidney (renal) disease and your laboratory values for kidney function have not returned to normal.
• if you recently had a heart attack and/or stroke.
• if you have or have had a thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• if you have a high risk of venous or arterial thrombosis.
• if you have severely elevated blood levels of triglycerides (special type of blood lipids).
• if you are pregnant or breastfeeding.

If any of these conditions appear for the first time while using ANGELIQ, stop taking it at once and consult your doctor.

Do not share medicines prescribed for you with any other person. Always take ANGELIQ exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How and when should ANGELIQ be taken?

Each blister pack is for 28 days of treatment. You have to take one tablet daily.

If you are using hormone replacement therapy for the first time or if you change from a continuous combination hormone replacement therapy (each of the tablets contains the same ingredients), you may begin ANGELIQ tablet taking at any time. If you are changing from a sequential combined hormone replacement therapy (tablets differ in their ingredients which is made visible with different colours), you should complete the current cycle of therapy before starting to take ANGELIQ. It does not matter at what time of the day you take your tablet, but once you have selected a particular time, you should keep to it every day. The tablet should be swallowed whole with some liquid irrespective of food intake.

How long should ANGELIQ be taken or used?

When you have finished one pack, start the next pack on the following day. Never leave a break between packs. Tablet taking should be continuous. Your doctor will advise you with respect to the duration of treatment.

If you take more ANGELIQ than you should

There have been no reports of ill effects from overdose. Overdose may cause nausea and vomiting and irregular bleeding. No specific treatment is necessary, but you should consult your doctor if you are concerned. In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take ANGELIQ

If you are less than 24 hours late, take your tablet as soon as possible. Take the next one at your normal time. But if you are more than 24 hours late, leave the forgotten tablet in the blister pack. Continue to take the remaining tablets at the usual time every day.

If you stop taking ANGELIQ

If you do not take ANGELIQ for several days, irregular bleeding may occur. If your bleeding pattern seems different ANGELIQ has been made to provide you with hormone replacement therapy without cyclical bleeding. You may, however, get some bleeding during the first few months of treatment. It could occur at any time but it is unlikely to be heavy. Bleeding episodes should eventually get less and finally stop. If significant bleeding continues or if at any time bleeding or spotting becomes unacceptable for you, ask your doctor whether you should discontinue treatment or change to a sequential therapy. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

ANGELIQ can have side effects. Not all side effects reported for ANGELIQ are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ANGELIQ, please consult your health care provider for advice. The most commonly reported side effects with ANGELIQ are breast pain, vaginal bleeding (female genital tract bleeding) and abdominal pains. During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting). These are usually temporary and normally disappear with continued treatment. If they do not, contact your doctor. Serious side effects are blood clots as well as breast cancer.

The following side effects of ANGELIQ are based on reports from clinical trials.

Frequent side effects

• breast pain, including breast discomfort
• vaginal bleeding (female genital tract bleeding)
• emotional lability
• headache
• abdominal pain
• cervical polyp

Less frequent side effects

• venous and arterial thromboembolic events (includes peripheral deep venous occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not specified as haemorrhagic)
• breast cancer

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ANGELIQ.

Store all medicines out of sight and reach of children. Store at or below 30 °C. Store in the original package. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).