Angeliq Film-Coated Tablets
1. What Angeliq is and what it is used for
2. What you need to know before you take Angeliq
PACKAGE LEAFLET: INFORMATION FOR THE USER Angeliq® film-coated Tablets
(estradiol/drospirenone)
This medicine will be referred to as Angeliq throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this booklet. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this booklet. See section 4.
In this leaflet
1. What Angeliq is and what it is used for
2. What you need to know before you take Angeliq Medical history and regular check-ups
Do not take Angeliq Warnings and precautions HRT and cancer
Effects of HRT on your heart or circulation
Other conditions
Other medicines and Angeliq
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Angeliq contains lactose
3. How to take Angeliq About the pack When to start
If you forget to take Angeliq If you stop taking Angeliq If you need to have surgery
4. Possible side effects
5. How to store Angeliq
6. Contents of the pack and other information
Angeliq is a Hormone Replacement Therapy (HRT). It contains two types of female hormone, an oestrogen and a progestogen. Angeliq is used in postmenopausal women with at least 12 months (1 year) since their last natural period.
What Angeliq is used for
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Angeliq alleviates these symptoms after menopause. You will only be prescribed Angeliq if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause, some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Angeliq to prevent osteoporosis after menopause.
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.
Once you have started on Angeliq, you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Angeliq.
Be sure to:
> go for regular breast screening and cervical smear tests.
> regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
Do not take Angeliq
if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Angeliq.
Do not take Angeliq
• if you have or have ever had breast cancer, or if you are suspected of having it
• if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium) or if you are suspected of having it
• if you have any unexplained vaginal bleeding
• if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• if you have or have ever had a blood clot in a vein (thrombosis) such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• if you have or have ever had a liver disease and your liver function tests have not yet returned to normal
• if you have a rare blood problem called “Porphyria” which is passed down in families (inherited)
• if you have severe kidney disease or acute kidney failure
• if you are allergic (hypersensitive) to oestrogens, progestogens or any of the other ingredients of Angeliq (listed in section 6)
• if you have any reason to believe that you either are, or may be, pregnant, or if you are producing milk (lactating) and breast-feeding. (See also the 'Pregnancy and breast-feeding' section of this booklet)
> If any of the above conditions appear for the first time while taking Angeliq, stop taking it at once and consult your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before taking Angeliq. Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Angeliq. If so, you should see your doctor more often for check-ups:
• fibroids inside your womb
• growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")
• increased risk of getting an oestrogen-sensitive cancer (such as a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• a liver disorder, such as benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
Stop taking Angeliq and see a doctor immediately
If you notice any of the following when taking HRT:
• any of the conditions mentioned in the ‘DO NOT take Angeliq' section
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as
- painful swelling and redness of the legs
- sudden chest pain
- difficulty breathing
For more information see ‘Blood clots in a vein (thrombosis)'
Note: Angeliq is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer).
The progestogen in Angeliq protects you from this extra risk.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Angeliq. However, if the irregular bleeding:
• carries on for more than the first 6 months
• starts after you have been taking Angeliq for more than 6 months
• carries on after you have stopped taking Angeliq > See your doctor as soon as possible.
Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT.
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
Your risk of breast cancer is also higher:
• if you have a close relative (mother, sister or grandmother) who has had breast cancer
• if you are seriously overweight Compare
Looking at women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your doctor, if you notice any changes in your breast, such as:
• dimpling or sinking of the skin
• changes in the nipple
• any lumps you can see or feel
Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare. It can be difficult to diagnose, because there are often no obvious signs of the disease. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case)._
Effects of HRT on your heart or circulation Blood clots in a vein (thrombosis)
The risk of blood clots in the veins (also called deep vein thrombosis, or DVT)
is about 1.3 to 3-times higher in HRT users than non-users, especially during the first year of taking it.
Blood clots can be serious if one travels to the lungs it can cause chest pain, breathlessness, fainting or even death. This condition is called pulmonary embolism or PE.
DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations apply to you:
• you are unable to walk for a long time because of major surgery, injury or illness (see also sections 3, If you need to have surgery)
• you are seriously overweight (BMI >30kg/m2)
• you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots such as warfarin
• if any of your close relatives has ever had a blood clot in the leg, lung or another organ
• you have had one or more miscarriages
• you have systemic lupus erythematosus (SLE)
• you have cancer
For signs of a blood clot, see “Stop taking Angeliq and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who are taking oestrogen-progestogen HRT, for over 5 years, there will be 9 - 12 cases in 1000 (i.e. an extra 5 cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.
If you get:
• a pain in your chest that spreads to your arm or neck
> See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.
Stroke
The risk of getting a stroke is about 1.5-times higher in HRT users than in nonusers. The number of extra cases of stroke due to HRT use will increase with age.
