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ANGELIQ 1MG/2MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ESTRADIOL HEMIHYDRATE

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Package leaflet: Information for the user
®
Angeliq 1mg/2mg film-coated tablets
(estradiol/drospirenone)
Your medicine is known as the above but 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.
What is 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 take more Angeliq than you should
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
1.

What Angeliq is and what it is used for

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.
2.

What you need to know before you take Angeliq

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 breastfeeding' 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 non–users. The
number of extra cases of stroke due to HRT use will increase with age.
Other things that can increase the risk of stroke include:
 getting older
 high blood pressure
 smoking
 drinking too much alcohol
 an irregular heartbeat
If you are worried about any of these things, or if you have had a stroke in the past,
talk to your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be
expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5
years (i.e. an extra 3 cases).

If you get:
 unexplained migraine-type headaches, with or without disturbed vision.
 weakness, numbness, or paralysis of the face, arm, or leg
 dizziness, loss of balance or coordination
 See a doctor as soon as possible and do not take any more HRT until your doctor
says you can. These headaches may be an early warning sign of a stroke.
Other conditions
 HRT will not prevent memory loss. There is some evidence of a higher risk of memory
loss in women who start using HRT after the age of 65. Speak to your doctor for advice.
 If you have heart or kidney problems, your doctor should examine you carefully as
oestrogens may cause fluid retention resulting in swelling.
 If you have pre-existing elevated triglycerides (a type of blood fat) your doctor should
monitor you closely during oestrogen replacement therapy or HRT. Rare cases of large
increases of plasma triglycerides (hypertriglyceridemia) leading to inflammation of the
pancreas (pancreatitis) have been reported with oestrogen replacement therapy.
 If you have a kidney disorder and have high serum potassium levels, particularly if
you are taking ACE inhibitors, angiotensin II antagonists and non-steroidal
anti-inflammatory agents, 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.
Other medicines and Angeliq
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Some medicines may interfere with the effect of Angeliq. This might lead to
irregular bleeding. This applies to the following medicines.
 medicines for epilepsy (such as phenobarbital, phenytoin, carbamazepine)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV infection (such as nevirapine, efavirenz, nelfinavir and ritonavir) and
Hepatitis C Virus infections
 medicines for inflammation or pain (such as aspirin and other non-steriodal antiinflammatory drugs (NSAIDS)
 medicines for certain types of heart disease or high blood pressure (ACE inhibitors
or angiotensin II receptor antagonists, verapamil, diltiazem). If you are having treatment
for high blood pressure and take Angeliq there may be an additional decrease in blood
pressure.
 Herbal remedies containing St. John’s wort (Hypericum perforatum)
 medicines for treatment of fungal infections (such as itraconazole, voriconazole,
fluconazole)
 medicines for treatment of bacterial infections (such as clarithromycin, erythromycin)
 grapefruit juice
 Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines including medicines obtained without a prescription, herbal medicines or other
natural products.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking Angeliq,
because this medicine can affect the results of some tests.
Pregnancy and breast-feeding
Angeliq is for use in post-menopausal women.
If you become pregnant, stop taking Angeliq immediately and contact your doctor.
Driving or using machines
There is nothing to suggest that the use of Angeliq affects driving or use of machines.
Angeliq contains lactose
Angeliq contains lactose (a type of sugar). If you have intolerance to some sugars, check
with your doctor before taking Angeliq.
3.

How to take Angeliq

Do not start taking Angeliq until at least 12 months after your last natural period.
About the pack
This pack is designed to help you remember to take your medicine. Each tablet is placed in
a section marked with the day of the week on which it should be taken. The arrows between
tablets show the order in which they must be taken. Your doctor may tell you when to start
(see "when to start" for further information).
On the day you start, take your first tablet from the top row of tablets marked with the
correct day. For instance, if you start on a Tuesday, press out the tablet from the blister
marked 'TUE'.

TP
TUE

TE
WED

ΠE
THURS

ΠA
FRI

ΣA
SAT

KY
SUN

Take one tablet each day, following the directions of the arrows, until you have finished all
28 tablets in the pack. When you have finished each memo strip, start the next memo strip
on the following day. Do not leave a break between memo strips.
It is best to take your tablet at the same time each day. You can take Angeliq with or without
food. The tablet should be swallowed whole with a glass of water or milk.
When to start
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 menstruation-like 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.
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 the menopause again, which may include hot
flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. Consult your doctor or
pharmacist if you want to stop taking Angeliq tablets. If you have any further questions on
the use of this medicine, ask your doctor or pharmacist.
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 section 2, “Blood clots in a vein (thrombosis)”). Ask your doctor when you can start
taking Angeliq again.
4.

Most frequent side effects:
 breakthrough bleeding at unexpected times (see also section 2 "HRT and cancer/
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of
the lining of the womb (endometrial cancer)")
 breast tenderness
 breast pains
These side effects occur during the first few months of treatment with Angeliq. They are
usually temporary and normally disappear with continued treatment. If they do 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
 non-cancerous breast tumour (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 menstrual period
 vaginal discharge
 loss of energy, localised swelling.
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, visual disturbances (such as dry eyes or blurred vision)
 palpitations
 blood clot, venous thrombosis (leg pain), 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, rash, excessive hair or hair problems
 backache, pains in hands and feet, joint pain, muscle cramps
 urinary tract disorders and infections
 thickening of the lining of the womb, thrush, vaginal dryness and itchiness or burning 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
 non-cancerous tumour of the womb (benign uterine neoplasm)
Rare side effects (affecting between 1 and 10 in every 10,000 patients):
 anaemia
 giddiness (vertigo)
 ringing in the ears (tinnitus)
 gall stones (cholelithiasis)
 muscle pain (myalgia)
 inflammation of the fallopian tubes (salpingitis)
 milky discharge from the nipples (galactorrhoea)
 chills
The following side effects have occurred in clinical trials of women with high blood pressure:
 high potassium levels (hyperkalaemia)
 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:
 gall bladder disease
 various skin disorders:
 discoloration of the skin especially of the face or neck known as “pregnancy patches”
(chloasma)
 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema multiforme)
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly (see details below).
By reporting side effects you can help provide more information on the safety of this
medicine. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
5.

Translation of days of the week:
∆E
MON

The following is a list of side effects that have been linked to the use of Angeliq:

Possible side effects

Like all medicines, Angeliq can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this
booklet, please tell your doctor or pharmacist.
The following diseases are reported more often in women using HRT compared to women
not using HRT:
Serious side effects
 breast cancer
 abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
 ovarian cancer
 blood clots in the veins of the leg or the lungs (venous thromboembolism)
 heart disease
 stroke
 probable memory loss if HRT is started over the age of 65
For more information about these side effects see Section 2.

How to store Angeliq

Keep out of the sight and reach of children.
Do not take the tablets if they are past the expiry date which is clearly marked on the pack.
If your doctor tells you to stop taking this medicine, return any unused tablets to your doctor
or pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
If your tablets have become discoloured or show any other signs of deterioration, consult
your doctor or pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are no longer required. These measures will
help to protect the environment
6.

Contents of the pack and other information

What Angeliq contains
Each film-coated tablet contains 1 mg estradiol (as estradiol hemihydrate) and 2 mg
drospirenone.
The other ingredients are: lactose monohydrate, maize starch, pregelatinised maize starch,
povidone, magnesium stearate E470B, hypromellose E464, macrogol 6000, talc E553B,
titanium dioxide E171 and red ferric oxide E172.
What Angeliq looks like and the contents of the pack
Angeliq are red, round tablets which are engraved on one side with the letters DL in a
regular hexagon.
They are supplied in calendar blister packs containing 3 x 28.
Manufacturer
Manufactured by Bayer Pharma AG, Muellerstrasse 170-178, D13353, Berlin Germany.
Procured from within the EU and repackaged by the Product Licence holder: G Pharma Ltd,
Salford M50 2PU.
POM

PL 16369/1652

Leaflet revision: 24/11/2015
Angeliq is a registered trademark of Bayer.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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