ANGELIQ FILM-COATED TABLETS

Active substance: ESTRADIOL HEMIHYDRATE

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film-coated tablets
Estradiol + Drospirenone

United Kingdom 80620942

PACKAGE BOOKLET: INFORMATION FOR THE USER
Read all of this booklet carefully before you
start taking this medicine.
 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. 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 get serious, or if you
notice any side effects not listed in this booklet,
please tell your doctor or pharmacist.






In this booklet
1. WHAT ANGELIQ IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE ANGELIQ
Medical history and regular check-ups
Do not take Angeliq
When to take special care with
Angeliq
HRT and cancer
Effects of HRT on your heart or
circulation

7
10
10
12
17
22
29



Other conditions
Using other medicines
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Important information about some of the
ingredients of Angeliq
3. HOW TO TAKE ANGELIQ
About the pack
When to start



39
42
44
45
45
46
47
47
49

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. FURTHER INFORMATION

50
50
51
52
53
64
65







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. 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
“Further information”)



 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.



When you need to take special care with 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 oestrogenprogestogen 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 14 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 20 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



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 if 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 any other 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.


Using 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)



 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). 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)


 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.



Important information about some of the
ingredients of Angeliq
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’.
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 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. 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.
The following is a list of side effects that have been
linked to the use of Angeliq:
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
 discolouration 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.



5. HOW TO STORE ANGELIQ
Keep out of the reach and sight of children.
Do not use Angeliq after the expiry date which is
printed on the label after “EXP”. The expiry date
refers to the last day of the month stated.
Do not dispose of medicines down the drain or in
the household rubbish. 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 estradiol hemihydrate
and drospirenone.
The other ingredients are lactose monohydrate,
maize starch, pregelatinised maize starch, povidone
and magnesium stearate. The ingredients of the
tablet coating are hypromellose, macrogol 6000,
talc, titanium dioxide (E171) and red 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 (memo strip)
containing 28 tablets with the days of the week
printed on the blister.
Boxes containing three blister packs are available.



Marketing Authorisation Holder
Bayer PLC
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
Manufacturer
Angeliq is made by: Bayer Pharma AG, Berlin,
Germany.
Date of the last revision of this booklet
November 2011.


United Kingdom 80620942



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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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