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ANGELIQ 1 MG/2 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ESTRADIOL HEMIHYDRATE

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Package leaflet: Information for the user

Angeliq® 1 mg/2 mg film-coated tablets
(estradiol + drospirenone)
This medicine is known by the above name but will be referred to as Angeliq
throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. 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 leaflet. 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 monohydrate
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

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 leaflet)
 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

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.

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.

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:

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).

What Angeliq is used for

• 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

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

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.

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.

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)’

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.

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.

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.

The following diseases are reported more often in women using HRT
compared to women not using HRT:

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'.
Translation of days of the week:
ΔE
MON

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.

Other medicines and Angeliq
When to start
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 nonsteriodal anti-inflammatory 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 monohydrate
Angeliq contains lactose monohydrate (a type of sugar). If you have
intolerance to some sugars, check with your doctor before taking Angeliq.

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. 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 leaflet, please tell your doctor or pharmacist.

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:
• 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.
United Kingdom
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
5. How to store Angeliq






Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the
label after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If the medicine becomes discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
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 and magnesium stearate (E470b).
The ingredients of the tablet coating are hypromellose (E464), macrogol
6000, talc (E553b), titanium dioxide (E171) and ferric oxide (E172).
What Angeliq looks like and contents of the pack
Angeliq are red round convex coated tablets, marked with the letters DL in a
regular hexagon on one side and blank on the other.
They are supplied in calendar blister packs of 1 x 28 or 3 x 28 tablets.
PL: 15814/1273

POM

Manufactured by Bayer Pharma AG, Berlin, Germany.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref): 19.07.2016.
Angeliq is a registered trademark of Bayer Intellectual Property GmbH.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

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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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