CYCLO-PROGYNOVA 2MG

Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• In this leaflet, Cyclo-Progynova 2 mg will be
called Cyclo-Progynova.
Information in this leaflet can be found by
looking under the following sections:
1.
What Cyclo-Progynova is for
1.1 Cyclo-Progynova is used for
2.
Before you take Cyclo-Progynova
2.1 Do not take Cyclo-Progynova if
2.2 Check with your doctor before taking CycloProgynova if
2.3 Safety of HRT
2.4 Heart disease
2.5 Stroke
2.6 Blood clots
2.7 Surgery (Surgical operations)
2.8 Breast cancer
2.9 Endometrial cancer
2.10 Ovarian cancer
2.11 Dementia
2.12 Tell your doctor if you are taking any of the
following medicines
2.13 Contraception
2.14 Pregnancy and breast-feeding
2.15 Driving and using machines
2.16 Warning about sugar intolerance
3.
How to take Cyclo-Progynova
3.1 When to start taking your medicine for the first
time
3.2 How to use the medicine
3.3 Medical check-ups
3.4 What bleeding pattern to expect with CycloProgynova
3.5 If you take more Cyclo-Progynova than you
should
3.6 If you forget to take Cyclo-Progynova
4.
Possible side effects
5.
How to store Cyclo-Progynova
6.
Further information.
6.1 What Cyclo-Progynova contains
6.2 What Cyclo-Progynova looks like
6.3 Marketing Authorisation Holder
6.4 Manufacturer

1.

What Cyclo-Progynova is for

Cyclo-Progynova belongs to a group of medicines
called hormone replacement therapy (HRT).
Cyclo-Progynova contains two hormones called
estradiol (an oestrogen) and norgestrel (a
progestogen). These act in different ways in your
body.
During the menopause (sometimes called “the
change of life”) a woman’s body slowly produces
less oestrogen. This may cause hot flushes, night
sweats, mood swings and dryness in the vagina.
Over a long time it may also cause a thinning of the
bones, which may be more likely to then break
(osteoporosis).
Cyclo-Progynova works by replacing the oestrogen
you lose during the menopause and therefore
improves the unpleasant symptoms you may get.
Oestrogen can also make the lining of your womb
grow more than usual, which may lead to cancer
developing there. The other hormone in CycloProgynova called a progestogen reduces the
chance of getting cancer of the womb.

1.1 Cyclo-Progynova is used for:
• Treating symptoms of the menopause. This
includes hot flushes, night sweats, mood swings
and dryness in the vagina
• Preventing thinning of the bones (osteoporosis)
in women who are not allowed to take other
types of medicines to prevent this from
happening
There are some small risks with taking HRT and
you should discuss this with your doctor before you
start taking Cyclo-Progynova (also see Section 2).

2.

Before you take Cyclo-Progynova

2.1 Do not take Cyclo-Progynova if you
have, or have ever had:
• An allergic reaction to estradiol or norgestrel
• An allergic reaction to any of the other
ingredients of Cyclo-Progynova (listed in
section 6)
• Breast or womb cancer
• Bleeding from your vagina and the cause is not
known
• Endometrial hyperplasia that is not being treated
(an overgrowth of the lining of the womb)
• Blood clots in a vein in your leg (deep vein
thrombosis or DVT) or in your lungs (pulmonary
embolus) or any other problems with blood clots
forming.
• if you have a high risk of venous or arterial
thrombosis (blood clot)
• Angina, a stroke or other heart disease
• Liver problems
• Kidney problems
• Porphyria (a rare blood disorder).
If any of the above applies to you, do not take
Cyclo-Progynova and talk to your doctor or
pharmacist.

2.2 Check with your doctor before taking
Cyclo-Progynova if you have, or have
ever had any of the following:
• Uterine fibroids (lumps of fibrous and muscular
tissue in your womb)
• Endometriosis (where tissue from the womb is
found outside the womb)
• Endometrial hyperplasia (overgrowth of the lining
of the womb)
• Risk factors for cancer, such as history of the
disease in your family
• Risk factors for blood clotting problems
• Risk factors for angina, a stroke or heart disease
• You have elevated levels of triglycerides (special
type of blood lipids)
• chloasma (patches of discoloration on the skin)
• High blood pressure
• Diabetes
• Gallstones
• Adenoma of the anterior lobe of the pituitary
gland (pituitary adenoma)
• Migraine or severe headache
• Systemic lupus erythematosus, (SLE or lupus for
short)
• Epilepsy
• Asthma
• Otosclerosis (hearing loss due to a problem with
the bones in the ear).
• A condition known as hereditary angioedema
(see section 4).
• Chorea minor
• Premature menopause

2.3 Safety of HRT
As well as benefits, HRT has some risks which
you may wish to discuss with your doctor when
you are deciding whether to start HRT, or whether
to carry on taking it.
Effects on your heart or circulation

2.4 Heart disease
HRT is not recommended for women who have
or have recently had heart disease. If you have
ever had heart disease, talk to your doctor to see
if you should be taking HRT.
HRT will not help to prevent heart disease.
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.

85253409_02.indd 1

2.5 Stroke
Recent research suggests that HRT slightly
increases the risk of having a stroke. 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, over a 5-year
period, 3 in 1000 would be expected to have a
stroke.
• For women in their 50s who are taking HRT,
the figure would be 4 in 1000.
• Looking at women in their 60s who are not
taking HRT — on average, over a 5-year
period, 11 in 1000 would be expected to have a
stroke.
• For women in their 60s who are taking HRT,
the figure would be 15 in 1000.
If you get:
Unexplained migraine-type headaches, with or
without disturbed vision.
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.

2.6 Blood clots
HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or
DVT), especially during the first year of taking it.
These blood clots are not always serious, but if
one travels to the lungs, it can cause chest pain,
breathlessness, collapse 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 if:
• You are seriously overweight
• You have had a blood clot before
• Any of your close family have had blood clots
• You have had one or more miscarriages
• You have any blood clotting problem that needs
treatment with a medicine such as warfarin
• You’re off your feet for a long time because of
major surgery, injury or illness
• You have a rare condition called SLE (see
Section 2).
If any of these things apply to you, talk to your
doctor to see if you should take HRT. Your doctor
will discuss with you the benefits and risks of
Cyclo-Progynova. She/he will check, e.g. whether
you have a higher risk of getting a thrombosis due
to a combination of risk factors or perhaps one
very strong risk factor. In the case of a
combination of factors the risk may be higher
than simply adding two individual risks. If the risk
is too high, your doctor will not prescribe HRT
treatment.
Compare:
• Looking at women in their 50s who are not
taking HRT — on average, over a 5-year
period, 3 in 1000 would be expected to get a
blood clot.
• For women in their 50s who are taking HRT,
the figure would be 7 in 1000.
• Looking at women in their 60s who are not
taking HRT — on average, over a 5-year
period, 8 in 1000 would be expected to get a
blood clot.
• For women in their 60s who are taking HRT,
the figure would be 17 in 1000.
If you get:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.
You must see a doctor as soon as possible
and do not take any more HRT until your doctor
says you can. These may be signs of a blood clot

2.7 Surgery (Surgical operations)
If you’re going to have surgery, make sure your
doctor knows about it. You may need to stop
taking HRT about 4 to 6 weeks before the
operation, to reduce the risk of a blood clot. Your
doctor will tell you when you can start taking HRT
again.
Effects on your risk of developing cancer

2.8 Breast cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast
cancer; so does having a later menopause,
alcohol intake and adiposity. The risk for a postmenopausal woman taking oestrogen-only HRT
for 5 years is about the same as for a woman of
the same age who is still having periods over that
time and not taking HRT. The risk for a woman
who is taking oestrogen plus progestogen HRT is
higher than for oestrogen-only HRT (but
oestrogen plus progestogen HRT is beneficial for
the endometrium, see ‘Endometrial cancer’
below).
For all kinds of HRT, the extra risk of breast
cancer goes up the longer you take it, but returns
to normal within about 5 years after stopping
HRT.
Your risk of breast cancer is also higher if you:
• Have a close relative (mother, sister or
grandmother) who has had breast cancer
• are seriously overweight.
Compare:
• Looking at women aged 50 who are not taking
HRT — on average, 32 in 1000 will be
diagnosed with breast cancer by the time they
reach the age of 65.
• For women who start taking oestrogen-only
HRT at age 50 and take it for 5 years, the figure
will be 33 and 34 in 1000 (i.e. an extra 1-2
cases).
• If they take oestrogen-only HRT for 10 years,
the figure will be 37 in 1000 (i.e. an extra 5
cases).
• For women who start taking oestrogen plus
progestogen HRT at age 50 and take it for 5
years, the figure will be 38 in 1000 (i.e. an
extra 6 cases).
• If they take oestrogen plus progestogen HRT
for 10 years, the figure will be 51 in 1000 (i.e.
an extra 19 cases).
If you notice any changes in your breast, such
as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Make an appointment to see your doctor as
soon as possible.
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.

11.05.2016 07:28:36

Peter
Wittmuetz

Estradiol valerate and norgestrel

Packaging Technology Berlin sgqwx
page 1
Bayer Pharma AG
client: JS86
material-no.: 85253409
PZ: 2599F-4
code-no.: 95
name: LF-Cyclo-Progynova 2MG SCT GB
country: GB/-/MEDA
colors: Black
version: 11.05.2016/02
approval:
dimension: 160 x 594 mm

®

Cyclo-Progynova 2 mg

Digitally signed by Peter Wittmuetz
DN: o=Bayer Group, ou=SignCert,
0.9.2342.19200300.100.1.1=GBKOP,
cn=Peter Wittmuetz
Date: 2016.05.12 13:51:44 +02'00'

Patient Information Leaflet

Taking oestrogen-only HRT for a long time can
increase the risk of cancer of the lining of the
womb (the endometrium). Taking a progestogen
as well as the oestrogen helps to lower the extra
risk.
If you still have your womb, your doctor will
usually prescribe a progestogen as well as
oestrogen. These may be prescribed separately,
or as a combined HRT product.
If you have had your womb removed (a
hysterectomy), your doctor will discuss with you
whether you can safely take oestrogen without a
progestogen.
If you’ve had your womb removed because of
endometriosis, any endometrium left in your
body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as
well as an oestrogen.
Your product, Cyclo-Progynova contains a
progestogen.
Compare
• Looking at women who still have a uterus and
who are not taking HRT – on average 5 in
1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
• For women who take oestrogen-only HRT, the
number will be 2 to 12 times higher,
depending on the dose and how long you take
it.
• The addition of a progestogen to oestrogenonly HRT substantially reduces the risk of
endometrial cancer.
If you get breakthrough bleeding or spotting,
it’s usually nothing to worry about, especially
during the first few months of taking HRT.
If the bleeding or spotting:
• carries on for more than the first few
months
• starts after you’ve been on HRT for a while
• carries on even after you’ve stopped taking
HRT.
You must make an appointment to see your
doctor. It could be a sign that your endometrium
has become thicker.

2.10 Ovarian cancer
Ovarian cancer is rare – much rarer than breast
cancer. It can be difficult to diagnose, because
there are often no obvious signs of the disease.
The use of oestrogen-only or combined
oestrogen-progestagen HRT has been associated
with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For
example, in women aged 50 to 54 who are not
taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for
5 years, there will be about 3 cases per 2000
users (i.e. about 1 extra case).

2.11 Dementia
HRT will not prevent memory loss. In one study of
women who started using combined HRT after
the age of 65, a small increase in the risk of
dementia was observed.

2.12 Liver tumor
During or after the use of hormones such as those
that are contained in Cyclo-Progynova, benign liver
tumors have rarely occurred, and malignant liver
tumors even more rarely. In isolated cases,
bleeding from such tumors into the abdominal
cavity has endangered life. Although such events
are extremely improbable you should inform your
doctor about any unusual feelings in your upper
abdomen that do not disappear within a short time.

2.13 Tell your doctor if you are taking any of
the following medicines:
• Anticonvulsants such as phenobarbital or
phenytoin (to treat epilepsy)
• Antibiotics such as rifampicin or rifabutin (to treat
infections)
• Herbal medicines containing the herb St. John’s
Wort
• Insulin or other medicines to treat diabetes
• Protease inhibitors (to treat HIV)
• Transcriptase inhibitors such as nevirapine or
efavirenz (to treat HIV)
• Any other medicine, including medicines
obtained without a prescription.

2.14 Contraception
This medicine will not act as a contraceptive.
Ask your doctor for advice if you are already using
a contraceptive. This medicine may interfere with it.

2.15 Pregnancy and breast-feeding
Do not take Cyclo-Progynova if you are pregnant or
breast-feeding.
If you become pregnant whilst taking this
medicine, you must immediately stop taking this
medicine and ask your doctor for advice.

2.16 Driving and using machines
Whilst taking Cyclo-Progynova you may feel dizzy.
If this happens, do not drive or operate machinery.

2.17 Warning about sugar intolerance
This medicine contains sugar. If you have been told
by your doctor that you have an intolerance to
some sugars, contact your doctor before taking
this medicine.

3.

How to take Cyclo-Progynova

Always take Cyclo-Progynova exactly as your
doctor has told you.
Important:
Your doctor will choose the dose that is right for
you. Your dose will be shown clearly on the label
that your pharmacist puts on your medicine. If it
does not, or you are not sure, ask your doctor or
pharmacist.

3.1 When to start taking your medicine for
the first time
Depending on your situation you should start to
take this medicine at the following times of the
month:
• If you are having regular periods, start taking the
medicine on the fifth day of your period.
• If you are not having regular periods, you can
start at any time.
• If you are changing from another HRT medicine
that gives you a period complete the treatment
course of the other medicine. Then on the next
day start to take this medicine.
• If you are changing from another HRT medicine
that does not give you a period, you can start at
any time.

3.2 How to use the medicine
• Your pack contains 1 foil memo-strip and 7 blue
stickers showing days of the week. Each blue
sticker starts with a different day of the week.
• Peel off a strip that starts with your starting day.
Stick this sticker along the top of the foil
memostrip where it states ‘fix the blue sticker
here’ so that the first day is above the pill
marked ‘start’.
• You can now see on which days you have to
take each tablet. Take one tablet each day,
following the direction of the arrows, until you
have finished all 21 tablets.
• Swallow the tablets whole with water. Do not
chew the tablets.
• Take the tablets at the same time every day.
• After day 21 you will have a 7 day tablet free
break. During this week, bleeding similar to a
period may occur. This is normal.
• Start the next strip immediately after the 7 day
break. You will start your new strip of tablets on
the same day of each month. Take the tablets
even if your bleeding has not finished.
If you are not sure how to use the sticker and the
memo-pack then please ask your pharmacist for
advice.

3.3 Medical check-ups
Once you are taking this medicine:
• Regularly check your breasts for any changes. If
you notice dimpling of the skin, changes in
the nipple, or any lumps you must see your
doctor as soon as possible.
• Go for regular breast screening
• Go for regular cervical smear tests
• See your doctor for regular check-ups (at least
once a year). At these check-ups, your doctor
will discuss with you the benefits and risks of
continuing to take HRT.

3.4 What bleeding pattern to expect with
Cyclo-Progynova
As with normal periods, the amount of blood loss
will vary from woman to woman.
Your bleeding pattern may change when you are
taking this medicine. You may have:
• Bleeding in the first three weeks of starting the
tablets. If so, ask your doctor for advice.
• Heavier bleeding. You may notice this more if
your periods have become short or lighter before
you started treatment. This is normal.
• Bleeding in the break where you take no tablets.
This is normal.
If after several months you are still getting
spotting or breakthrough bleeding, or you are
worried about your bleeding you must see your
doctor.

3.5 If you take more Cyclo-Progynova than
you should
If you accidentally take too much of your medicine,
immediately tell your doctor or go to the nearest
hospital casualty department.

3.6 If you forget to take Cyclo-Progynova
• If your tablet is less than 12 hours late, take the
tablet as soon as possible, then take your next
tablet at the normal time.
• If your tablet is more than 12 hours late, leave the
forgotten tablet in the pack, and take your next
tablet at the normal time.
• You may get some vaginal bleeding
(breakthrough bleeding) if you have missed a
tablet. This is normal.
If you have any further questions about the use of
this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines Cyclo-Progynova can cause side
effects, although not everybody gets them.
If you have any of the following symptoms:
• Chest pain that spreads to your arm or
neck
• Sudden numbness or confusion
• Difficulty breathing
• Severe rash that might blister
• Sudden pain and swelling in your leg
• You notice yellowing of your skin or eyes
• Severe or prolonged headache, possibly
with disturbed vision for the first time.
Seek immediate medical help and stop taking
Cyclo-Progynova.
If you get any of the following symptoms:
• If you notice any changes in your breast
such as a lump, dimpling in the skin or the
nipple changing
• If bleeding or spotting carries on for more
than the first few months, or starts after you
have been taking the tablets for a while
• If bleeding or spotting carries on even after
you’ve stopped taking HRT.
See your doctor as soon as possible.
Important: All the symptoms in the boxes above
are signs that you may be developing a serious
problem. If you ignore these symptoms they may
become worse.
Other possible side effects
The following symptoms, which may or may not
have been caused by hormone replacement
therapy, and which in some cases were probably
symptoms of the climacteric, have been reported in
users of different oral hormone replacement
therapy preparations:
Common undesirable effects (between 1 and 10
in every 100 users may be affected)
• weight loss or gain
• Headache
• stomach pain, nausea
• rash, itching
• vaginal bleeding including Spotting (bleeding
irregularities usually subside during continued
treatment)
Uncommon undesirable effects (between 1 and
10 persons in every 1,000 users may be affected)
• allergies (hypersensitivity reaction)
• depressed mood
• dizziness
• visual disturbances
• palpitations(irregular, rapid beating or pulsation
of the heart)
• dyspepsia (indigestion)
• erythema nodosum (reddish painful nodules),
• urticaria (hives)
• breast pain, breast tenderness
• edema(swelling due to excessive fluid retention)
Rare undesirable effects (between 1 and 10 in
every 10,000 users may be affected)
• anxiety, libido decreased or libido increased (an
increase or a decreased interest in sex)
• migraine
• contact lens intolerance
• bloating, vomiting
• hirsutism (excessive hair growth), acne
• muscle cramps
• dysmenorrhea (painful period), vaginal discharge,
Pre-menstrual-like syndrome, swollen breast
• fatigue
In women with episodes of swelling in body parts
such as hands, feet, face, airway passages that are
caused by a defect in the gene that controls a
blood protein called C1-inhibitor (hereditary
angioedema) the hormone estradiol valerate in
Cyclo-Progynova may induce or exacerbate
symptoms of hereditary angioedema.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5.

How to store Cyclo-Progynova

Keep out of the reach and sight of children. Do not
use Cyclo-Progynova after the expiry date on the
carton. The expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Return any
medicine you no longer need to your pharmacist.

6.

Further information

6.1 What Cyclo-Progynova contains
• There are two active substances in this medicine.
The white tablets contain 2mg of estradiol
valerate. The pale-brown tablets contain 2 mg of
estradiol valerate and 0.5 mg of norgestrel.
• The other ingredients are lactose, maize starch,
povidone, talc, magnesium stearate (E572),
sucrose, calcium carbonate (E170), polyethylene
glycol 6000.
The white tablets also contain titanium dioxide
(E171), yellow ferric oxide (E172) and red brown
ferric oxide (E172)
The pale-brown tablets also contain glycerin and
montan glycol wax.

6.2 What Cyclo-Progynova looks like
Cyclo-Progynova is made up of white and pale
brown tablets.
Each carton contains 1 or 3 memo-packs. Each
memo-pack contains 21 tablets, which include
11 white tablets and 10 pale brown tablets.
Not all pack sizes may be marketed.

6.3 Marketing Authorisation Holder
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU.

6.4 Manufacturer
Bayer Weimar GmbH und Co KG, Weimar,
Dobereinerstrasse 20D-99427, Germany and
Bayer Pharma AG, Berlin, Germany
This leaflet was last updated on April 2016.
If this leaflet is difficult to see or read or you
would like it in a different format, please contact
Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU.

85253409

85253409_02.indd 2

11.05.2016 07:29:20

Packaging Technology Berlin sgqwx
page 2
Bayer Pharma AG
client: JS86
material-no.: 85253409
PZ: 2599F-4
code-no.: 95
name: LF-Cyclo-Progynova 2MG SCT GB
country: GB/-/MEDA
colors: Black
version: 11.05.2016/02
approval:
dimension: 160 x 594 mm

2.9 Endometrial cancer (cancer of the
lining of the womb)