PROGYNOVA 2MG

Active substance: OESTRADIOL VALERATE

View full screen / Print PDF » Download PDF ⇩

Transcript
81645876_01.indd 1

5/17/2013 8:07:17 AM

In this leaflet
1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE PROGYNOVA
Medical history and regular check-ups
Do not take Progynova
When you need to take special care with Progynova
HRT and cancer
Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
Other conditions
Using other medicines
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Important information about some of the
ingredients of Progynova

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.
 If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Estradiol valerate

Progynova is a Hormone Replacement Therapy (HRT). It
contains the female hormone, oestrogen. Your ovaries
gradually make less of this hormone as you get older and
will no longer produce it after you have been through
the menopause. Progynova can be used in peri- and
postmenopausal women.

What Progynova is

1. WHAT PROGYNOVA IS AND WHAT IT IS
USED FOR

3. HOW TO TAKE PROGYNOVA
About the pack
When to start
If you take more Progynova than you should
If you forget to take Progynova
If you stop taking Progynova
If you need to have surgery
4. POSSIBLE SIDE FFECTS
5. HOW TO STORE PROGYNOVA
6. FURTHER INFORMATION

Progynova 2 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Progynova, 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 to take Progynova.

Medical history and regular check-ups

2. BEFORE YOU TAKE PROGYNOVA

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
Progynova to prevent osteoporosis after menopause.

Prevention of osteoporosis

Relief of symptoms occuring 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”). Progynova alleviates
these symptoms after menopause. You will only be prescribed
Progynova if your symptoms seriously hinder your daily life.

What Progynova is used for

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
Progynova,
Do not take Progynova
 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 vein 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 returned to normal
 If you have a rare blood problem called “porphyria” which
is passed down in families (inherited)
 If you are allergic (hypersensitive) to estradiol valerate
or to any of the other ingredients in Progynova (listed in
section 6 “Further information”)
 If you have been told to avoid lactose, that you have a
rare hereditary condition called Lapp lactase deficiency
or glucose-galactose malabsorption

Do not take Progynova:

Be sure to:
 go for regular breast screening and cervical smear
tests, as recommended by your doctor.
 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.

Tell you 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 Progynova. 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 mother, sister or grandmother who has had
breast cancer)
 high blood pressure
 a liver disorder, such as a 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

When you need to take special care with
Progynova

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 Progynova, stop taking it at once and
consult your doctor immediately.

 If you have any reason to believe that you either are,

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 womb lining (endometrial
cancer).
Taking a progestogen in addition to the oestrogen for at least
12 days of each 28 day cycle protects you from this extra risk.
If you still have your womb, your doctor will prescribe a
progestogen separately.
If you have had your womb removed (a hysterectomy), discuss
with your doctor whether you can safely take this product
without a progestogen.

HRT and cancer

If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take
Progynova’ 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 in breathing
for more information, see ‘Blood clots in a vein (thrombosis)’
Note: Progynova 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.

Stop taking Progynova and see a doctor
immediately

Compare
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).

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.
For women who have had their womb removed and who are
using oestrogen-only HRT for 5 years, little or no increase in
breast cancer risk is shown.
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

Breast cancer

Compare
In women who still have a womb 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, aged 50 to 65, who still have a womb and who
take oestrogen-only HRT, between 10 and 60 women in 1000
will be diagnosed with endometrial cancer (i.e. between 5
and 55 extra cases), depending on the dose and how long it
is taken.

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.

Packaging Technology Berlin pewi
client: 0086
itemno.: 81645876
name: LF-Progynova 2MG SCT 28
colors: Black
version: 17.05.2013/01

approval:

page 1
PZ: 2599F-4

Bayer Pharma AG
code-no.: 1417
country: GB BPH

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, and 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 >30 kg/m2)

Effects of HRT on heart or circulation

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).

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.

Ovarian cancer

Regularly check your breasts. See your doctor 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

81645876_01.indd 2

5/17/2013 8:07:41 AM

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.

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 oestrogenprogestogen HRT are slightly more likely to develop heart
disease than those not taking any HRT.
For women who have had their womb removed and are
taking oestrogen-only therapy there is no increased risk of
developing a heart disease.

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 oestrogenprogestogen HRT, for over 5 years, there will be 9 – 12 cases
in 1000 (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed
and have been taking oestrogen-only HRT for over 5 years,
there will be 5 to 8 cases in 1000 users (i.e. 1 extra case)

term treatment with a medicine used to prevent blood
clots
 any of your close relatives has ever a had 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 Progynova and see a
doctor immediately”.

 you have any blood clotting problem that needs long-

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 tendency to develop blotchy brown
patches (chloasma) on the face you should avoid
exposure to the sun or ultraviolet light whilst using
Progynova.

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).

Compare

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:
 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.

Progynova contains lactose (a type of sugar). If you have an
intolerance to some sugars, check with your doctor before
taking Progynova.

Important information about some of the
ingredients of Progynova

There is nothing to suggest that the use of Progynova affects
driving or use of machines.

Driving or using machines

Progynova is for use in post-menopausal women only. Do not
take if you are pregnant or breast-feeding.
If you become pregnant, stop taking Progynova immediately
and contact your doctor.

Pregnancy and breast-feeding

If you need a blood test, tell your doctor or the laboratory
staff that you are taking Progynova, because this medicine
can affect the results of some tests.

Laboratory tests

Some medicines may interfere with the effect of Progynova.
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, ritonavir and nelfinavir)
 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.

Using other medicines

terminal kidney insufficiency as the blood levels of
the active substances in Progynova will probably increase

 Your doctor will monitor you carefully if you have

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 Progynova tablet
the next day. Do not leave a break between your old tablets
and the Progynova tablets.

When to start

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 blue
section of the pack (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 memo
strip. 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 Progynova with or without
food. The tablet should be swallowed whole with a glass of
water or milk.
Your doctor may prescribe the hormone progestogen in
addition to Progynova for at least 12 - 14 days each month:
 if you still have your womb
 if you have a history of endometriosis

About the pack

Progynova is not for use in adolescents or children.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if
you think this dose is too strong or not strong enough.

3. HOW TO TAKE PROGYNOVA

If you are going to have surgery, tell the surgeon that you are
taking Progynova. You may need to stop taking Progynova
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 Progynova again.

If you need to have surgery

You may begin to feel the usual symptoms of 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 Progynova tablets.

If you stop taking Progynova

If you forget to take a tablet at your usual time and you are
less than 12 hours late, take it as soon as possible. Take the
next tablet at the usual time.
If you are more than 12 hours late, leave the forgotten tablet
in the pack. Continue to take the rest of the tablets at the
usual time every day. You may experience breakthrough
bleeding.

If you forget to take Progynova

If you have taken too many Progynova 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 take more Progynova than you should

If this is your first HRT treatment and you are still having
regular periods: start your Progynova tablets on the first
day of bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you
can start your Progynova tablets at any time if you are sure
you are not pregnant.

Other side effects that have been linked to the use of
Progynova and other oral hormone replacement therapies:
 During the first few months of treatment you may
experience some vaginal bleeding at unexpected times
(breakthrough bleeding and spotting). These symptoms
normally lessen with continued treatment. If they
don’t, contact your doctor (see 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)’ for more information)
 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, premenstrual symptoms, increased size of fibroids in the
womb, thrush, changes to the neck of the womb
 indigestion, a feeling of being bloated, passing wind,
feeling or being sick, abdominal pain, gall bladder disease

Like all medicines, Progynova 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.
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 legs or 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.

4. POSSIBLE SIDE EFFECTS

Keep out of the reach and sight of children.
Do not use Progynova 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.

5. HOW TO STORE PROGYNOVA

unusual hair loss or hair growth, increased skin pigment
especially on the face (chloasma – see section 2 ‘other
conditions’ for more information), some rare skin
problems
 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood
pressure, inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 changes in body weight and sex drive, increased appetite
 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions,
a worsening of glucose tolerance, bladder inflammation,
rare disorders (porphyria, chorea)
The following side effects have been reported with other
HRTs:
 various skin disorders:
 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema
multiforme)

 skin rashes or discolouration, itching, eczema, acne,

Packaging Technology Berlin pewi
client: 0086
itemno.: 81645876
name: LF-Progynova 2MG SCT 28
colors: Black
version: 17.05.2013/01

approval:

page 2
PZ: 2599F-4

Date of the last revision of this leaflet
May 2013

Bayer Pharma AG
code-no.: 1417
country: GB BPH

81645876

Manufacturer
Progynova 2 mg is made by:
Bayer Pharma AG, Berlin, Germany
or
Delpharm Lille SAS, Lys Lez Lannoy, France or
Bayer Weimar GmbH und Co. KG, 99427 Weimar, Germany.

Marketing Authorisation Holder
Bayer PLC
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA.

Progynova 2 mg tablets are pale blue sugar-coated tablets.
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.

What Progynova looks like and contents of the
pack

The active substance is estradiol valerate.
The other ingredients are lactose monohydrate, maize
starch, povidone 25,000, talc, magnesium stearate (E572),
sucrose, povidone 700,000, macrogol 6000, Calcium
carbonate (E170), titanium dioxide (E171), glycol 85% [E422],
montan glycol wax, carmine [E132], purified water.

What Progynova contains

6. FURTHER INFORMATION

Expand view ⇕

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.

Hide
(web4)