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PROGYNOVA TS 50

Active substance(s): ESTRADIOL

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Transcript
(Estradiol)

Package Booklet: Information for the user

Packaging Technology Berlin gbkop
page U 1
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / magenta
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

Enrico
Toense

09_01.indd cover:1

Digitally signed by Enrico Toense
DN: o=Bayer Group, ou=SignCert,
cn=Enrico Toense,
0.9.2342.19200300.100.1.1=shneb
Date: 2015.11.16 16:04:01 +01'00'

16.11.2015 15:58:56

Packaging Technology Berlin gbkop
page U 2
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / magenta
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

09_01.indd cover:2

16.11.2015 15:59:19

Packaging Technology Berlin gbkop
page U 3
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / magenta
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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85070509

Packaging Technology Berlin gbkop
page U 4
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / magenta
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Due to regulatory changes, the content of the
following Patient Information Leaflet may vary from
the one found in your medicine pack. Please compare
the ‘Leaflet prepared/revised date’ towards the end of
the leaflet to establish if there have been any
changes.
If you have any doubts or queries about your
medication, please contact your doctor or pharmacist.

1

Packaging Technology Berlin gbkop
page 1
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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2

Packaging Technology Berlin gbkop
page 2
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Package Booklet: Information for the user

Progynova TS 50
50 micrograms/24 hours transdermal patch
Estradiol

3

Packaging Technology Berlin gbkop
page 3
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Read all of this booklet carefully before you start
using this medicine because it contains important
information for you.
R Keep this booklet. You may need to read it again.
R If you have any further questions, ask your doctor
or pharmacist.
R 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.
R 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.

4

Packaging Technology Berlin gbkop
page 4
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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What is in this booklet
1. WHAT PROGYNOVA TS 50 IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE PROGYNOVA TS 50
Medical history and regular check-ups
Do not use Progynova TS 50
Warnings and precautions
HRT and Cancer
Effects of HRT on heart and circulation
Other conditions
Other medicines and Progynova TS 50
Laboratory tests
Pregnancy, breast-feeding and fertility
Driving or using machines

7
9
10
10
12
15
20
23
24
25
25
25

5

Packaging Technology Berlin gbkop
page 5
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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3. HOW TO USE PROGYNOVA TS 50
Applying the patch
If you have been taking other HRT
preparations
If you apply more Progynova TS 50 than
you should
If a patch falls off or if you forget to
apply Progynova TS 50
If you stop using Progynova TS 50
If you need to have surgery
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PROGYNOVA TS 50
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

26
26
27
28
28
29
29
30
37
38

6

Packaging Technology Berlin gbkop
page 6
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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1. WHAT PROGYNOVA TS 50 IS AND WHAT
IT IS USED FOR
Progynova TS 50 is a Hormone Replacement Therapy
(HRT). It contains the female hormone oestrogen.
Progynova TS 50 is used in postmenopausal women
with at least 12 months (1 year) since their last natural
period.
Progynova TS 50 is used for:
Relief of symptoms occuring after menopause
During the menopause, the amount of oestrogen
produced by a woman’s body drops. This can cause
symptoms such as hot face, neck and chest (“hot
flushes”). Progynova TS 50 alleviates these symptoms
after menopause. You will only be prescribed
Progynova TS 50 if your symptoms seriously hinder
your daily life.

7

Packaging Technology Berlin gbkop
page 7
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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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 Progynova TS 50 to prevent
osteoporosis after menopause.

8

Packaging Technology Berlin gbkop
page 8
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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2. WHAT YOU NEED TO KNOW BEFORE YOU
USE PROGYNOVA TS 50
Medical history and regular check-ups
R The use of HRT carries risks which need to be
considered when deciding whether to start using it,
or whether to carry on using it.
R 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.
R Before you start (or restart) Progynova TS 50, your
doctor will ask you 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.
R Once you have started on Progynova TS 50, you
should see your doctor for regular check- ups (at
9

Packaging Technology Berlin gbkop
page 9
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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least once a year). At these check-ups, discuss with
your doctor the benefits and risks of continuing
with Progynova TS 50.
R Your doctor may prescribe the hormone
progestogen in addition to Progynova TS 50 for
about 12 days each month:
R if you still have your womb
or
R if you have a history of endometriosis.
R Go for regular breast screening, as directed
by your doctor.
Do not use Progynova TS 50
If any of the following applies to you. If you are not
sure about any of the points below, talk to your
doctor before using Progynova TS 50
Do not use Progynova TS 50
R If you have or have ever had breast cancer, or if
you are suspected of having it
10

Packaging Technology Berlin gbkop
page 10
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R If you have a cancer which is sensitive to
oestrogens (such as cancer of the womb lining
(endometrium)), or if you are suspected of having it
R If you have any unexplained vaginal bleeding
R If you have excessive thickening of the womb
lining (endometrial hyperplasia) that has not been
treated
R If you have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep vein
thrombosis) or in the lungs (pulmonary embolism)
R If you have a blood clotting disorder (such as
protein C, protein S or antithrombin deficiency)
R If you have or recently have had a disease caused
by blood clots in the arteries such as a heart
attack, stroke or angina
R If you have or have ever had a liver disease and
your liver function tests have not yet returned to
normal
11

Packaging Technology Berlin gbkop
page 11
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R If you have a rare blood problem called
“porphyria” which is passed down in families
(inherited)
R If you are allergic (hypersensitive) to oestrogens
or any of the other ingredients in Progynova TS 50
(listed in section 6)
If any of the above conditions appear for the first
time while using Progynova TS 50, stop using it at
once and consult your doctor immediately.
Warnings and precautions
When to take special care with Progynova TS 50
Tell your doctor if you have ever had any of the
following problems, before you start treatment, as
these may return or become worse with
Progynova TS 50. If so, you should see your doctor
more often for check-ups:
R fibroids inside your womb

12

Packaging Technology Berlin gbkop
page 12
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R growth of womb lining outside your womb
(endometriosis) or a history of excessive growth of
the womb lining (endometrial hyperplasia)
R increased risk of developing blood clots (see ‘Blood
clots in a vein (thrombosis)’)
R increased risk of getting an oestrogen-sensitive
cancer (such as having a mother, sister or
grandmother who has had breast cancer)
R high blood pressure
R a liver disorder, such as benign liver tumour
R diabetes
R gallstones
R migraine or severe headaches
R a disease of the immune system that affects many
organs of the body (systemic lupus erythematosus,
SLE)
R epilepsy
R asthma
13

Packaging Technology Berlin gbkop
page 13
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R a disease affecting the eardrum and hearing
(otosclerosis)
R a very high level of fat in your blood (triglycerides)
R fluid retention due to cardiac or kidney problems
R if you suffer from hereditary angioedema
Stop using Progynova TS 50 and see your doctor
immediately
If you notice any of the following when using HRT:
R any of the conditions mentioned in the ‘Do not use
Progynova TS 50’ section
R yellowing of the skin or the whites of your eyes
(jaundice). These may be signs of liver disease
R a large rise in your blood pressure (symptoms may
be headache, tiredness, dizziness)
R migraine-like headaches which happen for the first
time
R if you become pregnant
14

Packaging Technology Berlin gbkop
page 14
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R if you notice signs of a blood clot, such as:
P painful swelling and redness of the legs
P sudden chest pain
P difficulty in breathing
For more information, see ‘Blood clots in a vein
(thrombosis)’
Note: Progynova TS 50 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)
Using oestrogen-only HRT will increase the risk of
excessive thickening of the lining of the womb
15

Packaging Technology Berlin gbkop
page 15
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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

16

Packaging Technology Berlin gbkop
page 16
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Unexpected bleeding
You will have a bleed once a month (so-called
withdrawal bleed) while using Progynova TS 50. But, if
you have unexpected bleeding or drops of blood
(spotting) besides your monthly bleeds, which:
R carries on for more than the first 6 months
R starts after you have been using Progynova TS 50
more than 6 months
R carries on after you have stopped using
Progynova TS 50
see your doctor as soon as possible.
Breast cancer
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.
17

Packaging Technology Berlin gbkop
page 17
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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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.
Compare
Women aged 50 to 79 who are not taking HRT, on
average, 9 to 17 in 1000 will be diagnosed with
breast cancer over a 5-year period. For women aged
50 to 79 who are taking oestrogen- progestogen HRT
over 5 years, there will be 13 to 23 cases in 1000
users (i.e. an extra 4 to 6 cases).
R Regularly check your breasts. See your doctor if
you notice any changes such as:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or feel
Additionally, you are advised to join mammography
screening programs when offered to you. For
mammogram screening, it is important that you
18

Packaging Technology Berlin gbkop
page 18
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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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 is rare. A slightly increased risk of
ovarian cancer has been reported in women taking HRT
for at least 5 to 10 years.
Compare
In 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).

19

Packaging Technology Berlin gbkop
page 19
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Effects of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to
3-times higher in HRT users than in non-users,
especially during the first year of using it.
Blood clots can be serious and if one travels to the
lungs, it can cause chest pain, breathlessness, fainting
or even death.
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
applies to you:
R you are unable to walk for a long time because of
major surgery, injury or illness (see also section 3 ‘If
you need to have surgery’)
R you are seriously overweight (BMI >30 kg/m²)
R you have any blood clotting problem that needs
long term treatment with a medicine used to
prevent blood clots
20

Packaging Technology Berlin gbkop
page 20
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R if any of your close relatives has ever had a blood
clot in the leg, lung or any other organ
R you have systemic lupus erythematosus (SLE)
R you have cancer
For signs of a blood clot, see “Stop using
Progynova TS 50 and see your 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 have been taking
oestrogen-progestogen HRT for over 5 years, there
will be 9 to 12 cases in 1000 users (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).
21

Packaging Technology Berlin gbkop
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
attack.
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 heart disease.
Stroke
The risk of having a stroke is about 1.5-times higher in
HRT users than in non-users. The number of extra
cases of stroke due to use of HRT will increase with
age.

22

Packaging Technology Berlin gbkop
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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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).
Other conditions
R 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.
R 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 TS 50.
R Women with hereditary angioedema who take
Progynova TS 50 may experience a return or a
worsening of their symptoms.
23

Packaging Technology Berlin gbkop
page 23
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R Your doctor will monitor you carefully if you have
heart or kidney problems.
Other medicines and Progynova TS 50
Some medicines may interfere with the effect of
Progynova TS 50. This might lead to irregular bleeding.
This applies to the following medicines.
R Medicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepine)
R Medicines for tuberculosis (such as rifampicin,
rifabutin)
R Medicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelfinavir)
R Herbal remedies containing St. John’s wort
(Hypericum perforatum)
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.
24

Packaging Technology Berlin gbkop
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are using Progynova TS 50,
because this medicine can affect the results of some
tests.
Pregnancy, breast-feeding and fertility
Progynova TS 50 is for use in post-menopausal women
only.
If you become pregnant, stop using Progynova TS 50
and contact your doctor.
Driving or using machines
There is nothing to suggest that the use of
Progynova TS 50 affects driving or the use of machines.

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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3. HOW TO USE PROGYNOVA TS 50
Always apply Progynova TS 50 exactly as your doctor
has told you. Check with your doctor or pharmacist if
you are not sure. Your doctor will tell you how long you
should apply Progynova TS 50 for and whether you
should have a gap week (no patch for 7 days).
Do not start using Progynova TS 50 until at least
twelve months after your last natural period.
Applying the patch
Remove the protective liner from the patch. Place the
patch, sticky side down, on a clean, dry area of the skin
of your lower abdomen or buttocks. Do not apply
Progynova TS 50 patches to the breasts. Apply the
patch to a different site every time. Never apply the
patch to the same place twice in a row. Do not choose
an area that is oily, damaged or irritated. Avoid the
waistline since tight clothing may rub the patch off.
Apply the patch immediately after opening the pouch
and removing the protective liner. Press the patch
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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firmly in place with the palm of the hand for about
10 seconds, making sure there is good contact,
especially around the edges. Change the patch once a
week. If the patch is applied correctly, you can bath or
shower as usual. However, the patch might come off in
very hot bath water or in the sauna.
If you have been taking other HRT preparations:
carry on until you have finished your current pack and
have taken all the treatment for that month. Start with
the first Progynova TS 50 patch the next day. Do not
leave a break between your old tablets and
Progynova TS 50.
If you have been using HRT treatment with a gap week:
start Progynova TS 50 immediately after the gap days.
If this is your first HRT treatment: you can start using
Progynova TS 50 any day.
Continuous use: Apply 1 patch per week. Remove this
patch after 7 days and apply a fresh patch to a
different site on your body.
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Cyclical use (includes a gap week): Apply 1 patch per
week for 3 weeks. Take a 7-day break and then start
again with the next patch.
You will have a bleed once a month (so-called
withdrawal bleed) while using Progynova TS 50.
If you apply more Progynova TS 50 than you should
Only apply one patch at a time. If you apply more by
mistake you may feel sick, throw up or have some
menstruation-like bleeding. If this happens remove the
patches. No specific treatment is necessary but you
should consult your doctor or pharmacist if you are
concerned.
If a patch falls off or if you forget to apply
Progynova TS 50
If a patch falls off before 7 days are up, it may be
reapplied. If necessary, you can apply a new patch for
the rest of the 7 days. If you forget to replace the patch
for several days you might have breakthrough bleeding
and spotting.
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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If you stop using Progynova TS 50
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 are
considering stopping your Progynova TS 50 treatment.
If you need to have surgery
If you are going to have surgery, tell the surgeon that
you are using Progynova TS 50. You may need to stop
using Progynova TS 50 about 4 to 6 weeks before the
operation to reduce the risk of a blood clot (see
section 2, ‘Blood clots in a vein’). Ask your doctor when
you can start using Progynova TS 50 again.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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Packaging Technology Berlin gbkop
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Progynova TS 50 can cause side
effects, although not everybody gets them.
The following diseases have been reported more often
in women using HRT compared to women not using
HRT:
R breast cancer
R abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer)
R ovarian cancer
R blood clots in the veins of the legs or lungs (venous
thromboembolism)
R heart disease
R stroke
R probable loss of memory if HRT is started over the
age of 65

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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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 Progynova TS 50:
Most frequent side effects:
R breakthrough bleeding at unexpected times (see
also section 2 ‘HRT and cancer’)
R breast tenderness
R breast pain
These side effects occur during the first few months of
treatment with Progynova TS 50. They are usually
temporary and normally disappear with continued
treatment. If they do not, contact your doctor.
Common side effects (may affect between 1 and 10 in
every 100 patients):
R depression, dizziness, nervousness, lack of energy,
increased sweating, hot flushes
R headache
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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wind, nausea
itching or rash at the site of application
fluid retention, weight gain
irregularities in your menstrual period, changes in
vaginal discharge
R generalized pain
Uncommon side effects (may affect between 1 and 10
in every 1000 patients):
R increase in blood cholesterol
R anxiety, inability to sleep, apathy, mood swings,
poor concentration, extreme feelings of euphoria,
tremor, agitation, altered sex drive
R pins and needles
R migraine
R visual disturbance, dry eye
R palpitations
R
R
R
R

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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R superficial inflammation of the veins (phlebitis),
high blood pressure
R breathlessness, runny or blocked nose
R increased appetite, constipation, indigestion,
diarrhoea, rectal disorder
R unusual bleeding or bruising under the skin
(purpura)
R acne, hair loss, dry skin, nail problems, small skin
swellings, excessive hair growth
R joint pain, muscle cramps
R increased and frequent urge to pass urine, urinary
incontinence, bladder infections (cystitis),
discoloured urine, blood in the urine
R benign growths in the lining of the womb,
thickening of the lining of the womb, problems
with the womb, swollen breasts, tender breasts
R tiredness, irregular blood tests, high temperature,
lack of energy, feeling generally unwell
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Additional side effects reported by healthcare
professionals:
R reduced oxygen flow to the brain or to a section of
the brain (see Section 2 ‘Stroke’)
R abdominal pain, bloating, yellowing of the skin or
eyes (jaundice)
R contact dermatitis
R fibroids
The following side effects have been reported with
other HRTs:
R gall bladder disease
R a variety of skin disorders:
P discoloration of the skin especially of the face
and neck known as “Pregnancy patches”
(chloasma)
P painful reddish skin nodules (erythema
nodosum)
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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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P rash with target-shaped reddening or sores
(erythema multiforme)
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
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

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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5. HOW TO STORE PROGYNOVA TS 50
Store your patches in the original packaging to protect
from moisture. Store below 30 °C.
Keep this medicine out of the sight and reach of
children.
Do not use Progynova TS 50 after the expiry date which
is stated on the label after “EXP”. The expiry date refers
to the last day of that month.
After use the patch still contains the active ingredient,
which may have harmful effects on the environment.
Therefore, the used patch should be discarded
carefully. Fold any used or unused patches in half,
sticky side together, and dispose of them in household
rubbish. 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 protect the environment.

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Progynova TS 50 contains
Progynova TS 50 is a hormone patch. The active
substance is estradiol hemihydrate.
Each 12.5 cm2 patch contains 3.8 mg estradiol (from
3.9 mg estradiol hemihydrate), releasing
50 micrograms of estradiol per 24 hours.
The other ingredients are isooctyl acrylate,
acrylamide, vinyl acetate copolymer, ethyl oleate,
isopropyl myristate and glycerol monolaurate on a
polyester release liner protected by a backing film.
What Progynova TS 50 looks like and contents of
the pack
Progynova TS 50 patches are oval translucent patches.
They are supplied in packs of 4 or 12 patches each.

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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Marketing Authorisation Holder
Bayer PLC
Bayer House
Strawberry Hill
Newbury Berkshire
RG14 1JA
Manufacturer
Progynova TS 50 is made by: 3M Drug Delivery
Systems, Northridge, California, USA. Batch release in
the EU by Bayer Weimar GmbH and Co. KG, 99427
Weimar, Germany.
This leaflet was last revised in October 2015

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Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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85070509

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page 40
Bayer Pharma AG
client: JS86
material-no.: 85070509
PZ: 2600A-4A
code-no.: 13
name: LF-BRO-Progynova TS 50 PA GB
country: GB/-/BPH
colors: Black / Pantone 2583 C
version: 16.11.2015/01
approval:
dimension: 75 x 76 mm

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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.

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