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DUOVA 2MG/5MG TABLETS

Active substance(s): ESTRADIOL VALERATE / MEDROXYPROGESTERONE ACETATE

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®

Indivina 1mg/2.5mg Tablets, Indivina 1mg/5mg Tablets,
Indivina 2mg/5mg Tablets
®

Ref: 100012/220316/1/F

®

(estradiol valerate / medroxyprogesterone acetate)
Patient Information 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.
Your medicine is called Indivina 1mg/2.5mg Tablets, Indivina 1mg/5mg
Tablets, Indivina 2mg/5mg Tablets but will be referred to as Indivina
throughout this leaflet.
What is in this leaflet
1

What Indivina is and what it is used for

2

What you need to know before you take Indivina

3

How to take Indivina

4

Possible side effects

5

How to store Indivina

6

Contents of the pack and other information

1

What Indivina is and what it is used for

Indivina is a Hormone Replacement Therapy (HRT). It contains two types of
female hormones, an oestrogen and progestogen. Indivina is used in
menopausal women with at least three years since their last natural period.
Indivina is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face, neck and
chest (“hot flushes”). Indivina alleviates these symptoms after menopause.
You will only be prescribed Indivina 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 Indivina to prevent
osteoporosis after menopause.

2

What you need to know before you take Indivina

Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited. If you have a premature menopause the
risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and
your family’s medical history. Your doctor may decide to perform a physical
examination. This may include an examination of your breasts and/or an
internal examination, if necessary.
Once you have started on Indivina 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 Indivina.
Go for regular breast screening as recommended by your doctor.
Do not take Indivina:
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 Indivina.
Do not take Indivina
* 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 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
medroxyprogesterone acetate or any of the other ingredients of Indivina
(listed in section 6).
If any of the above conditions appear for the first time while taking Indivina,
stop using it at once and consult your doctor immediately.
Warnings and precautions
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 Indivina. 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 having a
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
* hereditary angioedema
Stop taking Indivina 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 Indivina” 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: Indivina 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 womb
lining (endometrial cancer).
The progestogen in Indivina 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 Indivina. However, if the irregular bleeding:
* carries on for more than the first 6 months
* starts after you have been taking Indivina for more than 6 months
* carries on after you have stopped taking Indivina
see your doctor as soon as possible.
Breast cancer
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.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000
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 1,000 users (i.e. an extra 4 to 6 cases).
* Regularly check your breasts. See your doctor if you notice any
changes such as:
* dimpling of the skin
* changes in the nipple
* 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
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.
Women aged 50 to 69 who are not taking HRT, on average about 2 women
in 1,000 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 1,000 users (i.e. up to 1 extra case).
Effect 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 taking 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:
* 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)
* you are seriously overweight (BMI > 30 kg/m2)
* you have any blood clotting problem that needs long-term treatment with a
medicine used to prevent blood clots
* if any of your close relatives has ever had a blood clot in the leg, lung or
another organ
* you have systemic lupus erythematosus (SLE)
* you have cancer.
For signs of a blood clot, see “Stop taking Indivina 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 1,000 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 1,000 users (i.e. an extra 5
cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
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.
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 use of HRT will
increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in
1,000 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 1,000 users, over
5 years (i.e. an extra 3 cases).
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 are taking thyroid hormone replacement therapy (e.g. thyroxine),
your doctor may monitor your thyroid function more often when you start
treatment.
* If you have or have had cholasma (yellowish-brown pigmentation patches
on the skin, particularly of the face); if so, minimize your exposure to the
sun or ultraviolet radiation whilst using Indivina.
Other medicines and Indivina
Some medicines may interfere with the effect of Indivina. This might lead to
irregular bleeding. This applies to the following medicines:
* Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepin)
* 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).

Indivina 1mg/2.5mg Tablets, Indivina 1mg/5mg Tablets,
Indivina 2mg/5mg Tablets
®

®

Ref: 100012/220316/1/B

®

(estradiol valerate / medroxyprogesterone acetate)
Patient Information Leaflet (continued)
Tell your doctor or pharmacist if you are taking, have recently taken or might
take 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 Indivina, because this medicine can affect the results of some tests.
Indivina with food and drink
Indivina can be swallowed with a glass of water at the same time each day.
Pregnancy and breast-feeding
Indivina is for use in postmenopausal women only. If you become pregnant,
stop taking Indivina and contact your doctor.
Driving and using machines
Indivina has no influence on your ability to drive or use machines.
Indivina contains lactose
If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.

3

How to take Indivina

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. 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.
Take one Indivina tablet every day, preferably at about the same time each
day. Calendar days are printed on the blister sheet to help you follow your
daily tablet intake. Swallow the tablet whole with a drink if necessary. You
will normally start on the lowest dose of Indivina and this will be increased, if
necessary. Your doctor should aim to prescribe the lowest dose for the
shortest time that gives you relief from your symptoms. Talk to your doctor if
your symptoms are not better after three months. If you feel that the effect of
Indivina is too strong or too weak, do not change the dose or stop taking the
tablets yourself, but ask your doctor for advice.
If you are not having periods and you have not previously taken HRT or you
are changing from another continuous combined HRT product, treatment
with Indivina may be started on any day.
If you switch from a cyclic HRT regimen, start Indivina treatment one week
after taking the last tablet of the cyclic HRT. Talk to your doctor or pharmacist if you are unsure.
Whilst taking this medicine
When you first start taking Indivina you may get some bleeding at odd times
for a few months (Please also refer to the section above on Endometrial
cancer). However, if this is still happening after a few months or if you
experience heavy bleeding tell your doctor.
If you take more Indivina than you should
If you or somebody else has taken too many Indivina tablets, talk to your
doctor or pharmacist. An overdose of Indivina could make you feel sick, or
make you get a headache or uterine bleeding.
If you forget to take Indivina
It is best to take the tablet at the same time each day. If you forget to take a
tablet leave the forgotten tablet. You should then continue by taking the next
tablet at your usual time. Missing a tablet or irregular use of Indivina tablets
may cause breakthrough bleeding or spotting.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
If you stop taking Indivina
If you want to stop taking Indivina, talk to your doctor first. He/she will
explain the effects of stopping treatment and discuss other possibilities with
you.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Indivina.
You may need to stop using Indivina 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 Indivina again.

4

Uncommon side effects (may affect up to 1 in 100 people):
* benign breast tumor, benign growths in the lining of the womb
* allergic (hypersensitivity) reaction
* increased appetite, high level of cholesterol in the blood
* anxiety, inability to sleep, apathy, mood swings, poor concentration,
changes in sex drive or mood, euphoria, agitation
* migraine, sensation of tingling, prickling or numbness in skin, trembling
* visual impairment, dry eye
* feeling your heartbeat
* increased blood pressure, inflammation of a vein, purple patches like
bruising
* breathlessness, runny or blocked nose
* constipation, indigestion/heartburn, diarrhea, rectal disorder
* acne, hair loss, dry skin, nail problems, skin nodule, excessive hair growth
(hirsutism), painful reddish skin nodules (erythema nodosum), generalized
itchy rash
* joint disorders, muscle cramps
* increased frequency or urge to pass urine, lack of bladder control, bladder
infections, discoloured urine, blood in the urine
* breast enlargement, breast tenderness, thickening of the lining of the
womb, uterine disorder
* tiredness, abnormal laboratory tests, weakness, fever, flu-like symptoms,
feeling generally unwell.
Rare side effects (may affect up to 1 in 1,000 people):
* contact lens intolerance
* alterations in liver function and biliary flow
* skin rash
* blood clot, usually in a leg or lung, which causes pain, swelling or redness
* menstrual pain, pre-menstrual like syndrome
Frequency not known side effects (frequency cannot be estimated from
the available data)
* tumours in uterus
* worsening of the symptoms of hereditary angioedema
* reduced blood supply to the brain or to a section of the brain
* stomach pain, bloating, yellowing of the skin or eyes
* eczema
The following side effects have been reported with other HRTs:
* heart disease (heart attack)
* gall bladder disease
* inflammation of pancreas (pancreatitis)
* skin disorders:
- yellowish-brown pigmentation patches on the skin, particularly of the face
(chloasma)
- rash with target-shaped reddening or sores (erythema multiforme).
* Probable memory loss over the age of 65
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 via the national reporting system, see 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
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5

*
*
*
*

*

How to store

Do not store above 25ºC.
Store in the original package in order to protect from moisture.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not use this medicine after the expiry date shown on the carton label or
blister strip. Only keep this medicine if your doctor tells you to. If your
tablets become discoloured or show any any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do.
Medicines should not be disposed via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

Possible side effects

Like all medicines, this medicine can cause side effects although not
everybody gets them, particularly early on (in the first few months of
treatment), for example irregular bleeding may occur. These often disappear
with continued treatment.
There are a number of situations in which you may have to stop taking
Indivina. Tell your doctor immediately if you develop any of the following conditions:
* develop signs of jaundice (yellowing of the skin or the whites of the eyes)
* experience a migraine type headache for the first time
* become pregnant
* experience a significant increase in your blood pressure
The following diseases are reported more often in women using HRT
compared to women not using HRT:
* 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.
The following is a list of side effects that have been linked to the use of HRT:
Common side effects (may affect up to 1 in 10 people):
* weight increase or decrease, swelling caused by fluid retention
* depression, nervousness, lack of energy
* headache, dizziness
* hot flushes, increased sweating
* feeling sick,vomiting, stomach cramps, gas
* breast tension and pain, vaginal discharge, bleeding or spotting, disorder
of vulva/vagina, menstrual disorder.

6

Contents of the pack and other information

What Indivina contains:
Indivina 1mg/2.5mg tablets contain 1mg estradiol valerate and 2.5mg
medroxyprogesterone acetate.
Indivina 1mg/5mg tablets contain 1mg estradiol valerate and 5mg
medroxyprogesterone acetate.
Indivina 2mg/5mg tablets contain 2mg estradiol valerate and 5mg
medroxyprogesterone acetate.
The tablets also contain lactose monohydrate, maize starch, gelatine,
magnesium stearate
What Indivina looks like and contents of the pack
Indivina 1mg/2.5mg tablets are white, round, flat tablets embossed with "1 +
2.5" on one side and plain on the other.
Indivina 1mg/5mg tablets are white, round, flat tablets embossed with "1 + 5"
on one side and plain on the other.
Indivina 2mg/5mg tablets are white, round, flat tablets embossed with "2 + 5"
on one side and plain on the other.
The tablets will be referred to as Indivina throughout this leaflet. All 3
strengths are available in packs of 28 tablets or 3 x 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Orion Corporation, Tengstrominkatu 6-8,
20360 Turku, Finland and is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1000 Indivina 1mg/2.5mg Tablets
PL 15184/1001 Indivina 1mg/5mg Tablets
PL 15184/1002 Indivina 2mg/5mg Tablets

Indivina is a registered trademark of Orion Corporation.
Revision date: 22/03/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Duova 1mg/2.5mg Tablets, Duova 1mg/5mg Tablets,
Duova 2mg/5mg Tablets
®

®

Ref: 100012/220316/1/F

®

(estradiol valerate / medroxyprogesterone acetate)
Patient Information 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.
Your medicine is called Duova 1mg/2.5mg Tablets, Duova 1mg/5mg Tablets,
Duova 2mg/5mg Tablets but will be referred to as Duova throughout this
leaflet.
What is in this leaflet
1

What Duova is and what it is used for

2

What you need to know before you take Duova

3

How to take Duova

4

Possible side effects

5

How to store Duova

6

Contents of the pack and other information

1

What Duova is and what it is used for

Duova is a Hormone Replacement Therapy (HRT). It contains two types of
female hormones, an oestrogen and progestogen. Duova is used in
menopausal women with at least three years since their last natural period.
Duova is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face, neck and
chest (“hot flushes”). Duova alleviates these symptoms after menopause.
You will only be prescribed Duova 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 Duova to prevent
osteoporosis after menopause.

2

What you need to know before you take Duova

Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited. If you have a premature menopause the
risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own and
your family’s medical history. Your doctor may decide to perform a physical
examination. This may include an examination of your breasts and/or an
internal examination, if necessary.
Once you have started on Duova 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 Duova.
Go for regular breast screening as recommended by your doctor.
Do not take Duova:
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 Duova.
Do not take Duova
* 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 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
medroxyprogesterone acetate or any of the other ingredients of Duova
(listed in section 6).

* 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: Indivina 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 womb lining (endometrial cancer).
The progestogen in Indivina 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 Indivina. However, if the irregular bleeding:
* carries on for more than the first 6 months
* starts after you have been taking Indivina for more than 6 months
* carries on after you have stopped taking Indivina
see your doctor as soon as possible.
Breast cancer
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.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000
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 1,000 users (i.e. an extra 4 to 6 cases).
* Regularly check your breasts. See your doctor if you notice any
changes such as:
* dimpling of the skin
* changes in the nipple
* 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
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.
Women aged 50 to 69 who are not taking HRT, on average about 2 women
in 1,000 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 1,000 users (i.e. up to 1 extra case).
Effect 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 taking 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:
* 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)
* you are seriously overweight (BMI > 30 kg/m2)
* you have any blood clotting problem that needs long-term treatment with a
medicine used to prevent blood clots
* if any of your close relatives has ever had a blood clot in the leg, lung or
another organ
* you have systemic lupus erythematosus (SLE)
* you have cancer.
For signs of a blood clot, see “Stop taking Indivina 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 1,000 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 1,000 users (i.e. an extra 5
cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.

If any of the above conditions appear for the first time while taking Duova,
stop using it at once and consult your doctor immediately.

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.

Warnings and precautions
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 Duova. 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 having a
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
* hereditary angioedema

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 use of HRT will
increase with age.

Stop taking Duova 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 Duova” 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)

Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in
1,000 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 1,000 users, over
5 years (i.e. an extra 3 cases).
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 are taking thyroid hormone replacement therapy (e.g. thyroxine),
your doctor may monitor your thyroid function more often when you start
treatment.
* If you have or have had cholasma (yellowish-brown pigmentation patches
on the skin, particularly of the face); if so, minimize your exposure to the
sun or ultraviolet radiation whilst using Indivina.
Other medicines and Indivina
Some medicines may interfere with the effect of Indivina. This might lead to
irregular bleeding. This applies to the following medicines:
* Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepin)
* 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).

®

Duova 1mg/2.5mg Tablets, Duova 1mg/5mg Tablets,
Duova 2mg/5mg Tablets
®

Ref: 100012/220316/1/B

®

(estradiol valerate / medroxyprogesterone acetate)
Patient Information Leaflet (continued)
Tell your doctor or pharmacist if you are taking, have recently taken or might
take 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 Duova, because this medicine can affect the results of some tests.
Duova with food and drink
Duova can be swallowed with a glass of water at the same time each day.
Pregnancy and breast-feeding
Duova is for use in postmenopausal women only. If you become pregnant,
stop taking Duova and contact your doctor.
Driving and using machines
Duova has no influence on your ability to drive or use machines.
Duova contains lactose
If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this medicinal product.

3

How to take Duova

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. 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.
Take one Duova tablet every day, preferably at about the same time each
day. Calendar days are printed on the blister sheet to help you follow your
daily tablet intake. Swallow the tablet whole with a drink if necessary. You
will normally start on the lowest dose of Duova and this will be increased, if
necessary. Your doctor should aim to prescribe the lowest dose for the
shortest time that gives you relief from your symptoms. Talk to your doctor if
your symptoms are not better after three months. If you feel that the effect of
Duova is too strong or too weak, do not change the dose or stop taking the
tablets yourself, but ask your doctor for advice.
If you are not having periods and you have not previously taken HRT or you
are changing from another continuous combined HRT product, treatment
with Duova may be started on any day.
If you switch from a cyclic HRT regimen, start Duova treatment one week
after taking the last tablet of the cyclic HRT. Talk to your doctor or pharmacist if you are unsure.
Whilst taking this medicine
When you first start taking Duova you may get some bleeding at odd times
for a few months (Please also refer to the section above on Endometrial
cancer). However, if this is still happening after a few months or if you
experience heavy bleeding tell your doctor.
If you take more Duova than you should
If you or somebody else has taken too many Duova tablets, talk to your doctor or pharmacist. An overdose of Duova could make you feel sick, or make
you get a headache or uterine bleeding.
If you forget to take Duova
It is best to take the tablet at the same time each day. If you forget to take a
tablet leave the forgotten tablet. You should then continue by taking the next
tablet at your usual time. Missing a tablet or irregular use of Duova tablets
may cause breakthrough bleeding or spotting.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
If you stop taking Duova
If you want to stop taking Duova, talk to your doctor first. He/she will explain
the effects of stopping treatment and discuss other possibilities with you.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Duova.
You may need to stop using Duova 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 Duova again.

Uncommon side effects (may affect up to 1 in 100 people):
* benign breast tumor, benign growths in the lining of the womb
* allergic (hypersensitivity) reaction
* increased appetite, high level of cholesterol in the blood
* anxiety, inability to sleep, apathy, mood swings, poor concentration,
changes in sex drive or mood, euphoria, agitation
* migraine, sensation of tingling, prickling or numbness in skin, trembling
* visual impairment, dry eye
* feeling your heartbeat
* increased blood pressure, inflammation of a vein, purple patches like
bruising
* breathlessness, runny or blocked nose
* constipation, indigestion/heartburn, diarrhea, rectal disorder
* acne, hair loss, dry skin, nail problems, skin nodule, excessive hair growth
(hirsutism), painful reddish skin nodules (erythema nodosum), generalized
itchy rash
* joint disorders, muscle cramps
* increased frequency or urge to pass urine, lack of bladder control, bladder
infections, discoloured urine, blood in the urine
* breast enlargement, breast tenderness, thickening of the lining of the
womb, uterine disorder
* tiredness, abnormal laboratory tests, weakness, fever, flu-like symptoms,
feeling generally unwell.
Rare side effects (may affect up to 1 in 1,000 people):
* contact lens intolerance
* alterations in liver function and biliary flow
* skin rash
* blood clot, usually in a leg or lung, which causes pain, swelling or redness
* menstrual pain, pre-menstrual like syndrome
Frequency not known side effects (frequency cannot be estimated from
the available data)
* tumours in uterus
* worsening of the symptoms of hereditary angioedema
* reduced blood supply to the brain or to a section of the brain
* stomach pain, bloating, yellowing of the skin or eyes
* eczema
The following side effects have been reported with other HRTs:
* heart disease (heart attack)
* gall bladder disease
* inflammation of pancreas (pancreatitis)
* skin disorders:
- yellowish-brown pigmentation patches on the skin, particularly of the face
(chloasma)
- rash with target-shaped reddening or sores (erythema multiforme).
* Probable memory loss over the age of 65
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 via the national reporting system, see 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
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
5

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*
*
*

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4

Possible side effects

Like all medicines, this medicine can cause side effects although not
everybody gets them, particularly early on (in the first few months of
treatment), for example irregular bleeding may occur. These often disappear
with continued treatment.
There are a number of situations in which you may have to stop taking
Duova. Tell your doctor immediately if you develop any of the following conditions:
* develop signs of jaundice (yellowing of the skin or the whites of the eyes)
* experience a migraine type headache for the first time
* become pregnant
* experience a significant increase in your blood pressure
The following diseases are reported more often in women using HRT
compared to women not using HRT:
* 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.
The following is a list of side effects that have been linked to the use of HRT:
Common side effects (may affect up to 1 in 10 people):
* weight increase or decrease, swelling caused by fluid retention
* depression, nervousness, lack of energy
* headache, dizziness
* hot flushes, increased sweating
* feeling sick,vomiting, stomach cramps, gas
* breast tension and pain, vaginal discharge, bleeding or spotting, disorder
of vulva/vagina, menstrual disorder.

How to store

Do not store above 25ºC.
Store in the original package in order to protect from moisture.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not use this medicine after the expiry date shown on the carton label or
blister strip. Only keep this medicine if your doctor tells you to. If your
tablets become discoloured or show any any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do.
Medicines should not be disposed via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Duova contains:
Duova 1mg/2.5mg tablets contain 1mg estradiol valerate and 2.5mg
medroxyprogesterone acetate.
Duova 1mg/5mg tablets contain 1mg estradiol valerate and 5mg
medroxyprogesterone acetate.
Duova 2mg/5mg tablets contain 2mg estradiol valerate and 5mg
medroxyprogesterone acetate.
The tablets also contain lactose monohydrate, maize starch, gelatine,
magnesium stearate
What Duova looks like and contents of the pack
Duova 1mg/2.5mg tablets are white, round, flat tablets embossed with "1 +
2.5" on one side and plain on the other.
Duova 1mg/5mg tablets are white, round, flat tablets embossed with "1 + 5"
on one side and plain on the other.
Duova 2mg/5mg tablets are white, round, flat tablets embossed with "2 + 5"
on one side and plain on the other.
The tablets will be referred to as Duova throughout this leaflet. All 3
strengths are available in packs of 28 tablets or 3 x 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Orion Corporation, Tengstrominkatu 6-8,
20360 Turku, Finland and is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1000 Duova 1mg/2.5mg Tablets
PL 15184/1001 Duova 1mg/5mg Tablets
PL 15184/1002 Duova 2mg/5mg Tablets

Duova is a registered trademark of Orion Corporation.
Revision date: 22/03/16

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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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