Skip to Content

MERIMONO 1MG FILM-COATED TABLETS

Active substance(s): ESTRADIOL VALERATE

View full screen / Print PDF » Download PDF ⇩
Transcript
500870/PL1c

Climaval® 1 mg Film-Coated Tablets
(estradiol valerate)
Patient Information Leaflet
®
The name of your medicine is Climaval 1 mg Film-Coated
Tablets. Throughout this leaflet it will be referred to as
®
Climaval . Another strength is available.
Read all of this leaflet carefully, before you start
taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
®
1) What Climaval is and what it is used for
®
2) What you need to know before you take Climaval
®
3) How to use Climaval
4) Possible side effects
®
5) How to store Climaval
6) Content of the pack and other information
®

1) WHAT CLIMAVAL IS AND WHAT IT IS USED FOR
®
Climaval is a Hormone Replacement Therapy (HRT). It
contains the female hormone oestrogen.
Estradiol valerate is identical to the natural female hormone
oestrogen. This hormone is produced by the ovaries before
the menopause.

®

Stop taking Climaval 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
®
Climaval ’ 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, with or without disturbed vision. Headaches like
these can be an early sign of a stroke. If you have
already had a stroke, talk with your doctor about
whether the benefits of the treatment outweigh the
possibly increased risk.
• If you get pain in your chest that spreads to your arm
or neck. This pain may be a sign of heart disease.
• 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)’.
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).
Taking 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.

®

Climaval is used for:
Relief of symptoms occurring after menopause
Menopause occurs naturally in all women, usually between
the ages of 45 and 55 years. It occurs also in younger women
who have their ovaries removed by surgery. 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”), sleep problems,
irritability, and depression. Some women also have problems
with urine control or dryness of the vagina, which may cause
®
discomfort during or after sexual intercourse. Climaval
alleviates these symptoms after menopause. You will only be
®
prescribed Climaval if your symptoms seriously hinder your
daily life.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
®
CLIMAVAL
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) Climaval , 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. He/she should tell you what kind of
changes in the breast you should look out for and may advise
you to have a breast X-ray (a mammogram). Once you have
®
started on Climaval , 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
®
Climaval .
Go for regular breast screening, as recommended by your
doctor.

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.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal
®
bleed) while taking Climaval . But, if you have unexpected
bleeding or drops of blood (spotting) besides your monthly
bleeding, which:
• carries on for more than the first 6 months
®
• starts after you have been taking Climaval for more
than 6 months
®
• carries on after you have stopped taking Climaval
• if you have painful menstrual periods
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.
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 5year 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).

®

Do not take Climaval
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
®
Climaval ,
• 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 severe kidney disease;
• 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 any of the other ingredients of Climaval (listed in
section 6);
If any of the above conditions appear for the first time while
®
taking Climaval , stop taking it at once and consult your
doctor immediately.
®

When to take special care with Climaval
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 Climaval . 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 (liver
adenoma)
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many
organs of the body (Systemic lupus erythematosus,
SLE), an autoimmune disorder
• 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
• Hypothyroidism (a condition in which your thyroid
gland fails to produce enough thyroid hormone and for
which you are treated with thyroid hormone
replacement therapy)
• Hereditary angioedema or episodes of rapid swelling
of the hands, feet, face, lips, eyes, tongue, throat
(airway blockage) or digestive tract.

Regularly check your breasts. See your doctor if you
notice any changes such as:
• dimpling of the skin
• change in the nipple
• any lump you can see or feel
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 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).
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)
2
• you are seriously overweight (BMI >30 kg/m )
• you have any blood clotting problem that needs longterm 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 an other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
®

For signs of a blood clot, see “Stop taking Climaval and see
a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on
average, over a 5-year period, 4 to 7 in 1000 would be
expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogenprogestogen 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).
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 a heart disease.
Continued overleaf

Stroke
The risk of getting 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 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
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.
®

Other medicines and Climaval
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. Some medicines may interfere with
®
the effect of Climaval . 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, nelfinavir),
• herbal remedies containing St John’s wort
(Hypericum perforatum),
• other anti-infective medicines (such as ketoconazole,
erythromycin).

4) POSSIBLE SIDE EFFECTS
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.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some effects could be serious
These symptoms need immediate medical attention.
• Unexpected vaginal bleeding or spotting (breakthrough
®
bleeding) after taking Climaval for some time, or after
you stop treatment
• Painful menstrual periods
• Painful swelling and redness of the legs
• Sudden chest pain
• Difficulty in breathing
• Pain in your chest that spreads to your arm or neck
• Yellowing of the eyes and face (jaundice)
• Rapid increase in your blood pressure
• Unexplained migraine-like headaches
• Breast changes, including dimpling of the breast skin,
changes in the nipple, lumps that you can see or feel.
®

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

Stop taking Climaval and tell your doctor immediately if
you get any of the effects mentioned above. Check the risks
to be aware of with HRT in general in section 2, When to take
®
special care with Climaval .

Pregnancy and breast-feeding
®
Not applicable, because Climaval is only indicated in women
without a uterus.

Other side effects
In addition, the following side effects have been reported with
®
Climaval :
• Breast tension and pain, breast cancer.
• Discharge from the vagina.
• Headache, dizziness, vertigo, changes in sexual
desire, depression.
• Increased blood pressure, palpitations (sensation of
fluttering in the chest), fast heart beat or other heart
symptoms, tender or painful veins (signs of
thrombophlebitis), fluid retention, nose bleeds.
• Indigestion, wind, nausea, vomiting, abdominal pain
and bloating, problems with your gall bladder (biliary
stasis).
• General itching, hair loss, hives and skin rash.
• Glucose intolerance which can make you sweat or feel
faint after eating.
• Weight gain.
• Hypersensitivity reaction such as rash, itching, hives.

Driving and using machines
®
Climaval has no known effects on the ability to drive and use
machines.
®

Climaval contains lactose
Lactose is a form of sugar. If you have been told by your
doctor that you have an intolerance to some sugars, contact
®
your doctor before taking Climaval .
®

3) HOW TO TAKE CLIMAVAL
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. During
the treatment your doctor may adjust the dose according to
your individual needs.
When to start treatment
• If you are currently not taking any form of HRT
(patches or tablets), or if you have been taking a
continuous combined HRT product (where
oestrogen and the progestogen are given every day
®
without interruption), you can start to take Climaval on
any convenient day.
• If you are changing from a cyclic or sequential HRT
treatment (where the progestogen is added for 12–14
®
days of the cycle), you should start to take Climaval
on the day after you complete your previous cycle.
How to take Climaval

®

Take one tablet each day by following the sequence of
numbers and arrows on the calendar pack.
Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the
tablets correctly.
Write the name of the day you take your first tablet in the box
below. For example, if you start your tablets on a Wednesday,
then write “Wednesday” in the box. This day will also be the
day on which you will take tablets 8, 15 and 22. This will help
you check that you have taken each tablet on the right day.
Write your start day here:

When you finish one blister pack, start the new one the next
day whether or not you experience bleeding. This will
normally be the same day of the week as you started the
previous blister pack. Do not take a break between blister
packs unless your doctor tells you.
The tablets are best taken at the same time every day; try to
get into a routine.
Follow your doctor’s instructions as to how and when you
®
should take Climaval tablets and never change the dose
yourself, however well you feel.
If you are unsure about how much medicine to take or when
to take it, ask your doctor or pharmacist.

The following side effects have been reported with other
HRTs:
• Gall bladder disease
• Various skin disorders:
• discoloration of the skin especially of the face or neck
known as “pregnancy patches” (chloasma)
• painful reddish skin nodules (erythema nodosum),
• rash with target-shaped reddening or sores (erythema
multiforme)
• Decline in memory or mental ability
• Diarrhoea
• Migraine,
• Fibroids (benign growths in the uterus)
• Pain in extremity
• Dry eyes and contact lens discomfort
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
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
®

5) HOW TO STORE CLIMAVAL
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
• Do not store above 25°C.
• Store in the original package.
• If you notice any sign of deterioration of the tablets,
consult your pharmacist immediately.
• Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. This measure will
help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Climaval contains
• Each film-coated tablet contains 1 mg of estradiol
valerate (equivalent to 0.764 mg of estradiol).
• The other ingredients are lactose monohydrate, maize
starch, indigo carmine lake (E132), povidone (K30),
talc, magnesium stearate, hypromellose, propylene
glycol, sodium edetate and titanium dioxide.
®

What Climaval looks like and contents of the pack
®
• Climaval tablets are grey-blue tablets, embossed with
“OC” on one side and “CG” on the other.
®

®

How long to take Climaval
From time to time, you will need to discuss with your doctor
®
the possible risks and benefits associated with Climaval and
whether you still need the treatment. It is important that you
take the lowest possible effective dose and only as long as
needed.
®

If you take more Climaval than you should
Contact your doctor or pharmacist immediately if you have
®
taken too much Climaval .
®

If you forget to take Climaval
If you forget to take a tablet at your usual time, try to take it
within 12 hours. If this is not possible, leave the forgotten
tablet and continue to take the remaining tablets at the usual
time.

Climaval tablets are available in cartons of 84 tablets (3 x 28
calendar blisters).
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Novartis Pharma GmbH, 90327, Nuremburg,
Germany.
®

Climaval 1 mg Film-Coated Tablets
PL No: 18067/0302
POM
®

Climaval is a registered trademark of Novartis AG.
th

This leaflet was last revised: 17 August 2015.

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

If you stop taking Climaval
®
Stopping Climaval may increase the risk of breakthrough
bleeding or spotting. If this occurs after you stop treatment,
contact your doctor immediately. Your doctor will need to work
out the reasons for this.
After a long treatment break, consult your doctor before
®
starting to take Climaval again.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
500870/PL1c

5000000PL1c

®

Merimono 1 mg Film-Coated Tablets
(estradiol valerate)
Patient Information Leaflet
®
The name of your medicine is Merimono 1 mg Film-Coated
Tablets. Throughout this leaflet it will be referred to as
®
Merimono . Another strength is available.
Read all of this leaflet carefully, before you start
taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
®
1) What Merimono is and what it is used for
®
2) What you need to know before you take Merimono
®
3) How to use Merimono
4) Possible side effects
®
5) How to store Merimono
6) Content of the pack and other information
®

1) WHAT MERIMONO IS AND WHAT IT IS USED FOR
®
Merimono is a Hormone Replacement Therapy (HRT). It
contains the female hormone oestrogen.
Estradiol valerate is identical to the natural female hormone
oestrogen. This hormone is produced by the ovaries before
the menopause.

®

Stop taking Merimono 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
®
Merimono ’ 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, with or without disturbed vision. Headaches like
these can be an early sign of a stroke. If you have
already had a stroke, talk with your doctor about
whether the benefits of the treatment outweigh the
possibly increased risk.
• If you get pain in your chest that spreads to your arm
or neck. This pain may be a sign of heart disease.
• 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)’.
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).
Taking 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.

®

Merimono is used for:
Relief of symptoms occurring after menopause
Menopause occurs naturally in all women, usually between
the ages of 45 and 55 years. It occurs also in younger women
who have their ovaries removed by surgery. 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”), sleep problems,
irritability, and depression. Some women also have problems
with urine control or dryness of the vagina, which may cause
®
discomfort during or after sexual intercourse. Merimono
alleviates these symptoms after menopause. You will only be
®
prescribed Merimono if your symptoms seriously hinder your
daily life.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
®
MERIMONO
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) Merimono , 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. He/she should tell you what kind of
changes in the breast you should look out for and may advise
you to have a breast X-ray (a mammogram). Once you have
®
started on Merimono , 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
®
Merimono .
Go for regular breast screening, as recommended by your
doctor.

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.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal
®
bleed) while taking Merimono . But, if you have unexpected
bleeding or drops of blood (spotting) besides your monthly
bleeding, which:
• carries on for more than the first 6 months
®
• starts after you have been taking Merimono for more
than 6 months
®
• carries on after you have stopped taking Merimono
• if you have painful menstrual periods
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.
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 5year 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).

®

Do not take Merimono
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
®
Merimono ,
• 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 severe kidney disease;
• 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 any of the other ingredients of Merimono (listed in
section 6);
If any of the above conditions appear for the first time while
®
taking Merimono , stop taking it at once and consult your
doctor immediately.
®

When to take special care with Merimono
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 Merimono . 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 (liver
adenoma)
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many
organs of the body (Systemic lupus erythematosus,
SLE), an autoimmune disorder
• 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
• Hypothyroidism (a condition in which your thyroid
gland fails to produce enough thyroid hormone and for
which you are treated with thyroid hormone
replacement therapy)
• Hereditary angioedema or episodes of rapid swelling
of the hands, feet, face, lips, eyes, tongue, throat
(airway blockage) or digestive tract.

Regularly check your breasts. See your doctor if you
notice any changes such as:
• dimpling of the skin
• change in the nipple
• any lump you can see or feel
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 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).
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)
2
• you are seriously overweight (BMI >30 kg/m )
• you have any blood clotting problem that needs longterm 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 an other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
®

For signs of a blood clot, see “Stop taking Merimono and see
a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on
average, over a 5-year period, 4 to 7 in 1000 would be
expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogenprogestogen 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).
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 a heart disease.
Continued overleaf

Stroke
The risk of getting 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 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
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.
®

Other medicines and Merimono
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. Some medicines may interfere with
®
the effect of Merimono . 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, nelfinavir),
• herbal remedies containing St John’s wort
(Hypericum perforatum),
• other anti-infective medicines (such as ketoconazole,
erythromycin).

4) POSSIBLE SIDE EFFECTS
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.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some effects could be serious
These symptoms need immediate medical attention.
• Unexpected vaginal bleeding or spotting (breakthrough
®
bleeding) after taking Merimono for some time, or
after you stop treatment
• Painful menstrual periods
• Painful swelling and redness of the legs
• Sudden chest pain
• Difficulty in breathing
• Pain in your chest that spreads to your arm or neck
• Yellowing of the eyes and face (jaundice)
• Rapid increase in your blood pressure
• Unexplained migraine-like headaches
• Breast changes, including dimpling of the breast skin,
changes in the nipple, lumps that you can see or feel.
®

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

Stop taking Merimono and tell your doctor immediately if
you get any of the effects mentioned above. Check the risks
to be aware of with HRT in general in section 2, When to take
®
special care with Merimono .

Pregnancy and breast-feeding
®
Not applicable, because Merimono is only indicated in
women without a uterus.

Other side effects
In addition, the following side effects have been reported with
®
Merimono :
• Breast tension and pain, breast cancer.
• Discharge from the vagina.
• Headache, dizziness, vertigo, changes in sexual
desire, depression.
• Increased blood pressure, palpitations (sensation of
fluttering in the chest), fast heart beat or other heart
symptoms, tender or painful veins (signs of
thrombophlebitis), fluid retention, nose bleeds.
• Indigestion, wind, nausea, vomiting, abdominal pain
and bloating, problems with your gall bladder (biliary
stasis).
• General itching, hair loss, hives and skin rash.
• Glucose intolerance which can make you sweat or feel
faint after eating.
• Weight gain.
• Hypersensitivity reaction such as rash, itching, hives.

Driving and using machines
®
Merimono has no known effects on the ability to drive and
use machines.
®

Merimono contains lactose
Lactose is a form of sugar. If you have been told by your
doctor that you have an intolerance to some sugars, contact
®
your doctor before taking Merimono .
®

3) HOW TO TAKE MERIMONO
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. During
the treatment your doctor may adjust the dose according to
your individual needs.
When to start treatment
• If you are currently not taking any form of HRT
(patches or tablets), or if you have been taking a
continuous combined HRT product (where
oestrogen and the progestogen are given every day
®
without interruption), you can start to take Merimono
on any convenient day.
• If you are changing from a cyclic or sequential HRT
treatment (where the progestogen is added for 12–14
®
days of the cycle), you should start to take Merimono
on the day after you complete your previous cycle.
How to take Merimono

®

Take one tablet each day by following the sequence of
numbers and arrows on the calendar pack.
Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the
tablets correctly.
Write the name of the day you take your first tablet in the box
below. For example, if you start your tablets on a Wednesday,
then write “Wednesday” in the box. This day will also be the
day on which you will take tablets 8, 15 and 22. This will help
you check that you have taken each tablet on the right day.
Write your start day here:

When you finish one blister pack, start the new one the next
day whether or not you experience bleeding. This will
normally be the same day of the week as you started the
previous blister pack. Do not take a break between blister
packs unless your doctor tells you.
The tablets are best taken at the same time every day; try to
get into a routine.
Follow your doctor’s instructions as to how and when you
®
should take Merimono tablets and never change the dose
yourself, however well you feel.
If you are unsure about how much medicine to take or when
to take it, ask your doctor or pharmacist.

The following side effects have been reported with other
HRTs:
• Gall bladder disease
• Various skin disorders:
• discoloration of the skin especially of the face or neck
known as “pregnancy patches” (chloasma)
• painful reddish skin nodules (erythema nodosum),
• rash with target-shaped reddening or sores (erythema
multiforme)
• Decline in memory or mental ability
• Diarrhoea
• Migraine,
• Fibroids (benign growths in the uterus)
• Pain in extremity
• Dry eyes and contact lens discomfort
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
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
®

5) HOW TO STORE MERIMONO
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
• Do not store above 25°C.
• Store in the original package.
• If you notice any sign of deterioration of the tablets,
consult your pharmacist immediately.
• Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. This measure will
help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Merimono contains
• Each film-coated tablet contains 1 mg of estradiol
valerate (equivalent to 0.764 mg of estradiol).
• The other ingredients are lactose monohydrate, maize
starch, indigo carmine lake (E132), povidone (K30),
talc, magnesium stearate, hypromellose, propylene
glycol, sodium edetate and titanium dioxide.
®

What Merimono looks like and contents of the pack
®
• Merimono tablets are grey-blue tablets, embossed
with “OC” on one side and “CG” on the other.
®

®

How long to take Merimono
From time to time, you will need to discuss with your doctor
®
the possible risks and benefits associated with Merimono
and whether you still need the treatment. It is important that
you take the lowest possible effective dose and only as long
as needed.
®

If you take more Merimono than you should
Contact your doctor or pharmacist immediately if you have
®
taken too much Merimono .
®

If you forget to take Merimono
If you forget to take a tablet at your usual time, try to take it
within 12 hours. If this is not possible, leave the forgotten
tablet and continue to take the remaining tablets at the usual
time.

Merimono tablets are available in cartons of 84 tablets (3 x
28 calendar blisters).
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by Novartis Pharma GmbH, 90327, Nuremburg,
Germany.
®

Merimono 1 mg Film-Coated Tablets
PL No: 18067/0302
POM
®

Merimono is a registered trademark.
th

This leaflet was last revised: 17 August 2015.

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

If you stop taking Merimono
®
Stopping Merimono may increase the risk of breakthrough
bleeding or spotting. If this occurs after you stop treatment,
contact your doctor immediately. Your doctor will need to work
out the reasons for this.
After a long treatment break, consult your doctor before
®
starting to take Merimono again.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
5000000PL1c

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