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CLIMAVAL 1MG TABLETS

Active substance(s): ESTRADIOL VALERATE / ESTRADIOL VALERATE / ESTRADIOL VALERATE

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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.
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.








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 (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

PATIENT INFORMATION LEAFLET

Climaval 1mg Tablets
(estradiol valerate)
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.

5. HOW TO STORE CLIMAVAL







Do not store above 25°C.
Keep in original carton
Keep out of the sight and reach of childern
Keep tablets in their packs, only remove them
when you take your medicine.
Do not use this medicine after the expiry date
shown on the carton label or blister strip.

If your doctor tells you to stop taking this
medicine, return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to.
If your tablets become discoloured or show any
other signs of deterioration, consult your
pharmacist who will tell you what to do.
6. CONTENT OF THE PACK AND OTHER
INFORMATION
What Climaval contains
Each tablet contains 1mg of estradiol valerate as
the active ingredient.
Your medicine also contains the following inactive
ingredients: lactose monohydrate, maize starch,
indigo carmine, povidone (grade 30), talc
(sterilised, white), magnesium stearate,
hypromellose, propylene gylcol,
opaspray blue M-1-6516 and sodium edetate.

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.

What Climaval looks like and contents of the
pack
Climaval are film-coated blue tablets with OC on
one side and CG on the other.
Climaval is also available as Climaval 2mg tablets.
Climaval 1mg is available in cartons of 84
calender pack tablets.

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)

POM

Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma
GmbH, 90327 Nurnberg, Germany and are
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.

PL 15184/0443 - Climaval 1mg Tablets

Climaval is a registered trademark of Novartis AG.
Leaflet revision date: 01/04/15

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

Ref: 0443/010415/1/F

®

Your medicine is called Climaval 1mg Tablets and
will be referred to as Climaval throughout the rest
of this leaflet.
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.
Oestradiol valerate is identical to the natural
female hormone oestrogen. This hormone is
produced by the ovaries before the menopause.
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.
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 oestradiol
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 oestrogensensitive 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.

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.
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
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.

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).
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)
• 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 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
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).
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.

For women who have had their womb removed
and are taking oestrogen-only therapy there is no
increased risk of developing a heart disease.
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).

• 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.

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.

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.

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

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

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

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 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 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.

Ref: 0443/010415/1/B

Expand Transcript

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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