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CLIMAVAL 1MG TABLETS

Active substance(s): ESTRADIOL VALERATE

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CLIMAVAL® 1mg TABLETS
(estradiol valerate)
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.
The name of your medicine is CLIMAVAL 1mg TABLETS but will be
referred to as Climaval throughout 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.
Estradiol 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 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.
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 oestrogenonly 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 oestrogenonly 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).
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.
Pregnancy and breast-feeding
Not applicable, because Climaval is only indicated in women without a
uterus.
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.

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.

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:

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.

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.
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.
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.

4. Possible side effects

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.
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.

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, pharmacist or nurse. 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 take Climaval after the expiry date which is stated on the carton or
blister label after ‘Exp’. The expiry date refers to the last day of that
month.
Store in the original package. Do not store above 25°C.
Protect from light.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
If your tablet become discoloured or show any other signs of deterioration,
seek the advice of your pharmacist.

6. Content of the pack and other information
What Climaval contains
The active ingredient in Climaval is estradiol valerate.
Each 1mg tablet contains 1mg of estradiol valerate.
The other ingredients are:
Lactose monohydrate, maize starch, povidone, talc, sodium edetate,
magnesium stearate, hypromellose, propylene glycol, indigo carmine
aluminium lake (E132), and titanium dioxide (E171).
What Climaval looks like and contents of the pack
Climaval is blue-grey round coated tablet and is marked 'CG’ on one side
and ‘OC’ on the other side.
Climaval are available as blister packs of 28 and 84 tablets. Each tablet
strip is marked with numbers and arrows. This helps you remember when
to take your tablets.
Manufactured by: Novartis Pharma GmbH, 90327 Nurnburg, Germany.
procured from within the EU and repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
CLIMAVAL 1mg TABLETS
PL No: 18799/2712
Leaflet date: 20.07.2015

POM

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