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CLIMESSE TABLETS

Active substance(s): ESTRADIOL VALERATE / NORETHISTERONE

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S335 LEAFLET Climesse 20141223

S335 LEAFLET Climesse 20141223

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following side effects have been reported with other HRTs:


gallbladder disease,



various skin disorders:

CLIMESSE TABLETS
Your medicine is known as Climesse Tablets but will be referred to
as Climesse throughout the following leaflet.



discoloration of the skin specially of face or neck known as
“pregnancy patches” (chloasma)

Read all of this leaflet carefully, before you start taking this
medicine because it contains important information for you.



painful reddish skin nodules (erythema nodosum)



Keep this leaflet. You may need to read it again.



rash with target-shaped reddening or sores (erythema
multiforme)



If you have any further questions, ask your doctor or
pharmacist.



decline in memory or mental ability



diarrhoea



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.

Once you have started on Climesse, 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
Climesse.
Go for regular breast screening, as recommended by your doctor.
Do not take Climesse
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 Climesse,


if you have or have ever had breast cancer, or if you are
suspected of having it;



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.

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
norethisterone or any of the other ingredients of Climesse
(listed in section 6);



if you are pregnant, or think you might be.

What is in this leaflet:
1. What Climesse is and what it is used for
2. What you need to know before you take Climesse
3. How to take Climesse
4. Possible side effects
5. How to store Climesse
6. Content of the pack and other information

5. How to store Climesse


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use Climesse after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.



Do not store your tablets above 25°C.



Store in the original package. Protect from light.

6. Content of the pack and other information
What Climesse contains


Climesse Tablets: Each film-coated tablet contains 2mg of
estradiol valerate (a type of estrogen) and 700 micrograms of
norethisterone (a type of progestagen) as the active ingredient.



The other ingredients are: lactose monohydrate, maize starch,
povidone, talc, magnesium stearate, hypromellose, macrogol,
red iron oxide (E172) and titanium dioxide (E171).

What Climesse looks like and contents of the pack
Climesse tablets are round pink film coated tablets and marked
‘OG’ on one side and ‘CG’ on the other.
Climesse Tablets are available as calendar packs of 28 tablets (one
blister strip of 28 tablets) or 84 tablets (3 blister strips of 28 tablets
each)
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Novartis Pharma GmbH, 90327
Nurnberg, Germany.
POM

PL No: 19488/0335

1. What Climesse is and what it is used for
Climesse is a Hormone Replacement Therapy (HRT). It contains
two types of female hormones, an oestrogen and a progestogen.
Climesse is used in postmenopausal women with at least 12
months since their last natural period.
Oestradiol valerate is identical to the natural female hormone
oestrogen. This hormone is produced by the ovaries before the
menopause. Norethisterone belongs to the group of hormones
known as progestogens. It has effects similar to the natural female
hormone progesterone, also produced by the ovaries before the
menopause.
Climesse is used for:
Relief of symptoms occurring after menopause

S335 LEAFLET Climesse 20141223

When to take special care with Climesse

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.
Climesse alleviates these symptoms after menopause. You will only
be prescribed Climesse if your symptoms seriously hinder your daily
life.

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 Climesse. 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)”)

Prevention of osteoporosis



After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.

Increased risk of getting an oestrogen-sensitive cancer (such
as having a mother, sister or daughter 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)



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.

If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can take Climesse to
prevent osteoporosis after menopause.
2. What you need to know before you take Climesse
Medical history and regular check-ups

Leaflet revision date: 23 December 2014
Climesse is a registered trade mark of Novartis AG, Switzerland.

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

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. 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).

Stop taking Climesse and see a doctor immediately

Ovarian cancer

Laboratory tests

If you need to have surgery

If you notice any of the following when taking HRT:

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.

If you need a blood test, tell your doctor or the laboratory staff that
you are taking Climesse, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding

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



Any of the conditions mentioned in the ‘Do Not take Climesse’
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.

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

Driving and using machines

Blood clots in a vein (thrombosis)

Climesse has no known effects on the ability to drive and use
machines.

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.



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 become pregnant



If you notice signs of a blood clot, such as:

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:



painful swelling and redness of the legs





sudden chest pain



difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Climesse 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 Climesse protects you from this extra risk.

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)



starts after you have been taking Climesse for more than 6
months



carries on after you have stopped taking Climesse

 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.
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:

3. How to take Climesse
Always use this medicine exactly as your doctor has told you. 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.

breast cancer
abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)



ovarian cancer

When to start treatment



blood clots in the veins of the legs or lungs (venous
thromboembolism)



heart disease



stroke



you have systemic lupus erythematosus (SLE)

Climesse is a continuous combined HRT. This means that
oestrogen and progestogen are given continuously.



you have cancer.



If you are not currently taking HRT, or if you have been
using a continuous combined HRT (in which oestrogen and
progestogen are given every day without interruption), you can
start to take Climesse on any convenient day.



If you are changing from a sequential HRT or cyclic HRT (in
which the progestogen is added for 12-14 days of the cycle),
you should complete your treatment cycle and then start taking
Climesse immediately.

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 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



Painful menstrual periods



Painful swelling and redness of the legs



Sudden chest pain

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.



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

Write your start day here:



Unexplained migraine-like headaches



Breast changes, including dimpling of the breast skin, changes
in the nipple, lumps that you can see or feel.

Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the
tablets correctly.

The tablets are best taken at the same time every day; try to get
into a routine.

medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine),
medicines for tuberculosis (such as rifampicin, rifabutin),
medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir, teleprevir, nelfinavir),



dimpling of the skin





change in the nipple





any lump you can see or feel



herbal remedies containing St John’s wort (Hypericum
perforatum).

Some effects could be serious
These symptoms need immediate medical attention:
Unexpected vaginal bleeding or spotting (breakthrough
bleeding) after taking Climesse for some time, or after you stop
treatment

Other conditions



Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Take one tablet each day by following the sequence of
numbers and arrows on the calendar pack.

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).

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription, herbal medicines or other natural products.
Some medicines may interfere with the effect of Climesse. This
might lead to irregular bleeding. This applies to the following
medicines:

 probable memory loss if HRT is started over the age of 65
For more information about these side effects, see Section 2.



How to take Climesse

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.

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.

The following diseases are reported more often in women using
HRT compared to women not using HRT:


if any of your close relatives has ever had a blood clot in the
leg, lung or another organ

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.

4. Possible side effects





Heart disease (heart attack)

carries on for more than the first 6 months

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots

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.



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 Climesse.



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).

You may have irregular bleeding or drops of blood (spotting) during
the first 3-6 months of taking Climesse. However, if the irregular
bleeding:

After a long treatment break, consult your doctor before starting to
take Climesse again.

you are seriously overweight (BMI >30 kg/m )

For signs of a blood clot, see “Stop taking Climesse and see a
doctor immediately”.
Compare

If you stop taking Climesse
Stopping Climesse 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 reason for
this.

Climesse contains lactose



2

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.

Irregular bleeding

Climesse is for use in postmenopausal women only. If you become
pregnant, stop taking Climesse and contact your doctor. Do not
take Climesse if you are pregnant or while you are breast-feeding.

Stop taking Climesse 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
Climesse.
Other side effects

Follow your doctor’s instructions as to how and when you should
take Climesse 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.

In addition, the following side effects have been reported with
Climesse:

How long to take Climesse
From time to time, you will need to discuss with your doctor the
possible risks and benefits associated with Climesse and whether
you still need the treatment. It is important that you take the lowest
possible effective dose and only for as long as needed.
If you have taken more Climesse than you should
Contact your doctor or pharmacist immediately if you have taken
too much Climesse.
If you forget to take Climesse
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.



Breast tension and pain, enlargement of the breasts, breast
cancer.



Discharge from the vagina, irregular bleeding or spotting.



Headache, dizziness, vertigo, tiredness or irritability, changes in
sexual desire, depression.



Increased blood pressure, palpitations (sensation of fluttering in
the chest), 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, acne.



Glucose intolerance which can make you sweat or feel faint
after eating.



Weight gain, leg cramps.



Fibroids (benign growth in the uterus).



Pain in extremity
S335 LEAFLET Climesse 20141223

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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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