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CLIMAGEST 1MG FILM-COATED TABLETS

Active substance(s): NORETHISTERONE / OESTRADIOL VALERATE

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Package leaflet: Information for the user

Climagest® 1 and 2 mg film-coated tablets
(Oestradiol valerate, norethisterone)
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.
What is in this leaflet:
1. What Climagest is and what it is used for
2. What you need to know before you take Climagest
3. How to take Climagest
4. Possible side effects
5. How to store Climagest
6. Content of the pack and other information

1. What Climagest is and what it is used for

Climagest is a Hormone Replacement Therapy (HRT). It contains two types of
female hormones, an oestrogen and a progestogen. Climagest is used in
postmenopausal women with at least 6 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.

Climagest 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 unpleasant 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.
Climagest alleviates these symptoms after menopause. You will only be prescribed
Climagest if your symptoms seriously hinder your daily life.
If oestrogen is taken on its own, there is a greater risk of abnormal growth of the
womb lining (endometrial hyperplasia) and endometrial cancer. The norethisterone
in the white Climagest tablet reduces these risks in women who still have
their womb.

2. What you need to know before you take Climagest
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) Climagest, your doctor will ask you 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 Climagest 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 Climagest.
Go for regular breast screening, as recommended by your doctor.

Do not take Climagest

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 Climagest,
• 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);

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When to take special care with Climagest

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 Climagest. 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 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.
Stop taking Climagest 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 Climagest’ 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 become pregnant
–– If you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty in breathing
For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Climagest 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 Climagest protects you from this extra risk.
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.

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• 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 Climagest (listed in section 6);
• if you are pregnant, or think you might be.
If any of the above conditions appear for the first time while taking Climagest, stop
taking it at once and consult your doctor immediately.

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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.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first
3-6 months of taking Climagest. However, if the irregular bleeding:
–– carries on for more than the first 6 months
–– starts after you have been taking Climagest for more than 6 months
–– carries on after you have stopped taking Climagest
–– 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:
• 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
another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Climagest 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).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly
more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting 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).

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Other conditions

When to start treatment

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.

Climagest is a continuous sequential HRT. This means that oestrogen is given
continuously, and progestogen is added for 12 days of the cycle.
• If you are not currently taking HRT and still having periods, it is advisable to
take the first tablet on the first day of your period (first day of the bleed) unless
your doctor tells you otherwise. If your periods are infrequent, or have stopped,
your doctor may suggest that you start immediately.
• If you are changing from a sequential HRT or cyclic HRT, you should complete
your treatment cycle and then start taking Climagest immediately.
• If you are changing from a continuous combined HRT and your periods have
stopped, you can start taking Climagest at any time. If you still have periods,
start taking Climagest on the first day of your period.

From time to time, you will need to discuss with your doctor the possible risks and
benefits associated with Climagest 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.

How to take Climagest

If you need to have surgery

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 Climagest. 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, telaprevir, nelfinavir),
• herbal remedies containing St John’s wort (Hypericum perforatum).

Laboratory tests

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

Pregnancy and breast-feeding

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

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:

Driving and using machines

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

Climagest 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 Climagest.

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.

3. How to take Climagest

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

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.

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

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If you have taken more Climagest than you should

Contact your doctor or pharmacist immediately if you have taken too much Climagest.

If you forget to take Climagest

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

If you stop taking Climagest

Stopping Climagest 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 Climagest
again.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

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
Climagest 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 Climagest 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 Climagest.

Other side effects

In addition, the following side effects have been reported with Climagest:
• 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),
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.
• Fibroids (benign growth in the uterus).
• Pain in extremity.
The following side effects have been reported with other HRTs:
• gallbladder disease,

• various skin disorders:
– discoloration of the skin specially of 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
• dry eyes and contact lens discomfort
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

5. How to store Climagest
• 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.
• 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 Climagest contains

• Climagest 1 mg tablets. The active substance of the grey-blue tablets is
1 mg oestradiol valerate (equivalent to 0.764 mg oestradiol). The active
substances of the white tablets are 1 mg oestradiol valerate and 1 mg
norethisterone.
• Climagest 2 mg tablets. The active substance of the blue tablets is
2 mg oestradiol valerate (equivalent to 1.528 mg oestradiol). The active substances
of the pale yellow tablets are 2 mg oestradiol valerate and 1 mg norethisterone.
• The other ingredients are lactose monohydrate, maize starch, povidone, talc,
magnesium stearate, propylene glycol, hypromellose, purified water and colours
E132 (1 mg-grey-blue tablet/ 2 mg-blue tablet), E464 (1 mg-white tablet;
1mg-grey-blue tablet / 2 mg-blue tablet; 2mg-pale yellow tablet), E172
(2 mg-pale yellow tablet) and E171 (1 mg-white tablet; 1 mg-grey-blue
tablet / 2mg-pale yellow tablet).

What Climagest looks like and contents of the pack
• Climagest 1 mg tablets. The oestradiol valerate tablet is grey-blue with “OC” on
one side and “CG” on the other. There are 16 in each blister pack. The combination
tablets (oestradiol valerate and norethisterone) are white film-coated tablets with
“OE” on one side and “CG” on the other. There are 12 in each blister pack.
• Climagest 2 mg tablets. The oestradiol valerate tablet is blue with “OD” on one
side and “CG” on the other. There are 16 in each blister pack. The combination
tablets (oestradiol valerate and norethisterone) are pale yellow film-coated tablets
with “OF” on one side and “CG” on the other. There are 12 in each blister pack.
Climagest tablets are available in cartons of 28 tablets (1 blister pack) or 84 tablets
(3 blister packs). Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley,
Surrey GU16 7SR.
Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex,
RH12 5AB
United Kingdom and Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR,
England, United Kingdom.
This medicinal product is authorised in the Member States of the EEA under
the following name
Germany: Mericomb
United Kingdom: Climagest
This leaflet was revised in March 2014
If you would like any more information, or would like the leaflet in a different format,
please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370
Climagest is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

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How long to take Climagest

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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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