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CLIMESSE 2MG/0.7MG FILM-COATED TABLETS

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

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Climesse® 2mg/0.7mg
film-coated tablets

1180
26.05.15[14]

(Estradiol valerate, norethisterone)
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.
Your medicine will be called Climesse throughout the following leaflet.
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
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.
Estradiol 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
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.
Prevention of osteoporosis
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your doctor.
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
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).
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;
- 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.
If any of the above conditions appear for the first time while taking
Climesse, stop taking it at once and consult your doctor immediately.
When to take special care with Climesse
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)”)
- 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 Climesse 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 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.
- 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: 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.
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.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the
first 3–6 months of taking Climesse. However, if the irregular bleeding:
- carries on for more than the first 6 months
- 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:
- 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 Climesse 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).

If you need to have surgery
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

Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.

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.

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.

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

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).

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

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.
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:
- 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).
Laboratory tests
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
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.
Driving and using machines
Climesse has no known effects on the ability to drive and use machines.
Climesse 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
Climesse.
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.
When to start treatment
Climesse is a continuous combined HRT. This means that oestrogen and
progestogen are given continuously.
- 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.
How to take Climesse
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 and
mark the box on the carton. For example, if you start your tablets on a
Wednesday, then write “Wednesday” in the box below or mark the day in
the box on the carton. 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
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.
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.

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 Climesse 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 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, Take special care with Climesse.
Other side effects
In addition, the following side effects have been reported with Climesse:
- 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.
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
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 CLIMESSE
- Keep out of the sight and reach of children.
- Do not use Climesse after the expiry date which is stated on the carton.
The expiry date refers to the last day of the month.
- Do not store above 25oC. Store in a dry place. Protect from light. Do not
refrigerate.
- 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 tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
6. Contents of the pack and other information
What Climesse contains
- The active substances are 2 mg estradiol valerate (equivalent to 1.528
mg estradiol) and 0.7 mg norethisterone.
- The other ingredients are lactose monohydrate, maize starch, povidone,
talc, magnesium stearate, hypromellose, macrogol. The colouring in the
tablets is titanium dioxide (E 171) and iron oxide red (E 172).
What Climesse looks like and contents of the pack
- Climesse is available in small, round, pink film coated tablets, engraved
'CG' on one side and ‘OG’ on the other side of the tablet.
Climesse is available in cartons of 28 and 84 tablets.
Manufacturer and Product Licence Holder
Climesse tablets are manufactured by Novartis Pharma GmbH, 90327
Nurnberg, Germany and are procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

Climesse 2mg/0.7mg film-coated tablets PL 20636/1180

Leaflet revision and issue date (Ref.) 26.05.15[14]
Climesse is a registered trademark of Novartis AG.

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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