KLIOFEM FILM-COATED TABLETS

Active substance: NORETHISTERONE ACETATE

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8-2850-01-001-1_v1-38:Layout 1

Regulatory Operations
Insert size: 800x100-004
Current: 5.0

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Improved DI28MKII

Kliofem® 2 mg/1 mg
film-coated tablets

Colour: PMS 280C

estradiol /norethisterone acetate

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Read this entire leaflet carefully
before you start taking this
medicine.
• Keep this leaflet. You may need to
read it again.
• If you have further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed
for you. Do not pass it on to
others. It may harm
them, even if their symptoms are
the same as yours.
• If any of the side effects get serious
or if you notice any side effects not
listed in this leaflet please tell your
doctor or pharmacist.
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Page 1

In this leaflet:
1. What Kliofem® is and what it is
used for
2. Before you take Kliofem®
3. How to take Kliofem®
4. Possible side effects
5. How to store Kliofem®
6. Further information
1. What Kliofem® is and what it is
used for
Kliofem® is a continuous combined
Hormone Replacement Therapy (HRT)
which is taken every day without
interruption. It contains two types of
female hormones, an oestrogen and
a progestogen. Kliofem® is used in
postmenopausal women who have
not had their womb removed, with at
least 1 year since their last natural
period
Kliofem® is used for:
Relief of symptoms occurring
after menopause
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”). Kliofem® alleviates these symptoms after
menopause. You will only be pre-

scribed Kliofem® 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 use Kliofem® to prevent
osteoporosis after menopause.
The experience of treating women
older than 65 years is limited.
2. Before you take Kliofem®
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 should 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.
Once you have started on Kliofem®
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 Kliofem®.
Go for regular breast screening, as
recommended by your doctor
Do not take Kliofem®
If any of the following apply to you. If
you are not sure about any of the
points below, talk to your doctor
before taking Kliofem®.
Do not take Kliofem®:
• 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 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, norethisterone
acetate or any of the other
ingredients of Kliofem® (listed in
section 6 Further information)

If any of the above conditions appear
for the first time while taking
Kliofem®, stop taking it at once and
consult your doctor immediately.
When to take special care with
Kliofem®
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 Kliofem®. If so, you should
see your doctor more often for checkups:
• 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 a
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
• 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
Stop taking Kliofem® 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 Kliofem®’
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
- 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: Kliofem® 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 thicken-

ing of the lining of the womb (endometrial hyperplasia) and cancer of the
womb lining (endometrial cancer).
The progestogen in Kliofem® protects
you from this extra risk.
Compare
In women who still have a womb
and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women aged 50 to 65 who still
have a womb and who take oestrogen-only HRT, between 10 and
60 women in 1000 will be diagnosed with endometrial cancer (i.e.
between 5 and 55 extra cases),
depending on the dose and for how
long it is taken.
Irregular bleeding
You may have irregular bleeding or
drops of blood (spotting) during the
first 3-6 months of taking Kliofem®.
However, if the irregular bleeding:
• carries on for more than the first
6 months

• starts after you have been taking
Kliofem® for more than 6 months
• carries on after you have stopped
taking Kliofem®
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 14 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
20 cases in 1000 users (i.e. an extra
4 to 6 cases).

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• Regularly check your breasts.
See your doctor if you notice
any changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps 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.
Compare
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 Kliofem® 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).
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.
Using other medicines
Some medicines may interfere with
the effect of Kliofem®. This might
lead to irregular bleeding. This applies
to the following medicines:
• Medicines for epilepsy (such as
phenobarbital, phenytoin and
carbamazepine)
• Medicines for tuberculosis (such
as rifampicin, rifabutin)
• Medicines used for HIV infection
(such as nevirapine, efavirenz,
ritonavir and nelfinavir)

• Herbal remedies with St John’s
Wort (Hypericum perforatum).
Other medicines may increase the
effects of Kliofem®:
• Drugs containing ketoconazole
(a fungicide).
Concomitant administration of
cyclosporine may cause increased
blood levels of cyclosporine.
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.
Taking Kliofem® with food and
drink
The tablets can be taken with or
without food and drink.
Laboratory tests
If you need a blood test, tell your
doctor or the laboratory staff that you
are taking Kliofem®, because this
medicine can affect the results of
some tests.
Pregnancy and breast-feeding
Kliofem® is for use in postmenopausal
women only. If you become pregnant, stop taking Kliofem® and con-

tact your doctor. You should not use
Kliofem® if you are breast-feeding.
Driving and using machines
Kliofem® has no known effect on the
ability to drive or use machines.
Important information about
some of the ingredients in
Kliofem®:
Kliofem® contains lactose monohydrate. If you have an intolerance to
some sugars, contact your doctor
before taking Kliofem®.
3. How To Take Kliofem®
Always take Kliofem® exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are
unsure.
Take one tablet once a day, at
about the same time each day.
Take the tablet with a glass of water.
Take a tablet every day without
stopping. After you have used all
28 tablets in a calendar pack, go
straight to using the next pack.
See USER INSTRUCTIONS at the
end of the package leaflet
You may start treatment with
Kliofem® on any convenient day.
However, if you are switching from an

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HRT product where you have a
monthly bleed, start your treatment
straight after the bleeding has ended.
Your doctor should 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.
If you take more Kliofem® than
you should
If you have taken more Kliofem® than
you should, talk to your doctor or
pharmacist. An overdose of Kliofem®
could make you feel sick or vomit.
If you forget to take Kliofem®
If you forget to take your tablet at
the usual time, try and take it within
the next 12 hours. If more than 12
hours have gone by, start again as
normal the next day. Do not take a
double dose to make up for a forgotten tablet.
Forgetting a dose may increase the
likelihood of breakthrough bleeding
and spotting.
If you stop taking Kliofem®
If you want to stop taking Kliofem®,
talk to your doctor first. He/she will
explain the effects of stopping treat-

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Page 2

ment and discuss other possibilities
with you.
If you need to have surgery
If you are going to have surgery, tell
the surgeon that you are taking
Kliofem®. You may need to stop taking Kliofem® 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 Kliofem®
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.
Hypersensitivity/allergy
(uncommon side effect – affects 1 to
10 users in 1,000)
Though it is an uncommon event,
hypersensitivity/allergy may occur.
Signs of hypersensitivity/allergy may
include one or more of the following
symptoms: hives, itching, swelling,
difficulty in breathing, low blood
pressure (paleness and coldness of
skin, rapid heart beat), feeling dizzy,
sweating, which could be signs of
anaphylactic reaction/shock. If one of
the mentioned symptoms appears,
stop taking Kliofem® and seek
immediate medical help.
Bleeding with Kliofem®
Kliofem® will not cause regular
monthly bleeding. When first starting
the tablets, some women experience
slight vaginal bleeding or spotting.
If you get breakthrough bleeding or
spotting, it is usually nothing to worry
about, especially during the first few
months of taking HRT.

However, contact your doctor as soon
as possible:
• If bleeding carries on for more than
the first 3 months.
• If bleeding only starts after taking
HRT for a while.
• If bleeding continues after
stopping HRT.
Your doctor may ask you about any
vaginal bleeding with Kliofem® at
your regular check-ups. You may find
it helpful to make a note of any
bleedings in a diary.
The frequency of possible side effects
listed below is defined using the following convention:
Very common
(affects more than 1 user in 10)
Common
(affects 1 to 10 users in 100)
Uncommon
(affects 1 to 10 users in 1,000)
Rare
(affects 1 to 10 users in 10,000)
Very rare
(affects less than 1 user in 10,000)
Not known
(frequency cannot be estimated from
the available data)

Very common side effects
• Breast pain or breast tenderness
• Vaginal bleeding.
Common side effects
• Headache
• Weight gain caused by fluid
retention
• Vaginal inflammation
• Migraine, new or worse than
before
• Vaginal infection with a fungus
• Depression, new or worse than
before
• Nausea
• Abdominal pain, swelling or
discomfort
• Enlargement or swelling of the
breasts (breast oedema)
• Back pain
• Leg cramps
• Uterine fibroid (benign tumour),
aggravation, occurrence or
reoccurrence
• Swelling of arms and legs
(peripheral oedema)
• Weight increase
Uncommon side effects
• Bloating or flatulence
• Acne
• Hair loss (alopecia)

• Abnormal (male pattern) hair
growth
• Itching or hives (urticaria)
• Inflammation of a vein (superficial
thrombophlebitis)
• Drug ineffective
• Allergic reaction
• Nervousness
Rare side effects
• Blood clots in the blood vessels of
the legs or the lungs (deep vein
thrombosis, lung embolism).
Very rare side effects
• Cancer of the lining of the womb
(endometrial cancer)
• Excessive growth of the lining of
the womb (endometrial
hyperplasia)
• Increase in blood pressure or
worsening of high blood pressure
• Gallbladder disease, gallstones
occurrence/reoccurrence or
aggravated
• Excessive secretion of sebum, skin
eruption
• Acute or recurring attack of
oedema (angioneurotic oedema)
• Insomnia, dizziness, anxiety
• Change in sexual desire
• Visual disturbances

• Weight decreased
• Vomiting
• Heartburn
• Vaginal and genital itching
• Heart attack and stroke
If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
The following side effects have been
reported with other HRTs:
• 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)
5. How To Store Kliofem®
Keep out of the reach and sight of
children.
Do not use Kliofem® after the expiry
date, which is stated on the label and
outer carton after “EXP”. The expiry
date refers to the last day of that
month.

Do not refrigerate.
Keep the container in the outer carton in order to protect from light.
Medicines should not be disposed of
via waste water or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.
6. Further Information
What Kliofem® contains
The active substances are estradiol
2 mg (as estradiol hemihydrate) and
norethisterone acetate 1 mg.
The other ingredients are: lactose
monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium
stearate.
The film-coating contains:
Hypromellose, triacetin and talc.
What Kliofem® looks like and
contents of the pack
The film-coated tablets are white,
round with a diameter of 6 mm. The
tablets are engraved with NOVO 281.
Pack sizes available:

• 1 × 28 film-coated tablets
• 3 × 28 film-coated tablets
Not all pack sizes may be marketed.
Marketing authorisation holder
Novo Nordisk Limited
Broadfield Park, Brighton Road,
Crawley, West Sussex RH11 9RT
Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
This leaflet was last approved:
03/2012
USER INSTRUCTIONS
How to use the calendar pack
1. Set the day reminder
Turn the inner disc to set the day of
the week opposite the little plastic
tab.

2. Take the first day’s tablet
Break the plastic tab and tip out the
first tablet.

3. Move the dial every day
On the next day, simply move the
transparent dial clockwise 1 space as
indicated by the arrow. Tip out the
next tablet. Remember to take only
1 tablet once a day.
You can only turn the transparent
dial after the tablet in the opening has been removed.
Kliofem®is a trademark owned by
Novo Nordisk FemCare AG,
Switzerland

© 2012
Novo Nordisk A/S

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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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