Patient leaflet - Kliofem film-coated tablets
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. Kliofem® is used in postmenopausal women with at least 1 year since their last natural period.
The tablets contain 2 hormones: estradiol 2 mg (an oestrogen identical to the one made in the ovaries) and norethisterone acetate 1 mg (a progestagen that acts in a similar way to the body’s own hormone progesterone).
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 prescribed 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.
Kliofem® is prescribed for women who have not had their womb removed, and whose periods stopped more than a year ago.
The experience of treating women older than 65 years is limited.
2. What you need to know 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 will ask about your own and your family’s medical
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In women who still have a womb and who are not taking HRT, on average, 5 in 1 000 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 1 000 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.
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Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1 000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 who start taking oestrogen-only HRT for 5 years, there will be 16-17 cases in 1 000 users (i.e. an extra 0 to 3 cases).
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Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1 000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1 000 users (i.e. an extra 5 cases).
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Looking at women in their 50s who are not taking HRT, on average, 8 in 1 000 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 1 000 users over 5 years (i.e. an extra 3 cases).
For women aged 50 who start taking oestrogen-progestagen HRT for 5 years, there will be 21 cases in 1 000 users (i.e. an extra 4 to 8 cases).
Women aged 50 to 59 who are not taking HRT, on average, 27 in 1 000 will be diagnosed with breast cancer over a 10-year period.
For women aged 50 who start taking oestrogen-only HRT for 10 years, there will be 34 cases in 1 000 users (i.e. an extra 7 cases).
For women aged 50 who start taking oestrogen-progestagen HRT for 10 years, there will be 48 cases in 1 000 users (i.e. an extra 21 cases).
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Breast-feeding: You should not take 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 this medicine 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.
bleeding (metrorrhagia). Taking more progestagens than prescribed by your doctor may lead to depressive mood, fatigue, acne and growth of body or facial hair (hirsutism).
If you forget to take Kliofem®
If you forget to take your tablet at the usual time, 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 still have your womb.
If you stop taking Kliofem®
If you would like to stop taking Kliofem®, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
For further information on the use of the calendar 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 HRT product when you have monthly bleeding, 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 a doctor or pharmacist as soon as possible. Taking more oestrogens than prescribed by your doctor may cause breast tenderness, nausea, vomiting and/or irregular vaginal
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 (venous thromboembolism)). Ask your doctor when you can start taking Kliofem® again.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
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 ’What you need to know before you take Kliofem®’.
Hypersensitivity/allergy (uncommon side effect – may affect up to 1 in 100 people)
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 heartbeat), 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.
Very common side effects (may affect more than 1 in 10 people)
•
Breast pain or breast tenderness
•
Vaginal bleeding.
Common side effects (may affect up to 1 in 10 people)
•
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 recurrence
•
Excessive growth of the lining of
the womb (endometrial hyperplasia)
•
Increase in blood pressure or
worsening of high blood pressure
•
Gall bladder disease, gallstones
occurrence/recurrence 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.
Other side effects of combined HRT
The following side effects have been reported with other HRTs:
•
Various skin disorders:
discolouration 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)
red or purple discolourations of
the skin and/or mucous
membranes (vascular purpura)
•
Dry eyes
•
Tear film composition changes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Kliofem®
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the label and 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 it from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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 NOVO 281.
Pack sizes:
•
1x28 film-coated tablets
•
3x28 film-coated tablets
Not all pack sizes may be marketed.
Marketing authorisation holder
Novo Nordisk Limited
3 City Place, Beehive Ring Road,
Gatwick, West Sussex RH6 0PA
Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
This leaflet was last revised in 04/2025
•
Swelling of arms and legs
(peripheral oedema)
•
Weight increase.
Uncommon side effects (may affect up to 1 in 100 people)
•
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 (may affect up to 1 in 1 000 people)
•
Blood clots in the blood vessels
of the legs or the lungs (deep vein thrombosis, lung embolism).
Very rare side effects (may affect up to 1 in 10 000 people)
•
Cancer of the lining of the womb
(endometrial cancer)
Kliofem® is a trademark owned by Novo Nordisk Health Care AG, Switzerland
© 2025 Novo Nordisk A/S
Kliofem® may have an impact on a concomitant treatment with 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. Your doctor will advise you.
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.
Taking Kliofem® with food and drink
The tablets can be taken with or without food and drink.
Pregnancy and breast-feeding
Pregnancy: Kliofem® is for use in postmenopausal women only. If you become pregnant, stop taking Kliofem® and contact your doctor.
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.
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