The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 03132/0080.
Kliofem film-coated tablets
Kliofem® 2 mg/1 mg film-coated tablets
1. What Kliofem® is and what it is used for
2. What you need to know before you take Kliofem®
3. How to take Kliofem®
4. Possible side effects
5. How to store Kliofem®
6. Contents of the pack and other information
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:
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.
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.
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.
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.
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 Kliofem®.
Do not take 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 check-ups:
If you notice any of the following when taking HRT:
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.
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 progestagen in Kliofem® protects you from this extra risk.
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.
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Kliofem®. However, if the irregular bleeding:
see your doctor as soon as possible.
Evidence shows that taking combined oestrogen-progestagen or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within 3 years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.
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).
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).
Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra case).
Blood clots in a vein (venous thromboembolism)
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:
For signs of a blood clot, see Stop taking Kliofem® and see a doctor immediately.
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).
There is no evidence that HRT will prevent a heart attack. Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.
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.
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).
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.
Some medicines may interfere with the effect of Kliofem®. This might lead to irregular bleeding. This applies to the following medicines:
Other medicines may increase the effects of Kliofem®:
Medicines for Hepatitis C virus (HCV) (such as combination regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir as well as a regimen with glecaprevir/pibrentasvir) may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs containing ethinylestradiol. Kliofem® contains estradiol instead of ethinylestradiol. It is not known whether an increase in ALT liver enzyme can occur when using Kliofem® with this HCV combination regimen. Your doctor will advise you.
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.
The tablets can be taken with or without food and drink.
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: Kliofem® is for use in postmenopausal women only. If you become pregnant, stop taking Kliofem ® and contact your doctor.
Breast-feeding: You should not take Kliofem® if you are breast-feeding.
Kliofem® has no known effect on the ability to drive or use machines.
Kliofem® contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before taking 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.
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 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 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 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 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.
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.
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:
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)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
The following side effects have been reported with other HRTs:
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: www.mhra.gov.uk/yellowcard 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.
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.
The film-coated tablets are white, round with a diameter of 6 mm. The tablets are engraved NOVO 281.
Pack sizes available:
Not all pack sizes may be marketed.
This leaflet was last approved: 01/2022
Kliofem® is a trademark owned by Novo Nordisk Health Care AG, Switzerland
Novo Nordisk A/S
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.