This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Kliogest® 2mg/1mg
film-coated tablets
estradiol/norethisterone acetate
1. What Kliogest® is and what it is used for 2. Before you take Kliogest® 3. How to take Kliogest® 4. Possible side effects 5. How to store Kliogest® 6. Further information
Kliogest® 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.
Kliogest® is used in post-menopausal women who have not had their womb removed, with at least 1 year since their last natural period.
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”).
Kliogest® alleviates these symptoms after menopause. You will only be prescribed Kliogest® 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 Kliogest® to prevent osteoporosis after menopause.
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 Kliogest® 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 Kliogest®.
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 Kliogest®, Do not take Kliogest®
If any of the above conditions appear for the first time while taking Kliogest®, stop taking it at once and consult your doctor immediately.
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 Kliogest®. If so, you should see your doctor more often for check-ups:
If you notice any of the following when taking HRT:
Note: Kliogest® 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 progestogen in Kliogest® protects you from this extra risk.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Kliogest®. However, if the irregular bleeding:
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).
Regularly check your breasts.
See your doctor if you notice any changes such as:
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).
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:
For signs of a blood clot, see “Stop taking Kliogest® 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 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.
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).
Some medicines may interfere with the effect of Kliogest®. This might lead to irregular bleeding. This applies to the following medicines:
Other medicines may increase the effects of Kliogest®:
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.
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 Kliogest®, because this medicine can affect the results of some tests.
Kliogest® is for use in post-menopausal women only. If you become pregnant, stop taking Kliogest® and contact your doctor. You should not use Kliogest® if you are breast-feeding.
Kliogest® has no known effect on the ability to drive or use machines.
Kliogest® contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before taking Kliogest®.
Always take Kliogest® 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 Kliogest® 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 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.
If you have taken more Kliogest® than you should, talk to a doctor or pharmacist. An overdose of Kliogest® could make you feel sick or vomit.
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 Kliogest®, talk to your doctor first. He/she will explain the effects of stopping treatment and discuss other possibilities with you.
If you are going to have surgery, tell the surgeon that you are taking Kliogest®. You may need to stop taking Kliogest® 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 Kliogest® again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
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 Kliogest® and seek immediate medical help.
Bleeding with Kliogest®
Kliogest® 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:
Your doctor may ask you about any vaginal bleeding with Kliogest® at your regular check-ups. You may find it helpful to make a note of any bleeding in your 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
Common side effects
Uncommon side effects
Rare side effects
Very rare side effects
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:
Keep out of the reach and sight of children.
Do not use Kliogest® 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.
Store below 25°C
Do not refrigerate.
Keep the container in the outer carton in order to protect from light.
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.
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.
The film-coated tablets are white, round with a diameter of 6 mm. The tablets are imprinted NOVO 281.
Pack sizes available:
This medicinal product is authorised in the Member States of the EEA under the following names:
Member States of the EEA:
Kliogest® – except for
Germany: Kliogest® N
United Kingdom: Kliofem®
This leaflet was last approved in: 11/2011
Further Information on Kliogest® is available to the medical and allied professions from:
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.
Kliogest® is a trademark owned by Novo Nordisk FemCare AG, Switzerland
© 2011
Novo Nordisk A/S
8-2850-11-001-1
Link to this document from your website:http://www.medicines.ie/medicine/14530/XPIL/Kliogest/