Table of Contents
· PACKAGE LEAFLET: INFORMATION FOR THE USER
· 1. What Kliogest® is and what it is used for
· 2. What you need to know before you take Kliogest®
· 3. How to take Kliogest®
· 4. Possible side effects
· 5. How to store Kliogest®
· 6. Contents of the pack and other information
· USER INSTRUCTIONS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Kliogest® 2mg/1mg film-coated tablets
Read this entire 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. See section 4.
What is in this leaflet
1. What Kliogest® is and what it is used for
2. What you need to know before you take Kliogest®
3. How to take Kliogest®
4. Possible side effects
5. How to store Kliogest®
6. Contents of the pack and other information
1. What Kliogest® is and what it is used for
Kliogest® is a continuous combined Hormone Replacement Therapy (HRT) which is taken every day without interruption. Kliogest® 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 progestogen that acts in a similar way to the body’s own hormone progesterone).
Kliogest® 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’).
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.
Kliogest® 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 Kliogest®
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.
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.
Do not take Kliogest®
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 you have, have had or suspect having breast cancer.
· If you have, have had or suspect having cancer of the womb lining (endometrial cancer), or any other oestrogen dependent cancer.
· If you have any abnormal 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 (venous thromboembolism), 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 previously 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 Kliogest®(listed in section 6 Contents of the pack and other information).
Warnings and precautions
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:
· fibroids inside your womb
· growth of the 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 (venous thromboembolism))
· 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
· migraine or severe headaches
· a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
· 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
· lactose intolerance.
Stop taking Kliogest® 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 Kliogest® 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 (venous thromboembolism)
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.
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 Kliogest® 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 Kliogest®. However, if the irregular bleeding:
· carries on for more than the first 6 months
· starts after you have been taking Kliogest® for more than 6 months
· carries on after you have stopped taking Kliogest®
see your doctor as soon as possible.
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.
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000 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 1,000 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
· changes in the nipple
· any lumps you can see or feel
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 1,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra case).
Effect of HRT on heart and circulation
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 apply 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 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 1,000 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 1,000 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.
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.
Using other medicines
Some medicines may interfere with the effect of Kliogest®. 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 and rifabutin)
· Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
· Medicines for hepatitis C infections (such as telaprevir)
· Herbal remedies containing St John’s Wort (Hypericum perforatum).
Other medicines may increase the effects of Kliogest®:
· Medicines containing ketoconazole (a fungicide).
Kliogest® 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.
Taking Kliogest® with food and drink
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.
Pregnancy and breast-feeding
Pregnancy: Kliogest® is for use in postmenopausal women only. If you become pregnant, stop taking Kliogest® and contact your doctor.
Breast-feeding: You should not take Kliogest® if you are breast-feeding.
Driving and using machines
Kliogest® has no known effect on the ability to drive or use machines.
Important information about some of the ingredients in Kliogest®
Each Kliogest® tablet contains 36.3 mg lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before taking Kliogest®.
3. How to take Kliogest®
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 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 should aim to prescribe the lowest dose to treat your symptoms for as short as necessary.
Speak to your doctor if you think this dose is too strong or not strong enough.