Femoston 2/10 Tablets
1. What Femoston is and what it is used for
2. Before you take Femoston
PACKAGE LEAFLET: INFORMATION FOR THE USER FEMOSTON® 2/10 TABLETS
(oestradiol and dydrogesterone)
Your medicine is available in the above name and strength but will be referred to as Femoston throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.
Read all of this 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 or nurse.
- 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 or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Femoston is and what it is used for
2. What you need to know before you take Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Contents of the pack and other information
Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. HRT is used in woman who require oestrogen replacement and who have not had their womb removed (hysterectomy). Femoston is used in postmenopausal women at least 6 months since last menses.
Femoston is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Femoston alleviates these symptoms after menopause. You will only be prescribed Femoston 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 Femoston to prevent osteoporosis after menopause.
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 Femoston 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 Femoston. Go for regular breast screening, as recommended by your doctor.
Do not take Femoston
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 Femoston,
Do not take Femoston
• 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 a tumor which is sensitive to progestogen, such as a tumor of the brain (meningioma)
• 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 oestradiol/ dydrogesterone or any
of the other ingredients of Femoston (listed in section 6 Further information)
If any of the above conditions appear for the first time while taking Femoston, stop taking it at once and consult your doctor immediately.
When to take special care with Femoston
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 Femoston. If so, you should see your doctor more often for check-ups:
• 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 an 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 Femoston 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 Femoston' 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: Femoston 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 Femoston 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 Femoston. However, if the irregular bleeding:
• carries on for more than the first 6 months
• starts after you have been taking Femoston for more than 6 months
• carries on after you have stopped taking Femoston see your doctor as soon as possible.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed) while taking Femoston. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
• carries on for more than the first 6 months
• starts after you have been taking Femoston more than 6 months
• carries on after you have stopped taking Femoston see your doctor as soon as possible
Breast cancer
Evidence suggests that taking combined oestrogenprogestogen 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:
- 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. 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 any other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Femoston 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 having a 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 Femoston. 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)
• Herbal remedies containing St John’s Wort
