Femoston-Conti 1mg/5mg Film-Coated Tablets
S0097 Leaflet Femoston conti 20150909
Rare (may affect up to 1 in 1,000 patients):
(*Side effects from the market not observed in clinical trials have been attributed to the frequency “rare”.)
illness resulting from the destruction of red blood cells (haemolytic anaemia)* meningioma (a brain tumor)*
change in the surface of the eye (steepening of corneal curvature)*, not being able to wear your contact lenses (contact lense intolerance*
heart attack (myocardial infarction) stroke*
swelling of the skin around the face and throat.
This may cause difficulty in breathing (angioedema) purplish patches or spots on the skin (vascular purpura) painful reddish skin nodules (erythema nodosum)*, discoloration of the skin especially of the face or neck known as “pregnancy patches” (chloasma or melasma)*
leg cramps*
The following side effects have been reported with other HRTs:
benign or malignant tumours which may be affected by the levels of oestrogens, such as cancer of the womb lining, ovarian cancer (see section 2 for more information)
increased size of tumours that may be affected by the levels of progestagens (such as meningioma)
a disease where the immune system abnormally attacks many
organs of the body (systemic lupus erythematosus)
probable dementia
worsening of fits (epilepsy)
muscle twitches you cannot control (chorea)
blood clots in the arteries (arterial thromboembolism)
inflammation of the pancreas (pancreatitis) in women with preexisting high levels of certain blood fats (hypertriglyceridemia)
rash with target-shaped reddening or sores (erythema multiforme)
urinary incontinence
painful/lumpy breasts (fibrocystic breast disease) erosion of the neck of the womb (uterine cervical erosion) worsening of a rare blood pigment disorder (porphyria) high levels of certain blood fats (hypertriglyceridemia) increased total thyroid hormones Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Femoston
• KEEP OUT OF THE SIGHT & REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton label or blister strip.
• Do not store above 30°C. Store in the original package in order to protect from light and moisture.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Femoston contains
• Each tablet contains 1mg of the active ingredient estradiol and 5mg of the active ingredient dydrogesterone,
• Femoston tablets also contain the following inactive ingredients: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate and macrogol 400. The colours used are titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
What Femoston looks like and contents of the pack
• Famoston is a salmon coloured, round, biconvex, film-coated tablet marked ‘379’ on one side and plain on the other.
• Femoston is available as blister packs of 28 or 84 tablets (3 x 28 tablets).
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HAO 1DX.
Manufacturer
This product is manufactured by Abbott Biologicals B.V., Weesp,
Netherlands.
| POM| PL. 19488/0097
Leaflet revision date: 09 September 2015
Femoston is a registered trade mark of Solvay Pharmaceuticals B V,
The Netherlands.
S0097 Leaflet Femoston conti 20150909
S0097 Leaflet Femoston conti 20150909
PACKAGE LEAFLET: INFORMATION FOR THE USER FEMOSTON-CONTI 1mg/5mg FILM-COATED TABLETS (estradiol/dydrogesterone)
The name of your medicine is Femoston-Conti 1mg/5mg Film-Coated Tablets but will be referred to as Femoston throughout the following 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.
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.
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
1. What Femoston is and what it is used for
Femoston is a Hormone Replacement Therapy (HRT).
It contains two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in postmenopausal women with at least 12 months since their last natural period.
Femoston 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"). 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.
2. What you need to know before you take Femoston
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 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 estradiol, dydrogesterone or any of the other ingredients of this medicine (listed in section 6)
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)
a tumour of the brain that may be affected by the levels of progestagens (meningioma)
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.
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 17 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 23 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.
Compare
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).
Effects 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 another 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 getting 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.
Tell your doctor if you have or have had any of the following medical conditions since he will have to monitor you more closely:
> heart disease
> kidney impairment
> higher than normal levels of certain blood fats (hypertriglyceridemia)
Children
Femoston is not intended for use in children.
Using other medicines
> Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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, carbamazepine, phenytoin),
medicines for tuberculosis (such as rifampicin, rifabutin), medicines for HIV infection [AIDS] (such as ritonavir, nelfinavir, nevirapine, efavirenz)
herbal remedies containing St John’s Wort (Hypericum perforatum)
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.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking Femoston, because this medicine can affect the results of some tests.
Femoston with food and drink Femoston can be taken with or without food.
Pregnancy and breast-feeding
Femoston is for use in postmenopausal women only.
If you become pregnant
> stop taking Femoston and contact your doctor.
Femoston is not indicated for use during breast-feeding.
Driving and using machines
The effect of Femoston on driving or using machinery has not been studied. An effect is unlikely.
Femoston tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Femoston
4. Possible side effects
Always take Femoston exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
When to start taking Femoston
Do not start taking Femoston until at least 12 months after your last natural period.
You can start taking Femoston on any convenient day if:
• you are currently not taking any HRT product
• you are switching from a “continuous combined” HRT product. This is when you take a tablet or use a patch every day that contains both, an oestrogen and a progestogen.
You start taking Femoston the day after you finish the 28 day cycle if:
• you are switching from a ‘cyclic’ or ‘sequential’ HRT product. This is when you take a tablet or use a patch that contains oestrogen for the first part of your cycle. Afterwards you take a tablet or use a patch containing both an oestrogen and a progestogen for up to 14 days.
Taking this medicine
• Swallow the tablet with water.
• You can take your tablet with or without food
• Try to take your tablet at the same time each day.
This will make sure that there is a constant amount of the product in your body. This will also help you remember to take your tablets.
• Take one tablet every day, without a break between packs. The blisters are marked with the days of the week. This makes it easier for you to remember when to take your tablets
How much to take
• Your doctor will 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.
• If you are taking Femoston to prevent osteoporosis, your doctor will adjust the dose to suit you. It will depend on your bone mass.
• Take one salmon-coloured tablet every day for a 28 day cycle.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Femoston. You may need to stop taking Femoston 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 Femoston again.
If you take more Femoston than you should
If you (or someone else) take too many Femoston tablets, you are unlikely to come to any harm. You may feel sick (nauseous), or be sick (vomit), may have tender or painful breasts, dizziness, abdominal pain, drowsiness/tiredness, or withdrawal bleeding. No treatment is necessary. But if you are worried, contact your doctor for advice.
If you forget to take Femoston
Take the missed tablet as soon as you remember. If it is more than 12 hours after you should have taken the tablet, take the next dose at the regular time. Do not take the forgotten tablet. Do not take a double dose.
Bleeding or spotting may occur if you miss a dose.
If you stop taking Femoston
Do not stop taking Femoston without first talking to your doctor.
> If you have any fu rther questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Femoston can cause 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 The following side effects may happen with this medicine:
Very common (may affect more than 1 in 10 patients):
headache abdominal pain back pain
tender or painful breasts Common (may affect up to 1 in 10 patients):
vaginal thrush (a vaginal infection due to a fungus called
Candida albicans)
feeling depressed, nervousness
migraine. If you have a migraine-like headache for the first time, stop taking Femoston and see a doctor immediately dizziness
feeling sick (nausea), vomiting, bloating (swelling of the abdomen), including wind (flatulence)
allergic skin reactions (such as rash, severe itching (pruritus) or hives (urticaria))
menstrual disorder such as irregular bleeds, spotting, painful periods (dysmenorrhoea), heavier or less bleeding
pelvic pain
vaginal discharge
feeling weak, tired or unwell
swelling of your ankles, feet or fingers (peripheral oedema) weight increase
Uncommon (may affect up to 1 in 100 patients):
cystitis-like symptoms
growths in the womb (fibroids) get bigger
hypersensitivity reactions such as dyspnoea (allergic asthma)
change in sex drive
blood clots in the legs or lungs (venous thromboembolism or
pulmonary embolism)
high blood pressure (hypertension)
problems with your circulation (peripheral vascular disease)
enlarged and tortuous (varicose) vein
indigestion
liver disorders, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia) or generally feeling unwell (malaise), and abdominal pain. If you notice yellowing of the skin or the whites of your eyes, stop taking Femoston and see a doctor immediately.
gallbladder disease swelling of your breasts pre-menstrual syndrome (PMS) weight decrease
S0097 Leaflet Femoston conti 20150909