0.5 mg / 2.5 mg film-coated tablet
estradiol / dydrogesterone
1. What Femostonconti is and what it is used for
Femostonconti is a preparation used for hormone replacement therapy ( hormone replacement therapy, HRT ). It contains two female sex hormones: an estrogen called estradiol and a progestogen called dydrogesterone. Femostone accounts are used in women who have passed menopause (menopause) when at least 12 months have passed since their last natural menstruation.
What Femostonconti is used for
Relieve symptoms after menopause
During menopause, the amount of estrogen in a woman’s body decreases. It can cause problems such as a hot face, neck, and chest (hot flashes). Femostone accounts relieve these symptoms after menopause. Femostone accounts are only prescribed if your symptoms cause significant problems in daily life.
Estradiol/dydrogesterone contained in Femostonconti may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Femostonconti
Medical background and regular check-ups
The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or have undergone surgery). If you belong to that group, the risks of HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your own and your family’s medical background. The doctor may perform a general medical examination. If necessary, it may include an examination of the breasts and/or a gynecological examination.
Once you have started treatment with Femostonconti, you should go for regular medical check-ups (at least once a year). During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.
Get regular check-ups of your breasts according to your doctor’s recommendations.
DO NOT USE Femostone Accounts if any of the following apply to you. Talk to your doctor before using Femostonconti if you are unsure at any point.
DO NOT USE Femostone accounts
- if you have or have had breast cancer or there is a suspicion that you may have it
- if you have estrogen-dependent cancer, such as cancer of the uterine lining (endometrium), or if there is a suspicion of such cancer
- if you have unexplained vaginal bleeding
- if you have severe thickening of the uterine lining ( endometrial hyperplasia ) and are not treated for it
- if you have or have had a blood clot in a friend ( thrombosis ) e.g. in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism )
- if you have coagulation disorders (eg lack of protein C, protein S, or antithrombin)
- if you have or have recently had a disease caused by a blood clot in an artery, e.g. heart attack, stroke, or angina
- if you have or have had any liver disease and still have abnormal liver values
- if you have a rare, inherited blood disorder called porphyria
- if you are allergic to estradiol, dydrogesterone, or any of the other ingredients of this medicine (listed in section 6)
If any of the above affects you for the first time while you are taking Femostonconti, stop using Femostonconti and contact a doctor immediately.
Warnings and cautions
If you have or have had any of the following problems, talk to your doctor or pharmacist before using Femostonconti. They may recur or worsen during treatment with Femostonconti. Should this occur, have more frequent check-ups with a doctor.
- muscle nodules ( fibroids ) in the uterus
- growth of the uterine lining outside the uterus ( endometriosis ) or previous severe thickening of the uterine lining ( endometrial hyperplasia )
- brain tumor (meningioma), which can be affected by progestogen levels
- – increased risk of getting a blood clot (see “Blood clot in a vein ( thrombosis )”)
- increased risk of developing estrogen-dependent cancer (eg mother, sister, grandmother, or grandmother who has had breast cancer)
- high blood pressure
- liver disease, e.g. benign liver tumor
- diabetes
- gallstone disease
- migraine or severe headache
- an autoimmune disease that affects many organs in the body (systemic lupus erythematosus, SLE )
- epilepsy
- asthma
- a disease affecting the middle ear and hearing (otosclerosis)
- very high blood fat levels ( hypertriglyceridemia )
- fluid retention due to heart or kidney disease
Contact a doctor immediately and stop the treatment
If any of the following occur during treatment:
- any of the things mentioned in the section “Do not use Femostonconti”
- yellowing of the skin or whites of the eyes (jaundice); it may be a symptom of liver disease
- blood pressure rises sharply (symptoms may include headache, fatigue, or dizziness)
- you get migraine-like headaches for the first time
- if you become pregnant
- if you get symptoms of a blood clot, such as painful swelling and redness of the legs sudden chest pain breathing difficulties
For more information, see “Blood clot in a vein ( thrombosis )”.
Note: Femostone accounts are not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
Use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer). The progestogen contained in Femostonconti protects you against this increased risk.
Irregular bleeding
You may experience irregular or spotting during the first 3 to 6 months of using Femostonconti. About the irregular bleeding:
- lasts longer than the first 6 months
- starts after using Femostonconti for over 6 months
- continues after you stop using Femostonconti.
you should see a doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
Comparison
Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 will be diagnosed with breast cancer over a 5-year period. In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur. In women who are 50 years old and start taking HRT with the estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4-8 extra cases). Among women aged 50–59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over a 10-year period. In women who are 50 years old and start taking HRT with only estrogen 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur. In women who are 50 years old and start taking HRT with estrogen-progesterone for 10 years, 48 cases per 1,000 users (ie 21 extra cases) will occur.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- indentations or pits in the skin
- changes of the nipple
- nodules you can see or feel.
Also, it is recommended that you participate in mammography screenings when they are offered to you. You must inform the nurse/healthcare professional performing the mammogram that you are using HRT, as the HRT treatment may increase the density of the breast tissue, which may affect the results of the mammogram. An increased density in the breasts can make it more difficult to detect lumps on the
mammography images.
Ovarian cancer
Ovarian cancer is much rarer than breast cancer. Use of HRT with estrogen alone or combined estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 between the ages of 50 and 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (ie about 1 extra case).
How HRT affects the heart and blood circulation
A blood clot in a friend ( thrombosis )
The risk of blood clots in the veins is 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment. Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, fainting, or even death. The risk of getting a blood clot in a vein increases with age and if any of the following applies to you. Tell your doctor if any of the following apply to you:
- you cannot walk for a long time due to a major operation, injury or illness (see section 3, “If you need surgery”)
- you are severely overweight ( BMI over 30 kg / m 2 )
- you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- if a close relative has had a blood clot in the bone, lung, or another organ
- you have systemic lupus erythematosus ( SLE )
- you have cancer.
The symptoms of a blood clot are described in the section “Contact a doctor immediately and stop the treatment”.
Comparison
Of women in their 50s who do not take HRT, an average of 4–7 out of 1,000 are expected to have a blood clot in a vein over a 5-year period. Of women in their 50s who take HRT with the estrogen-progestogen for more than 5 years, an average of 9-12 out of 1,000 users are expected to have a blood clot in a vein (ie 5 extra cases).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attack. For women over the age of 60 who take HRT with the estrogen-progestogen, the risk of developing heart disease is slightly higher than for those who do not take HRT.
Stroke (stroke)
The risk of stroke is about 1.5 times higher for those who take HRT compared with those who do not. The number of cases of stroke due to the use of HRT increases with age.
Comparison
Of women in their 50s who do not take HRT, an average of 8 out of 1,000 are expected to have a stroke over a 5-year period. Of women in their 50s who take HRT for more than 5 years, an average of 11 out of 1,000 users is expected to have a stroke (ie 3 extra cases). Other conditions The use of HRT does not prevent memory loss. The risk of memory loss has been found tis in women who start using HRT after the age of 65. Consult your doctor.
Tell your doctor if you have or have had any of the following medical conditions as a closer follow-up is needed during treatment:
- heart disease
- renal impairment
- higher than normal levels of certain blood fats ( hypertriglyceridemia ).
Children
Femostone accounts are not intended for children.
Other drugs and Femostonconti
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect the effect of Femostonconti, which can lead to irregular bleeding. The following applies:
- antiepileptic drugs (eg phenobarbital, carbamazepine and phenytoin )
- drugs against tuberculosis (eg rifampicin, rifabutin)
- drugs against HIV – infection [AIDS] (ritonavir, nelfinavir, nevirapine and efavirenz)
- an herbal medicine containing St. John’s wort ( Hypericum perforatum ).
Laboratory tests
If you need to take blood samples, tell your doctor or laboratory staff that you are using Femostonconti, as this may affect the results of some tests.
Femoston accounts with food and drink
Femostone accounts can be taken with or without food.
Pregnancy and breastfeeding
Femostone accounts are intended for women whose menstruation has stopped.
If you become pregnant
- stop taking Femostonconti and contact a doctor.
Femostone accounts should not be used if you are breast-feeding.
Driving and using machines
The effect of Femostonconti on the ability to drive and use machines has not been studied. The impact is unlikely.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Femostone accounts contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Femostonconti
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
When you can start taking Femostonconti Do not start taking Femostonconti until 12 months after your natural menstrual bleeding has stopped.
You can start taking Femostonconti any day if:
- you are not currently taking any HRT,
- you switch from a continuous combination hormone treatment. This means that you take a tablet every day or use a patch that contains both estrogen and progestogen.
You should start taking Femostonconti the day after the 28-day menstrual cycle if:
- you switch from a cyclic or sequential HRT treatment. This means that you are taking a tablet or using an estrogen-containing patch during the first part of your menstrual cycle. After this, take a tablet or use a patch that contains both estrogen and progestogen for up to 14 days.
How to take Femostonconti
- Swallow the tablet with water.
- The tablets can be taken with or without food.
- Try to take the tablet at the same time each day. In this way, the amount of drugs that work in your body is even throughout the day. This will also help you remember to take your tablets.
- Take one tablet every day, without a break between packs. The days of the week have been marked on the blister maps. This makes it easier for you to remember when to take the tablets.
How much medicine to take
- Your doctor prescribes the lowest effective dose that provides symptom relief and as short a treatment time as possible. Discuss with your doctor if you think your dose is too high or too low.
- Take one yellow tablet every day for a 28-day cycle.
If you need surgery
If you are going to have surgery, tell the staff that you are using Femostonconti. You may need to stop using Femostonconti for 4-6 weeks before surgery to reduce the risk of blood clots (see section 2, Venous thrombosis). Ask your doctor when it is appropriate to start using Femostonconti again.
If you take more Femostonconti then you should
If you (or anyone else) take too many Femostonconti tablets, it is unlikely to be harmful. You may experience nausea, vomiting, tenderness or pain in the breasts, dizziness, abdominal pain, drowsiness, or loss of bleeding. No treatment is needed, but if you are worried, consult a doctor for advice.
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Femostonconti
Take the forgotten tablet as soon as you remember. If it has been more than 12 hours since you should have taken the tablet, skip the forgotten tablet and take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. Breakthrough bleeding or splashing bleeding may occur if you miss a dose.
If you stop taking Femostonconti
Do not stop taking Femostonconti without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following diseases are more common in women taking HRT than in those who do not:
- breast cancer
- severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining
- ovarian cancer
- blood clots in veins in bones or blood clots in lungs ( venous thromboembolism )
- heart disease
- stroke (stroke)
- possible memory loss, if HRT begins after the age of 65.
For more information on these side effects, see section 2.
The following side effects may occur with the use of this medicine:
Very common (may affect more than 1 user in 10):
- headache
- abdominal pain
- back pain
- tenderness or pain in the breasts.
Common (may affect up to 1 in 10 people):
- vaginal fungal infection ( infection caused by the fungus Candida albicans )
- depression, nervousness
- migraine. If you experience migraine-like headaches for the first time, stop taking Femostonconti and see a doctor immediately.
- dizziness
- nausea, vomiting, bloating (swollen stomach), and flatulence ( flatulence )
- allergic skin reactions (eg rash, severe itching, or hives)
- menstrual disorders such as irregular menstrual bleeding, spotting, painful menstrual bleeding ( dysmenorrhea ), more or less menstrual bleeding
- pelvic pain
- vaginal discharge
- weakness, fatigue, or malaise
- swelling of the ankles, feet, or fingers (peripheral edema )
- weight gain.
Uncommon (may affect up to 1 in 100 people):
- symptoms reminiscent of bladder inflammation
- growth in the uterus ( fibroids ) becomes larger
- hypersensitivity reaction you like shortness of breath (allergic asthma )
- altered sex drive
- blood clots in the legs or lungs ( venous thrombosis or pulmonary embolism )
- high blood pressure ( hypertension )
- disorders of blood circulation (peripheral vascular disease)
- enlarged vein and varicose veins
- indigestion
- liver disease, with or without yellowing of the skin (jaundice), weakness or general malaise, and abdominal pain. If you notice that the skin or whites of the eyes turn yellow, stop taking Femostonconti and see a doctor immediately.
- gallbladder disease
- swollen breasts
- premenstrual syndrome (PMS)
- weight loss.
Rare (may affect up to 1 in 1,000 people):
(* Post-marketing adverse reactions that have not been observed in clinical trials have been classified as “rare”.)
- disease due to destruction of red blood cells (hemolytic anemia ) *
- meningioma (a brain tumor) *
- changes in the surface of the eye (sharper curvature of the cornea) *, problems with contact lenses (contact lens intolerance) *
- heart attack (heart attack)
- stroke *
- swelling of the face and neck. This can lead to breathing difficulties ( angioedema )
- purple spots on the skin ( vascular purpura)
- sore, red bumps on the skin (erythema nodosum) *, discoloration of the skin especially on the face or neck (so-called pregnancy spots/liver spots), (chloasma or melasma) *
- leg cramps *.
The following side effects have been reported with the use of other hormone replacement therapies:
- benign or malignant estrogen-dependent tumors, such as cancer of the uterine lining and ovarian cancer (see section 2)
- increased size of the tumor that may be affected by progestogen levels (eg meningioma)
- an autoimmune disease that affects many organs in the body (systemic lupus erythematosus, SLE )
- probably dementia
- aggravated epilepsy
- muscle cramps (Korea)
- arterial blood clots (arterial thromboembolism)
- inflammation of the pancreas ( pancreatitis ) in women with high blood fat levels ( hypertriglyceridemia ) previously
- rash with sharply defined red spots or sores (erythema multiforme)
- urinary incontinence
- sore/lumpy breasts (fibrocystic breast changes)
- erosion of the cervix
- worsening of a rare, inherited pigment disorder in the blood ( porphyria )
- high blood fat levels ( hypertriglyceridemia )
- the increased amount of thyroid hormone.
5. How to store Femoston accounts
Keep this medicine out of the sight and reach of children.
No special storage instructions. Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiration date is the last day of the specified month.
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.
6. Contents of the packaging and other information
Content declaration
- The active substances are estradiol (estradiol hemihydrate) and dydrogesterone.
- Each tablet contains 0.5 mg estradiol and 2.5 mg dydrogesterone.
- The other ingredients in the tablet core are lactose monohydrate, hypromellose, corn starch, anhydrous colloidal silica, and magnesium stearate.
- The other ingredients in the film coating of the tablet are:
- Titanium dioxide (E171), yellow iron oxide (E172), polyvinyl alcohol, macrogol, and talc.
What the medicine looks like and the contents of the pack
- Film-coated tablets. Round, biconvex tablet with the marking 379 on one side (7 mm). Each blister contains 28 tablets.
- Yellow film-coated tablets.
- The tablets are packaged in PVC / aluminum blister packs.
- The packs contain 28, 84 (3 x 28) or 280 (10 x 28) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer:
Abbott Biologicals BV
Vieweg 12
8121 AA Olst
Netherlands
| This medicinal product is authorized under the European Economic Area under the names: | |
|---|---|
| AT | Femoston conti 0.5 mg / 2.5 mg – Film tablets |
| ASK | Femoston Low 0.5 mg / 2.5 mg film-coated tablets |
| CZ | Femoston mini 0.5 mg / 2.5 mg |
| THE | Femoston mini 0.5 mg / 2.5 mg Film tablet |
| DK | Femoston Conti |
| EE | Femostone accounts for 0.5 mg / 2.5 mg |
| ES | Femoston 0.5mg / 2.5mg compresses recovered with film |
| FI | Femoston conti 0.5 / 2.5 tablets, calvapäällysteinen |
| FR | Climaston 0.5mg / 2.5 mg, compressed pill |
| IE | Femoston-conti 0.5 mg / 2.5 mg film-coated tablets |
| IT | Femoston 0.5 mg / 2.5 mg compress rivestite with film |
| LT | Femoston contains 0.5 mg / 2.5 mg full tablet tablets |
| LU | Femoston Low 0.5 mg / 2.5 mg compressed pellets |
| LV | Femoston 0.5 mg / 2.5 mg apvalkotās tablets |
| MT | Femoston-conti 0.5 mg / 2.5 mg film-coated tablets |
| NL | Femosto continuous 0.5 mg / 2.5 mg film-coated tablets |
| NO | Femostonconti |
| PL | Femoston mini |
| PT | Femoston, 2.5 mg + 0.5 mg, compressed revestido |
| SEE | Femostonconti |
| SI | Femphascon contains 0.5 mg / 2.5 mg film-free tablets |
| SK | Femostone contains 0.5 mg / 2.5 mg film-free tablets |
| UK | Femoston-conti 0.5 mg / 2.5 mg, film-coated tablets |