Femoston Conti is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. Femoston Conti is used in postmenopausal women at least 6 months since last menses. 

Femoston is used for

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in menopausal women at least 12 months since last menses.

Prevention of osteoporosis in postmenopausal womenat high risk of future fractures. Femoston 1/10 should only be used in patients who are 

intolerant of other products, approved for the prevention of osteoporosis or for whomthese products are contra-indicated (see also section 4.4).

Experience with treatment of women older than 65 years is limited

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 Conti. Go for regular breast screening (X-ray), 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 Conti.

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 recently have had a disease cased 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 has 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Femoston if you have or ever have had any of the following problems listed below, 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 problem;

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 Conti’ section;

- Yellowing of your skin or the whites of your eyes (jaundice). These may be a sign 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;

- You become pregnant;

- 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 hormone progestogen in this medicine protects from this extra risk.

Unexpected vaginal bleeding

You will  have a bleed once a month (so-called withdrawal bleed) while asking 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 shows that taking combined oestrogen-progestogen or oestrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear after 3 years of use. After stopping HRT, the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.

Compare

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 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.

Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e., about 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 women using HRT than in non-users, especially during the first year of treatment.

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 Conti 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 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.

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 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).

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.

Other medicines and Femoston Conti

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

Some medicines may limit the effect of Femoston, which might lead to irregular bleeding. This applies to:

- 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)

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are using Femoston, because this may affect the results of some tests.

What should you watch out for 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,

Ø stop taking Femoston immediately 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.

Always take this medicine 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 6 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 everyday a tablet or use a patch which contains both an oestrogen and a progestogen.

You start taking Femoston the day after you finish the 28 days’ 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 an 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 every 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 a period as short as possible. Speak to your doctor if you think this dose is too high or just too low.

·  If you are taking Femoston to prevent osteoporosis, your doctor will adjust the dose as it suits you. It will depend on your bone mass.

·  Take one white tablet every day for the first 14 days followed by one grey tablet every day for the next 14 days. This is shown on the 28 days calendar pack.

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 surgery to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking this medicine again.

If you take more Femoston than you should

If you (or someone else) take too many Femoston tablets, it is unlikely that this will cause any harm. You may feel sick (nauseous), or you must vomit, you may have tender or painful breasts, dizziness, abdominal pain, drowsiness/tiredness or withdrawal bleeding. Treatment is not 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 to compensate for the forgotten dose. Bleeding or spotting may occur if you miss a dose.

If you stop taking Femoston

Do not stop taking Femoston Conti without first talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine 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 maximum 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 maximum 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

Rare (may affect maximum 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 tumour)*

- Change in the surface of the eye (steepening of corneal curvature)*, not being able to wear contact

lenses (contact lens 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 progestogens (such as meningioma)

- A disease of the immune system that affects 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 pre-existing 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

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Shelf life: 3 years.

Do not use this medicine after the expiry date, which is stated on the blister and the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment