Femoston

• Hormone Replacement Therapy (HRT)
• For relief of menopausal symptoms
• No tablet-free week

Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen (oestradiol) and a progestogen (dydrogesterone). Femoston is used in postmenopausal women who have not had a period in more than six months.

Femoston is used for:

• Relief of symptoms occurring after menopause (e.g., hot flashes).
• Prevention of osteoporosis (fragile bones).

Always use this medicine exactly as your doctor or pharmacist has told you. Contact your doctor or pharmacist if you are not sure.

When to start taking Femoston

You can begin taking Femoston on any convenient day if:

• You are not taking any other HRT preparations.
• You are switching from a combined continuous HRT product (i.e., combined oestrogenprogestogen tablets or patches).

You can begin taking Femoston immediately after the 28-day cycle if:

• You are currently using a ‘cyclic’ or ‘sequential’ HRT preparation, which involves taking an oestrogen tablet or patch for part of the month, followed by both oestrogen and progestogen tablet or patch for up to 14 days.

How to take Femoston

Take the tablet with a drink of water. Femoston tablets can be taken with or without food. It is also important to take your tablet each day at about the same time to avoid missing a dose and to keep a constant level of medicine in the body.

Femoston is taken without a break between packs. The days of the week are printed on the back of the blister strips. This is to show you on which day to take each tablet.

Dosage

Each strip of Femoston contains 28 tablets. The two tablet strengths have different colours.

• Take one tablet a day. Follow the order printed on the calendar pack. The tablets from the part marked with arrow 1 should be taken first, then the tablets from the part marked with arrow 2 should be taken. When a strip is empty, you must start with a new strip of Femoston on the next day. There is no tabletfree week.

Alcohol/driving

This medicine does not interact with alcohol or impair your ability to drive safely.

If you take more or less Femoston than you should/stop taking Femoston

If you have taken more Femoston tablets than you should, dizziness, nausea, breast tenderness and withdrawal bleeding may occur. 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 since you took the last one, take the next dose without taking the forgotten tablet. Do not take a double dose. Bleeding or spotting may occur if you miss a dose.

Do not stop taking Femoston without consulting your doctor first.

Femoston is not suitable for every female. Do not take this medicine if:

• You have, or have had, breast cancer, or if you are suspected of having it.
• You have a malignant tumour which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being
• treated.
• You have, or have had, a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• You have a blood clotting disorder (e.g., protein C, protein S, or antithrombin deficiency).
• You have, or recently have had, a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have, or have had, a liver disease and your liver function tests have not returned to normal.
• You have a rare blood problem called porphyria, which is passed down in families.
• You are allergic to any of the other ingredients in Femoston (see section 'What Femoston contains').

If any of the above conditions appear for the first time while taking Femoston, stop taking it at once and consult your doctor immediately.

If you are going to have surgery, tell the surgeon that you are taking Femoston. You may need to stop taking Femoston about four to six weeks before the operation to reduce the risk of a blood clot.

When should this medicine be used with caution?

Tell your doctor if you have ever had any of the following problems before you start the treatment:

• Fibroids inside your womb.
• Growth of womb lining outside your womb (endometriosis).
• Excessive growth of the womb lining (endometrial hyperplasia).
• Benign brain tumour (meningioma).
• Increased risk of developing blood clots.
• Increased risk of getting an oestrogensensitive 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.
• Systemic lupus erythematosus (SLE).
• Epilepsy.
• Asthma.
• Otosclerosis.
• A very high level of fat in your blood (triglycerides).
• Fluid retention due to cardiac or kidney problems.

You can find more information on this topic in the package leaflet.

Pregnancy and breastfeeding

Femoston is not intended for women who are in the fertile age bracket. This medicine is not a contraceptive. Stop taking Femoston and see a doctor immediately if you become pregnant while taking Femoston.

Do not use this medicine if you are breastfeeding.

Other medicines and Femoston

Some medicines may interfere with the effect of Femoston. This can lead to irregular bleeding. This applies to the following medicines:

• Medicines for epilepsy(e.g., phenobarbital, phenytoin, carbamazepine).
• Medicines for tuberculosis(e.g., rifampicin, rifabutin).
• Medicines for HIV infection (e.g.., nevirapine, efavirenz, ritonavir, nelfinavir).
• 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.

The following serious side effects may occur during treatment with Femoston:

Very common (more than 1 in 10 patients treated):

• Headache.
• Abdominal pain.
• Back pain.
• Breast pain or tenderness.

Common(up to 1 in 10 patients treated):

• Vaginal yeast infection.
• Depression, nervousness.
• Migraine (consult a doctor if you have never had migraine headaches before).
• Dizziness.
• Problems affecting the stomach and intestines.
• Allergic skin reactions (skin irritation, itching).
• Menstrual problems.
• Pelvic pain.
• Vaginal discharge.
• Generally feeling unwell, weak or tired.
• Swelling of the ankles, feet or fingers (peripheral oedema).
• Weight gain.

For a list of less common and rare side effects, please see the package leaflet. The use of Femoston has been associated with a slightly increased risk of thrombosis and certain types of cancer. Please see the package leaflet for more information. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

Femoston is available in two forms:

Femoston 1/10

The active ingredients in this medicine are oestradiol (oestradiol hemihydrate) and dydrogesterone. Each white tablet contains 1 mg oestradiol. Each grey tablet contains 1 mg oestradiol and 10 mg dydrogesterone.

The other ingredients are:

• Tablet core: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate.
• Film coating: titanium dioxide (E171), black iron oxide (E172), polyvinyl alcohol, macrogol 3350, talc, macrogol 400, hypromellose.

Femoston 2/10

The active ingredients in this medicine are oestradiol (oestradiol hemihydrate) and dydrogesterone. Each brick red tablet contains 2 mg oestradiol. Each yellow tablet contains 2 mg oestradiol and 10 mg dydrogesterone.

The other ingredients are:

• Tablet core: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate.
• Film coating: titanium dioxide (E171), yellow iron oxide (E172), hypromellose, macrogol 400, talc, red iron oxide (E172), black iron oxide (E172).

The manufacturer of Femoston is:

Abbott Biologicals B.V. Veerweg 12
8121 AA Olst
The Netherlands

Read the package leaflet before use. The official package leaflet of Femoston 1/10 is available for download here. You can find the package leaflet of Femoston 2/10 here.