Femoston Tablets Pack Of 28

Femoston(R) Tablets

Oestradiol/Dydrogesterone
Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Femoston tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Femoston against the benefits they expect it will have for you.

If you have any concerns about using Femoston, ask your doctor or pharmacist.

Your doctor and pharmacist have more information.

Keep this leaflet with the medicine.

You may need to read it again.

When you must not use Femoston

Do not use Femoston or other oestrogens, with or without a progestogen to prevent heart attacks, stroke or dementia.

A study called the Women`s Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated oestrogens 0.625 mg and the progestogen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women`s Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated oestrogens and MPA. There are no comparable data currently available for others doses of conjugated oestrogens and MPA or others combinations of oestrogens and progestogens. Therefore, you should assume the risks will be similar for other medicines containing oestrogen and progestogen combinations.

Talk regularly with your doctor about whether you still need treatment with Zumenon.

Treatment with oestrogens, with or without progestogens should be used at the lowest effective dose and for the shortest period of time.

  • What Femoston is used for

    Femoston is a type of treatment called hormone replacement therapy (HRT). It contains the hormones oestradiol and dydrogesterone.

    Femoston helps to relieve the discomfort many women feel during and after the menopause. It also helps to prevent thinning of the bones (osteoporosis), which can cause fractures. Femoston is used by women who still have a uterus (womb).

    Menopause may be natural or a surgical menopause, where the womb is still intact.

  • HRT should not be used for the long-term maintenance of general health or to prevent heart disease. It is not suitable for birth control and it will not restore fertility.
  • How it works

  • Oestradiol is a natural female sex hormone called an oestrogen. It is the same hormone that your ovaries were producing before the menopause. Dydrogesterone is a hormone called a progestogen. It has effects similar to the female hormone, progesterone, which your ovaries also produced before the menopause.
  • The menopause occurs naturally in the course of a woman`s life, usually between the ages of 45 and 55. After menopause your body produces much less oestrogen than it did before. This can cause unpleasant symptoms such as a feeling of warmth in the face, neck and chest, “hot flushes” (sudden intense feelings of heat and sweating throughout the body), sleep problems, irritability and depression. Some women also have problems with urine control or with dryness of the vagina causing discomfort during or after sex. Oestrogens can be given to reduce these symptoms.
  • After the age of 40, and especially after the menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and more likely to break, especially the bones of the spine, hip and wrist. The risk of osteoporosis is increased by lack of oestrogen. Oestrogens can be given to reduce this risk if other treatments are not suitable.
  • Women who still have a uterus must take both oestrogen and progestogen as part of HRT. This is because oestrogen stimulates the growth of the lining of the uterus (called the endometrium). Before menopause this lining is removed during your period through the action of a natural progestogen. After menopause, taking oestrogen on its own as HRT may lead to irregular bleeding and to a disorder called endometrial hyperplasia. Progestogens such as dydrogesterone help to protect the lining of the uterus from developing this disorder.

    Femoston is not a contraceptive and will not prevent pregnancy. Ask your doctor for advice about your need for contraception.

    Ask your doctor if you have any questions why Femoston has been prescribed for you.

    Femoston has been approved for the uses listed above. However, your doctor may prescribe this medicine for another use. If you would like more information ask your doctor.

    HRT should not be used to prevent heart disease or dementia.

    There is no evidence that Femoston is addictive.

    The medicine is available only with a doctor`s prescription.

  • Before you take Femoston

    When you must not take it

    HRT should only be used if you have been fully informed of the risks.

    The decision to use HRT should be based on your particular need and health, and made after a careful medical evaluation.

    Do not use Femoston if you have an allergy to:

  • Oestradiol or dydrogesterone, the active ingredients, or to any of the other ingredients listed at the end of this leaflet
  • Any other medicine containing oestrogen or progestogen, including the birth control pill.
  • Signs of allergy include a skin rash, itching, shortness of breath, and/or swelling of the face, lips, tongue or other parts of the body.

    Do not use Femoston if you have:

  • Cancer of the breast or uterus (womb) or any other oestrogen dependent cancer, or you have had this condition in the past
  • blood clots in your blood vessels, now or in the past. You may have had painful inflammation of the veins or blockage of a blood vessel in the legs, lungs, brain or heart
  • a condition that increases the tendency for you to get blood clots
  • endometriosis (a disorder of the uterus that may cause painful periods and abnormal bleeding)
  • abnormal vaginal bleeding that has not been investigated
  • severe liver disease
  • a condition called porphyria
  • a tumour of the pituitary gland or hypothalamus
  • a disease of the connective tissue
  • hearing loss due to a problem with the bones in the ear called otosclerosis
  • If you are not sure whether any of the above conditions apply to you, your doctor can advise you.

    Do not use Femoston if you are pregnant or breast-feeding.

    It may affect your baby.

    Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering, or if the tablets do not look quite right.

    In that case, return it to your pharmacist.

    You must stop taking Femoston 4 weeks before certain types of surgery.

    Please consult your doctor.

    Before you start to take it

    You must have a thorough medical check-up before starting HRT for the first time or recommencing HRT.
    Tell your doctor if you have:

  • A family history of breast cancer
  • Nodules, lumps or cysts in your breasts or any other benign breast condition (not cancer)
  • Fibroids or other benign tumours of the uterus (not cancer)
  • Unusual or irregular bleeding or spotting from the vagina
  • Endometriosis
  • High blood pressure
  • Liver problems, including yellowing of the skin and whites of the eyes and a condition called porphyria
  • Had a problem in the past with a condition called cholestatic jaundice when you were pregnant or took an oestrogen (eg birth control pill or HRT)
  • Kidney problems
  • Heart problems
  • Diabetes
  • Migraine
  • Asthma
  • Epilepsy
  • Systemic lupus erythematosus
  • Gall bladder disease
  • A high level of triglycerides (fats) in the blood
  • High or low levels of calcium in the blood.
  • Tell your doctor if you are likely to have an increased risk of developing blood clots in your blood vessels. The risk increases as you get older and it may also be increased if:

  • Anyone in your immediate family has ever had blood clots in the blood vessels of the legs or lungs
  • You are overweight
  • You have varicose veins
  • You have a disorder called systemic lupus erythematosus (SLE).
  • Your doctor will advise you whether or not to take Femoston, or if you need to adjust the dose, or adapt your treatment.

  • Taking other medicines

    Tell your doctor if you are taking birth control pills.

    Femoston is not a contraceptive. Since pregnancy may be possible early in the menopause while you are still having menstrual periods, you should ask your doctor to suggest another (non-hormonal) method of birth control.

    Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

    Some medicines and Femoston may interfere with each other. These include:

  • Herbal medicines containing St John`s wort
  • Some medicines for epilepsy such as phenytoin, phenobarbitone and carbamazepine
  • Some antibiotics and anti-infectives such as rifampicin and ritonavir
  • Femoston may affect these medicines or they may affect how well it works. You may need to take different amounts of your medicines or take different medicines.

    Your doctor or pharmacist has more information on medicines to be careful with or avoid while you are using Femoston.

    Femoston will NOT influence your ability to drive or to operate machinery or equipment.

    If you have not told your doctor about any of these things, tell them before you start using Femoston.

  • How to take Femoston

    Follow all directions given to you by your doctor carefully.

    These instructions may differ from the information contained in this leaflet.

    If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

    When to start it

    If you are having regular periods, you may start taking Femoston on the first day of your period. If you are having irregular periods, discuss the starting day with your doctor. If you have not had a period for 12 months or more, you can start Femoston immediately.

    How much to take

    The usual dose is one tablet daily.

    How to take it

    Swallow the tablets whole with a glass of water.

    Femoston can be taken with or without a meal.

    When to take it

    Femoston tablets should preferably be taken at the same time each day.

    The tablets are labelled with the days of the week to help you make sure you are taking your tablets every day.

    You must always start by taking the tablets in the half of the pack with an arrow marked “1”. When you come to the end of these tablets, start taking the tablets in the other half of the pack marked “2”.

    You should start each new pack the day after you have finished the old pack. Do not leave a gap between packs.

    How long to take it

    Although some women have no symptoms of the menopause or only mild ones, and may not need extra hormones, other women may need to use Femoston.

    Your doctor can advise you how long you may need to take Femoston.

    Your doctor can discuss the risks and benefits of long-term treatment with HRT in your particular case. Some recent studies have shown that women using HRT have a small increase in breast cancer risk after several years of use. The risk increases with the length of HRT use.

    Recent studies have also shown that HRT is associated with a small increase in the risk of heart attacks, strokes, blood clots, including clots in the lungs. On the other hand the risk of hip fractures and bowel cancer may be reduced.

    Another study has shown that in women older than 65 years, HRT is associated with a small increase in the risk of dementia, including Alzheimer`s disease. It is not known if this finding applies to younger women.

    If you forget to take it

    Take it as soon as you remember, and then go back to taking it as you would normally.

    If it is almost time for your next dose, skip the tablet you missed, and take your next tablet when you are meant to. A slight vaginal bleeding, like an irregular period, could occur.
    Do not take a double dose to make up for the one you missed.

    If you have forgotten to take more than one tablet, discuss this with your doctor.

    If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

    Overdose

    Telephone your doctor, or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) or go to casualty at your nearest hospital immediately if you think you or anybody else may have taken too much Femoston.

    In general, taking too many Femoston tablets would not make you ill.

    While you are taking Femoston

    Things you must do

    Always follow your doctor`s instructions carefully.

    Tell other doctors, dentists and pharmacists who are treating you that you are taking Femoston.
    If you are about to be started on any new medicine, tell your doctor, dentist of pharmacist that you are taking Femoston.
    If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Femoston.
    If you become pregnant while using Femoston, tell your doctor immediately.

    It should not be used while you are pregnant.

    See your doctor at least once a year for a check-up. Some women will need to go more often. Your doctor will:

  • check your breasts and order a mammogram at regular intervals
  • check your uterus and cervix and do a pap smear at regular intervals
  • check your blood pressure and cholesterol level.
  • Check your breasts each month and report any changes promptly to your doctor.

    Your doctor or nurse can show you how to check your breasts properly.

    If you notice any changes to your breasts, see your doctor.

    Include foods that are good sources of calcium and Vitamin D in your daily diet and exercise regularly. Calcium, Vitamin D and exercise may help prevent thinning of the bones. Your doctor can advise you on which foods and types of exercise are best for you.

    Tell your doctor that you are using Femoston well in advance of any expected hospitalisation or surgery. If you go to hospital unexpectedly, tell the doctor who admits you that you are using it.

    The risk of developing blood clots in your blood vessels may be temporarily increased as a result of an operation, serious injury or having to stay in bed for a prolonged period. If possible, this medicine should be stopped at least 4 weeks before surgery and it should not be restarted until you are fully mobile.

    If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Femoston.

    Tell any other doctor, dentist or pharmacist who treats you that you are using Femoston.

    Things you must not do

    Do not use this medicine to treat any other complaints unless your doctor tells you to.

  • Do not give it to anyone else, even if their symptoms seem similar to yours.
  • Do not take more or less than the recommended amount.
    Do not stop taking Femoston without checking with your doctor first.

    Never allow others to take medicines recommended for you, and never use medicines prescribed for others.

    SIDE EFFECTS

    Tell your doctor as soon as possible if you do not feel well while you are using Femoston.

    All medicines can have side effects. Often they are not serious but sometimes they can be. You may need medical treatment if you get some side effects.

    Do not be alarmed by this list of possible side effects. You may not experience any of them.
    Ask your doctor or pharmacist to answer any questions you may have.
    Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing
  • signs that blood clots may have formed, such as sudden severe headache, sudden loss of coordination, blurred vision or sudden loss of vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood
  • pain or tenderness in the abdomen, which may be accompanied by fever, loss of appetite, nausea and vomiting
  • a yellow colour to the skin or eyes, itching, dark coloured urine or light coloured bowel motions.
  • The above side effects are serious, requiring urgent medical attention or hospitalisation. These side effects are rare.

    Tell your doctor if you notice any of the following and they worry you:

  • irregular vaginal bleeding or spotting (if bleeding is heavy, check with your doctor as soon as possible)
  • tender, painful or swollen breasts
  • period-like pain
  • vaginal itching, inflammation or fluid discharge
  • swelling of the lower legs, ankles, fingers or abdomen due to fluid retention
  • nausea (feeling sick), abdominal cramps, vomiting, heartburn, wind, diarrhoea
  • headache, migraine
  • rise in blood pressure
  • weakness or dizziness
  • depression, nervousness, rapid changes in mood, difficulty sleeping
  • back pain
  • change in sex drive
  • weight gain
  • acne, itchy or dry skin, skin discolouration
  • Tell your doctor if you notice anything else that is making you feel unwell.

    Other side effects not listed above may happen in some people.

    After using Femoston

    Storage

    Keep your Femoston below 30 degrees C and protected from light.

    Keep your Femoston tablets in the pack till it is time to take them.

    Do not store Femoston, or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car on hot days.

  • Heat and dampness can destroy some medicines.
  • Keep your Femoston where young children cannot reach it.

  • A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
  • Disposal

    Once you have finished using Femoston tablets, ask your pharmacist what to do with any that are left over.

  • Product Description

    What it looks like

    Femoston 2/10 tablets are available in blister strip packs containing 28 tablets. Each blister strip contains: Fourteen brick-red, round tablets and fourteen yellow, round tablets.

    Ingredients

    The brick-red tablets each contain 2mg of oestradiol (as hemihydrate).

    The yellow tablets each contain 2mg of oestradiol (as hemihydrate) and 10mg of dydrogesterone.

    Femoston 2/10 tablets also contain the excipients; lactose, hypromellose, maize starch, colloidal anhydrous silica, and magnesium stearate.

    The colour ingredients used in Femoston 2/10 is Opadry OY-6957 pink (for 2 mg oestradiol tablet only) and Opadry OY-02B22764 yellow (for combination tablet with 2 mg oestradiol and 10 mg dydrogesterone).

    Manufacturer

    Femoston tablets are made in The Netherlands for

  • Solvay Pharmaceuticals
  • ACN 007 401 201
  • A division of Solvay Biosciences Pty. Ltd.
  • Level 1, Bldg. 2, 20 Bridge Street,
  • Pymble NSW 2073
  • Telephone: (02) 9440 0977
  • Femoston 2/10 Tablets AUST R 75889
  • Date of Preparation: October 2006
  • ENQUIRE

    1800 200 736