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					Premia(R) 2.5
Continuous & Premia 5
Conjugated oestrogens and Medroxyprogesterone acetate Tablets

Consumer Medicine Information

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What is in this leaflet                   oestrogens 0.625 mg and the            Premia Continuous helps to relieve
                                          progestogen medroxyprogesterone        the discomfort many women feel
This leaflet answers some of the          acetate (MPA). The researchers         during and after the menopause. It
common questions about Premia             stopped the study after 5 years when   also helps to prevent thinning of the
Continuous Tablets. It does not           it was determined the risks were       bones (osteoporosis), which can
contain all of the available              greater than the benefits in this      cause fractures. Premia Continuous
information.                              group. The Women's Health              is used by women who still have a
                                          Initiative Memory Study indicated      uterus (womb).
It does not take the place of talking     increased risk of dementia in women
to your doctor or pharmacist.                                                    If your doctor thinks you will need to
                                          aged 65-79 years taking conjugated
                                                                                 take HT for a long time, including
All medicines have risks and              oestrogens and MPA. There are no
                                                                                 for the prevention of osteoporosis,
benefits. Your doctor has weighed         comparable data currently available    your doctor will have considered the
the risks of you taking Premia            for other doses of conjugated
                                                                                 benefits and risks of other treatments
Continuous against the benefits they      oestrogens and MPA or other
                                                                                 before prescribing Premia
expect it will provide.                   combinations of oestrogens and         Continuous for you.
                                          progestogens. Therefore, you should
If you have any concerns about
                                          assume the risks will be similar for
using Premia Continuous, ask your                                                How it works
doctor or pharmacist.                     other medicines containing oestrogen
                                          and progestogen combinations.          Conjugated oestrogens are a mixture
Your doctor and pharmacist have
                                          Talk regularly with your doctor        of natural female sex hormones.
more information.
                                          about whether you still need           They are like the hormones that your
Keep this leaflet with the medicine       treatment with Premia                  ovaries were producing before
You may need to read it again.            Continuous.                            menopause.
                                          Treatment with oestrogens, with or     Medroxyprogesterone acetate (MPA)
                                          without progestogens should be used    is a hormone called a progestogen. It
                                          at the lowest effective dose and for   has effects similar to the female
When you must not                         the shortest period of time.           hormone, progesterone, which your
use Premia Continuous                                                            ovaries also produced before the
Do not use Premia or other                                                       The menopause occurs naturally in
oestrogens, with or without a             What Premia                            women usually between the ages of
progestogen to prevent heart              Continuous is used for                 45 and 55. During menopause, your
attacks, stroke or dementia.                                                     body produces less oestrogen than it
A study called the Women's Health         Premia Continuous is a type of         did before. This can cause
Initiative indicated increased risk of    treatment called hormone therapy       unpleasant symptoms such as a
heart attack, stroke, breast cancer,      (HT) and contains the hormones         feeling of warmth in the face, neck
and blood clots in the legs or lungs in   conjugated oestrogens and              and chest, "hot flushes", which are
women receiving treatment with a          medroxyprogesterone acetate (MPA).     like sudden, intense feelings of heat
product containing conjugated                                                    and sweating throughout the body.

PREMIA(R) CONTINUOUS                                                                                                     1
Some women also have problems            Before you take Premia                   If you are not sure whether any of the
with dryness of the vagina causing       Continuous                               above conditions apply to you, ask
discomfort during or after sexual                                                 your doctor.
intercourse. Oestrogens can be given
                                                                                  Do not take Premia Continuous if
to reduce or eliminate these             When you must not take it                you are pregnant or think you are
symptoms.                                                                         pregnant or you are
                                         HT should only be used if you have       breast-feeding.
After the age of 40, and especially
                                         been fully informed of the risks.
after the menopause, some women                                                   It may harm your baby. Oestrogens
develop osteoporosis. This is a          The decision to use HT should be
                                                                                  have been found in breast milk and
thinning of the bones that makes         based on your particular needs and
                                                                                  may reduce the production of breast
them weaker and more likely to           health, and made after a careful
break, especially the bones of the       medical evaluation.
spine, hip and wrist. The risk of                                                 Do not take Premia Continuous
                                         Do not take Premia Continuous if         after the expiry date printed on the
osteoporosis is increased by a lack of   you have an allergy to:                  pack or if the packaging is torn or
oestrogen. Oestrogens can be given
                                         *   Conjugated oestrogens or MPA,        shows signs of tampering.
to reduce this risk.
                                             the active ingredients in Premia     If this is the case, take the tablets
Women who still have a uterus must           Continuous                           back to your pharmacist.
take both oestrogen and progestogen      *   Any of the ingredients listed at
as part of HT. This is because               the end of this leaflet              Premia Continuous is not for use in
oestrogen stimulates the growth of                                                children.
                                         *   Any other medicine containing
the lining of the uterus (called the                                              If you are not sure whether you
                                             oestrogen or progestogen,
endometrium). Before menopause                                                    should take Premia Continuous,
                                             including the birth control pill.
this lining is shed during your period                                            contact your doctor.
through the action of a natural          Signs of allergy include a skin rash,
progestogen.                             itching, shortness of breath and/or a
                                         swollen face, lips, tongue or other      Before you start to take it
After menopause, taking oestrogen        parts of the body.
on its own as HT may lead to                                                      You must have a thorough medical
irregular bleeding and a disorder of     Do not take Premia Continuous if         check-up before starting HT for
                                         you have:                                the first time or recommencing
the uterus lining called endometrial
hyperplasia, which can become            *   Cancer of the breast or uterus or
endometrial cancer. Progestogens             any other oestrogen dependent        Tell your doctor if you have:
such as MPA help protect the lining          cancer, or you have had this         *   A family history of breast cancer
of the uterus from developing this           condition in the past or think you
                                                                                  *   Nodules, lumps or cysts in your
disorder.                                    have one of these conditions.
                                                                                      breasts or any other benign breast
Ask your doctor if you have any          *   A problem with blood clots               condition (not cancer)
questions why Premia Continuous              forming in your blood vessels,
                                                                                  *   Fibroids or other benign tumours
has been prescribed for you.                 now or in the past. You may
                                                                                      of the uterus (not cancer)
                                             have had painful inflammation of
Premia Continuous has been                                                        *   Unusual or irregular bleeding or
                                             the veins (thrombophlebitis) or
approved for the uses listed above.                                                   spotting from the vagina
                                             blockage of a blood vessel in the
However, your doctor may have                                                     *   Endometriosis
                                             legs (deep vein thrombosis), or
prescribed it for another use.                                                    *   High blood pressure
                                             lungs (pulmonary embolism).
Premia is available only with a          *   Heart disease or have recently       *   Liver problems, including
doctor's prescription. It is not             had a stroke.                            yellowing of the skin and whites
habit-forming.                           *   Abnormal genital bleeding,               of the eyes and a condition called
Premia Continuous is not suitable for        which your doctor has not                porphyria
birth control and it will not restore        checked out.                         *   Had a problem in the past with a
fertility.                               *   Problems with your breasts,              condition called cholestatic
                                             which your doctor has not                jaundice when you were pregnant
                                             checked out.                             or took an oestrogen (eg birth
                                                                                      control pill or HT)
                                         *   Liver disease.
                                                                                  *   Kidney problems
                                         *   Severe uncontrolled high blood
                                             pressure.                            *   Heart problems
                                                                                  *   Diabetes

PREMIA(R) CONTINUOUS                                                                                                      2
*   Migraine                             *   Some antibiotics and                 How long to take it
*   Asthma                                   anti-infectives such as rifampicin
                                                                                  Although some women have no
*   Epilepsy                                 and erythromycin
                                                                                  symptoms of the menopause or only
*   Systemic lupus erythematosus         *   Thyroid replacement therapy
                                                                                  mild ones, and may not need extra
*   Gall bladder disease                 *   Dexamethasone                        hormones, other women may need to
*   A high level of triglycerides        *   Aminoglutethemide.                   use Premia Continuous.
    (fats) in the blood                  Premia Continuous may affect these       Your doctor can advise you how
*   High or low levels of calcium in     medicines or they may affect how         long you may need to take Premia
    the blood.                           well it works. You may need to take      Continuous.
                                         different amounts of your medicines
Tell your doctor if you are likely to                                             Your doctor can discuss the risks and
                                         or take different medicines.
have an increased risk of                                                         benefits of long-term treatment with
developing blood clots in your           Your doctor or pharmacist has more       HT in your particular case. Some
blood vessels. The risk increases as     information on medicines to be           recent studies have shown that
you get older and it may also be         careful with or avoid while you are      women using HT have a small
increased if:                            using Premia Continuous.                 increase in breast cancer risk after
*   Anyone in your immediate                                                      several years of use. The risk
    family has ever had blood clots in                                            increases with the length of HT use.
    the blood vessels of the legs or
                                                                                  Recent studies have also shown that
    lungs                                How to Take Premia                       HT is associated with a small
*   You are overweight                   Continuous                               increase in the risk of heart attacks,
*   You have a disorder called                                                    strokes, blood clots, including clots
    systemic lupus erythematosus         Follow all directions given to you       in the lungs. On the other hand the
    (SLE).                               by your doctor or pharmacist.            risk of hip fractures and bowel cancer
If you have not told your doctor         These instructions may differ from       may be reduced.
about any of these things, tell them     the information contained in this        Another study has shown that in
before you start using Premia            leaflet.                                 women older than 65 years, HT is
                                         If you do not understand the             associated with a small increase in
                                         instructions on the label, ask your      the risk of dementia, including
Taking Other Medicines                   doctor or pharmacist for help.           Alzheimer's disease. It is not known
Tell your doctor if you are taking                                                if this finding applies to younger
birth control pills.                     When to start it                         women.

Premia Continuous is not a               If you are not already using any type
contraceptive. Since pregnancy may                                                If you forget to take it
                                         of HT you can start Premia
be possible early in the menopause       Continuous on any convenient day.        If less than 12 hours has passed
while you are still having menstrual                                              from the time you normally take
periods, you should ask your doctor      If you are already using a different
                                                                                  Premia Continuous, take the
to suggest another (non-hormonal)        type of HT, your doctor can advise
                                                                                  missed tablet.
method of birth control.                 you when to start Premia
                                         Continuous.                              Take the next tablet at the usual time.
Tell your doctor or pharmacist if
                                                                                  If more than 12 hours has passed,
you are taking any other
                                         How much to take                         discard the missed tablet and take
medicines, including medicines
                                                                                  the next tablet when you normally
that you buy without a                   Treatment consists of a 28-day cycle.    would.
prescription from a pharmacy,
supermarket or health food shop.         Take one tablet daily.                   Do not take a double dose to make
Some medicines and Premia                Take all tablets in a blister pack       up for the one you missed.
Continuous may interfere with each       before starting a new pack.              If you have trouble remembering
other. These include:                    Swallow the tablets whole with a         when to take your medicine, ask your
*   Herbal medicines containing St       glass of water.                          pharmacist for some hints.
    John's wort                          Premia Continuous can be taken with
*   Some medicines for epilepsy          a meal or between meals.
    such as phenytoin,
    phenobarbitone and

PREMIA(R) CONTINUOUS                                                                                                   3
Overdose                                Calcium, Vitamin D and exercise          need medical treatment if you get
                                        may help prevent thinning of the         some side effects.
Telephone your doctor, or the           bones. Your doctor can advise you
Poisons Information Centre              on which foods and types of              Do not be alarmed by this list of
(telephone 13 11 26 Australia) or       exercise are best for you.               possible side effects. You may not
go to Accident and Emergency at                                                  experience any of them.
your nearest hospital immediately       Tell your doctor well in advance
                                        (at least 4 to 6 weeks) of any           Ask your doctor or pharmacist to
if you think you or anybody else                                                 answer any questions you may
has taken too much Premia               expected hospitalisation or
                                        surgery. If you go to hospital           have.
                                        unexpectedly, tell the doctor who        Tell your doctor immediately or go
If you have taken too much,             admits you that you are using            to Accident and Emergency at
symptoms you may get include            Premia Continuous.                       your nearest hospital if you notice
nausea, vomiting, breast tenderness,                                             any of the following:
                                        The risk of developing blood clots in
dizziness, stomach pain, and
                                        your blood vessels may be                *   Signs of allergy such as rash,
drowsiness or tiredness. Women
                                        temporarily increased as a result of         itching or hives on the skin;
may also get breakthrough bleeding.
                                        an operation, serious injury or having       swelling of the face, lips, tongue
                                        to stay in bed for a prolonged period.       or other part of the body;
                                        Tell your doctor if you have any             shortness of breath, wheezing or
                                        breakthrough bleeding or spotting,           troubled breathing.
While you are taking                    which persists after 2 to 3 months       *   Signs that clots may have formed,
Premia Continuous                       of treatment with Premia                     such as sudden severe headache,
                                        Continuous.                                  sudden loss of coordination,
                                        Breakthrough bleeding or spotting            blurred vision, slurred speech,
Things you must do                                                                   numbness or tingling in an arm
                                        may occur during the first few
If you become pregnant while            months of treatment and then stop.           or leg, painful swelling in the
using Premia Continuous, tell your      However, if the bleeding continues           calves or thighs, chest pain,
doctor immediately.                     your doctor may wish to check why            difficulty breathing, coughing
                                        this is happening.                           blood.
It should not be used while you are
pregnant.                                                                        *   Sudden partial or complete loss
                                        If you are about to be started on
                                                                                     of vision or other problems with
See your doctor at least every six      any new medicine, remind your
                                                                                     your eyesight.
months for a check up. Some             doctor or pharmacist that you are
                                        taking Premia Continuous.                *   Pain or tenderness in the
women will need to go more often.
Your doctor will:                                                                    abdomen, which may be
                                        Tell any other doctor, dentist or            accompanied by fever, loss of
*   Check your breasts and order a      pharmacist who treats you that
                                                                                     appetite, nausea and vomiting.
    mammogram at regular intervals.     you are taking Premia Continuous.
                                                                                 *   A yellow colour to the skin or
*   Check your uterus and cervix and                                                 eyes, itching, dark coloured urine
    do a pap smear at regular           Things you must not do                       or light coloured bowel motions.
                                        Do not use Premia Continuous to          The above side effects are serious,
*   Check your blood pressure           treat any other complaints unless        requiring urgent medical attention or
Your doctor may also take blood to      your doctor tells you to.                hospitalisation. These side effects
check your blood fat and sugar levels                                            are rare.
                                        Do not give Premia Continuous to
and liver function.
                                        anyone else, even if their symptoms      Tell you doctor if you notice any of
This helps to prevent unwanted          seem to be the same as yours.            the following and they worry you:
effects of HT.
                                                                                 *   Irregular vaginal bleeding or
Conduct monthly self-examination                                                     spotting (if bleeding is heavy
of your breasts.                                                                     check with your doctor as soon as
Your doctor or nurse can show you
                                        Side Effects                                 possible)
how to check your breasts properly.                                              *   Tender, painful or swollen
If you notice any changes to your       Tell your doctor as soon as possible         breasts, secretions from the
                                        if you do not feel well while you are        breasts
breasts, see your doctor.
                                        taking Premia Continuous.
                                                                                 *   Period-like pain
Include foods that are good sources     All medicines have side effects.
of calcium and Vitamin D in your                                                 *   Vaginal discharge or change in
                                        Often they are not serious but               secretions
daily diet and exercise regularly.
                                        sometimes they can be. You may

PREMIA(R) CONTINUOUS                                                                                                      4
*   Vaginal thrush                        Heat and dampness can destroy some      *   Calcium sulfate
*   Enlargement of fibroids in the        medicines.                              *   Glyceryl mono-oleate
    uterus                                Keep Premia Continuous where            *   Macrogol 20000
*   Stomach cramps or swelling or         young children cannot reach it.         *   Shellac
    passing wind                                                                  *   Stearic acid
                                          A locked cupboard at least
*   Nausea or vomiting                    one-and-a-half metres above the         *   Titanium dioxide
*   Headache or migraine                  ground is a good place to store         *   Carnauba wax
*   Loss of memory                        medicines.                              *   Black Ink.
*   Irregular, rapid jerky movements
                                                                                  The following colouring agent is
*   Dizziness                             Disposal                                found in Premia 2.5 Continuous:
*   Depression or anxiety
                                          Once you have finished taking           *   Ferric Oxide (red) (CI 77491).
*   Problems sleeping or sleepiness       Premia Continuous Tablets ask your      The following colouring agent is
*   Moodiness or irritability             pharmacist what to do with any that     found in Premia 5 Continuous:
*   Changes in sex drive                  are left over.
                                                                                  *   Indigo carmine (CI 73015).
*   Swelling of the lower legs, ankles
    or fingers due to fluid retention
*   Swelling and redness along a
    vein which is extremely tender to     Product Description                     Premia Continuous Tablets are
    touch                                                                         supplied in Australia by:
*   Weight changes
*   Acne, itchy skin, or skin
                                          What it looks like                      Wyeth Australia Pty Limited
    discolouration                        Premia 2.5 Continuous comes in a        ABN 16 000 296 211
*   Skin rash                             blister pack containing 28 peach oval   17-19 Solent Circuit
*   Hair loss or extra hair growth        tablets printed with "0.625/2.5" in     Baulkham Hills NSW 2153
*   Intolerance to contact lenses         black ink.
*   Worsening of porphyria                Premia 5 Continuous comes in a          Telephone: (02) 9761 8200 or (02)
*   Enlargement of a pre-existing         blister pack containing 28 blue oval    8850 8200
    benign liver tumour                   tablets printed with "0.625/5" in
                                          black ink.                              If you would like more information
*   Inflammation of the pancreas.
                                                                                  about Premia Continuous call Wyeth
Tell your doctor if you notice
anything else that is making you          Ingredients                             on free call:
feel unwell.                              The active ingredients are conjugated   1800 500 498 (Australia) or
Other side effects not listed above       oestrogens and MPA.                     email:
may happen in some people.                Each Premia 2.5 Continuous Tablet
                                          contains conjugated oestrogens 0.625    Australian Registration Numbers:
                                          mg and MPA 2.5mg.                       Premia 2.5 Continuous
                                          Each Premia 5 Continuous Tablet         AUST R 59300
After taking Premia                       contains conjugated oestrogens 0.625    Premia 5 Continuous
Continuous                                mg and MPA 5mg.                         AUST R 59299
                                          The following inactive ingredients
                                          are also found in Premia 2.5            This leaflet was prepared on 16th
                                          Continuous and Premia 5                 March 2007
Keep your Premia Continuous               Continuous:
Tablets below 30 degrees C.                                                       (R) Registered Trade Mark
                                          *   Lactose
Keep Premia Continuous tablets in         *   Methylcellulose
the pack until it is time to take them.
                                          *   Microcrystalline cellulose
Do not leave Premia Continuous in         *   Povidone
the car or on windowsills.                *   Sucrose
Do not store Premia Continuous,           *   Magnesium stearate
or any medicine in the bathroom           *   Calcium phosphate
or near a sink.

PREMIA(R) CONTINUOUS                                                                                                   5

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