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.
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
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
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,
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
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: firstname.lastname@example.org
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
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