conjugated estrogens and medroxyprogesterone acetate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about PREMIA Continuous 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 risks and benefits. Your doctor has weighed the risks of you taking PREMIA Continuous against the benefits this medicine is expected to have for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What PREMIA Continuous is used for
PREMIA Continuous is a type of treatment called hormone replacement therapy (HRT) and contains the hormones, conjugated estrogens and medroxyprogesterone acetate (MPA).
PREMIA Continuous helps to relieve the discomfort many women feel during and after menopause, including symptoms such as "hot flushes", sweating and vaginal dryness. It also helps to prevent thinning of the bones (osteoporosis), which can cause fractures. PREMIA Continuous is used by women who still have a uterus (womb).
If your doctor thinks you will need to take HRT for a long time, including for the prevention of osteoporosis, your doctor will have considered the benefits and risks of other treatments before prescribing PREMIA Continuous for you.
How it works
Menopause occurs naturally in women typically between the ages of 45 and 55. During menopause, your body produces less estrogen than it did beforehand. This can cause symptoms such as "hot flushes", a sudden, intense feeling of heat and sweating throughout the body. Some women also have problems with dryness of the vagina causing discomfort during or after sexual intercourse. Some women develop osteoporosis during or after menopause. 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.
When given during or after menopause, estrogens can help control the symptoms.
Conjugated estrogens and MPA are similar to the hormones produced by the ovaries before menopause.
Women who still have a uterus must take both estrogen and progestogen as part of HRT. This is because taking estrogen on its own may lead to irregular bleeding and a disorder of the uterine lining (endometrium) called endometrial hyperplasia, which can lead to endometrial cancer. Progestogens such as MPA help protect the uterine lining from developing this disorder.
Ask your doctor if you have any questions why PREMIA Continuous has been prescribed for you.
Your doctor may have prescribed it for another use.
This medicine is available only with a doctor's prescription.
PREMIA Continuous is not addictive.
PREMIA Continuous is not suitable for birth control, and it will not restore fertility.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Before you take PREMIA Continuous
When you must not take PREMIA Continuous
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 needs and health, and made after a careful medical evaluation.
Talk regularly with your doctor about whether you still need treatment with PREMIA Continuous.
Treatment with estrogens, with or without progestogens, should be used at the lowest effective dose and for the shortest period of time.
Clinical trials have reported a slight increase in risk of ovarian cancer in women aged between 50-54 years old when PREMIA or estrogens alone.is taken over 5 years.
Do not take PREMIA Continuous to prevent heart attacks, stroke or dementia.
Do not take PREMIA Continuous if you have an allergy or think you have an allergy to:
any medicine containing conjugated estrogens or MPA, the active ingredients in PREMIA Continuous
any of the ingredients listed at the end of this leaflet
any other similar medicines containing estrogen or progestogen, such as other HRT medicines or oral contraceptives ("birth control pill").
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take PREMIA Continuous if you have or have had any of the following medical conditions:
breast cancer
endometrial or cervical cancer
abnormal genital bleeding, which your doctor has not investigated
a problem with blood clots forming in your blood vessels, such as painful inflammation of the veins (thrombophlebitis) or the blockage of a blood vessel in the legs (deep vein thrombosis or DVT), or lungs (pulmonary embolism)
heart disease or stroke
very high blood pressure that is not properly controlled
problems with your breasts that your doctor has not investigated
liver disease
blood clotting problems.
If you are not certain whether these may apply to you, or you are worried about anything in this list, talk to your doctor.
Do not take this medicine if you are pregnant or think you are pregnant.
Pregnancy must be excluded before you take PREMIA Continuous.
Do not take PREMIA Continuous if you are breast feeding.
Estrogens have been found in breast milk and may reduce the production of breast milk.
Do not give this medicine to a child.
This medicine is not suitable for use in children.
Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
If it is expired or damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take PREMIA Continuous
You must have a thorough medical check-up before starting PREMIA Continuous for the first time or if you are taking it again after a break.
Tell your doctor if you are allergic to any foods, dyes preservatives or any other medicines.
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 genital bleeding or spotting
endometriosis (material similar to the lining of the uterus growing outside the uterus, causing pain or bleeding)
high blood pressure
liver problems
a condition called porphyria
hearing difficulties
yellowing of the whites of the eyes or skin (jaundice) during pregnancy or when taking estrogens (e.g., birth control pill or HRT)
fluid retention
kidney problems
heart problems
diabetes
migraine
asthma
epilepsy
lupus (systemic lupus erythematosus)
hereditary angioedema (swelling of the face, lips, tongue or throat that may cause difficulty swallowing or breathing)
gall bladder disease
high levels of blood fats
high or low levels of calcium in the blood
underactive thyroid gland
obesity.
Tell your doctor if anyone in your immediate family has had blood clots in the deep veins of the legs or blood vessels of the lungs, a stroke or heart attack.
Taking Other Medicines
Tell your doctor if you are taking birth control pills.
PREMIA Continuous is not a contraceptive. Since pregnancy may be possible early in menopause, while you are still having menstrual periods, you should ask your doctor about another (non-hormonal) method of birth control.
Tell your doctor or pharmacist if you are taking any other medicines, including:
all prescription medicines
all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.
Some medicines may be affected by PREMIA Continuous or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
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, erythromycin and clarithromycin
antifungal agents such as ketoconazole and itraconazole
thyroid replacement therapy
corticosteroids, such as dexamethasone
ritonavir for the treatment of HIV infection
cyclosporin used to prevent organ rejection
aminoglutethemide used to treat breast cancer and a disease called Cushings syndrome.
Grapefruit juice may also affect how well PREMIA Continuous works.
If you have not told your doctor about any of the above, tell them before you start taking PREMIA Continuous.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while you are taking this medicine.
How to take PREMIA Continuous
Follow all directions given to you by your doctor or pharmacist carefully.
They 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.
How to take it
Swallow tablets whole with a full glass of water. Do not divide, crushed, chew, or dissolve the tablet in your mouth.
When to take PREMIA Continuous
If you are not already using any type of HRT you can start PREMIA Continuous on any convenient day. However, it is recommended you start PREMIA Continuous after your last period. If you do not have predictable periods, then start PREMIA Continuous on a Monday as this matches the directions on the calendar pack.
If you are already using a different type of HRT, your doctor can advise you when to start PREMIA Continuous.
It does not matter if you take PREMIA Continuous before or after food.
How much to take
Treatment consists of a 28-day cycle.
Take one tablet daily.
Take all tablets in a blister pack before starting a new pack.
How long to take it
Continue to take your medicine for as long as your doctor tells you.
Your doctor can discuss the risks and benefits of long-term treatment with HRT in your particular case.
If you forget to take it
If less than 12 hours has passed from the time you normally take PREMIA Continuous, take the missed tablet.
Take the next tablet at the usual time.
If more than 12 hours has passed, discard the missed tablet and take the next tablet when you normally would.
Do not take a double dose to make up for the one you missed.
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 on 13 11 26) or go to Accident and Emergency at the nearest hospital if you think you or anybody else has taken too much PREMIA Continuous.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include:
feeling sick or vomiting
dizziness
feeling sleepy or tired
breast tenderness
stomach pain.
Women may also experience menstrual bleeding.
While you are taking PREMIA Continuous
Things you must do
Tell any doctors, dentists and pharmacists who treat you that you are taking PREMIA Continuous.
If you are about to take any new medicines, tell your doctor or pharmacist that you are taking PREMIA Continuous.
If you become pregnant while taking PREMIA Continuous, tell your doctor immediately.
PREMIA Continuous should not be taken while you are pregnant.
See your doctor at least every six months for a check-up.
Some women will need to go more often.
Your doctor will:
check your breasts
send you to have a mammogram
check your uterus and cervix
do a Pap smear
check your blood pressure.
Your doctor may also take blood to check your blood fats, sugar levels and liver function.
This helps to monitor for unwanted effects of HRT.
If you have used PREMARIN as HRT for 5 or more years, there may be a slight increase in risk of you developing ovarian cancer.
See your doctor if you experience symptoms such as pressure, discomfort or pain in your stomach or pelvis; swollen or bloated stomach; appetite loss; changes in toilet habits (e.g., constipation, diarrhoea, passing urine more frequently, increased flatulence); heartburn and nausea; tiredness; unexplained weight loss or weight gain especially if these symptoms are new for you or continue for a few weeks.
Having these symptoms does not necessarily mean you have ovarian cancer, but it is best to have a check-up. Your doctor will physically check your pelvic organs and conduct blood tests, to rule out the ovarian cancer.
If you need to have blood tests tell the doctor that you are taking PREMIA Continuous.
PREMIA Continuous can affect the results of some tests. These include hormone and liver function tests.
Check your breasts regularly.
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 well in advance (at least 4 to 6 weeks) of any expected hospitalisation or surgery.
If you go to hospital unexpectedly, tell the doctor who admits you that you are taking PREMIA Continuous.
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.
Tell your doctor if you have any breakthrough bleeding or spotting, which persists after 2 to 3 months of treatment with PREMIA Continuous.
Breakthrough bleeding or spotting may occur during the first few months of treatment and then stop. However, if the bleeding continues your doctor may wish to check why it is happening.
Things you must not do
Do not take PREMIA Continuous to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking PREMIA Continuous without checking with your doctor.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PREMIA Continuous.
All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some side effects.
It can be difficult to tell whether side effects are the result of taking PREMIA Continuous or are side effects of another medicine you are taking.
Do not be alarmed by the list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
abnormal genital bleeding or spotting (if bleeding is heavy check with your doctor as soon as possible)
tender, painful or swollen breasts, secretions from the breasts
period-like pain
vaginal discharge or change in secretions
vaginal thrush
stomach pain
stomach swelling or passing wind
nausea or vomiting
headache or migraine
loss of memory
dizziness
problems sleeping or sleepiness
moodiness or irritability
changes in sex drive
weight changes
acne, itchy skin, or skin discolouration
skin rash
hair loss or extra hair growth
intolerance to contact lenses.
Tell your doctor as soon as possible if you notice any of the following:
loss of hearing
irregular, rapid jerky movements
depression or anxiety
swelling of the lower legs, ankles or fingers
worsening of porphyria, a rare blood pigment disorder.
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
swelling and redness along a vein which is extremely tender to touch
signs that clots may have formed, such as sudden severe headache, sudden loss of coordination blurred vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the calves or thighs, chest pain, difficulty breathing, coughing blood
sudden partial or complete loss of vision or other problems with your eyesight
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
bloody diarrhoea, abdominal pain or tenderness, fever, loss of appetite, nausea or vomiting.
Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may also occur in some patients.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
After taking PREMIA Continuous
Storage
Keep your tablets in the blister pack until it is time to take them.
If you take them out of the blister, they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store PREMIA Continuous, or any medicine, in a bathroom or near a sink. Do not leave PREMIA Continuous in the car or on windowsills.
Heat and dampness can destroy some medicines.
Keep it where 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
If your doctor tells you to stop taking PREMIA Continuous Tablets, or the expiry date has passed, ask your pharmacist what to do with any leftover medicine.
Product Description
What it looks like
PREMIA Continuous tablets are available in two different strengths:
PREMIA 2.5 Continuous tablets
PREMIA 5 Continuous tablets.
Each strength comes in a blister pack containing 28 tablets.
Ingredients
The active ingredients are conjugated estrogens and MPA.
Each peach, oval PREMIA 2.5 Continuous Tablet contains conjugated estrogens 0.625 mg and MPA 2.5 mg, and is printed with "0.625/2.5" in black ink.
Each blue, oval PREMIA 5 Continuous Tablet contains conjugated estrogens 0.625 mg and MPA 5 mg and is printed with "0.625/5" in black ink.
The following inactive ingredients are also found in PREMIA 2.5 Continuous and PREMIA 5 Continuous:
Lactose monohydrate
methylcellulose
microcrystalline cellulose
powdered cellulose
povidone
sucrose
magnesium stearate
calcium phosphate
calcium sulfate
glyceryl monooleate
macrogol 20000
shellac
stearic acid
titanium dioxide
carnauba wax
black ink.
The colouring agent found in PREMIA 2.5 Continuous is red iron oxide.
The colouring agent found in PREMIA 5 Continuous is indigo carmine.
