PROGYNOVA® (PRO·guy·no·va)

estradiol valerate

Consumer Medicine Information

WHAT IS IN THIS Progynova replaces the hormone • any of the ingredients listed at the
estradiol that the body no longer end of this leaflet.
LEAFLET makes and prevents or relieves
This leaflet answers some of the symptoms such as hot flushes, Some of the symptoms of an
common questions about Progynova sweats, sleep disturbances, allergic reaction may include:
tablets. It does not contain all of the depressive moods, irritability, • shortness of breath
available information. It does not dizziness, headaches as well as • wheezing or difficulty breathing
take the place of talking to your vaginal dryness and burning. • swelling of the face, lips, tongue
doctor or pharmacist. or other parts of the body
If you have not had your uterus • rash, itching or hives on the skin.
All medicines have risks and removed (hysterectomy) your
benefits. Your doctor has weighed doctor will prescribe another Do not take Progynova if you
the risks of you taking Progynova hormone progestogen to take with have:
against the benefits they expect it Progynova. • undiagnosed vaginal bleeding
will provide. • breast cancer or a suspicion of
In addition, the loss of the breast cancer
If you have any concerns about • other tumours (including liver
hormones produced by the ovaries
taking Progynova, ask your tumours) or a suspicion of other
leads to thinning of the bones. In
doctor or pharmacist. tumours, if sex hormone related
some women this effect may be
extensive (postmenopausal • severe liver disease including
Keep this leaflet with the jaundice (yellowing of the skin
osteoporosis) resulting in fractures
medicine. You may need to read it and/or eyes)
of the bones in later life. Your
again. • had a heart attack and/or stroke
doctor may also prescribe
Progynova to prevent osteoporosis. • a history of or have a blood clot
or are at a high risk of a blood
WHAT PROGYNOVA IS clot in the blood vessels of the
Progynova is not a contraceptive.
USED FOR It will not prevent you from falling legs (deep venous thrombosis) or
pregnant. the lungs (pulmonary embolism)
Progynova provides hormone
replacement therapy (HRT) for the • risk factors for blood clots
treatment of menopausal complaints Ask your doctor if you have any including inherited conditions
after the cessation of monthly questions about why this (e.g. antithrombin III deficiency)
bleeding, or after surgical removal medicine has been prescribed for • high levels of fat in the blood
of the ovaries (oophorectomy). you. (triglycerides)
Progynova is only intended for Your doctor may have prescribed it
short term use. for another reason. Do not take this medicine if you
are pregnant.
Progynova contains estradiol It may affect your developing baby
if you take it during pregnancy.
valerate, a precursor of the hormone BEFORE YOU TAKE
estradiol. During menopause, the
estradiol production of the ovaries
PROGYNOVA Do not breast-feed if you are
declines. Although menopause is When you must not take it taking this medicine.
natural, it often causes distressing The active ingredient in Progynova
Do not take Progynova if you
symptoms, which are connected passes into breast milk and there is
have an allergy to:
with the gradual loss of the a possibility that your baby may be
• estradiol valerate, the active
hormones produced by the ovaries. affected.
ingredient in Progynova

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Do not take this medicine if you This is because estrogen stimulates • hearing loss caused by an
are under 18 years old. the liver to remove more cholesterol abnormal bone growth in the ear
from blood and divert it to the gall (otosclerosis)
Do not take this medicine after bladder. • chorea minor (involuntary
the expiry date printed on the movement disorder)
pack and blister. Before starting Progynova, your • hereditary angioedema (repeated
The expiry date is printed on the doctor should conduct a thorough episodes of severe swelling)
carton and on each blister after medical and gynaecological
“EXP” (e.g. 11 18 refers to examination (including the breasts). Tell your doctor if you are 65 years
November 2018). The expiry date Your doctor should conduct this or older when HRT is initiated. The
refers to the last day of that month. examination periodically. If you reason is that there is limited
If it has expired return it to your have liver disease, your doctor will evidence from clinical studies that
pharmacist for disposal. also conduct liver function tests hormonal treatment may increase
from time to time. Your doctor will the risk of significant loss of
Do not take this medicine if the also note your family medical intellectual abilities such as memory
packaging is torn or shows signs history and exclude pregnancy. capacity (dementia).
of tampering.
If the packaging is damaged, return Your doctor may also monitor your If HRT is used in the presence of
it to your pharmacist for disposal. blood pressure while you are taking any of the conditions listed above
Progynova. This is because small you will need to be kept under close
If you are not sure whether you increases in blood pressure have observation. Your doctor can
should start taking this medicine, been reported in women taking explain this to you. Therefore, if
talk to your doctor. HRT. If this occurs, you may need any of these apply to you, tell your
to stop taking Progynova. doctor before starting to take
Before you start to take it Progynova.
Tell your doctor if you have or
Tell your doctor if you have have had any of the following: HRT and cancer
allergies to any other medicines, • liver disease including jaundice
foods, preservatives or dyes. Endometrial cancer
(yellowing of the skin and/or The risk of cancer of the lining of
eyes) the womb (endometrial cancer)
Tell your doctor if:
• high calcium levels in the blood increases when estrogens are used
• you smoke
• endometriosis (the presence of alone for prolonged periods. Taking
• you are overweight tissue of the lining of the womb
• you or anyone in your immediate a progestogen in addition to the
in places in the body where it is estrogen lowers the increased risk.
family has had blood clots not normally found)
(thrombosis) • asthma Please inform your doctor if you
• you have any hospitalisation, • diabetes frequently have bleeding
surgery or prolonged
• epilepsy irregularities or persistent bleeding
immobilisation
• migraine during the treatment with
• porphyria (an inherited disease Progynova.
You have an increased risk of a
blood clot if you have any of the where the body cannot convert
naturally occurring compounds Breast cancer
above risk factors. In addition to
into haem, which contains iron) Please inform your doctor if you
these, there may be other risk
• systemic lupus erythematosus have suffered from fibrocystic
factors. Talk to your doctor if you
(SLE; a chronic inflammatory disease of the breasts (lumpy or
have any concerns.
disease) painful breasts) or if you have first
• tumours in your womb or degree relatives (mother, sisters,
Taking Progynova may also
pituitary gland daughters) who have had breast
increase your risk of coronary heart
• chloasma (yellow brown patches cancer.
disease. Tell your doctor if you
experience chest pain or discomfort. on the skin); if so, avoid too
much exposure to the sun or Breast cancer has been diagnosed
ultraviolet radiation slightly more often in women who
Taking Progynova may increase
• lumpy or painful breasts (benign have used hormone replacement
your risk of gall bladder disease.
breast disease) therapy (HRT) than in women of

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the same age who have never used Tell your doctor or pharmacist if be careful with or avoid while
HRT. The risk increases with you are taking any other taking this medicine.
duration of treatment. If you are medicines, including any that you
concerned about this information get without a prescription from
you should discuss this with your your pharmacy, supermarket or HOW TO TAKE
doctor. It is recommended that health food shop.
yearly breast examinations are
PROGYNOVA
conducted and regular self- Some medicines and Progynova Follow all directions given to you
examination (monthly) should be may interfere with each other. by your doctor or pharmacist
carried out. HRT has been reported These include: carefully. They may differ from the
to result in an increased number of • medicines to treat high blood information contained in this leaflet.
abnormal mammograms requiring pressure, chest pain and/or
further evaluation. irregular heart beat such as ACE If you do not understand the
inhibitors, verapamil, diltiazem instructions printed on the
HRT increases the density of • medicines used for contraception, pharmacist label, ask your doctor
mammographic images. This may such as oral contraceptives or pharmacist for help.
complicate the mammographic • medicines used to treat
detection of breast cancer in some epilepsy such as hydantoins, How to take it
cases. Therefore your doctor may barbiturates, primidone,
choose to use other breast cancer Take one tablet at the same time
carbamazepine, oxcarbazepine, each day.
screening techniques as well. topiramate, felbamate
• rifampicin for the treatment of Taking it at the same time each day
Ovarian cancer tuberculosis)
Some observational studies show a • macrolide antibiotics (e.g. will have the best effect. It will also
slightly increased overall risk of help you remember when to take it.
clarithromycin, erythromycin It does not matter if you take this
developing ovarian cancer in • herbal medicines containing St
women who have used HRT medicine before or after food.
John’s Wort
compared to women who have
• medicines used to treat HIV such When you have finished each blister
never used HRT. In women
as ritonavir or nevirapine foil start the next one on the
currently using HRT, this risk was
• some medicines used to treat following day. Never leave a break
further increased. These
Hepatitis C Virus (HCV) such as between blister foils unless your
associations have not been shown in
boceprevir, telaprevir doctor has advised you to. Tablet
all studies. There is no consistent
• medicines used to treat fungal taking should be continuous.
evidence that the risk of developing
infections such as ketoconazole,
ovarian cancer is related to the
itraconazole, voriconazole, Swallow the tablets whole with a
duration of use of HRT. However,
fluconazole glass of water.
the risk may be more relevant with
long-term use (for several years). • grapefruit juice
• medicines used to treat pain and How long to take it
Liver tumour fever (e.g. paracetamol) Progynova is only intended for
During or after the use of hormones short term use. Your doctor will
such as those that are contained in These medicines may be affected by advise you on how long to use
Progynova, benign liver tumours Progynova or may affect how well Progynova. Your doctor will
have rarely occurred, and malignant it works. You may need different discuss the risks of long term
liver tumours even more rarely. In amounts of your medicines, or you treatment with HRT with you.
isolated cases, bleeding has may need to take different Some recent studies have shown
occurred from such tumours into the medicines. that women using HRT have a small
abdominal cavity. Although such increase in breast cancer risk. The
events are rare, you should inform If you are diabetic, your doctor may risk increases with the length of
your doctor about any pain in your alter the dose of the diabetes HRT use.
upper abdomen that does not medication.
disappear within a short time. HRT is associated with a small
Your doctor and pharmacist have increase in the risk of developing
more information on medicines to breast cancer, heart attacks, strokes,
Taking other medicines

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blood clots, including clots in the If you are going to have surgery, Do not take Progynova to treat
lungs, and dementia. However, the tell the surgeon or anaesthetist any other complaints unless your
evidence is inconclusive. On the that you are taking this medicine. doctor tells you to.
other hand the risk of hip fractures It may affect other medicines used
and bowel cancer may be reduced. during surgery. Do not give your medicine to
Your doctor can discuss these risks anyone else, even if they have the
and benefits with you, taking into The use of HRT may affect the same condition as you.
account your particular results of certain laboratory tests.
circumstances. If you are about to have any Do not stop taking your medicine
blood tests, tell your doctor that without checking with your
If you forget to take it you are taking this medicine. doctor.
It may interfere with the results of If you stop taking it suddenly, your
If you are less than 24 hours late some tests. condition may worsen or you may
take your tablet as soon as possible, have unwanted side effects.
and take the next one at the normal Stop taking it immediately if
time. If you miss tablets for several What to be careful of
days, irregular bleeding may occur.You should stop treatment at once
and consult your doctor if you have Excess intake of alcohol during use
If you take too much any of the following conditions: of HRT has an influence on the
• your very first attack of migraine treatment. Your doctor will advise
(overdose)
(typically a throbbing headache you.
Immediately telephone your and nausea preceded by visual
doctor or the Poisons Information disturbances)
Centre (New Zealand: 0800
POISON or 0800 764 766) for
• worsening of pre-existing SIDE EFFECTS
migraine, any unusually frequent
advice, or go to Accident and Tell your doctor or pharmacist as
or unusually severe headaches
Emergency at the nearest soon as possible if you do not feel
• sudden disturbances of vision or
hospital, if you think that you or well while you are taking
hearing
anyone else may have taken too Progynova.
• swollen veins (phlebitis)
much Progynova.
• itching of the whole body All medicines can have side effects.
Do this even if there are no signs • unusual upper abdominal pain Sometimes they are serious, most of
of discomfort or poisoning. that do not disappear within a the time they are not. You may need
You may need urgent medical short period of time. medical attention if you get some
attention. of the side effects.
If you get a blood clot while you are
taking Progynova or there is a Do not be alarmed by this list of
suspicion of this you should stop possible side effects. You may not
WHILE YOU ARE taking it immediately and contact experience any of them.
TAKING PROGYNOVA your doctor. Warning signs to look
Things you must do out for are: During the first few months of
• coughing blood treatment you may experience some
If you are about to be started on
• unusual pains or swelling of your breast tenderness or enlargement.
any new medicine, remind your
arms or legs These symptoms are usually
doctor and pharmacist that you
are taking Progynova. • sudden shortness of breath temporary and normally disappear
• fainting. with continued treatment. If they do
Tell any other doctors, dentists, not, contact your doctor.
and pharmacists who treat you Progynova must also be stopped at
that you are taking this medicine. once if you develop jaundice The following symptoms have been
(yellowing of the skin and/or eyes). reported in users of various oral
If you become pregnant while Tell your doctor immediately if HRT preparations; tell your doctor
taking this medicine, tell your either occurs. if they worry you:
doctor immediately. • changes in body weight
Things you must not do • changes in vaginal bleeding
pattern including spotting

PROGYNOVA® CMI Vx1.0 4

• nausea Do not leave it in the car. • glycerol
• stomach pain Heat and dampness can destroy • glycol montanate
• rash and/or itching some medicines. • titanium dioxide
• headache • iron oxide yellow
Keep it where children cannot
reach it. A locked cupboard at least Inactive ingredients per 2 mg tablet:
Tell your doctor immediately, or one-and-a half metres above the
go to Accident and Emergency • lactose
ground is a good place to store • maize starch
department at your nearest medicines.
hospital if you notice any of the • povidone
following: • purified talc
Disposal
• signs of allergy such as rash, • magnesium stearate
swelling of the face, lips, mouth, If your doctor tells you to stop • sucrose
throat or other parts of the body, taking this medicine or the expiry • macrogol 6000
shortness of breath, wheezing or date has passed, ask your • calcium carbonate
trouble breathing pharmacist what to do with any
• glycol montanate
• visual disturbances such as medicine that is left over.
partial or complete loss of Suppliers
vision, bulging eyes, double Return any unused medicine to
your pharmacist. Bayer New Zealand Limited
vision
P O Box 2825
• irregular heartbeat Shortland Street
• swelling of the hands, ankles or Auckland 1140
feet PRODUCT
New Zealand
DESCRIPTION Free phone 0800 233 988
Tell your doctor or pharmacist if What it looks like
you notice anything that is Date of preparation
Progynova (1 mg) are small round
making you feel unwell. December 2020
beige sugar coated tablets packaged
in calendar blister strips containing
Other side effects not listed above See MEDSAFE website
28 tablets.
may also occur in some people. (www.medsafe.govt.nz) for latest
Progynova (2 mg) are small round New Zealand Consumer Medicine
Also tell your doctor if you have
white sugar coated tablets packaged Information.
any of the symptoms listed under
in calendar blister strips containing
“While you are taking Progynova - ® Registered trademark of the
28 tablets.
stop taking it immediately”. Bayer group, Germany.
Each pack contains 3 blister strips. All rights reserved.
AFTER TAKING Ingredients
PROGYNOVA Active ingredients per tablet
Storage • Progynova 1 – 1 mg estradiol
Keep your tablets in the pack valerate
until it is time to take them. • Progynova 2 – 2 mg estradiol
If you take the tablets out of the valerate
pack they may not keep well.
Inactive ingredients per 1 mg tablet:
Keep your tablets in a cool dry • lactose
place. Store your tablets as per • maize starch
directions on the carton. • povidone
• purified talc
Do not store it or any other • magnesium stearate
medicine in the bathroom, near a • sucrose
sink, or on a window-sill. • macrogol 6000
• calcium carbonate

PROGYNOVA® CMI Vx1.0 5