PREMARIN 0.625MG COATED TABLETS

Active substance: CONJUGATED ESTROGENS

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PACKAGE LEAFLET: INFORMATION FOR
THE USER

CONJUGATED ESTROGENS
0.3 mg, CONJUGATED ESTROGENS
0.625 mg & 1.25 mg Coated Tablets
CONJUGATED ESTROGENS

CONJUGATED ESTROGENS

have had their womb removed (hysterectomy).
However, women who have not had this
operation can still take Premarin and their doctor
may prescribe a second type of tablet containing
another hormone called a progestogen to be
taken for 12-14 days per month as well as the
Premarin tablets.

2. BEFORE YOU TAKE PREMARIN

Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have further questions, please ask
your doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.

Medical history and regular check-ups

In this leaflet:
1. HAT PREMARIN IS AND WHAT IT IS
W
USED FOR
2. EFORE YOU TAKE PREMARIN
B
3. OW TO TAKE PREMARIN
H
4. OSSIBLE SIDE EFFECTS
P
5. OW TO STORE PREMARIN
H
6. URTHER INFORMATION
F

Before you start (or restart) HRT, your doctor will
ask about your own and your family’s medical
history. Your doctor may decide to perform
a physical examination. This may include an
examination of your breasts and/or an internal
examination, if necessary.

Premarin is a Hormone Replacement Therapy
(HRT). It contains the female hormone estrogen.
Premarin is used to treat some of the symptoms
and conditions associated with the menopause.
Premarin is used for:
Relief of symptoms occurring after
menopause
During the menopause, the amount of the
estrogen produced by a woman’s body drops.
This can cause symptoms such as hot face, neck
and chest ("hot flushes"). Premarin alleviates these
symptoms after menopause. You will only be
prescribed Premarin if your symptoms seriously
hinder your daily life.
Prevention of osteoporosis
After the menopause some women may be at
risk of developing fragile bones (osteoporosis).
You should discuss all available treatment
options with your doctor.
If you are at an increased risk of fractures due to
osteoporosis and other medicines are not suitable
for you, you can use Premarin 0.625 mg or
1.25 mg Coated Tablets to prevent osteoporosis
after menopause.
Premarin is usually prescribed for women who

The experience in treating women with a
premature menopause (due to ovarian failure
or surgery) is limited. If you have a premature
menopause the risks of using HRT may be
different. Please talk to your doctor.

Once you have started on Premarin you should
see your doctor for regular check-ups (at least
once a year). At these check-ups, discuss with
your doctor the benefits and risks of continuing
with Premarin.
Go for regular breast screening, as
recommended by your doctor.

2.1 Do not take Premarin
If any of the following applies to you. If you are
not sure about any of the points below, talk to
your doctor before taking Premarin.
Do not take Premarin if:
• you are allergic (hypersensitive) to conjugated
estrogens or any of the ingredients of Premarin;
the ingredients are listed in Section 6 of this
leaflet
• you have or have ever had breast cancer,
or if you are suspected of having it
• you have cancer which is sensitive to
estrogens such as cancer of the lining of
the womb (endometrium) or if you are
suspected of having it
• you have any unexplained vaginal bleeding
• you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not
being treated
• you have ever had a blood clot in a vein
(thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism)

When to take special care with Premarin
Tell your doctor if you have ever had any of
the following problems, before you start the
treatment, as these may return or become worse
during treatment with Premarin. If so, you should
see your doctor more often for check-ups:
• fibroids inside your womb
• growth of womb lining outside your womb
(endometriosis) or a history of excessive
growth of the womb lining (endometrial
hyperplasia)
• increased risk of developing blood clots
(see Section 2.3 ‘Blood Clots in a vein
(thrombosis)’ for more detail)
• increased risk of getting estrogen-sensitive
cancer (such as having a mother, sister or
grandmother who has had breast cancer)
(see Section 2.2 HRT and cancer)
• high blood pressure
• heart disease
• a liver disorder (e.g. a benign liver tumour)
• kidney disease
• fluid retention due to cardiac or kidney
problems
• diabetes
• gallbladder disease or gallstones
• migraine or severe headaches
• a disease of the immune system that affects
many organs of the body (systemic lupus
erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and
hearing (otosclerosis)
• low blood calcium levels (hypocalcaemia)
• a very high level of fat in your blood
(triglycerides).
Stop taking Premarin and see a doctor
immediately
If you notice any of the following when taking
HRT:
• any of the conditions mentioned in the “Do
not take Premarin” section

• yellowing of the skin or the whites of your
eyes (jaundice). These may be signs of a
liver disease
• a large rise in your blood pressure (symptoms
may be headache, tiredness, dizziness)
• migraine-like headaches which happen for
the first time
• if you become pregnant
• have an allergic reaction, signs of which
include a rash, itching, shortness of breath,
difficulty in breathing and a swollen face
• if you notice signs of a blood clot, such as:
o painful swelling and redness of the legs
o sudden chest pain
o difficulty in breathing.
For more information, see section titled
‘Blood Clots in a vein (thrombosis)’ below.
Premarin is not a contraceptive. If it is less than
12 months since your last menstrual period
or you are under 50 years old, you may still
need to use additional contraception to prevent
pregnancy. Speak to your doctor for advice.

2.2

HRT and cancer:

Excessive thickening of the lining of
the womb (endometrial hyperplasia)
and cancer of the lining of the womb
(endometrial cancer)
Taking estrogen-only HRT will increase the risk
of excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the
womb lining (endometrial cancer).
Taking a progestogen in addition to the
estrogen for at least 12 days of each 28 day
cycle protects you from this extra risk. So your
doctor will prescribe a progestogen separately if
you still have your womb. If you have had your
womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this
product without a progestogen.
In women who still have a womb and who are
not taking HRT, on average, 5 in 1000 will be
diagnosed with endometrial cancer between the
ages of 50 and 65.
For women aged 50 to 65 who still have a
womb and who take estrogen-only HRT, between
10 and 60 women in 1000 will be diagnosed
with endometrial cancer (i.e. between 5 and
55 extra cases), depending on the dose and for
how long it is taken.
Premarin 0.625 mg and 1.25 mg tablets contain a
higher dose of estrogens than other estrogen-only
HRT products. The risk of endometrium cancer when
using Premarin 0.625 mg and 1.25 mg tablets
together with a progestogen is not known.

If you still have your womb, your doctor may
prescribe a progestogen as well as estrogen. If
so, these may be prescribed separately, or as a
combined HRT product.
If you have had your womb removed
(a hysterectomy), your doctor will discuss with
you whether you can safely take estrogen
without a progestogen.
If you’ve had your womb removed because
of endometriosis, any endometrium left in
your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as
well as an estrogen.
Your product, Premarin, is an estrogen-only
product.
Looking at women who still have a uterus and
who are not taking HRT - on average 5 in
1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women who take estrogen-only HRT,
the number will be 2 to 12 times higher,
depending on the dose and how long you take
it. After stopping treatment risk may remain
elevated for at least 10 years. In women
with a uterus, use of estrogen-only HRT is not
recommended because it increases the risk of
endometrial cancer.
Irregular bleeding
If you get break-through bleeding or
spotting, it’s usually nothing to worry about,
especially during the first 3-6 months of taking
HRT.
But if the bleeding or spotting:
• carries on for more than the first 6 months
• starts after you’ve been taking Premarin for
more than 6 months
• carries on even after you’ve stopped taking
Premarin
 ake an appointment to see your
M
doctor. It could be a sign that your
endometrium has become thicker.
Breast Cancer
Women who have breast cancer, or have
had breast cancer in the past, should not
take HRT.
Evidence suggests that taking combined estrogen-progestogen and possibly also estrogenonly HRT increases the risk of breast cancer. The
extra risk depends on how long you take HRT.
The additional risk becomes clear within a few
years. However, it returns to normal within a few
years (at most 5) after stopping treatment.

For women who have had their womb removed
and who are using estrogen-only HRT for 5 years,
little or no increase in breast cancer risk is shown.
Your risk of breast cancer is also higher:
• if you have a close relative (mother, sister or
grandmother) who has had breast cancer
• if you are seriously overweight.
Compare
Women aged 50 to 79 who are not taking HRT,
on average, 9 to 14 in 1000 will be diagnosed
with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking
estrogen-progestogen HRT over 5 years, there
will be 13 to 20 cases in 1000 users (i.e. an
extra 4 to 6 cases).
Regularly check your breasts. See your
doctor if you notice any changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is
very rare, but it is serious. It can be difficult to
diagnose, because there are often no obvious
signs of the disease.
A slightly increased risk of ovarian cancer has
been reported in women taking HRT for at least
5 to 10 years. Women aged 50 to 69 who are
not taking HRT, on average about 2 women in
1000 will be diagnosed with ovarian cancer
over a 5-year period. For women who have
been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to
1 extra case).

2.3

• if any of your close family has ever had a
blood clot in the leg, lung or an other organ
• you are pregnant or in your postpartum period
• you have any blood clotting problem that
needs treatment with a medicine used to
prevent blood clots
• you are unable to walk for a long time
because of major surgery, injury or illness (see
also “if you’re going to have surgery” below)
• you have a rare condition called SLE
(systemic lupus erythematosus)
• you have cancer.
For signs of a blood clot, see “Stop taking
Premarin and see a doctor immediately”.
Compare
Looking at women in their 50s who are not
taking HRT, on average, over a 5-year period,
4 to 7 in 1000 would be expected to get a
blood clot in a vein.
For women in their 50s who have had
their womb removed and have been taking
estrogen-only HRT for over 5 years, there will be
5 to 8 cases in 1000 users (i.e. 1 extra case).
If you’re going to have surgery, make sure
your doctor knows about it or tell the surgeon
that you are taking Premarin. You may need to

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1.  HAT PREMARIN IS AND
W
WHAT IT IS USED FOR

The use of HRT carries risks which need to be
considered when deciding whether to start
taking it, or whether to carry on taking it.

• you have a blood clotting disorder (such
as protein C, protein S, or antithrombin
deficiency)
• you have or recently have had a disease
caused by blood clots in the arteries, such
as a heart attack, stroke or angina
• you have or have previously had liver
disease
• you have a rare blood problem called
“porphyria” which is passed down in
families (inherited)
• you are pregnant, or you are breast-feeding.
If any of the above conditions appear for
the first time while taking Premarin, stop
taking it at once and consult your doctor
immediately.

Effects of HRT on your heart or circulation:

Blood Clots in a vein (thrombosis)
The risk of blood clots in the veins (also called
deep vein thrombosis, or DVT), is about 1.3
to 3- times higher in HRT users than in nonusers, especially during the first year of taking it.
Blood clots can be serious and if one travels to
the lungs, it can cause chest pain, breathlessness,
collapse or even death. This condition is called
pulmonary embolism, or PE.
DVT and PE are examples of a condition called
venous thromboembolism, or VTE.
You are more likely to get a blood clot in your
veins as you get older and if any of the following
applies to you. Inform your doctor if any of these
situations applies to you:
• you are seriously overweight (BMI>30 kg/m2)
• you have had a blood clot before

CONJUGATED ESTROGENS
CONJUGATED 1.25 mg
0.3 mg, 0.625 mg & ESTROGENSCoated Tablets
CONJUGATED ESTROGENS

CONJUGATED ESTROGENS

stop taking Premarin about 4 to 6 weeks before
the operation, to reduce the risk of a blood clot.
Your doctor will tell you when you can start
taking Premarin again.
Heart Disease (heart attack)
HRT is not recommended for women who
have heart disease, or have had heart
disease recently. If you have ever had heart
disease, talk to your doctor to see if you should
be taking HRT.
There is no evidence that HRT will prevent
a heart attack.
/please turn over

For women who have had their womb removed
and are taking estrogen-only therapy there is no
increased risk of developing a heart disease.
If you get:
• a pain in your chest that spreads to your arm
or neck
 ee a doctor as soon as possible and do
S
not take any more HRT until your doctor
says you can. This pain could be a sign of
heart disease.
Stroke
The risk of having a stroke is about 1.5 times
higher in HRT users than in non-users. The
number of extra cases of stroke due to use of
HRT will increase with age.
Other things that can increase the risk of stroke
include:
• high blood pressure
• smoking
• drinking too much alcohol
• an irregular heartbeat.
If you are worried about any of these
things, or if you have had a stroke in the
past, talk to your doctor to see if you should
take HRT.
Compare
Looking at women in their 50s who are not
taking HRT - on average, over a 5-year period,
8 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the
figure would be 11 in 1000 users, over a five
year period (i.e. an extra 3 cases).
If you get:
• unexplained migraine-type headaches, with
or without disturbed vision
 ee a doctor as soon as possible and do
S
not take any more HRT until your doctor
says you can. These headaches may be an
early warning sign of a stroke.

2.4

Other conditions

HRT will not prevent memory loss. There is some
evidence of a higher risk of memory loss in women
who start using HRT after the age of 65. Speak to
your doctor for advice.
Women with hypertriglyceridaemia may
experience large increases of their plasma
triglycerides, which can lead to inflammation
of the pancreas (pancreatitis). Symptoms of
pancreatitis may include abdominal pain,
abdominal swelling, fever and feeling or
being sick.

If you are taking thyroid hormone replacement
therapy (e.g. thyroxine), your doctor may
monitor your thyroid function more often when
you start treatment.
HRT may affect some medical tests. If you visit
a hospital or clinic for any medical tests, you
should tell the doctor concerned that you are
taking HRT.

2.5

Taking other medicines

Some medicines may interfere with the effect of
Premarin. This might lead to irregular bleeding.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription, herbal remedies or other natural
products.
In particular tell your doctor if you are taking:
• an anticonvulsant (used to treat epilepsy e.g.
phenobarbital, phenytoin, carbamazepine)
• an anti-infective e.g. used to treat tuberculosis
(rifampicin, rifabutin) or HIV (nevirapine,
efavirenz, ritonavir and nelfinavir)
• a herbal preparation such as St. John’s
wort (Hypericum perforatum)
• metyrapone (most commonly used in the
treatment of Cushing’s syndrome).
The way that Premarin works may be altered if
other medicines are used at the same time.

2.6

Laboratory tests

If you need a blood test, tell your doctor or the
laboratory staff that you are taking Premarin,
because this medicine can affect the results of
some tests.

2.7

Pregnancy and breast-feeding

You should stop taking Premarin and tell your
doctor immediately if you know or suspect you
are pregnant, or if you are breast-feeding.

2.8

Driving and using machinery

There is no evidence to suggest that Premarin
will affect your ability to drive or to operate
machinery.

2.9 Important information about

some of the ingredients in Premarin
Premarin contains lactose and sucrose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
The colouring agent E110 (sunset yellow), that
is used in the yellow tablets, may cause allergic
reactions.

3. HOW TO TAKE PREMARIN
3.1

Starting to take Premarin

Always take Premarin exactly as your doctor
has instructed you. You should check with your
doctor or pharmacist if you are unsure. The
usual dose is one tablet every day.
Your doctor will aim to give you the lowest dose
for the shortest time to treat your symptoms for
as short as necessary. Speak to your doctor if
you think this dose is too strong or not strong
enough.
Take your tablet at the same time each day as
this will help to remind you to take your medicine.
If you are not already taking an HRT product or
if you are taking an HRT product that does not
give you a monthly bleed you may start your
first pack of Premarin at any convenient time.
If you are changing from an HRT product that
gives you a monthly bleed, start Premarin the day
after you finish the course of the previous product,
unless instructed otherwise by your doctor.
While you are taking Premarin you will have no
tablet-free days. You should start your next pack
the day after you finish the previous one.

3.2

The usual dose

a gradual reduction in withdrawal bleeding and
it may eventually stop; this is quite normal. If you
experience troublesome bleeding or it continues
beyond the first 3 months of treatment discuss this
with your doctor (see section titled Endometrial
Cancer above).
If you take more Premarin than

you should
If you take too many tablets don’t worry. You may
feel some nausea (sickness), breast tenderness,
dizziness, abdominal pain and drowsiness/
fatigue. If you have not had a hysterectomy
you may experience a short period of vaginal
bleeding, but it is unlikely that serious problems
will occur. If you are concerned, talk to your
doctor or pharmacist.

3.4

3.5

If you forget to take Premarin

If you forget to take a tablet don’t worry. Take
it as soon as you remember and then carry on
taking the remaining tablets at the usual time.
If more than one tablet has been forgotten, do
not take extra to try to make up for the missed
tablets.
Missed tablets may cause a short period of
light bleeding in women who have not had a
hysterectomy.

For menopausal symptoms the usual dose is one
tablet every day. Your doctor will prescribe the
lowest dose that will control your symptoms.
Premarin 0.3 mg is the lowest starting dose. If
your symptoms are not adequately controlled
higher doses of Premarin can be used.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

For the treatment of osteoporosis the usual dose
is one 0.625 mg tablet every day but your doctor
may advise you to use 1.25 mg each day. You
and your doctor should review the need for
treatment regularly.

The following diseases are reported more often
in women using HRT compared to women not
using HRT:
• breast cancer
• abnormal growth or cancer of the lining
of the womb (endometrial hyperplasia or
cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs
(venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over
the age of 65 

Do not try to take off the coating, divide or crush
the tablets as this could affect the way Premarin
works.

3.3

While you are taking Premarin

If you have had a hysterectomy you are not
expected to have a period.
If you have not had a hysterectomy, you may
be taking an additional progestogen tablet for
12-14 days each month, and you will probably
have a "period", or withdrawal bleed each
month at about the time you finish the additional
progestogen tablets. This is caused by the
hormones in the HRT and is perfectly natural.
Some women taking "combined HRT" (estrogen
plus the additional progestogen) may experience

4. POSSIBLE SIDE EFFECTS
Like all medicines, Premarin can cause side
effects, although not everybody gets them.

For more information about these side effects,
see Section 2.
In addition to those discussed in Section 2, the
following side effects have been reported in
women taking HRT:
• abdominal uterine bleeding such as

breakthrough bleeding or spotting, changes
in menstrual flow, pelvic pain, vaginal
inflammation and vaginal discharge
• a tendency to get thrush
• breast pain, breast tenderness, swollen
breasts, discharge from the nipples and
changes in breast tissue
• feeling or being sick, a feeling of being
bloated, abdominal pain
• headache or migraine
• dizziness
• changes in mood including anxiety,
depression and irritability
• joint pain, leg cramps
• changes in your interest in sex (increased
or decreased libido)
• visible swelling of the face or ankles
• rash, itchiness, acne and dark or red patches
on the skin
• changes in hair growth (loss or increase)
• minor changes to the eye, difficulty wearing
contact lenses
• changes in weight (increase or decrease)
• changes in your triglyceride levels (fatty
substances in the blood)
• an intolerance to glucose
• memory loss (dementia)
• a worsening of chorea (an existing
neurological disorder characterised by
involuntary spasmodic movements of the
body)
• a worsening of asthma
• a worsening of hypocalcaemia (low blood
levels of calcium)
• gallbladder disease or jaundice (e.g. gallstones
or yellowing of the skin)
• growth of benign meningioma (a tumour of
the membranes around the brain or spinal
cord)
• inflammation of the colon (part of the
intestine) which may present as lower left
sided abdominal pain and/or bloody
diarrhoea
• induce or exacerbate symptoms of
angioedema, which consists of generalized
swelling of parts of the body, most
frequently around the face, mouth,
tongue and neck areas, particularly in
women with hereditary angioedema.
These side effects are usually temporary and
should get better over time.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE PREMARIN
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date
stated on the carton and blister. The expiry date
refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help the
environment.

6. FURTHER INFORMATION
6.1

What Premarin contains

The active substance is a mixture of hormones
called conjugated estrogens.
Premarin is available in three different strengths;
the green tablets marked with ‘0.3’ in white
ink contain 0.3 mg conjugated estrogens, the
maroon tablets marked with ‘0.625’ contain
0.625 mg conjugated estrogens and the yellow
tablets marked with ‘1.25’ contain 1.25 mg
conjugated estrogens.
The other ingredients in your tablets are
lactose monohydrate, microcrystalline cellulose,
magnesium stearate, hypromellose, sucrose,
hydroxypropyl cellulose, macrogol, carnauba
wax, edible ink and coating.

What Premarin looks like and

contents of the pack
Your Premarin carton contains three calendar
blister packs, each containing 28 tablets of
the same colour. Not all pack sizes may be
marketed.

6.2

The marketing authorisation holder is
Pfizer Limited, Ramsgate Road, Sandwich, Kent
CT13 9NJ. United Kingdom.
The manufacturer is Pfizer Ireland
Pharmaceuticals, Little Connell, Newbridge,
County Kildare, Republic of Ireland.
This leaflet applies to Premarin tablets only.
This leaflet was last approved in 05/2012
*Trademark

This leaflet can be made available
in large print, audio or Braille on
request. Contact 0800 198 5000
to request this, quoting one of the
following numbers: 00057/1284,
00057/1285 or 00057/1286
Ref: PA 6_2 UK

The edible ink on the green and maroon tablets
contains hypromellose, titanium dioxide (E171)
and propylene glycol (E1520). The edible ink on
the yellow tablets contains hypromellose, iron
oxide black (E172) and propylene glycol (E1520).
The coating on the green tablets contains
hypromellose, titanium dioxide (E171), quinoline
yellow (E104), indigo carmine (E132), macrogol
and polysorbate 80.
The coating on the maroon tablets contains
hypromellose, titanium dioxide (E171), red
aluminium lake (E129), indigo carmine (E132)
and macrogol.
The coating on the yellow tablets contains
hypromellose, titanium dioxide (E171),
quinoline yellow (E104), sunset yellow (E110),
macrogol and polysorbate 80.
These dyes are approved for use as food
colourings.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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