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PREMARIN 0.625MG TABLETS

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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 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).
3.4 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.
3.5 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.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Premarin can cause side
effects, although not everybody gets them.
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
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 sight 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.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
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

PATIENT INFORMATION LEAFLET

PREMARIN 0.625MG TABLETS
(conjugated estrogens)
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.
This product is Premarin 0.625mg Tablets but will
be referred to as Premarin throughout this Patient
Information Leaflet. Please note that the leaflet
also contains information about other strengths of
the medicine, Premarin 0.3mg Tablets and
Premarin 1.25mg Tablets.
In this leaflet:
1. What Premarin is and what it is used for
2. Before you take Premarin
3. How to take Premarin
4. Possible side effects
5. How to store Premarin
6. Further information
1. WHAT PREMARIN IS AND WHAT IT IS USED
FOR
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:

What Premarin contains
• Each coated tablet contains 0.625mg conjugated
estrogens.
• Also contains lactose monohydate,
methylcellulose, magnesium stearate, sucrose,
glycerol mono-oleate, macrogol, carnauba wax,
calcium sulphate anhydrous, microcystalline
cellulose, shellac solution, titanium dioxide
E171, stearic acid, erythrosine E127, Indigo
carmine E132, sunset yellow E110, povidone,
sodium benzoate and shellac E904.

Relief of symptoms occurring after menopause

What Premarin looks like and contents of the
pack
• Premarin are maroon oval biconvex
sugar-coated tablets marked with ‘0.625’ in
white ink on one side and plain on the other.
• They come in calendar blister packs size 28’s.

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.

Manufacturer and Licence Holder
This medicine is manufactured by Wyeth Medica
Ireland, Little Connell, Newbridge, Co. Kildare,
Republic of Ireland and is procured from within the
EU. Product Licence Holder: LTT Pharma Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE and
repackaged by Lexon (UK) Limited, B98 0RE.

POM

PL 33723/0149

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

Premarin is usually prescribed for women who
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.

Premarin is a registered trademark of Wyeth LLC.
2. BEFORE YOU TAKE PREMARIN
Leaflet revision date: 25/09/2012

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: LTT149/250912/1/F

®

Medical history and regular check-ups
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.
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.
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.
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)
• 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.
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.

Breast Cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take
HRT.

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).

For more information, see section titled ‘Blood
Clots in a vein (thrombosis)’ below.



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.

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 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.

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.

Heart Disease (heart attack)

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
- Make an appointment to see your doctor.
It could be a sign that your endometrium
has become thicker.

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
• 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).

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.
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
- See a doctor as soon as possible and do
not take any more HRT until your doctor
says you can. This pain could be a sign of
heart disease.

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.

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
• 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.

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.

2.3 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 non-users,
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
• 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)
• 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.

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
- See a doctor as soon as possible and do
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.

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
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.
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.
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
Ref: LTT149/250912/1/B

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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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