HARMOGEN 1.5MG

Active substance: ESTROPIPATE

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PATIENT INFORMATION LEAFLET

Harmogen

®



1.5mg Tablets
Estropipate

Read all of this leaflet carefully before
you start using this medicine.
•  eep this leaflet. You may need to read it
K
again.
• f you have any further questions, please
I
ask your doctor or pharmacist.
•  his medicine has been prescribed for
T
you personally and you should not pass
it on to others. It may harm them, even if
their symptoms are the same as yours.
• f any of the side effects gets serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

1. hat Harmogen is and
W
what it is used for

• Harmogen is a type of hormone treatment
that contains the active ingredient Estropipate.
Estropipate is a semi-synthetic oestrogen which
your body breaks down to form estrone, one of
the naturally occurring female sex hormones
made by your body.
• Women’s ovaries gradually produce less
estrogen as they approach menopausal
age (also referred to as ‘the change’). Low
levels of estrogen can cause symptoms
such as hot flushes, sweats, and vaginal
dryness which leads to sore or painful sexual
intercourse. Harmogen is used as part of
hormone replacement therapy (HRT) treatment
to maintain adequate levels of estrogen to
relieve these symptoms during and after the
menopause.
• It is also used as a treatment to reduce the risk
of your bones breaking due to the thinning of
the bones (osteoporosis) after the menopause
when other treatments are not suitable.
• Harmogen is not a contraceptive. You should
speak to your doctor if you need contraceptive
advice.

2. Before you take Harmogen
BAR CODE AREA

In this leaflet:
1. 
What Harmogen is and what it is
used for
2. Before you take Harmogen
3. How to take Harmogen
4. Possible side effects
5. How to store Harmogen
6. Further information

Harmogen v2 pw.indd 1

Harmogen may not be suitable for all women. Your
doctor will assess your general health and discuss
with you the benefits and risks of taking hormone
replacement therapy (HRT) before prescribing
Harmogen. Your doctor could ask about your own
and/or your family’s medical history. Depending
on your condition, your doctor may need to
examine your breasts and/or your abdominal area
and may also do an internal examination. These
examinations will only be done if necessary for
you, based on your medical history or if you have
any special concerns.

Regular Check ups

Whilst taking Harmogen, it is recommended that
you see your doctor for regular check-ups (at least
once a year). At these check-ups, your doctor
may discuss with you the benefits and risks of
continuing to take HRT.
It is important that you regularly:
• go for breast screening and cervical smear tests
• check your breasts for any lumps or changes

in skin or around the nipple.

Do not take Harmogen if you have the
following conditions:

• hypersensitivity (allergy) to estropipate or similar
medicines for hormone replacement therapy, or
any of the other ingredients in Harmogen (see
Section 6 for further information)
• a hereditary blood disorder (porphyria)
• abnormal growth in the womb lining
• have or have had breast cancer or any
other cancer
• have or have had a blood circulation disorder
like a blood clot in the veins of the leg or
the lungs
• unexpected vaginal bleeding
• previous or recent liver disease (where liver
function tests are still abnormal)
• previous or a present case of heart diseases
such as angina or heart attack
• if you are pregnant or breast-feeding.

Take special care with Harmogen:

While on HRT, some medical conditions may
require your doctor to keep a close watch on you.
Tell your doctor if you have or have had in the past
any of the following conditions as HRT can make
them worse:
• history of breast cancer or any cancer in your
family (especially hormone dependent cancer)
• heart diseases including blood clots or a history
of blood clots in the family
• high blood pressure
• diabetes
• migraine or severe headache
• epilepsy
• liver disease
• gallstones
• a rare disease called systemic lupus
erythematosus (SLE)
• history of endometrial hyperplasia (overgrowth
of the lining of the womb)
• uterine fibroids and endometriosis (inner lining
cells of the womb found in places other than
the womb)
• hearing disorder caused by scarring in the ear
(otosclerosis)
• asthma
• raised levels of fat in the blood
(hypertriglyceridaemia)
• raised levels of thyroid hormones.

Safety of Hormone Replacement Therapy
(HRT)

As well as benefits, HRT has some risks which you
need to consider when you’re deciding whether to
take it, or whether to carry on taking it.

Effects on Your Heart or Circulation
Heart Disease

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.

HRT will not help to prevent heart disease
Studies with one type of HRT (containing conjugated
estrogen plus the progestogen MPA) have shown
that women may be slightly more likely to get
heart disease during the first year of taking the
medication. For other types of HRT, the risk is likely
to be similar, although this is not yet certain.

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.

Stroke

Recent research suggests that HRT slightly
increases the risk of having a stroke. Other things
that can increase the risk of stroke include:
• getting older
• high blood pressure
• smoking
• drinking too much alcohol
• an irregular heartbeat.
If you are warned 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.
Stroke

Compare:

Looking at women in their 50s who are not
taking HRT - on average, over a 5-year period,
3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT,
the figure would be 4 in 1000.
Looking at women in their 60s who are not
taking HRT - on average, over a 5-year period,
11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT,
the figure would be 15 in 1000.

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.

Blood Clots

HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or DVT),
especially during the first year of taking it.
These blood clots are not always serious, but
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:
• if you are seriously overweight
• if you have had a blood clot before
• if any of your close family have had blood clots
• if you have had one or more miscarriages
• if you have any blood clotting problem that needs
treatment with a medicine such as warfarin
• if you’re off your feet for a long time because of
major surgery, injury or illness
• if you have a rare condition called SLE.
If any of these things apply to you, talk to your

doctor to see if you should take HRT.
Blood clots

Compare:

Looking at women in their 50s who are
not taking HRT - on average, over a 5-year
period, 3 in 1000 would be expected to get a
blood clot.
For women in their 50s who are taking HRT,
the figure would be 7 in 1000.
Looking at women in their 60s who are
not taking HRT - on average, over a 5-year
period, 8 in 1000 would be expected to get a
blood clot.
For women in their 60s who are taking HRT,
the figure would be 17 in 1000.

If you get:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.
See a doctor as soon as possible and do not
take any more HRT until your doctor says you

can. These may be signs of a blood clot.
If you’re going to have surgery, make sure
your doctor knows about it. You may need to
stop taking HRT 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
HRT again.

Effects on Your Risk of Developing Cancer
Breast Cancer

Women who have breast cancer, or have had
breast cancer in the past, should not take HRT.
Taking HRT slightly increases the risk of breast
cancer; so does having a later menopause.
The risk for a post-menopausal woman taking
estrogen-only HRT for 5 years is about the same
as for a woman of the same age who is still having
periods over that time and not taking HRT. The
risk for a woman who is taking estrogen plus
progestogen HRT is higher than for estrogenonly HRT (but estrogen plus progestogen HRT is
beneficial for the endometrium, see ‘Endometrial
cancer’ below).
For all kinds of HRT, the extra risk of breast cancer
goes up the longer you take it, but returns to
normal within about 5 years after stopping HRT.
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 overweight.
Breast cancer

Compare:

Looking at women aged 50 who are not taking
HRT - on average, 32 in 1000 will be diagnosed
with breast cancer by the time they reach the
age of 65.
For women who start taking estrogen-only HRT
at age 50 and take it for 5 years, the figure will
be 33 and 34 in 1000 (i.e. an extra 1-2 cases).
If they take estrogen-only HRT for 10 years, the
figure will be 37 in 1000 (i.e. an extra 5 cases).
For women who start taking estrogen plus
progestogen HRT at age 50 and take it for
5 years, the figure will be 38 in 1000 (i.e. an
extra 6 cases).
If they take estrogen plus progestogen HRT
for 10 years, the figure will be 51 in 1000
(i.e. an extra 19 cases).

If you notice

any changes in your breast, such as:
• dimpling of the skin
• changes in the nipple.
• any lumps you can see or feel.
Make an appointment to see your doctor

as soon as possible.

Continued overleaf...

26/02/2009 13:52:32

Endometrial Cancer
(cancer of the lining of the womb)

Taking estrogen-only HRT tablets for a long time
can increase the risk of cancer of the lining of
the womb (the endometrium).
• If you still have your womb, your doctor will

usually prescribe a progestogen as well as
estrogen. These may be prescribed separately,
or as a combined HRT product.
• If you have had your womb removed (in a
procedure referred to as a hysterectomy), your
doctor will discuss with you whether you can
safely take oestrogen 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.
Harmogen is an estrogen-only product.
Endrometrial cancer

Compare:

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.
The addition of a progestogen to estrogen-only HRT
substantially reduces the risk of endometrial cancer.
If you get: breakthrough bleeding or spotting,
it’s usually nothing to worry about especially during
the first few months of taking HRT.
But if the bleeding or spotting:

• carries on for more than the first few months
• starts after you’ve been on HRT for a while
• carries on even after you’ve stopped taking HRT.
Make an appointment to see your doctor.

It could be a sign that your endometrium has
become thicker.

Risk of Dementia

HRT will not prevent memory loss. In one study of
women who started using combined HRT after the
age of 65, a small increase in the risk of dementia
was observed.

Taking other medicines:

Tell your doctor or pharmacist if you are taking any
of the following medicines as they may affect how
Harmogen works:
• anticonvulsants for treating epilepsy like
phenobarbitol, phenytoin, carbamazepine
• anti-infective medicines such as rifampicin,
rifabutin, nevirapine, and efavirenz
• herbal preparations containing St. John’s wort
(Hypericum perforatum)
• ritonavir and nelfinavir (drugs used to treat HIV).
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.

Blood tests

If you are about to have any blood tests, (e.g.
to test for presence of high levels of fats
(triglycerides) in your blood), you must tell your
doctor that you are using Harmogen as these tests
can be affected by this medicine.

Pregnancy

Harmogen should not be used during pregnancy.
You should stop using Harmogen if you become
pregnant while being treated. Tell your doctor
immediately if you are pregnant.

Breast-feeding

Harmogen should not be taken while breastfeeding. Ask your doctor or pharmacist for advice
before taking any medicine while breast-feeding.

Driving and using machinery

There are no special precautions, you can drive
or operate machinery as long as you feel well and
able to do so.

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.
Some studies have indicated that taking estrogenonly HRT for more than 5 years may increase the
risk of ovarian cancer. It is not yet known whether
other kinds of HRT increase the risk in the
same way.

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3. How to take Harmogen

• Always take your medicine as directed by your
doctor. You should check with your doctor or
pharmacist if you are not sure.
• Your doctor will aim to give you the lowest
dose for the shortest time needed to treat your
symptoms.
• Your doctor will tell you how many tablets you
should take.

• It is recommended that you swallow the tablets
whole, do not chew, crush, or put them in water.
• If you think that the tablets are too strong or
that they are not working, talk to your doctor
or pharmacist, as the dose may need to be
adjusted.
• Harmogen is not recommended for use in
children.

Adults and elderly
Treatment of:

Dosage:

Menopausal
symptoms

One or two tablets
(1.5mg to 3mg) daily

Prevention of
post-menopausal
osteoporosis

One tablet (1.5mg)
daily

If you are advised to take two tablets per day,
you can either take both at the same time, or you
can take one tablet at two different times. It is
recommended to get into a routine of taking your
tablets at a regular time, e.g. at breakfast, in the
early afternoon or at bedtime.
When you finish the tablets in one pack, start
your new pack the next day.

When to take Harmogen

The list below tells you when to start your
treatment with Harmogen:
• if you are having regular periods then you
should start taking your Harmogen tablets within
5 days of the start of your bleeding
• if you are not having regular periods then you
can start taking your Harmogen tablets at any
time
• if you are changing from a HRT product that
makes you bleed when you stop taking it, then
you should finish the treatment cycle and start
taking your Harmogen tablets within 5 days of
the withdrawal bleeds starting
• if you are changing from a HRT product that
does not give you a withdrawal bleed then you
can start using Harmogen on any day.
Remember, when you finish the tablets in one
pack of Harmogen, start your new pack the next
day. Do not leave a break between packs.

If you stop taking Harmogen

If you want to stop taking Harmogen you should
discuss this with your doctor first. When you
stop taking Harmogen, you may notice that the
symptoms you experienced before taking this
medicine return.

If you miss a dose

If you miss a dose, take the dose if it is missed
within a few hours of when you normally take it,
otherwise take the next dose at the scheduled
time.
Do not take a double dose to make up for the
one you missed.

If you take more Harmogen than you
should

It unlikely that taking more than one tablet will
do you any harm but you may feel sick or have
some vaginal bleeding. Take your usual dose the
following day. If you or someone else takes a larger
number of tablets by mistake, contact your doctor
immediately for advice.

Additional medicines you may be given
while taking Harmogen

• If you have had a hysterectomy (had your womb
removed) your HRT will be Harmogen only.
• If you have not had your womb taken out your
doctor will normally also give you a progestogen
treatment (another hormone replacement
treatment which balances the effect of
estropipate on your womb). You will take this
for two weeks of each monthly cycle. This is
part of your HRT.
While you are using Harmogen and a
progestogen treatment you will probably
have either a ‘period’ or some regular
bleeding each month. This is quite normal.

4. Possible side effects

Like all medicines, Harmogen can sometimes
cause side effects although not everybody gets
them. Whilst using Harmogen, you may experience
side effects, but most of these side effects do not
stop you continuing your treatment.

Please see your doctor straight away if you
have the following symptoms as your treatment
will be discontinued if it is found that you have
these conditions:

• you develop any of the symptoms listed in
‘Section 2 - Do not take Harmogen if you have
the following conditions’
• blood clot formation, e.g. in the legs or lungs
(see Section 4 - ‘Risk of Blood Clots’)
• yellow skin and whites of the eyes (jaundice)
• rise in blood pressure
• migraine for the first time or new type of
severe headache
• if you suspect you may be pregnant.

If any of the following side effects gets serious,
or if you notice any other side effects not
listed in this leaflet, please tell your doctor or
pharmacist.

Minor side effects of Harmogen

The following are a list of the less serious but more
common side effects:
• nausea (feeling sick) or vomiting (being sick)
• unexpected vaginal bleeding, itching,
discomfort/pain or unpleasant discharge
• stomach cramp, bloating
• tenderness to breasts, or unexpected discharge
from breast
• skin discolouration or rash
• excessive general itching
• hair loss, or abnormal distribution of hair growth
• migraine
• dizziness
• mood change (elation/depression)
• nervous disorders (such as twitching of arms
and legs)
• loss of sex drive
• visual disturbances
• intolerance of contact lenses
• change in body weight, water or salt retention.
Other side effects that have been reported while
taking Harmogen are:
• breast cancer (See Section 2 on ‘Risk of
developing cancer’)
• increased awareness of, or size, of fibroids (see
Section 2 ‘Take special care with Harmogen’),
or aggravation of endometriosis
• stroke (See Section 2 on ‘Risk of developing
a Stroke’)
• liver tumours and disorders
• increased blood pressure.
Endometrial cancer has been seen in some
patients taking HRT (See Section 2 on ‘Risk of
developing cancer’).

What Harmogen looks like and contents
of the pack

Harmogen tablets are flat, bevel-edged, oval, and
peach coloured with ‘U/3773’ and a line on both
sides. It is packaged in blister strips containing
28 tablets in a pack.

Marketing Authorisation Holder

Pharmacia Ltd., Ramsgate Road, Sandwich,
Kent, CT13 9NJ, UK.

Manufacturer

Pfizer Service Company BVBA, 10 Hoge Wei,
1930 Zaventem, Belgium.

Company Contact address

For further information on this medicine, please
contact Medical Information at Pfizer Limited in
Walton Oaks, Tadworth, Surrey.
Tel: 01304 616161.

This leaflet was last updated January 2009.
Document Reference: HA 5_4

5. How to store Harmogen

• Do not store the tablets above 30˚C.
• Keep out of the reach and sight of children.
• Do not use Harmogen tablets after the expiry
date which is stated on the pack. The expiry
date refers to the last day of that month.

BAR CODE AREA

6. Further Information
What Harmogen contains

Harmogen tablets contain 1.5mg Estropipate
(piperazine estrone sulphate), equivalent to
0.93mg estrone. The other ingredients in the tablet
include lactose, dibasic potassium phosphate,
tromethamine, hydroxypropyl cellulose, sodium
starch glycollate, microcrystalline cellulose,
colloidal silicon dioxide, magnesium stearate,
hydrogenated vegetable oil wax and sunset yellow
(E110), purified water and alcohol 200 proof.

26/02/2009 13:52:32

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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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