PREMIQUE 0.625MG/5MG COATED TABLETS

Active substance: MEDROXYPROGESTERONE ACETATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER
0.625/5mg

*

of the hormones estrogen and progesterone.

do an internal examination — but only if these

As well as benefits, HRT has some risks which

11 in 1000 would be expected to have a stroke.

If you get:

You may experience a number of unpleasant

examinations are necessary for you, or if you

you need to consider when you’re deciding

For women in their 60s who are taking HRT, the

•  ainful swelling in your leg
p

symptoms, including hot flushes, night sweats and

have any special concerns.

whether to take it, or whether to carry on taking it.

figure would be 15 in 1000.

•  udden chest pain
s

2.2 Effects on your heart or circulation:

If you get:

•  ifficulty breathing
d

•  nexplained migraine-type headaches, with
u

➢ 
See a doctor as soon as possible and do

vaginal dryness, around the time of menopause.

P r em i q u e

®

Premique can relieve some of these symptoms by
replacing some of the lost estrogen.

Once you’ve started on HRT, you should see
your doctor for regular check-ups (at least

C o n j u g at e d E s t r o g e n s a n d
M e d r o x y p r o g e s t e r o n e Ac e tat e

once a year). At these check-ups, your doctor

Heart Disease

After the menopause some women may develop

may discuss with you the benefits and risks of

HRT is not recommended for women who

bone thinning (osteoporosis). If you are at an

continuing to take HRT.

have heart disease, or have had heart disease

not take any more HRT until your doctor

increased risk of fractures due to osteoporosis

0.625 mg/5 mg Coated Tablets

You are advised to:

recently. If you have ever had heart disease, talk

says you can. These headaches may be an

to your doctor to see if you should be taking HRT.

early warning sign of a stroke.

but are unable to take other treatments or if other
therapies prove to be ineffective, Premique may
also be used for this purpose. Your doctor should
discuss all the available options with you.

•  o for regular breast screening and cervical
g
smear tests
•  egularly check your breasts for any changes
r
such as dimpling of the skin, changes in the
nipple, or any lumps you can see or feel.

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

In this leaflet:
1. WHAT PREMIQUE IS AND WHAT IT IS
USED FOR
2. BEFORE YOU TAKE PREMIQUE
3. HOW TO TAKE PREMIQUE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PREMIQUE
6. FURTHER INFORMATION

1. WHAT PREMIQUE IS AND WHAT IT IS
USED FOR
Premique is one of a group of medicines known
as Hormone Replacement Therapy (HRT). It
is used to treat some of the symptoms and
conditions associated with the menopause.
Premique is a period-free HRT (an HRT product
where you do not have a monthly bleed).
Your periods will stop once menopause is
reached. This change is due to lowered levels

2.1 Do not take Premique if:
•  ou are allergic (hypersensitive)
y
to conjugated estrogens or
medroxyprogesterone acetate or any of
the other ingredients of Premique; the
ingredients are listed in Section 6 of this
leaflet
•  ou have or have had breast cancer
y
•  ou have endometrial cancer (cancer of the
y
lining of the womb) or have been told you
have another type of estrogen-dependent
cancer
•  ou have been told you have a blood
y
circulation disorder or have had a blood clot
• 
you have a blood clotting disorder
(thrombophilic disorder, such as protein C,
protein S, or antithrombin deficiency)
•  ou have a heart condition such as angina or
y
have had a heart attack
•  ou have porphyria (a rare inherited
y
metabolic disorder)
•  ou have recently had unexpected or very
y
heavy vaginal bleeding
•  ou have been told that you have
y
endometrial hyperplasia (abnormal growth of
the lining of the womb)
•  ou have or have previously had liver
y
disease
•  ou are pregnant, or you are breast-feeding.
y
Before you start taking HRT, your doctor should
ask about your own and your family’s medical
history. Your doctor may decide to examine
your breasts and/or your abdomen, and may

Some diseases may be made worse by HRT.
Therefore, if you have or have ever had any of
the following remind your doctor as he or she may

Studies with one type of HRT (containing
conjugated estrogens 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

want to monitor you more closely:

certain.

• uterine fibroids or endometriosis

If you get:

• risk factors for blood clots (see section

•  pain in your chest that spreads to your arm
a

2.2 - Blood Clots for more detail)
• a close relative who has had breast cancer
or an estrogen dependent cancer, such as
cancer of the womb or ovaries (see section
2.3 – Effects on your risk of developing
cancer for more detail)
• high blood pressure
• heart disease (see section
2.2 – Heart Disease for more detail)
• liver disease (e.g. liver adenoma)
• kidney disease
• diabetes
• gallbladder disease or gallstones
• migraine
• systemic lupus erythematosus
(SLE – a rare chronic inflammatory disease)
• epilepsy
• asthma
• otosclerosis (hearing loss due to a problem
with the bones in your ear)
• low blood calcium levels (hypocalcaemia)
• high levels of fatty substances in the blood
(hypertriglyceridaemia).
If there is a change in any of the above conditions
whilst taking Premique tell your doctor.

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.

➢ 
See a doctor as soon as possible and do

veins (also called deep vein thrombosis, or

again.

These blood clots are not always serious, but

2.3 Effects on your risk of developing
cancer:

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:
• f you are seriously overweight
i
• f you have had a blood clot before
i
•  any of your close family have had blood
if
clots

needs treatment with a medicine such as

Other things that can increase the risk of stroke

warfarin
•  you’re off your feet for a long time because
if
of major surgery, injury or illness
• f you have a rare condition called SLE
i
(systemic lupus erythematosus).

•  rinking too much alcohol
d

If any of these things apply to you, talk to your

•  n irregular heartbeat.
a

doctor to see if you should take HRT.

If you are worried about any of these things, or

Looking at women in their 50s who are not

if you have had a stroke in the past, talk to your

taking HRT — on average, over a 5-year period,

doctor to see if you should take HRT.

3 in 1000 would be expected to get a blood clot.

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,

doctor will tell you when you can start taking HRT

DVT), especially during the first year of taking it.

• f you have any blood clotting problem that
i

Looking at women in their 50s who are not

your doctor knows about it. You may need to
operation, to reduce the risk of a blood clot. Your

increases the risk of having a stroke.

•  moking
s

If you’re going to have surgery, make sure

HRT may increase the risk of blood clots in the

Recent research suggests that HRT slightly

•  igh blood pressure
h

clot.

stop taking HRT about 4 to 6 weeks before the

• f you have had one or more miscarriages
i

•  etting older
g

says you can. These may be signs of a blood

Blood Clots

Stroke

include:

not take any more HRT until your doctor

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,

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 the same age who’s 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.
Your risk of breast cancer is also higher:
•  you have a close relative (mother, sister or
if
grandmother) who has had breast cancer
•  you are seriously overweight.
if
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 in their 60s who are taking HRT, the

For women who start taking estrogen-only HRT
at age 50 and take it for 5 years, the figure will
be between 33 and 34 in 1000 (i.e. an extra 1-2

figure would be 17 in 1000.

cases).

8 in 1000 would be expected to get a blood clot.

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:
•  impling of the skin
d
•  hanges in the nipple
c
•  ny lumps you can see or feel
a

➢ 
Make an appointment to see your doctor
as soon as possible.

Endometrial Cancer (cancer of the lining
of the womb)
Taking estrogen-only HRT for a long time
can increase the risk of cancer of the lining
of the womb (the endometrium). Taking a
progestogen as well as the estrogen helps to
lower the extra risk.

PAA026030

• f any of the side effects gets serious, or
I
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

2. BEFORE YOU TAKE PREMIQUE

HRT will not help to prevent heart disease.

or without disturbed vision

If they take estrogen-only HRT for 10 years, the
figure will be 37 in 1000 (i.e. an extra 5 cases).

*

P r em i q u e

®

0.625 mg/5 mg Coated Tablets
C o n j u g at e d E s t r o g e n s a n d
M e d r o x y p r o g e s t e r o n e Ac e tat e

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.
/please turn over

Your product, Premique, contains a progestogen.
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 they take it.
The addition of a progestogen to estrogenonly 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

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
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.
In particular tell your doctor if you are taking:
•  n anticonvulsant (used to treat epilepsy e.g.
a
phenobarbital, phenytoin, carbamazepine)
•  anti-infective (e.g. rifampicin, rifabutin,
an

• 
starts after you’ve been on HRT for a while

nevirapine, efavirenz, erythromycin,

• 
carries on even after you’ve stopped taking

ketoconazole, ritonavir, nelfinavir)

HRT

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

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.

•  herbal preparation such as St. John’s wort
a
(Hypericum perforatum)
•  etyrapone (most commonly used in the
m
treatment of Cushing’s syndrome)
•  minoglutethimide (most commonly used in
a
the treatment of breast cancer and Cushing’s
syndrome).
The way that Premique works may be altered if
other medicines are used at the same time.

Some studies have indicated that taking

2.6 Pregnancy and breast-feeding

estrogen-only HRT for more than 5 years may

You should stop taking Premique and tell your

increase the risk of ovarian cancer. It is not yet
known whether other kinds of HRT increase the
risk in the same way.

2.4 Other Conditions
HRT will not help 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.

doctor immediately if you know or suspect you are
pregnant, or if you are breast-feeding.
Premique is not a contraceptive. It is important
that you use a reliable form of non-hormonal
contraception (e.g. condom or diaphragm) if
there is any possibility that you may still become
pregnant. You should discuss this with your
doctor.

Women with hypertriglyceridaemia (high levels

2.7 Driving and using machines

of fatty substances in the blood) may experience

There is no evidence to suggest that Premique

large increases of their plasma triglycerides,
which can lead to inflammation of the pancreas
(pancreatitis). Symptoms of pancreatitis include
sudden sharp abdominal pains, abdominal
swelling, fever and feeling or being sick.

will affect your ability to drive or to operate
machinery.

2.8 Important information about some of
the ingredients in Premique
Premique contains lactose and sucrose. If you
have been told by your doctor that you have an

dizziness, abdominal pain, drowsiness, fatigue or

2 - Before you take Premique.

Very rare (affect less than 1 in 10000 women)

experience a short period of vaginal bleeding, but

4.2 Other side effects

• jaundice (e.g. yellowing of the skin)

phosphate tribasic, calcium sulphate,

• a worsening of chorea (an existing

microcrystalline cellulose, carnauba wax,

Very common (affect more than 1 in

neurological disorder characterised by

glyceryl mono-oleates, lactose, magnesium

10 women)

involuntary spasmodic movements of the body)

stearate, methylcellulose, macrogol,

• breast pain

• a worsening of hypocalcaemia (low blood

pharmaceutical glaze, povidone, sucrose,

Common (affect less than 1 in 10 women)

levels of calcium)

titanium dioxide (E171), stearic acid and

• blurred vision or loss of vision

colour (E132, indigo carmine) and edible ink

• worsening of porphyria (a rare inherited

containing iron oxide black (E172), shellac,

metabolic disorder)

N-Butyl alcohol, propylene glycol and ethyl

• growth of benign liver tumours

acetate.

it is unlikely that serious problems will result. If you
are concerned talk to your doctor or pharmacist.

intolerance to some sugars, contact your doctor

3.3 If you forget to take Premique

before taking this medicinal product.

If you forget to take a tablet don’t worry. Take
it as soon as you remember and then carry on

3. HOW TO TAKE PREMIQUE

3.1 Instructions for proper use
Always take Premique exactly as your doctor has
told 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.
Take your tablet at the same time each day as
this will help to remind you to take your medicine.
If you are not currently taking HRT or you are
taking another period-free HRT, you may start
your first pack of Premique at any convenient
time.
If you are changing from an HRT product that
gives you a monthly bleed, start Premique the day
after you finish the course of the previous product,
unless instructed otherwise by your doctor.
Begin your pack of Premique by taking the first
tablet marked for that day of the week. Continue
to take one tablet each day following the arrows
until all 28 tablets have been taken.
While you are taking Premique you will have no
tablet-free days. You should start your next pack
the day after you finish the previous one.
Premique does not cause periods. However, you
may experience some irregular bleeding or light
bleeding (spotting) during your first few months of
taking Premique. If the bleeding is troublesome,
or continues beyond the first 3 months of
treatment you should discuss this with your doctor
(see section titled Endometrial Cancer above).
Do not try to take off the coating, divide or crush
the tablets as this could affect the way Premique
works.

3.2 If you take more Premique than you
should
If you take too many tablets don’t worry. You may
feel some nausea (sickness), breast tenderness,

taking the remaining tablets at the usual time.

• breakthrough bleeding or spotting, vaginal
inflammation, period pain

If more than one tablet has been forgotten, do

• breast tenderness, swollen breasts, nipple

not take extra to try to make up for the missed

discharge

tablets.

• depression

These side effects are usually temporary and

Missed tablets may cause a short period of

•  uscle and joint aches, leg cramps
m

• 
The other ingredients are calcium

should get better over time.

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, Premique can cause side
effects, although not everybody gets them.

4.1 Serious side effects.
Stop taking Premique and tell your doctor

•  eight change (increase or decrease)
w
•  hanges in your triglyceride levels (fatty
c
substances in the blood)
Uncommon (affect less than 1 in 100 women)
•  hanges in menstrual flow, vaginal discharge
c
• hrush
t
•  ausea, bloating, abdominal pain
n
• headache, migraine






















immediately if you:
•  ave an allergic reaction, signs of which
h
include rash, itching, shortness of breath,
difficulty breathing and a swollen face
•  xperience a migraine type headache
e
(typically a throbbing headache and nausea
preceded by visual disturbances) for the first
time
•  evelop signs of jaundice (yellowing of the
d
skin or the whites of the eyes)
•  ecome pregnant
b
•  xperience a significant increase in your
e
blood pressure
•  evelop a contraindication i.e. circumstances
d
which make treatment inadvisable (see
Section 2 - Before you take Premique).
Do not take any more tablets until your doctor
says you can.
HRT can also increase the risk of heart disease,
stroke, blood clots, breast cancer, endometrial
cancer and ovarian cancer. Please see section

blood clots in the veins
d
 izziness
c
 hanges in mood including anxiety
c
 hanges in your interest in sex (increased or
decreased libido)
v
 isible swelling of the face or ankles
itchiness, acne

difficulty wearing contact lenses
gallbladder disease (e.g. gallstones)
hair loss

Rare (affect less than 1 in 1000 women)
• vomiting
• changes in breast tissue, milky secretion
from the breasts
• irritability
• allergic reactions including swelling, rash or
red patches on the skin
• increase in hair growth
• an intolerance to glucose
• a worsening of asthma
• increased size of fibroids
• ovarian cancer
• worsening of epilepsy
• heart attack, stroke
• inflammation of veins just under the skin

Other side effects that may occur while taking an
estrogen-progesterone combined HRT are:
• memory loss (dementia)
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 PREMIQUE
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 the month.
Do not store above 25°C. Keep the blister in the
outer carton to protect from light.
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 to protect the
environment.

6. FURTHER INFORMATION

6.1 What Premique contains
•  he active ingredients are an estrogen
T
(conjugated estrogens) and a progestogen
(medroxyprogesterone acetate).
 
Each blister pack contains 28 oval coated
tablets, each tablet contains 0.625mg
of conjugated estrogens and 5mg of
medroxyprogesterone acetate (MPA). The

• inflammation of the pancreas

with “ 0.625/5”.

are approved for use as food colourings.

6.2 What Premique looks like and
contents of the pack
Your Premique carton contains either one or
three blisters, each containing 28 tablets.
Not all pack sizes may be marketed.
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 Premique tablets only.
This leaflet was last revised in 10/2011
*Trade mark

This leaflet can be made available
in large print, audio or Braille
on request. Contact 0800 198
5000 to request this, quoting the
following number: 00057/1290.
Ref PQ 4_1

tablets are light blue coloured and marked

• irregular dark spots (usually on the face)

•  he inks and dyes used to coat your tablets
T

PAA026030

Expand view ⇕

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.

Hide
(web3)