PREMIQUE LOW DOSE 0.3MG/1.5MG MODIFIED RELEASE TABLETS

Active substance: MEDROXYPROGESTERONE ACETATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

This change is due to lowered levels of the
hormones estrogen and progesterone. You may
experience a number of unpleasant symptoms,
including hot flushes, night sweats and vaginal
dryness, around the time of menopause. Premique
Low Dose can relieve some of these symptoms by
replacing some of the lost estrogen.

2. BEFORE YOU TAKE premique

low dose
2.1 Do not take Premique Low Dose if:

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

1.  hat Premique Low Dose IS
W
and what it is used for
Premique Low Dose 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 Low Dose 0.3mg/1.5mg Modified
Release Tablets is a period-free HRT (an HRT
product where you do not have a monthly bleed).
Your periods will stop once menopause is reached.

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
do an internal examination — but only if these
examinations are necessary for you, or if you have
any special concerns.
Once you’ve started on HRT, you should 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.
You are advised to:
•  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.

Profile

P666

MFB PREMIQUE LD 0.3 MG/1.5 MG 28S ENG
Leaflet (Front)
NEWBRIDGE
2014-0001899001
FPO
N/A

Job No.
Pass No.
Date last modified

Black

MRP Component Description:
Component
Packaging Plant
Item Code
Pharma Code
Barcode No.

225157
2
01 Sep 14

Telephone +353 (0)1 440 3222
info@perigordpremedia.com
www.perigordpremedia.com

TEXT SIZE

The BODY text
on this A/W is at:

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.

2.2 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 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 certain.
If you get:
•  pain in your chest that spreads to your arm
a
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.

GRADIENT VALUES

P666 - 60%

11.0 pt

The SMALLEST text
on this A/W is at:

8.0 pt

Perigord House
Damastown Industrial Park
Dublin 15
Ireland

TINT VALUES

If there is a change in any of the above conditions
whilst taking Premique Low Dose tell your doctor.

P666 - 30%

P666 - 5% - 25%

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 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.
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:
•  nexplained migraine-type headaches, with
u
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
• f any of your close family have had blood
i
clots
• if you have had one or more miscarriages
• f you have any blood clotting problem that
i
needs treatment with a medicine such as
warfarin
• f you’re off your feet for a long time because
i
of major surgery, injury or illness
• f you have a rare condition called SLE
i
(systemic lupus erythematosus).

If any of these things apply to you, talk to your
doctor to see if you should take HRT.
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.

2.3 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 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:
• f you have a close relative (mother, sister or
i
grandmother) who has had breast cancer
• if you are seriously overweight.
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 between 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.
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.
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, Premique Low Dose, 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 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
•  arries on even after you’ve stopped taking
c
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.
Some studies have indicated that taking
estrogen-only 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.

2014-0001899001

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

• you have or have had breast cancer
•  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 are allergic to any of the ingredients in
y
Premique Low Dose; the ingredients are listed
in Section 6 of this leaflet
•  ou have porphyria (a rare inherited metabolic
y
disorder)
•  ou have recently had unexpected or very
y
heavy vaginal bleeding
•  ou have been told that you have endometrial
y
hyperplasia (abnormal growth of the lining of
the womb)
• you have or have previously had liver disease
• you are pregnant, or you are breast-feeding.

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 want
to monitor you more closely:
 uterine fibroids or endometriosis
 risk factors for blood clots (see section
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).

Modified Release Tablets
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.
Women with hypertriglyceridaemia (high levels
of fatty substances in the blood) may experience
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.
If you are taking thyroid hormone replacement
therapy (e.g. thyroxine), your doctor may monitor
/please turn over

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)
•  n anti-infective (e.g. rifampicin, rifabutin,
a
nevirapine, efavirenz, erythromycin,
ketoconazole, ritonavir, nelfinavir)
•  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
a
in the treatment of breast cancer and
Cushing’s syndrome).
The way that Premique Low Dose works may be
altered if other medicines are used at the same
time.

2.6 Pregnancy and breast-feeding
Ask your doctor or pharmacist for advise before
taking any medicine.
You should stop taking Premique Low Dose
and tell your doctor immediately if you know or
suspect you are pregnant, or if you are breastfeeding.
Premique Low Dose 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.

2.7 Driving and using machines
There is no evidence to suggest that Premique
Low Dose will affect your ability to drive or to
operate machinery.

2.8 Important information about some of
the ingredients in Premique Low Dose
Premique Low Dose 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.

3. How to take Premique Low

Dose
3.1 Instructions for proper use
Always take Premique Low Dose 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.
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 Low Dose at any convenient
time.
If you are changing from an HRT product that
gives you a monthly bleed, start Premique Low
Dose the day after you finish the course of the
previous product, unless instructed otherwise by
your doctor.
Begin your pack of Premique Low Dose by taking
the first tablet 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 Low Dose you will
have no tablet-free days. You should start your
next pack the day after you finish the previous one.
Premique Low Dose does not cause periods.
However, you may experience some irregular
bleeding or light bleeding (spotting) during your
first few months of taking Premique Low Dose.
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
Low Dose works.

3.2 If you take more Premique Low Dose
than you should
If you take too many tablets don’t worry. You may
feel some nausea (sickness), breast tenderness,
dizziness, abdominal pain, drowsiness, fatigue or
experience a short period of vaginal bleeding, but it
is unlikely that serious problems will result. If you are
concerned talk to your doctor or pharmacist.

3.3 If you forget to take Premique Low Dose
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.

Profile

P666

MFB PREMIQUE LD 0.3 MG/1.5 MG 28S ENG
Leaflet (Back)
NEWBRIDGE
2014-0001899001
FPO
N/A

Job No.
Pass No.
Date last modified

Black

MRP Component Description:
Component
Packaging Plant
Item Code
Pharma Code
Barcode No.

225157
2
01 Sep 14

Telephone +353 (0)1 440 3222
info@perigordpremedia.com
www.perigordpremedia.com

Perigord House
Damastown Industrial Park
Dublin 15
Ireland

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

4.1 Serious side effects.
Stop taking Premique Low Dose and tell your
doctor 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 (typically
e
a throbbing headache and nausea preceded by
visual disturbances) for the first time
•  evelop signs of jaundice (yellowing of the skin
d
or the whites of the eyes)
• become pregnant
•  xperience a significant increase in your blood
e
pressure
•  evelop a contraindication i.e. circumstances
d
which make treatment inadvisable (see Section
2 - Before you take Premique Low Dose).
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
2 - Before you take Premique Low Dose.

4.2 Other side effects
Very common (affect more than 1 in 10 women)
• breast pain
Common (affect less than 1 in 10 women)
• breakthrough bleeding or spotting, vaginal
inflammation, period pain
• breast tenderness, swollen breasts, nipple
discharge
• depression
• muscle and joint aches, leg cramps
• weight change (increase or decrease)
• changes in your triglyceride levels (fatty
substances in the blood)
Uncommon (affect less than 1 in 100 women)
• changes in menstrual flow, vaginal discharge
• thrush
• nausea, bloating, abdominal pain












headache, migraine
blood clots in the veins
dizziness
changes in mood including anxiety
changes in your interest in sex (increased or
decreased libido)
visible 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
• inflammation of the pancreas
• irregular dark spots (usually on the face)
Very rare (affect less than 1 in 10000 women)
• jaundice (e.g. yellowing of the skin)
• a worsening of chorea (an existing neurological
disorder characterised by involuntary spasmodic
movements of the body)
• a worsening of hypocalcaemia (low blood
levels of calcium)
• blurred vision or loss of vision
• worsening of porphyria (a rare inherited
metabolic disorder)
• growth of benign liver tumours
These side effects are usually temporary and should
get better over time.
Other side effects that may occur while taking an
estrogen-progesterone combined HRT are:
• memory loss (dementia)
Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

5.  OW TO STORE Premique Low
H
Dose

This leaflet was last revised in 07/2014
*Trade mark

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date
stated on the carton and blister. This 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 measurements will help to protect
the environment.

6. FURTHER INFORMATION
6.1 What Premique Low Dose contains
The active substances are conjugated estrogens
(an estrogen) and medroxyprogesterone acetate
(a progestogen).
Each tablet contains 0.3mg of conjugated
estrogens and 1.5mg of medroxyprogesterone
acetate (MPA). The tablets are cream coloured
and marked in black ink.
The other ingredients in your tablets are lactose
monohydrate, microcrystalline cellulose,
hypromellose, magnesium stearate, sucrose,
hydroxypropyl cellulose, polyethylene glycol, ethyl
acrylate, methacrylate, titanium dioxide (E171),
yellow iron oxide (E172), hydroxyethyl cellulose,
povidone, polydextrose, maltitol, poloxamer and
edible ink that contains black iron oxide (E172),
propylene glycol and hypromellose.

6.2 What Premique Low Dose looks like
and contents of the pack
Your Premique Low Dose carton contains either
one or three blister packs, 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 Low Dose tablets
only.

Ref PQ 6_0

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: 00057/1288
2014-0001899001

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
(web2)