PREMIQUE CYCLE 0.625 MG/10 MG COATED TABLETS

Active substance: MEDROXYPROGESTERONE ACETATE

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UK PQ 005

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREMIQUE CYCLE® 0.625mg/10mg Coated Tablets
Conjugated Estrogens and Medroxyprogesterone Acetate
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.
 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.
In this leaflet:
1. What Premique Cycle is and what it is used for
2. Before you take Premique Cycle
3. How to take Premique Cycle
4. Possible side effects
5. How to store Premique Cycle
6. Further information
1. WHAT PREMIQUE CYCLE IS AND WHAT IT IS USED FOR
Premique Cycle 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 Cycle is a sequential HRT (an HRT product where you have a
monthly bleed).
Your periods will stop once menopause is reached. 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 Cycle can relieve some of these symptoms by replacing some of
the lost estrogen.
After the menopause some women may develop bone thinning (osteoporosis). If you are at
an increased risk of fractures due to osteoporosis but are unable to take other treatments
or if other therapies prove to be ineffective, Premique Cycle may also be used for this
purpose. Your doctor should discuss all the available options with you.
2. BEFORE YOU TAKE PREMIQUE CYCLE
2.1 Do not take Premique Cycle if:
 you are allergic (hypersensitive) to conjugated estrogens or medroxyprogesterone
acetate or any of the ingredients of Premique Cycle; the ingredients are listed in
Section 6 of this leaflet
 you have or have had breast cancer
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you have endometrial cancer (cancer of the lining of the womb) or have been told
you have another type of estrogen-dependent cancer
you have been told you have a blood 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)
you have a heart condition such as angina or have had a heart attack
you have porphyria (a rare inherited metabolic disorder)
you have recently had unexpected or very heavy vaginal bleeding
you have been told that you have endometrial 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.

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:
 go for regular breast screening and cervical smear tests
 regularly check your breasts for any changes such as dimpling of the skin,
changes in the nipple, or any lumps you can see or feel.
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).
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If there is a change in any of the above conditions whilst taking Premique Cycle tell your
doctor.
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:
 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 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:
 unexplained migraine-type headaches, with or without disturbed vision
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 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 (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:
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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 estrogen-only 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:
 if you have a close relative (mother, sister or 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.
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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 Cycle, 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
 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.
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.
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 your thyroid function more often when you start treatment.
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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:
 an anticonvulsant (used to treat epilepsy e.g. phenobarbital, phenytoin,
carbamazepine)
 an anti-infective (e.g. rifampicin, rifabutin, nevirapine, efavirenz, erythromycin,
ketoconazole, ritonavir, nelfinavir)
 a herbal preparation such as St. John’s wort (Hypericum perforatum)
 metyrapone (most commonly used in the treatment of Cushing’s syndrome)
 aminoglutethimide (most commonly used in the treatment of breast cancer and
Cushing’s syndrome).
The way that Premique Cycle works may be altered if other medicines are used at the
same time.
2.6 Pregnancy and breast-feeding
You should stop taking Premique Cycle and tell your doctor immediately if you know or
suspect you are pregnant, or if you are breast-feeding.
Premique Cycle is not a contraceptive. It is important that you use a reliable form of nonhormonal 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 Cycle will affect your ability to drive or to
operate machinery.
2.8 Important information about some of the ingredients in Premique Cycle
Premique Cycle contains lactose and sucrose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
The green tablets contain methylhydroxybenzoate and propylhydroxybenzoate. These
ingredients may cause allergic reactions (possibly delayed).
3. HOW TO TAKE PREMIQUE CYCLE
Always take Premique Cycle exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are unsure.

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Your doctor will aim to give you the lowest dose for the shortest time to treat your
symptoms.
The usual dose is one white tablet on days 1-14 and one green tablet on days 15-28.
While you are taking Premique Cycle you will have no tablet free days. You should start
your next pack the day after you finish the previous one.
Take your tablets at the same time each day as this will help to remind you to take your
medicine.
Begin your pack of Premique Cycle by taking a white tablet marked for that day of the
week. Continue to take one tablet daily following the arrows until all 14 white tablets in
the pack have been taken. The next day, take a green tablet marked for that day of the
week. Continue to take one green tablet daily following the arrows until all 14 green
tablets have been taken. You may have a bleed similar to a period soon after finishing
each pack. Start a new pack of Premique Cycle the next day.
You may start your first pack at any convenient time. However, if you are still having
periods you should start on the first day of your next period.
If you are transferring from another HRT product that gives you a monthly bleed, start
Premique Cycle the day after you finish the course of the previous product, unless instructed
otherwise by your doctor.
When you take Premique Cycle you will probably have a regular “period” or “withdrawal
bleed” each month. This is caused by the hormones, and is perfectly normal. Some
women on HRT do not bleed. This is also quite normal. If you have an irregular bleed or
bleeding is excessively heavy, 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 Cycle works.
3.1 If you take more Premique Cycle 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.
3.2 If you forget to take Premique Cycle
If you forget to take your tablets don’t worry. Take them as soon as you remember and then
carry on taking the remaining tablets at the usual time.
If more than two tablets have been forgotten, do not take extra to try to make up for the
missed tablets.

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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 Cycle can cause side effects, although not everybody gets
them.
4.1 Serious side effects
Stop taking Premique Cycle and tell your doctor immediately if you:
 have an allergic reaction, signs of which include rash, itching, shortness of breath,
difficulty breathing and a swollen face
 experience a migraine type headache (typically a throbbing headache and nausea
preceded by visual disturbances) for the first time
 develop signs of jaundice (yellowing of the skin or the whites of the eyes)
 become pregnant
 experience a significant increase in your blood pressure
 develop a contraindication i.e. circumstances which make treatment inadvisable
(please see section 2 - Before you take Premique Cycle)
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 Cycle.
4.2 Other side effects
Ver y common (affect mor e 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
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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)

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 CYCLE
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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 date of that 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 the
environment.
6. FURTHER INFORMATION
6.1 What Premique Cycle contains
The active substances are conjugated estrogens and medroxyprogesterone acetate.
Premique Cycle contains two types of tablets - the white tablets (marked “0.625”) contain
0.625mg conjugated estrogens; the green tablets (marked “0.625/10”) contain 0.625mg
conjugated estrogens and 10mg of a progestogen - medroxyprogesterone acetate (MPA).
The other ingredients in the conjugated estrogens tablets (white tablets) are: calcium
phosphate tribasic, calcium sulphate, carnauba wax, microcrystalline cellulose, glyceryl
mono-oleates, lactose, magnesium stearate, methylcellulose, macrogol, shellac, sucrose,
titanium dioxide (E171) and edible printing ink†.
The other ingredients in the medroxyprogesterone acetate tablets (green tablets) are: calcium
phosphate tribasic, calcium sulphate, carnauba wax, microcrystalline cellulose, glyceryl
mono-oleates, lactose, magnesium stearate, methylcellulose, methyl hydroxybenzoate,
macrogol, povidone, propyl hydroxybenzoate, shellac, sodium benzoate, sucrose, indigo
carmine (E132), titanium dioxide (E171), iron oxide yellow (E172) and edible printing ink†.


edible printing ink contains iron oxide black (E172), shellac, propylene glycol, ethanol,
ethyl acetate, N-Butyl alcohol, purified water, ammonia solution.
The inks and dyes used to coat your tablets are approved for use as food colourings.
6.2 What Premique Cycle looks like and contents of the pack
Your Premique Cycle carton contains three blister packs of tablets. Each blister pack
contains 14 conjugated estrogens tablets and 14 combined conjugated estrogens/MPA
tablets.
The marketing authorisation holder is Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
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United Kingdom
The manufacturer is Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County
Kildare, Republic of Ireland.
This leaflet applies to Premique Cycle tablets only.
Leaflet approved: 11/2011
* Trade mark
Ref: PQ 4_0

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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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