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PREMPAK-C 0.625 MG/0.15 MG COATED TABLETS

Active substance(s): CONJUGATED ESTROGENS / NORGESTREL

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If you are at an increased risk of fractures due to
osteoporosis and other medicines are not suitable
for you, you can use Prempak-C to prevent
osteoporosis after menopause.

0.625 mg/0.15 mg & 1.25 mg/0.15 mg Coated Tablets
conjugated estrogens
and norgestrel

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it
again.
 If you have any further questions, ask your
doctor, pharmacist or nurse.
 This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
 If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in the
leaflet. See section 4.
What is in this leaflet
1. What Prempak-C is and what it is used for
2. What you need to know before you take
Prempak-C
3. How to take Prempak-C
5. How to store Prempak-C
6. Contents of the pack and other information

1. What Prempak-C is and what
it is used for
Prempak-C is a Hormone Replacement Therapy
(HRT) preparation containing two types of female
hormones, an estrogen and a progestogen
(norgestrel). Prempak C is used in menopausal
and postmenopausal women.
It is used for:
Relief of symptoms occurring after
menopause
During the menopause, the amount of the
estrogen produced by a woman’s body drops.
This can cause symptoms such as hot face,
neck and chest (“hot flushes”). Prempak-C
alleviates these symptoms after menopause.
You will only be prescribed Prempak-C if your
symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop
fragile bones (osteoporosis). You should discuss
all available options with your doctor.

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2. What you need to know before
you take Prempak-C
Medical history and regular check-ups
The use of HRT carries risks which need to be
considered when deciding whether to start taking
it, or whether to carry on taking it.
The experience in treating women with a
premature menopause (due to ovarian failure
or surgery) is limited. If you have a premature
menopause the risks of using HRT may be
different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will
ask about your own and your family’s medical
history. Your doctor may decide to perform
a physical examination. This may include an
examination of your breasts and/or an internal
examination, if necessary.
Once you have started on Prempak-C you should
see your doctor for regular check-ups (at least
once a year). At these check-ups, discuss with
your doctor the benefits and risks of continuing
with Prempak C.
Go for regular breast screening, as recommended
by your doctor.
2.1 Do not take Prempak-C
If any of the following applies to you. If you are
not sure about any of the points below, talk to
your doctor before taking Prempak-C.
Do not take Prempak-C:
 If you are allergic (hypersensitive) to
conjugated estrogens or norgestrel or any of
the other ingredients of this medicine (listed
in section 6)
 If you have or have ever had breast cancer,
or if you are suspected of having it
 If you have cancer which is sensitive to
estrogens, such as cancer of the lining of the
womb (endometrium) or if you are suspected
of having it
 If you have ever had a blood clot in a vein
(thrombosis), such as in the legs (deep
venous thrombosis) or the lungs (pulmonary
embolism)
 If you have a blood clotting disorder (such
as protein C, protein S, or antithrombin
deficiency)

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

MFB PREMPAK-C 0.625/1.25/0.15 40S GB/MT
Leaflet (Front)
NEWBRIDGE
201600555001
FPO
N/A

Job No.
Pass No.
Date last modified

272838
2
16 Feb 2016

TEXT SIZE

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11.0 pt

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8.0 pt

by blood clots in the arteries, such as a heart
attack, stroke or angina
 If you have a rare blood problem called
“porphyria” which is passed down in families
(inherited)
 If you have any unexplained vaginal bleeding
 If you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not
being treated
 If you have or have previously had liver
disease
 If you are pregnant, or you are breastfeeding.
If any of the above conditions appear for
the first time while taking Prempak-C, stop
taking it at once and consult your doctor
immediately.
Warning and precautions
Talk to your doctor, pharmacist or nurse before
taking Prempak-C if you have ever had any
of the following problems, before you start the
treatment, as these may return or become worse
during treatment with Prempak-C. If so, you
should see your doctor more often for check-ups:
 fibroids inside your womb
 growth of womb lining outside your womb
(endometriosis) or a history of excessive
growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots
(see section 2.3 – “Blood Clots in a vein
(thrombosis)” for more detail)
 increased risk of getting an estrogensensitive cancer (such as having a mother,
sister or grandmother who has had breast
cancer) (see section 2.2 – HRT and cancer
for more detail)
 high blood pressure
 heart disease (see section 2.3 – Heart
Disease for more detail)
 a liver disorder (e.g. a benign liver tumour)
 kidney disease
 fluid retention due to cardiac or kidney
problems
 diabetes
 gallbladder disease or gallstones
 migraine or severe headaches
 a disease of the immune system that effects
many organs of the body (systemic lupus
erythematosus, SLE)
 epilepsy
 asthma
 a disease affecting the eardrum and hearing
(otosclerosis)
 low blood calcium levels (hypocalcaemia)

 a very high level of fat in the blood
(triglycerides).
Stop taking Prempak-C and see a doctor
immediately
If you notice any of the following when taking
HRT:

 any of the conditions mentioned in the ‘DO
NOT take Prempak-C’ section
 yellowing of your skin or the whites of your
eyes (jaundice). These may be signs of a
liver disease
 a large rise in your blood pressure
(symptoms may be headache, tiredness,
dizziness)
 migraine-like headaches which happen for
the first time
 if you become pregnant
 have an allergic reaction, signs of which
include rash, itching, shortness of breath,
difficulty breathing and a swollen face
 if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- difficulty in breathing
For more information, see ‘Blood clots in a
vein (thrombosis)’.
Note: Prempak-C is not a contraceptive. If it is
less than 12 months since your last menstrual
period or you are under 50 years old, you may still
need to use additional contraception to prevent
pregnancy. Speak to your doctor for advice.
2.2 HRT and cancer
Excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the
lining of the womb (endometrial cancer)
Taking estrogen-only HRT will increase the risk
of excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the womb
lining (endometrial cancer). The progestogen in
Prempak-C protects you from this 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 have 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, Prempak-C, 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. After
stopping treatment risk may remain elevated for
at least 10 years. In women with a uterus, use of
estrogen-only HRT is not recommended because
it increases the risk of endometrial cancer.
The addition of a progestogen to estrogenonly HRT for at least 12 days per cycle can
prevent this increased risk.
Irregular bleeding
If you get breakthrough bleeding or spotting,
it’s usually nothing to worry about, especially
during the first 3-6 months of taking HRT.
But if the bleeding or spotting:
 carries on for more than the first 6 months
 starts after you’ve been on HRT for more
than 6 months
 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.
Breast Cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take HRT.
Evidence suggests that taking combined
estrogen-progestogen and possibly also estrogenonly HRT increases the risk of breast cancer. The
extra risk depends on how long you take HRT.
The additional risk becomes clear within a few
years. However, it returns to normal within a few
years (at most 5) after stopping treatment.
Your risk of breast cancer is also higher:
 if you have a close relative (mother, sister or
grandmother) who has had breast cancer
 if you are seriously overweight.
Compare
Women aged 50 to 79 who are not taking HRT,
on average, 9 to 14 in 1000 will be diagnosed
with breast cancer over a 5-year period. For
women aged 50 to 79 who are taking estrogenprogestogen HRT over 5 years, there will be
13 to 20 cases in 1000 users (i.e. an extra 4 to
6 cases).
Regularly check your breasts. See your doctor
if you notice any changes, such as:
 dimpling of the skin

 changes in the nipple
 any lumps you can see or feel
Ovarian Cancer
Ovarian cancer (cancer of the ovaries) is
very rare, but it is serious. It can be difficult to
diagnose, because there are often no obvious
signs of the disease.
A slightly increased risk of ovarian cancer has
been reported in women taking HRT at least
5 to 10 years. Women aged 50 to 69 who are
not taking HRT, on average about 2 women in
1000 will be diagnosed with ovarian cancer over
a 5-year period. For women who have been
taking HRT for 5 years, there will be between
2 and 3 cases per 1000 users (i.e. up to 1 extra
case).
 ffects of HRT on your heart or
2.3 E
circulation:
Blood Clots in a vein (thrombosis)
The risk of blood clots in the veins (also called
deep vein thrombosis, or DVT) is about
1.3 – 3 times higher in HRT users than in nonusers, especially during the first year of taking it.
Blood clots can be serious, and if one
travels to the lungs, it can cause chest pain,
breathlessness, collapse or even death. This
condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called
venous thromboembolism, or VTE.
You are more likely to get a blood clot in your
veins as you get older or if any of the following
applies to you. Inform your doctor if any of these
situations applies to you:
 you are seriously overweight (BMI >30 kg/m2)
 you have had a blood clot before
 if any of your close family has ever had a
blood clot in the leg, lung or another organ
 you are pregnant or in your postpartum
period
 you have any blood clotting problem that
needs treatment with a medicine used to
prevent blood clots
 you are unable to walk for a long time
because of major surgery, injury or illness
(see also ‘if you’re going to have surgery’
below)
 you have a rare condition called SLE
(systemic lupus erythematosus)
 you have cancer
For signs of a blood clot, see “Stop taking
Prempak-C and see a doctor immediately”.

Compare
Looking at women in their 50s who are not
taking HRT — on average, over a 5-year period,
4 to 7 in 1000 would be expected to get a blood
clot in a vein.
For women in their 50s who are taking estrogenprogestogen HRT for over 5 years, there will be
9 to 12 cases in 1000 users (i.e. an extra
5 cases).
If you’re going to have surgery, make sure
your doctor knows about it, or tell the surgeon
that you are taking Prempak-C. You may need
to stop taking Prempak-C 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 Prempak-C again.
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.

201600555001

4. Possible side effects

You must talk to a doctor if you do not feel better
or if you feel worse.

 If you have recently had a disease caused

201600555001

Package leaflet:
Information for the patient

0.625 mg/0.15 mg & 1.25 mg/0.15 mg Coated Tablets
conjugated estrogens
and norgestrel

There is no evidence that HRT will prevent a
heart attack.
Women over the age of 60 who use estrogenprogestogen HRT are slightly more likely to
develop heart disease than those not taking any
HRT.
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.

/please turn over

Stroke
The risk of having a stroke is about 1.5 times
higher in HRT users than in non-users. The
number of extra cases of stroke due to use of
HRT will increase with age.
Other things that can increase the risk of stroke
include:
 high blood pressure
 smoking
 drinking too much alcohol
 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.
Compare
Looking at women in their 50s who are not
taking HRT — on average, over a 5-year period,
8 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the
figure would be 11 cases in 1000 users, over
5 years (i.e. an extra 3 cases).
If you get:
 unexplained migraine-type headaches, with
or without disturbed vision

See a doctor as soon as possible and do
not take any more HRT until your doctor
says you can. These headaches may be an
early warning sign of a stroke.
2.4 Other Conditions
HRT will not help prevent memory loss. There is
some evidence of a higher risk of memory loss in
women who start using HRT after the age of 65.
Women with hypertriglyceridemia (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.
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 Other medicines and Prempak-C
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, herbal remedies or other natural
products.

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Some medicines may interfere with the effect of
Prempak-C. This might lead to irregular bleeding.

Take your tablet at the same time each day as this
will help to remind you to take your medicine.

In particular tell your doctor if you are taking:
 an anticonvulsant (used to treat epilepsy e.g.
phenobarbital, phenytoin, carbamazepine)
 an anti-infective (e.g. used to treat
tuberculosis (rifampicin, rifabutin) or
HIV (nevirapine, efavirenz, ritonavir and
nelfinavir))
 a herbal preparation such as St. John’s wort
(Hypericum perforatum)
 metyrapone (most commonly used in the
treatment of Cushing’s syndrome)
 aminoglutethimide (most commonly used in
the treatment of breast cancer and Cushing’s
syndrome).

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 sequential HRT
product, treatment should begin the day following
completion of the prior product, unless instructed
otherwise by your doctor.

The way that Prempak-C works may be altered if
other medicines are used at the same time.
2.6 Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are taking Prempak-C,
because this medicine can affect the results of
some tests.
2.7 Pregnancy, breast-feeding and fertility
Prempak-C is for use in postmenopausal women
only. You should stop taking Prempak-C and tell
your doctor immediately if you know or suspect
you are pregnant, or if you are breast-feeding.
2.8 Driving and using machines
There is no evidence to suggest that Prempak-C
will affect your ability to drive or to operate
machinery.
 rempak-C contains lactose monohydrate
2.9 P
and sucrose
Prempak-C contains lactose monohydrate 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 colouring agent E110 (sunset yellow), that is
used in the maroon and yellow tablets, may cause
allergic reactions.

3. How to take Prempak-C
Always take this medicine exactly as your doctor
or pharmacist has told you. 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 to treat your symptoms for as
short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.

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

MFB PREMPAK-C 0.625/1.25/0.15 40S GB/MT
Leaflet (Back)
NEWBRIDGE
201600555001
FPO
N/A

Job No.
Pass No.
Date last modified

272838
2
16 Feb 2016

The usual dose is one estrogen tablet every day
until Day 16. You should then take one estrogen
tablet every day plus one norgestrel tablet every
day from days 17-28 as marked on the pack.
Do not leave a break between packs unless your
doctor tells you to. Do not stop taking Prempak-C
without first discussing it with your doctor.
3.1 Instructions for proper use
Start your pack with the tablet marked “Day 1”.
You will see that the days of the week have
been printed on the top of your pack. Make a
hole through the day of the week on which you
take your first pill. Pills 8, 15 and 22 will also be
taken on this day of the week, so if you are not
sure if you have taken your pill(s) you can count
backwards, as a reminder.
When you take HRT 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 a bleed at
any other time, or bleeding is excessively heavy,
please inform your doctor.
Do not try to take off the coating, divide or crush
the tablets as this could affect the way Prempak-C
works.
3.2 If you take more Prempak-C 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 Prempak-C
If you forget to take a tablet don’t worry. Take
it as soon as you remember and then carry on
taking the remaining tablets at the usual time.
If more than one tablet has been forgotten, do
not take extra to try to make up for the forgotten
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, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
4.1 Serious side effects
The following diseases are reported more often in
women using HRT compared to women not using
HRT:
• breast cancer
• abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs
(venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over
the age of 65
For more information about these side effects,
see section 2.
4.2 Other side effects
Very common: may affect more than 1 in
10 women
• breast pain
Common: may affect up to 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: may affect up to 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: may affect up to 1 in 1,000 women
• vomiting
• changes in breast tissue, milky secretion
from the breasts
• irritability
• 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
• various skin disorders:
- discoloration of the skin especially of
the face or neck known as “pregnancy
patches” (chloasma)
- painful reddish skin nodules (erythema
nodosum)
- rash with target-shaped reddening or
sores (erythema multiforme)
Very rare: may affect up to 1 in 10,000 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly (see details below). By
reporting side effects you can help provide more
information on the safety of this Medicine.
United Kingdom
Yellow card scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Prempak-C
Keep this medicine out of the sight and reach of
children.
Do not use Prempak-C after the expiry date which
is 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.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
6.1 What Prempak-C contains

 The active substances are conjugated
estrogens and norgestrel.
Prempak-C contains two types of tablets: the
set of 28 maroon or yellow tablets each contain
conjugated estrogens, and the set of 12 light
brown tablets each contain 0.15 mg of the
progestrogen norgestrel.
The colour of the 28 estrogen tablets will depend
upon which dose of estrogen your doctor has
prescribed for you: the maroon tablets marked
with ‘0.625’ contain 0.625 mg conjugated
estrogens, and the yellow tablets marked with
‘1.25’ contain 1.25 mg of conjugated estrogens.
The other ingredients in the estrogen tablets
are: lactose monohydrate, sucrose (see
section 2.9 Prempak-C contains lactose
monohydrate and sucrose), methylcellulose,
magnesium stearate, glyceryl mono-oleate,
Macrogol, carnauba wax, calcium sulfate
anhydrous, microcrystalline cellulose,
pharmaceutical glaze (shellac), titanium dioxide
(E171) stearic acid, edible ink and coating.
The edible ink on the maroon tablets contains
titanium dioxide (E171), purified water, shellac
(E904), ethanol, n-butyl alcohol, propylene glycol
(E1520), ammonia solution and ethyl acetate.
The edible ink on the yellow tablets contains iron
oxide black (E172), purified water, shellac (E904),
ethanol, n-butyl alcohol, propylene glycol (E1520),
ammonia solution and ethyl acetate.
The coating on the maroon tablets contains
sucrose, purified water, erythrosine (E127),
titanium dioxide (E171), sunset yellow (E110),
indigo carmine (E132), povidone and sodium
benzoate.

The coating on the yellow tablets contains
quinoline yellow (E104) and sunset yellow (E110).
The other ingredients in the norgestrel tablets
are: lactose monohydrate, sucrose, (see section
2.9 Prempak-C contains lactose monohydrate
and sucrose), starch, povidone, talc, magnesium
stearate, Macrogol, calcium carbonate, bleached
wax, carnauba wax, titanium dioxide (E171) and
colour (E172).
Not all strengths and pack sizes may be
marketed.
6.2 What Prempak-C looks like and contents
of the pack
Prempak-C contains three calendar packs. Each
calendar pack contains 28 days’ treatment:
28 estrogen tablets with 12 norgestrel tablets
to take with the last 12 estrogen tablets in
each pack. The calendar pack has days 1 to
28 printed on it to help you keep track of your
tablets.
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 Prempak-C tablets only.
This leaflet was last revised in 12/2015.
Ref: PC 7_0

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.

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