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VALLCLARA 28 0.02 MG/3 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
0.02 mg / 3 mg 28 film-coated tablets
Ethinylestradiol/Drospirenone
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 any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do no 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 is and what it is used for
2. Before you take
 When you should not use
 When to take special care with
and venous and arterial blood clots
and cancer
 Bleeding between periods
 What to do if no bleeding occurs during the placebo days
and using other medicines
 Taking with food and drink
 Laboratory tests
 Pregnancy
 Breast-feeding
 Driving and using machines
 Important information about some of the ingredients of
3. How to take
 When can you start with the first strip?
 If you take more than you should
 If you forget to take
 What to do in the case of vomiting or severe diarrhoea
 Delaying your period: what you need to know
 Changing the first day of your period: what you need to know
 If you want to stop taking
4. Possible side effects
5. How to store
6. Further information

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1. WHAT IS AND WHAT IT IS USED FOR





is a contraceptive pill and is used to prevent pregnancy.
Each of the 21 pink tablets contains a small amount of two different female hormones, namely
drospirenone and ethinylestradiol.
The 7 white tablets contain no active substances and are also called placebo tablets.
Contraceptive pills that contain two hormones are called “combination” pills.

2. BEFORE YOU TAKE
General notes
Before you can begin taking , your doctor will ask you some questions about your
personal health history and that of your close relatives. The doctor will also measure your blood
pressure, and, depending upon your personal situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop using , or
where the reliability of may be decreased. In such situations you should either
not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom
or another barrier method. Do not use rhythm or temperature methods. These methods can be
unreliable because alters the monthly changes of body temperature and of the
cervical mucus.
, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.
When you should not use
Do not take :












if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), lung
(pulmonary embolism) or other organs
if you have (or have ever had) a heart attack or stroke
if you have (or have ever had) a disease that can be an indicator of a heart attack in the future
(for example, angina pectoris, which causes severe pain in the chest) or of a stroke (for
example, a passing slight stroke with no residual effects).
if you have a disease that may increase the risk of a clot in the arteries. This applies to the
following diseases:
 diabetes with damaged blood vessels
 very high blood pressure
 a very high level of fat in the blood (cholesterol or triglycerides)
if you have a disturbance of blood clotting (for example, protein C deficiency)
if you have (or have ever had) a certain form of migraine (with so-called focal neurological
symptoms)
if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
if you have (or have ever had) a liver disease and your liver function is still not normal.
if your kidneys are not working well (renal failure)
if you have (or have ever had) a tumour in the liver

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if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the
genital organs
if you have any unexplained bleeding from the vagina
if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of
. This may cause itching, rash or swelling.

When to take special care with
In some situations you need to take special care while using or any other
combination pill, and your doctor may need to examine you regularly. If any of the following
conditions applies to you, tell your doctor before starting to use . Also, if any of
the following applies or if any of the conditions develops or worsens while you are using name> consult your doctor:














if a close relative has or has ever had breast cancer
if you have a disease of the liver or the gallbladder
if you have diabetes
if you have depression
if you have Crohn's disease or inflammatory bowel disease (ulcerative colitis)
if you have a blood disease called HUS (haemolytic uraemic syndrome) which causes kidney
damage
if you have a blood disease called sickle cell anaemia
if you have epilepsy (see " and using other medicines")
if you have a disease of the immune system, called SLE (systemic lupus erythematosus)
if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for
example, hearing loss, a blood disease called porphyria, skin rash with blisters during
pregnancy (gestational herpes), a nerve disease causing sudden movements of the body
(Sydenham's chorea)).
if you have or have ever had chloasma (a discolouration of the skin, especially of the face or
neck known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light.
if you have hereditary angioedema, products containing oestrogens may cause or worsen
symptoms. You should see your doctor immediately if you experience symptoms of
angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives
together with difficulty breathing.

and venous and arterial blood clots
The use of any combination pill, including , increases a woman’s risk of
developing a venous blood clot (venous thrombosis) compared with women who do not take any
contraceptive pill.
The risk of venous blood clots in users of combination pills increases:





with increasing age
if you are overweight
if one of your close relatives ever had a blood clot in the leg, lung (pulmonary embolism), or
other organ at a young age
if you have to have surgery, if you have had a serious accident or if you are immobilised for a
long time. It is important to tell your doctor that you are using as you may

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have to stop taking it. Your doctor will tell you when to start again. This is usually about two
weeks after you are back on your feet.
Your chances of having a blood clot are increased by taking the Pill.
- Of 100,000 women who are not on the Pill and not pregnant, about 5-10 may have a blood clot in
a year.
- Of 100,000 women taking a Pill like , between 30-40 may have a blood clot in a
year, the exact number is unknown.
- Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.
A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung
embolus). Formation of blood clots in the veins may be fatal in 1-2% of cases.
The level of risk may vary according to the type of pill you take. Discuss with your doctor the
available options.
The use of combination pills has been connected with an increase of the risk of an arterial blood
clot (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain
(stroke).
The risk of an arterial blood clot in users of combination pills increases:








if you smoke. You are strongly advised to stop smoking when you use ,
especially if you are older than 35 years.
if the fat content of your blood is increased (cholesterol or triglycerides)
if you are overweight
if one of your close relatives ever had a heart attack or stroke at a young age
if you have high blood pressure
if you suffer from migraine
if you have a problem with your heart (valve disorder, a disturbance of the cardiac rhythm)

Stop taking and contact your doctor immediately if you notice
possible signs of a blood clot, such as:
• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the body
and cancer
Breast cancer has been observed slightly more often in women using combination pills, but it is not
known whether this is caused by the treatment. For example, it may be that more tumours are
detected in women on combination pills because they are examined by their doctor more often. The
occurrence of breast tumours becomes gradually less after stopping the combination hormonal
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contraceptives. It is important to regularly check your breasts and you should contact your doctor if
you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been
reported in pill users. Contact your doctor if you have unusually severe abdominal pain.
Bleeding between periods

During the first few months that you are taking you may have unexpected
bleeding (bleeding outside the week when you are taking the white tablets). If this bleeding
occurs for more than a few months, or if it begins after some months, your doctor must find
out what is wrong.
What to do if no bleeding occurs during the placebo days

If you have taken all the pink active tablets correctly, have not had vomiting or severe
diarrhoea and you have not taken any other medicines, it is highly unlikely that you are
pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant.
Contact your doctor immediately. Do not start the next strip until you are sure that you are
not pregnant.
and using other medicines
Always tell your doctor which medicines or herbal products you are already using. Also tell any
other doctor or dentist who prescribes another medicine (or the pharmacist) that you use name>. They can tell you if you need to take additional contraceptive precautions (for example
condoms) and if so, for how long.
Some medicines can make less effective in preventing pregnancy, or can cause
unexpected bleeding. These include:
 medicines used for the treatment of
o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
o tuberculosis (e.g. rifampicin)
o HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin,
penicillin, tetracycline)
o high blood pressure in the blood vessels in the lungs (bosentan)
 the herbal remedy St John’s wort
may influence the effect of other medicines, e.g.
 medicines containing ciclosporin
 the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
Ask your doctor or pharmacist for advice before taking any medicine.
Taking with food and drink
may be taken with or without food, if necessary with a small amount of water.

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Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because
hormone contraceptives can affect the results of some tests.
Pregnancy
If you are pregnant, do not take . If you become pregnant while taking name> stop immediately and contact your doctor. If you want to become pregnant, you can stop
taking at any time (see also “If you want to stop taking ”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of is generally not advisable when a woman is breast-feeding. If you want to
take the pill while you are breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of affects driving or use of machines.
Important information about some of the ingredients of
contains lactose.
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
Each blister contains 21 active pink tablets and 7 white placebo tablets.
The two differently coloured tablets of are arranged in order. A strip contains 28
tablets.
Take one tablet of every day, if necessary with a small amount of water. You
may take the tablets with or without food, but you should take the tablets every day around the same
time.
One strip contains 28 tablets. each marked with a day of the week. Start by taking a tablet marked
with the correct day of the week. If, for example, you start on Wednesday, you should take a tablet
with “WED” at the side.
Follow the direction of the arrows on the strip until you have taken the 28 tablets. Do not confuse
the tablets: take a pink tablet once per day for the first 21 days, and then one white tablet per day
for the last 7 days. Then you should start a new strip (21pink tablets and 7 white tablets).
Consequently there is no drug-free interval between strips.
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Preparation of the pack
A box of contains "7 week stickers" labels which indicate the days of the week.
Each label starts with a different day. Remove the label starting with the day on which you will take
your first tablet. For example, if you start taking the tablets on a Wednesday, use the label that starts
with "WED". Stick this label in the space provided for this purpose on the pack. The first day of the
label must be placed above the "START" slot. You must always start your pack with the pale pink
tablets and end with the white tablets.
You must continue your treatment following the order indicated by the arrows.
Always start a new row with the tablet on the left.


Remove the label starting with the day on which you will take
your first tablet. For example, if you start taking the tablets on
a Wednesday, use the label that starts with "WED".

START
MON
TUE

TUE
WED

WED
THU

THU
FRI

FRI
SAT

SAT
SUN

SUN
MON

WED

THU

FRI

SAT

SUN

MON

TUE

THU

FRI

SAT

SUN

MON

TUE

WED

FRI

SAT

SUN

MON

TUE

WED

THU

SAT

SUN

MON

TUE

WED

THU

FRI

SUN

MON

TUE

WED

THU

FRI

SAT

START

Stick the week-sticker here

EN

Start a new pack the day after the last tablet.

During the 7 days when you are taking the white placebo tablets (the placebo days), bleeding should
begin (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last pink
active tablet of . Once you have taken the last white tablet, you should start with
the following strip, whether your bleeding has stopped or not. This means that you should start
every strip on the same day of the week, and that the withdrawal bleed should occur on the same
days each month.
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If you use in this manner, you are protected against pregnancy also during the 7
days when you are taking a placebo tablet.
When can you start with the first strip?


If you have not used a contraceptive with hormones in the previous month
Begin with on the first day of the cycle (that is the first day of your period). If
you start on the first day of your period you are immediately protected against
pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective
measures (for example, a condom) for the first 7 days.



Changing from a combination hormonal contraceptive, or combination contraceptive vaginal
ring or patch
You can start preferably on the day after the last active tablet (the last tablet
containing active substances) of your previous pill, but at the latest on the day after the tabletfree days of your previous pill (or after the last inactive tablet of your previous pill). When
changing from a combination contraceptive vaginal ring or patch, follow the advice of your
doctor.



Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a
progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from an implant or an IUD on the day
of its removal, from an injectable when the next injection would be due) but in all of these
cases use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.



After a miscarriage
Follow the advice of your doctor.



After having a baby
You can start between 21 and 28 days after having a baby. If you start later
than day 28, use a so-called barrier method (for example, a condom) during the first seven days
of use. If, after having a baby, you have had sex before starting name> (again), be sure that you are not pregnant or wait until your next period.



If you are breast-feeding and want to start (again) after having a baby.
Read the section on "Breast-feeding".

Ask your doctor what to do if you are not sure when to start.
If you take more than you should
There are no reports of serious harmful results of taking too many tablets.
If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls
may have bleeding from the vagina.
If you have taken too many tablets, or you discover that a child has taken some,
ask your doctor or pharmacist for advice.
If you forget to take

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The tablets in the 4th row of the strip are the placebo tablets. If you forget one of these tablets, this
has no effect on the reliability of . Throw away the forgotten placebo tablet.
If you miss a pink active tablet from the 1st, 2nd or 3rd row, do as follows:
 If you are less than 12 hours late taking a tablet, the protection against pregnancy is not
reduced. Take the tablet as soon as you remember and then take the following tablets again at
the usual time.
 If you are more than 12 hours late taking a tablet, the protection against pregnancy may be
reduced. The greater the number of tablets that you have forgotten, the greater is the risk of
becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a pink tablet at the
beginning or at the end of the strip. Therefore, you should keep to the following rules (see the
diagram below):


More than one tablet forgotten in this strip
Contact your doctor.

 One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two
tablets at the same time. Continue taking the tablets at the usual time and use extra precautions
for the next 7 days, for example, a condom. If you have had sex in the week before forgetting
the tablet you may be pregnant. In that case, contact your doctor.
 One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two
tablets at the same time. Continue taking the tablets at the usual time. The protection against
pregnancy is not reduced, and you do not need to take extra precautions.
 One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take
two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking
the white placebo tablets on this strip, throw them away and start the next strip.
Most likely, you will have a period at the end of the second strip - while taking the white
placebo tablets - but you may have light or menstruation-like bleeding during the second
strip.
2. You can also stop the active pink tablets and go directly to the 7 white placebo tablets
(before taking the placebo tablets, record the day on which you forgot your tablet). If
you want to start a new strip on the day you always start, take the placebo tablets for less
than 7 days.
If you follow one of these two recommendations, you will remain protected against pregnancy.


If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the
normal placebo days, you may be pregnant. Contact your doctor before you start the next strip.

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More than varios
Olvido de 1 pink
tablet forgotten in
comprimidos del
1 strip blister
mismo

Ask your doctorsu médico
Pida consejo a for advice

Yes
En la
In week 1
semana 1

¿Mantuvo the previous week before forgetting?
Had sex in relaciones sexuales la semana anterior?
No

Only 1 pink tablet
Olvido de 1 sólo
forgotten (taken
comprimido
more than 12 de
(tomado más
hours late)
12 horas tarde)

-- Tome the forgotten tablet
Take el comprimido olvidado
-- Utilice un método de barrera (preservativo) durante
Use a barrier method (condom) for the following 7
days and
los 7 días siguientes
-- Y finalice el blister
Finish the strip
Enweek 2
In la
semana 2

-- Tome the forgotten tablet
Take el comprimido olvidado y
-- Finalice el blister
Finish the strip
- - Tome thecomprimido olvidado y
Take el forgotten tablet and
- - Finalice el blister pink tablets
Finish taking the
- - En lugar de la semana de descanso comience de
Throw away the 7 white tablets
- Startseguida con el siguiente blister
forma the next strip
or
o

Enweek 3
In la
semana 3

- - Pare de tomartablets immediately blister
Stop the pink los comprimidos del
- inmediatamentethe 7 white tablets
Go directly to
- - Inicie la semana de strip
Then start the next descanso (no más de 7 días,
incluyendo el comprimido olvidado)
- Después, continúe con el siguiente blister

What to do in the case of vomiting or severe diarrhea
If you vomit within 3-4 hours after taking an active pink tablet or you have severe diarrhoea, there
is a risk that the active substances in the pill will not be fully taken up by your body. The situation is
almost the same as forgetting a tablet. After vomiting or diarrhoea, take another pink tablet from a
reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your
pill. If that is not possible or 12 hours have passed, you should follow the advice given under "If
you forget to take ".
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by not taking the white placebo
tablets from the 4th row and going straight to a new strip of and finishing it. You
may experience light or menstruation-like bleeding while using this second strip. Finish this second
strip by taking the 7 white tablets from the 4th row. Then start your next strip.
You might ask your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your period will begin during the placebo
week. If you have to change this day, reduce the number of placebo days – when you take the white
placebo tablets - (but never increase them – 7 is the maximum!). For example, if you normally start
taking the placebo tablets on a Friday, and you want to change this to a Tuesday (3 days earlier)
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start a new strip 3 days earlier than usual. If you make the placebo interval very short (for example,
3 days or less) you may not have any bleeding during these days. You may then experience light or
menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking
You can stop taking whenever you want. If you do not want to become pregnant,
ask your doctor for advice about other reliable methods of birth control . If you want to become
pregnant, stop taking and wait for a period before trying to become pregnant. You
will be able to calculate the expected delivery date more easily.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, can cause side effects although not everybody gets them.
The following is a list of the side effects that have been linked with the use of .
Common side effects (between 1 and 10 in every 100 users may be affected):
- mood swings
- headache
- abdominal pain (stomach ache)
- acne
- breast pain, breast enlargement, painful or irregular periods
- weight gain.
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
- Candida (fungal infection)
- cold sores (herpes simplex)
- allergic reactions
- increased appetite
- depression, nervousness, sleep disorder, decreased interest in sex
- feeling of “pins and needles”, giddiness (vertigo)
- problems with vision
- irregular heart beat or unusually fast heart rate
- a blood clot (thrombosis) in a vessel of the leg or the lungs (pulmonary embolism), high blood
pressure, low blood pressure, migraine, varicose veins
- sore throat
- nausea, vomiting, inflammation of stomach and/or intestine, diarrhoea, constipation
- sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty
swallowing or hives together with difficulty breathing (angioedema), hair loss (alopecia), eczema,
itching, rashes, dry skin, oily skin disorders (seborrheic dermatitis)
- neck pain, limb pain, muscle cramps
- bladder infection
- breast lump (benign and cancer), milk production while not pregnant (galactorrhea), ovarian cysts,
hot flushes, absence of periods, very heavy periods, vaginal discharge, vaginal dryness, lower
abdominal (pelvic) pain, abnormal cervical smear (Papanicolaou or Pap smear)
- fluid retention, lack of energy, excessive thirst, increased sweating
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- weight loss.
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
- asthma
- hearing impairment
- blockage of a blood vessel by a clot formed elsewhere in the body
- erythema nodosum (characterized by painful reddish skin nodules)
- erythema multiforme (rash with target-shaped reddening or sores).
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet or if
you think that this may be the case, please tell your doctor or pharmacist.
5. HOW TO STORE
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Expiry date
Do not use after the expiry date which is stated on the blister and package after
the phrase "Do not use after:" or "EXP:"
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 protect the environment.
6. FURTHER INFORMATION
What contains
A strip of contains 21 pink active tablets in the 1st, 2nd and 3rd rows of the strip
and 7 white placebo tablets in row 4.
Active tablets:
The active ingredients are ethinylestradiol 0.02 mg and drospirenone 3 mg.
The other ingredients are:
Tablet core: lactose monohydrate, pregelatinised starch (maize), povidone, croscarmellose sodium,
polysorbate 80, magnesium stearate.
Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol 3350, talc, yellow
iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Placebo tablets:
Tablet core: lactose anhydrous, povidone, magnesium stearate.
Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol 3350, talc.
What looks like and contents of the pack
Active tablets are pink, round film-coated tablets.
Placebo tablets are white, round film-coated tablets.
is available in boxes of 1, 2, 3, 6 and 13 blisters, each one containing 28 tablets
(21 active plus 7 placebo tablets).
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Not all package sizes may be marketed
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last approved in:
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Villaquilambre, León.
Spain

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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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