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VANQUORAL 50 MG CAPSULES SOFT

Active substance(s): CICLOSPORIN / CICLOSPORIN / CICLOSPORIN

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150 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

What is in this leaflet:

Monitoring during your treatment with Vanquoral
Your doctor will check:

the levels of ciclosporin in your blood, especially if you have
had a transplant

your blood pressure before the start of your treatment and
regularly during treatment

how well your liver and kidneys are working

your blood lipids (fats).
If you have any questions about how Vanquoral, works or why this
medicine has been prescribed for you, ask your doctor.

1 What Vanquoral is and what it is used for
What Vanquoral is
The name of your medicine is Vanquoral. It contains the active
substance ciclosporin. This belongs to a group of medicines known
as immunosuppressive agents. These medicines are used to lower
the body’s immune reactions.

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Sunlight and sun protection
Vanquoral suppresses your immune system. This increases your
risk of developing cancers, particularly of the skin and lymphoid
system. You should limit your exposure to sunlight and UV light by:

wearing appropriate protective clothing

often applying a sunscreen with a high protection factor.
Talk to your doctor before taking Vanquoral:

if you have or have had alcohol-related problems

if you have epilepsy

if you have any liver problems

if you are pregnant

if you are breast-feeding

if this medicine is being prescribed for a child.
If any of the above apply to you (or you are not sure), tell your
doctor before taking Vanquoral. This is because this medicine
contains alcohol (see section below “Vanquoral contains ethanol”).

What Vanquoral is and what it is used for
What you need to know before you take Vanquoral
How to take Vanquoral
Possible side effects
How to store Vanquoral
Contents of the pack and other information

What Vanquoral is used for and how Vanquoral works

If you have had an organ transplant, bone marrow and stem
cell transplantation, the function of Vanquoral is to control your
body’s immune system. Vanquoral prevents rejection of
transplanted organs by blocking the development of certain
cells which would normally attack the transplanted tissue.

If you have an autoimmune disease, in which your body’s
immune response attacks your body’s own cells, Vanquoral
stops this immune reaction. Such diseases include eye
problems which threaten your vision (endogenous uveitis,
including Behçet's uveitis), severe cases of certain skin diseases
(atopic dermatitis, or eczema and psoriasis), severe rheumatoid
arthritis and a kidney disease called nephrotic syndrome.

2 What you need to know before you take Vanquoral
If you are taking Vanquoral following a transplant it will only be
prescribed for you by a doctor with experience in transplants and/or
autoimmune diseases.
The advice in this leaflet may vary depending on whether you are
taking the medicine for a transplant or for an autoimmune disease.
Follow all your doctor’s instructions carefully. They may differ from
the general information contained in this leaflet.
Do not take Vanquoral

if you are allergic to ciclosporin or any of the other ingredients
of this medicine (listed in section 6)

with products containing Hypericum perforatum (St John´s
Wort)

with products containing dabigatran etexilate (used to avoid
blood clots after surgery) or bosentan and aliskiren (used to
reduce high blood pressure).
Do not take Vanquoral and tell your doctor if the above applies to
you. If you are not sure, talk to your doctor before taking Vanquoral.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vanquoral.
Before and during treatment with Vanquoral tell your doctor
straight away:

if you have any signs of infection, such as fever or a sore throat.
Vanquoral suppresses the immune system and may also affect
your body’s ability to fight against infection

if you have liver problems

if you have kidney problems. Your doctor will carry out regular
blood tests and may change your dose if necessary

if you develop high blood pressure. Your doctor will check your
blood pressure regularly and may give you a medicine to lower
blood pressure if necessary

if you have low levels of magnesium in your body. Your doctor
may give you magnesium supplements to take, especially just
after your operation if you have had a transplant

if you have high levels of potassium in your blood

if you have gout

if you need to have a vaccination.
If any of the above applies to you before or during treatment with
Vanquoral, tell your doctor straight away.

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In addition if you are taking Vanquoral for a non-transplant disease
(intermediary or posterior uveitis and Behçet's uveitis, atopic
dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do
not take Vanquoral:

if you have kidney problems (except for nephrotic syndrome)

if you have an infection which is not under control with
medication

if you have any type of cancer

if you have high blood pressure (hypertension) which is not
under control with medication. If you get high blood pressure
during treatment and it cannot be controlled, Vanquoral should
be stopped by your doctor.
Do not take Vanquoral if any of the above applies to you. If you are
not sure, talk to your doctor or pharmacist before taking Vanquoral.
If you are being treated for Behçet`s uveitis, your doctor will
monitor you particularly carefully if you have neurological
symptoms (for example: increased forgetfulness, personality
changes noticed over time, psychiatric or mood disorders, burning
sensation in limbs, decreased sensation in limbs, tingling sensation
in limbs, weakness of limbs, walking disturbances, headache with
or without nausea and vomiting, vision disturbances including
restricted movement of eyeball).
Your doctor will closely monitor you if you are elderly and are
being treated for psoriasis or atopic dermatitis. If you have been
prescribed Vanquoral to treat your psoriasis or atopic dermatitis,
you must not be exposed to any UVB-rays or phototherapy during
treatment.
Children and adolescents
Vanquoral should not be given to children for a non-transplant
disease, except for treatment of nephrotic syndrome.
Elderly population (65 years of age and older)
There is limited experience with Vanquoral in elderly patients. Your
doctor should monitor how well your kidneys work. If you are over
65 and have psoriasis or atopic dermatitis, you should only be
treated with Vanquoral if your condition is particularly severe.
Other medicines and Vanquoral
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
In particular tell your doctor or pharmacist if you are taking any of
the following medicines before or during Vanquoral treatment:

medicines that may affect your potassium levels. These include
medicines which contain potassium, potassium supplements,
water tablets (diuretics) called potassium-sparing diuretics and
some medicines which lower your blood pressure

methotrexate. This is used to treat tumours, severe psoriasis
and severe rheumatoid arthritis

medicines which may increase or decrease the level of
ciclosporin (the active substance of Vanquoral) in your blood.
Your doctor might check the level of ciclosporin in your blood
when starting or stopping treatment with other medicines

medicines which may increase the level of ciclosporin in your
blood include: antibiotics (such as erythromycin or
azithromycin), anti-fungals (voriconazole, itraconazole),
medicines used for heart problems or high blood pressure
(diltiazem, nicardipine, verapamil, amiodarone),
metoclopramide (used to stop sickness), oral contraceptives,
danazol (used to treat menstrual problems), medicines used to
treat gout (allopurinol), cholic acid and derivatives (used to
treat gallstones), protease inhibitors used to treat HIV, imatinib
(used to treat leukaemia or tumours), colchicine, telaprevir
(used to treat hepatitis C)

medicines which may decrease the level of ciclosporin in your
blood include: barbiturates (used to help you to sleep), some
anti-convulsant medicines (such as carbamazepine or

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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 or pharmacist.
• 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

1.
2.
3.
4.
5.
6.

2

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phenytoin), octreotide (used to treat acromegaly or
neuroendocrine tumours in the gut), anti-bacterial medicines
used to treat tuberculosis, orlistat (used to help weight loss),
herbal medicines containing St. John’s wort, ticlopidine (used
after a stroke), certain medicines which lower blood pressure
(bosentan), and terbinafine (an anti-fungal medicine used to
treat infections of the toes and nails)

medicines which may affect your kidneys. These include:
anti-bacterial medicines (gentamycin, tobramycin,
ciprofloxacin), anti-fungal medicines which contain
amphotericin B, medicines used for urinary tract infections
which contain trimethoprim, medicines for cancer which
contain melphalan, medicines used to lower the amount of acid
in your stomach (acid secretion inhibitors of the H2-receptor
antagonist type), tacrolimus, pain killers (non-steroid
anti-inflammatory medicines such as diclofenac), fibric acid
medicines (used to lower the amount of fat in the blood)

nifedipine. This is used to treat high blood pressure and heart
pain. You might get swollen gums that might grow over your
teeth if you are taking nifedipine during your treatment with
ciclosporin

digoxin (used to treat heart problems), medicines which lower
cholesterol (HMG-CoA reductase inhibitors also called statins),
prednisolone, etoposide (used to treat cancer), repaglinide (oral
anti-diabetic medicine), immunosuppressives (everolimus,
sirolimus), ambrisentan and specific anti-cancer medicines
called anthracyclines (such as doxorubicin).
If any of the above applies to you (or you are not sure), talk to your
doctor or pharmacist before taking Vanquoral.

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VANQUORAL
10 mg, 25 mg, 50 mg, 100 mg
CAPSULES, SOFT
ciclosporin

Version:

Vanquoral with food and drink
Do not take Vanquoral with grapefruit or grapefruit juice. This is
because these can affect how Vanquoral works.

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231-30-36809-D LEA CICLOSPORIN (VANQUORAL) 10mg, 25mg, 50mg, 100mg CAPS TUK
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking this
medicine. Your doctor will discuss with you the potential risks of
taking Vanquoral during pregnancy.




Tell your doctor if you are pregnant or intend to become
pregnant. Experience with Vanquoral in pregnancy is limited. In
general, Vanquoral should not be taken during pregnancy. If it is
necessary for you to take this medicine, your doctor will
discuss with you the benefits and potential risks of taking it
during pregnancy.
Tell your doctor if you are breast-feeding. Breast-feeding is not
recommended during treatment with Vanquoral. This is because
ciclosporin, the active substance, passes into breast milk. This
may affect your baby.

Vanquoral
10 mg, 25 mg, 50 mg, 100 mg
Capsules, soft
ciclosporin

Driving and using machines
Vanquoral contains alcohol. This may affect your ability to drive and
use machines.
Vanquoral contains ethanol.
Vanquoral contains approximately 14.7 vol. % ethanol (alcohol),
which corresponds up to 797.7 mg per dose used in transplant
patients. This is equivalent to 20 ml beer or about 8 ml wine per
dose.
Alcohol may be harmful if you have alcohol related problems,
epilepsy, brain injury, liver problems or if you are pregnant or
breast-feeding. It may also be harmful if this medicine is given to
children.
Vanquoral contains macrogolglycerol hydroxystearate
Vanquoral contains macrogolglycerol hydroxystearate, which may
cause stomach discomfort and diarrhoea.



Vanquoral contains sorbitol.
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 Vanquoral
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
Do not take more than the recommended dose.
The dose of this medicine will be carefully adjusted to your
individual needs by your doctor. Too much of the medicine can
affect your kidneys. You will have regular blood tests and visits to
the hospital, especially after a transplant. This will give you the
chance to talk to your doctor about your treatment and talk about
any problems you may be having.
How much Vanquoral to take
Your doctor will work out the correct dose of Vanquoral for you.
This depends on your body weight and what you are taking the
medicine for. Your doctor will also tell you how often to take your
medicine.



In adults:
Organ, bone marrow and stem cell transplantation

The total dose each day is usually between 2 mg and 15 mg
per kilogram body weight. This is divided in two doses.

Usually, higher doses are used before and just after your
transplant. Lower doses are used once your transplanted
organ or bone marrow has stabilised.

Your doctor will adjust your dose to one that is ideal for
you. To do this, your doctor may need to do some blood
tests.
Endogenous uveitis

The total dose each day is usually between 5 mg and 7 mg
per kilogram body weight. This is divided in two doses.
Nephrotic syndrome

The total dose each day for adults is usually 5 mg per
kilogram bodyweight. This is divided in two doses. In
patients with kidney problems, the first dose taken each day
should not be more than 2.5 mg per kilogram body weight.
Severe rheumatoid arthritis

The total dose each day is usually between 3 mg per
kilogram of your body weight and 5 mg per kilogram body
weight. This is divided in two doses.
Psoriasis and atopic dermatitis

The total dose each day is usually between 2.5 mg per
kilogram of your body weight and 5 mg per kilogram body
weight. This is divided in two doses.

In children:
Nephrotic syndrome

The total dose each day for children is usually 6 mg per
kilogram body weight. This is divided in two doses. In
patients with kidney problems, the first dose taken each day
should not be more than 2.5 mg per kilogram body weight.
Follow your doctor's instructions exactly and never change the
dose yourself, even if you feel well.

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TEVA UK Ref:

TEVA UK Ref:

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231-30-36809-D LEA CICLOSPORIN (VANQUORAL) 10mg, 25mg, 50mg, 100mg CAPS TUK
150 mm

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How long to take Vanquoral
Your doctor will tell you how long you need to take Vanquoral for.
This depends on whether you are taking it after a transplant or for
the treatment of a severe skin condition, rheumatoid arthritis,
uveitis or nephrotic syndrome. For severe rash, the treatment
usually lasts for 8 weeks.
Keep taking Vanquoral for as long as your doctor tells you.
If you have questions about how long to take Vanquoral, talk to
your doctor or your pharmacist.
If you take more Vanquoral than you should
If you accidentally take too much of your medicine, talk to your
doctor immediately or go to your nearest hospital emergency unit.
You may need medical attention.
If you forget to take Vanquoral

If you forget to take a dose, take it as soon as you remember it.
However, if it is almost time for your next dose, skip the missed
dose. Then go on as before.

Do not take a double dose to make up for a forgotten dose.

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If you stop taking Vanquoral
Do not stop taking Vanquoral unless your doctor tells you to.
Keep taking Vanquoral even if you feel well. Stopping your
treatment with Vanquoral may increase the risk of your transplanted
organ being rejected.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4 Possible side effects
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Like all medicines, this medicine can cause side effects, although
not everybody gets them.

When to take Vanquoral
Take Vanquoral at the same time every day. This is very important if
you have had a transplant.

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Some side effects could be serious
Tell your doctor straight away if you notice any of the following
serious side effects:

like other medicines that act on the immune system, ciclosporin
may influence your body’s ability to fight against infection and
may cause tumours or other cancers, particularly of the skin.
Signs of infection might be fever or sore throat

changes in your sight, loss of coordination, being clumsy,
memory loss, difficulty speaking or understanding what others
say, and muscle weakness. These might be signs of an infection
of the brain called progressive multifocal leukoencephalopathy

brain problems with signs such as seizures, confusion, feeling
disorientated, being less responsive, personality changes,
feeling agitated, sleeplessness, changes to your sight,
blindness, coma, paralysis of part or all of the body, stiff neck,
loss of coordination with or without unusual speech or eye
movements

swelling at the back of the eye. This may be associated with
blurred vision. It may also affect your sight because of the
higher pressure inside your head (benign intracranial
hypertension)

liver problems and damage with or without yellow skin and
eyes, nausea, loss of appetite and dark urine

kidney problems which may greatly reduce the amount of urine
you produce

low level of red blood cells or platelets. The signs include pale
skin, feeling tired, being breathless, having dark urine (this is a
sign of the breakdown of red blood cells), bruising or bleeding
with no obvious reasons, feeling confused, feeling
disorientated, being less alert and having kidney problems.
Other side effects include:
Very common: may affect more than 1 in 10 people.

kidney problems

high blood pressure

headache

shaking of your body which you cannot control

excessive growth of body and facial hair

high level of lipids in your blood.
If any of these affects you severely, tell your doctor.







feeling numb or tingling
pain in your muscles, muscle spasm
stomach ulcer
gum tissue overgrowing and covering your teeth
high level of uric acid or potassium in your blood, low levels of
magnesium in your blood.
If any of these affects you severely, tell your doctor.
Uncommon: may affect up to 1 in 100 people

symptoms of brain disorders including sudden fits, mental
confusion, sleeplessness, disorientation, disturbance of vision,
unconsciousness, sense of weakness in the limbs, impaired
movements

rash

general swelling

weight gain

low level of red blood cells, low level of platelets in your blood
which could increase the risk of bleeding.
If any of these affects you severely, tell your doctor.
Rare: may affect up to 1 in 1,000 people

nerve problems with numbness or tingling in fingers and toes

inflammation of the pancreas with severe upper stomach pain

muscle weakness, loss of muscle strength, pain in muscles of
the legs or hands or anywhere in the body

destruction of red blood cells, involving kidney problems with
symptoms such as swelling of the face, stomach, hands and/or
feet, decreased urination, breathing difficulty, chest pain, fits,
unconsciousness

changes in menstrual cycle, breast enlargement in men.
If any of these affects you severely, tell your doctor.
Very rare: may affect up to 1 in 10,000 people

swelling at the back of the eye which may be associated with an
increase in pressure inside the head and eyesight disturbances.
If this affects you severely, tell your doctor.
Not known: frequency cannot be estimated from the available data.

serious liver problems both with and without yellowing of the
eyes or skin, nausea (feeling sick), loss of appetite, dark
coloured urine, swelling of the face, feet, hands and/or the
whole body

bleeding underneath the skin or purple skin patched, sudden
bleeding with no apparent cause

migraine or severe headache often with feeling and being sick
(nausea, vomiting) and being sensitive to light.
If any of these affects you severely, tell your doctor.

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100 mg
gelatin, glycerol 85%, non-crystallizing sorbitol 70% (E420),
glycine, titanium dioxide (E171), iron oxide brown (E172) and
paraffin, light liquid.
What Vanquoral looks like and contents of the pack
Vanquoral 10 mg soft capsules are opaque white to off-white soft
gelatin capsules containing colourless to slightly yellowish oily
liquid. Approximate size of 9.0 x 5.5 mm.
Vanquoral 25 mg soft capsules are opaque yellow soft gelatin
capsules containing colourless to slightly yellowish oily liquid, with
printing the IVAX “hourglass” logo “25”. Approximate size of
12.2 x 7.6 mm.
Vanquoral 50 mg soft capsules are opaque ochre-yellow soft gelatin
capsules containing colourless to slightly yellowish oily liquid, with
printing the IVAX “hourglass” logo “50”. Approximate size of
20.7 x 7.8 mm.
Vanquoral 100 mg soft capsules are opaque brown soft gelatin
capsules containing colourless to slightly yellowish oily liquid, with
printing the IVAX “hourglass” logo “100”. Approximate size of
24.7 x 9.9 mm.
The 10 mg, 25 mg and 50 mg capsules are available in pack sizes of
20, 30, 50, 50x1, 60, 90 and 100 in OPA/Alu/PVC – Aluminium
blisters.
The 100 mg capsules are available in pack sizes of 20, 30, 30x1, 50,
50x1, 60, 90 and 100 in OPA/Alu/PVC – Aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770
Opava-Komarov, Czech Republic
This leaflet was last revised in 07/2016
PL 00289/1404, PL 00289/1405, PL 00289/1406 and PL 00289/1407

Additional side effects in children and adolescents
There are no additional side effects to be expected in children and
adolescents compared to adults.
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 How to store Vanquoral
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton box and blister after EXP. The expiry date refers to the last
day of that month.
Store below 30°C. Do not freeze. Store in the original package in
order to protect from light and moisture.
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

Common: may affect up to 1 in 10 people

fits (seizures)

liver problems

high level of sugar in your blood

tiredness

loss of appetite

nausea (feeling sick), vomiting, abdominal pain, constipation,
diarrhoea

excessive hair growth

acne, hot flushes

fever

low level of white blood cells

Approved

11 August 2016

520 mm

If your doctor switches you from one oral formulation of ciclosporin
to another
After you change from one oral formulation of ciclosporin to
another:

your doctor will monitor you more closely for a short time

you may have some side effects. If this happens, tell your
doctor or pharmacist. Your dose may need to be changed.
Never change your dose yourself, unless a doctor has told
you to.

2

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How to take Vanquoral
Your daily doses should always be taken in 2 divided doses.
Remove the capsules from the blister. Swallow the capsules whole
with water.

Switch from oral ciclosporin to oral microemulsified ciclosporin
You may have already been taking another oral ciclosporin. Your
doctor may decide to change to this medicine, Vanquoral.

These medicines all contain ciclosporin as the active ingredient.

Vanquoral is a different, improved formulation of ciclosporin.
Ciclosporin is absorbed into your blood better with Vanquoral
and absorption is less likely to be affected by taking the
medicine with food. This means that the levels of ciclosporin in
your blood stay more constant with Vanquoral.
If your doctor changes you from oral ciclosporin to oral
microemulsified ciclosporin:

do not go back to taking your previous medicine unless your
doctor tells you to

following your transfer, your doctor will monitor you more
closely for a short time. This is because of the change in how
ciclosporin is absorbed into your blood. Your doctor will make
sure that you get the right dose for your individual needs

you may have some side effects. If this happens, tell your
doctor or pharmacist. Your dose may need to be lowered. Never
lower your dose yourself, unless a doctor has told you to.

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What Vanquoral contains

The active substance is ciclosporin.
Each soft capsule contains 10 mg ciclosporin.
Each soft capsule contains 25 mg ciclosporin.
Each soft capsule contains 50 mg ciclosporin.
Each soft capsule contains 100 mg ciclosporin.

The other ingredients in the capsule fill are macrogolglycerol
hydroxystearate, glycerol monolinoleate, diethylene glycol
monoethyl ether, anhydrous ethanol and D,L-α-tocopherol.

The other ingredients in the capsule shell are:
10 mg
gelatin, glycerol 85%, non-crystallizing sorbitol 70% (E420),
glycine, titanium dioxide (E171) and paraffin, light liquid.
25 mg & 50 mg
gelatin, glycerol 85%, non-crystallizing sorbitol 70% (E420),
glycine, titanium dioxide (E171), iron oxide yellow (E172) and
paraffin, light liquid.

36809-D

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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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