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Patient Information
DIOVAN® (DYE´-o-van)
Rx only
Read the Patient Information that comes with DIOVAN
before you take it and each time you get a refill. There
may be new information. This leaflet does not take the
place of talking with your doctor about your medical
condition or treatment. If you have any questions about
DIOVAN, ask your doctor or pharmacist.
What is the most important information I should know
about DIOVAN?
Taking DIOVAN during pregnancy can cause injury and
even death to your unborn baby. If you get pregnant,
stop taking DIOVAN and call your doctor right away.
Talk to your doctor about other ways to lower your
blood pressure if you plan to become pregnant.
What is DIOVAN?
DIOVAN is a prescription medicine called an angiotensin
receptor blocker (ARB). It is used in adults to:
; lower high blood pressure (hypertension) in adults and
children, 6 to 16 years of age.
; treat heart failure in adults. In these patients, DIOVAN
may lower the need for hospitalization that happens
from heart failure.
; improve the chance of living longer after a heart attack
(myocardial infarction) in adults.
DIOVAN is not for children under 6 years of age or children with certain kidney problems.
High Blood Pressure (Hypertension). Blood pressure is
the force in your blood vessels when your heart beats
and when your heart rests. You have high blood pressure when the force is too much. DIOVAN can help your
blood vessels relax so your blood pressure is lower.
High blood pressure makes the heart work harder to
pump blood throughout the body and causes damage to
the blood vessels. If high blood pressure is not treated, it
can lead to stroke, heart attack, heart failure, kidney failure and vision problems.
Heart Failure occurs when the heart is weak and cannot
pump enough blood to your lungs and the rest of your
body. Just walking or moving can make you short of
breath, so you may have to rest a lot.
Heart Attack (Myocardial Infarction): A heart attack is
caused by a blocked artery that results in damage to the
heart muscle.
What should I tell my doctor before taking DIOVAN?
Tell your doctor about all your medical conditions
including whether you:
; have any allergies. See the end of this leaflet for a complete list of ingredients in DIOVAN.
; have a heart condition
; have liver problems ; have kidney problems
; are pregnant or planning to become pregnant. See
“What is the most important information I should
know about DIOVAN?”
; are breast-feeding. It is not known if DIOVAN passes
into your breast milk. You and your doctor should
decide if you will take DIOVAN or breast-feed, but not
both. Talk with your doctor about the best way to feed
your baby if you take DIOVAN.
Tell your doctor about all the medicines you take
including prescription and nonprescription medicines,
vitamins and herbal supplements. Especially tell your
doctor if you take:
; other medicines for high blood pressure or a heart
problem
; water pills (also called “diuretics”)
; potassium supplements
; a salt substitute
; nonsteroidal anti-inflammatory drugs
(like ibuprofen or naproxen)
Know the medicines you take. Keep a list of your medicines with you to show to your doctor and pharmacist
when a new medicine is prescribed. Talk to your doctor
or pharmacist before you start taking any new medicine.
Your doctor or pharmacist will know what medicines are
safe to take together.
How should I take DIOVAN?
; Take DIOVAN exactly as prescribed by your doctor.
; For treatment of high blood pressure, take DIOVAN one
time each day, at the same time each day.
; If your child cannot swallow tablets, or if tablets are not
available in the prescribed strength, your pharmacist
will mix DIOVAN as a liquid suspension for your child.
If your child switches between taking the tablet and the
suspension, your doctor will adjust the dose as
needed. Shake the bottle of suspension well for at least
10 seconds before pouring the dose of medicine to
give to your child.
; For adult patients with heart failure or who have had a
heart attack, take DIOVAN two times each day, at the
same time each day. Your doctor may start you on a
low dose of DIOVAN and may increase the dose during
your treatment.
; DIOVAN can be taken with or without food.
; If you miss a dose, take it as soon as you remember. If
it is close to your next dose, do not take the missed
dose. Take the next dose at your regular time.
; If you take too much DIOVAN, call your doctor or
Poison Control Center, or go to the nearest hospital
emergency room.
What are the possible side effects of DIOVAN?
DIOVAN may cause the following serious side effects:
Injury or death to an unborn baby. See “What is the most
important information I should know about DIOVAN?”
Low Blood Pressure (Hypotension). Low blood pressure is most likely to happen if you also take water pills,
are on a low-salt diet, get dialysis treatments, have heart
problems, or get sick with vomiting or diarrhea. Lie down,
if you feel faint or dizzy. Call your doctor right away.
Kidney problems. Kidney problems may get worse in
people that already have kidney disease. Some people
will have changes on blood tests for kidney function and
may need a lower dose of DIOVAN. Call your doctor if
you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing
DIOVAN.
The most common side effects of DIOVAN used to treat
people with high blood pressure include:
; headache ; tiredness ; flu symptoms
; dizziness ; stomach (abdominal) pain
Side effects were generally mild and brief. They generally
have not caused patients to stop taking DIOVAN.
The most common side effects of DIOVAN used to treat
people with heart failure include:
; dizziness ; joint and back pain
; low blood pressure ; tiredness
; diarrhea ; high blood potassium
Common side effects of DIOVAN used to treat people
after a heart attack which caused them to stop taking
the drug include:
; low blood pressure
; cough
; high blood creatinine (decreased kidney function)
; rash
Tell your doctor if you get any side effect that bothers
you or that does not go away.
These are not all the possible side effects of DIOVAN.
For a complete list, ask your doctor or pharmacist.
How do I store DIOVAN?
; Store DIOVAN tablets at room temperature between
59° to 86°F (15°C-30°C).
; Keep DIOVAN tablets in a closed container in a dry
place.
; Store bottles of DIOVAN suspension at room temperature less than 86°F (30°C) for up to 30 days, or refrigerate between 35°F-46°F (2°C-8°C) for up to 75 days.
; Keep DIOVAN and all medicines out of the reach of
children.
General information about DIOVAN
Medicines are sometimes prescribed for conditions that
are not mentioned in patient information leaflets. Do not
use DIOVAN for a condition for which it was not prescribed. Do not give DIOVAN to other people, even if
they have the same symptoms you have. It may harm
them.
This leaflet summarizes the most important information
about DIOVAN. If you would like more information, talk
with your doctor. You can ask your doctor or pharmacist
for information about DIOVAN that is written for health
professionals.
For more information about DIOVAN, ask your pharmacist or doctor, visit www.DIOVAN.com on the Internet, or
call 1-866-404-6361.
What are the ingredients in DIOVAN?
Active ingredient: valsartan
Inactive ingredients: colloidal silicon dioxide, crospovi-done, hydroxypropyl methylcellulose, iron oxides (yellow,
black and/or red), magnesium stearate, microcrystalline
cellulose, polyethylene glycol 8000, and titanium dioxide
Distributed by:
Novartis Pharmaceuticals Corp.
East Hanover, NJ 07936
© Novartis
T2011-70/T2011-71
