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VALSARTAN 40 MG CAPSULES

Active substance(s): VALSARTAN / VALSARTAN / VALSARTAN

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Jubilant Pharmaceuticals nv

Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 1/9
November 2014

PACKAGE LEAFLET: INFORMATION FOR THE USER
Valsartan 40 mg capsules
Valsartan 80 mg capsules
Valsartan 160 mg capsules
Valsartan

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.

What is in this leaflet:
1. What Valsartan is and what it is used for
2. What you need to know before you take Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Contents of the pack and other information

1. What Valsartan is and what it is used for
Valsartan belongs to a class of medicines known as angiotensin II receptor
antagonists, which help to control high blood pressure. Angiotensin II is a substance
in the body that causes vessels to tighten, thus causing your blood pressure to
increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood
vessels relax and blood pressure is lowered.
Valsartan 40, 80 and 160 mg capsules can be used
• to treat adult patients after a recent heart attack (myocardial infarction).
“Recent” here means between 12 hours and 10 days.
• to treat symptomatic heart failure in adult patients. Valsartan is used when a
group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a
medication to treat heart failure) cannot be used or it may be used in addition to
ACE inhibitors when other medication to treat heart failure cannot be used. Heart
failure symptoms include shortness of breath, and swelling of the feet and legs
due to fluid build-up. It is caused when the heart muscle cannot pump blood
strongly enough to supply all the blood needed throughout the body.

Jubilant Pharmaceuticals nv

Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 2/9
November 2014

In addition
Valsartan 80 and 160 mg capsules can be used
• to treat high blood pressure. High blood pressure increases the workload on the
heart and arteries. If not treated it can damage the blood vessels of the brain, heart,
and kidneys, and may result in a stroke, heart failure, or kidney failure.
High blood pressure increases the risk of heart attacks. Lowering your blood
pressure to normal reduces the risk of developing these disorders.

2. What you need to know before you take Valsartan
Do not take Valsartan:
• if you are allergic to valsartan or any of the other ingredients of this medicine
(listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan in
early pregnancy - see pregnancy section).
• if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.
If any of these apply to you, do not take Valsartan.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan
• if you have liver disease.
• if you have severe kidney disease or if you are undergoing dialysis.
• if you are suffering from a narrowing of the kidney artery.
• if you have recently undergone kidney transplantation (received a new kidney).
• if you are treated after a heart attack or for heart failure. Your doctor may check
your kidney function.
• if you have severe heart disease other than heart failure or heart attack.
• if you have ever experienced swelling of the tongue and face caused by an allergic
reaction called angioedema when taking another drug (including ACE inhibitors),
tell your doctor. If these symptoms occur when you are taking Valsartan, stop
taking this medicine immediately and never take it again. See also section 4,
“Possible side effects”.
• if you are taking medicines that increase the amount of potassium in your blood.
These include potassium supplements or salt substitutes containing potassium,
potassium-sparing medicines and heparin. It may be necessary to check the
amount of potassium in your blood at regular intervals.
• if you suffer from aldosteronism. This is a disease in which your adrenal glands
make too much of the hormone aldosterone. If this applies to you, the use of
Valsartan is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high
doses of water pills (diuretics).

Jubilant Pharmaceuticals nv







Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 3/9
November 2014

you must tell your doctor if you think you are (or might become) pregnant.
Valsartan is not recommended in early pregnancy, and must not be taken if you
are more than 3 months pregnant, as it may cause serious harm to your baby if
used at that stage (see pregnancy section).
if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you
have diabetes-related kidney problems.
- aliskiren.
if you are being treated with an ACE-inhibitor together with certain other
medicines to treat your heart failure, which are known as mineralocorticoid
receptors antagonists (MRA) (for example spironolactone, eplerenone) or
betablockers (for example metoprolol).

Your doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Valsartan”.
If any of these apply to you, tell your doctor before you take Valsartan.
Children and adolescents
The use of Valsartan in children and adolescents is not recommended (below the age
of 18 years).
Other medicines and Valsartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The effect of the treatment can be influenced if Valsartan is taken together with
certain other medicines. It may be necessary to change the dose, to take other
precautions, or in some cases to stop taking one of the medicines. This applies to both
prescription and non-prescription medicines, especially:







other medicines that lower blood pressure, especially water pills (diuretics).
if you are taking an ACE-inhibitor or aliskiren (see also information under the
headings “Do not take Valsartan” and “Warnings and precautions”).
medicines that increase the amount of potassium in your blood. These include
potassium supplements or salt substitutes containing potassium, potassiumsparing medicines and heparin.
certain type of pain killers called non-steroidal anti-inflammatory medicines
(NSAIDs).
some antibiotics (rifamycin group), a drug used to protect against transplant
rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection
(ritonavir). These drugs may increase the effect of Valsartan.
lithium, a medicine used to treat some types of psychiatric illness.

Jubilant Pharmaceuticals nv



Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 4/9
November 2014

if you are being treated with an ACE-inhibitor together with certain other
medicines to treat your heart failure, which are known as mineralocorticoid
receptors antagonists (MRA) (for example spironolactone, eplerenone) or
betablockers (for example metoprolol).

In addition:
• if you are being treated after a heart attack, a combination with ACE inhibitors (a
medication to treat heart attack) is not recommended.
• if you are being treated for heart failure, a triple combination with ACE
inhibitors and beta blockers (medications to treat heart failure) is not
recommended.
Taking Valsartan with food and drink
You can take Valsartan with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.


You must tell your doctor if you think that you are (or might become)
pregnant. Your doctor will normally advise you to stop taking Valsartan before
you become pregnant or as soon as you know you are pregnant, and will advise
you to take another medicine instead of Valsartan. Valsartan is not recommended
in early pregnancy, and must not be taken when more than 3 months pregnant, as
it may cause serious harm to your baby if it is used after the third month of
pregnancy.



Tell your doctor if you are breast-feeding or about to start breast-feeding.
Valsartan is not recommended for mothers who are breast-feeding, and your
doctor may choose another treatment for you if you wish to breast-feed, especially
if your baby is newborn, or was born prematurely.

Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out other activities
that require concentration, make sure you know how Valsartan affects you. Like many
other medicines used to treat high blood pressure, Valsartan may in rare cases cause
dizziness and affect the ability to concentrate.

3. How to take Valsartan
Always take this medicine exactly as your doctor or pharmacist has told you in order
to get the best results and reduce the risk of side effects. You should check with your
doctor or pharmacist if you are not sure. People with high blood pressure often do not
notice any signs of this problem. Many may feel quite normal. This makes it all the
more important for you to keep your appointments with the doctor even if you are
feeling well.

Jubilant Pharmaceuticals nv

Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 5/9
November 2014

After a recent heart attack: After a heart attack the treatment is generally started as
early as after 12 hours, usually at a low dose of 20 mg twice daily. This low dose is
provided by a 40 mg divisible tablets. Your doctor will increase this dose gradually
over several weeks to a maximum of 160 mg twice daily. The final dose depends on
what you as an individual patient can tolerate.
Valsartan can be given together with other treatment for heart attack, and your doctor
will decide which treatment is suitable for you.
Heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will
increase the dose gradually over several weeks to a maximum of 160 mg twice daily.
The final dose depends on what you as an individual patient can tolerate.
Valsartan can be given together with other treatments for heart failure, and your
doctor will decide which treatment is suitable for you.
High blood pressure: The usual dose is 80 mg daily. In some cases your doctor may
prescribe higher doses (e.g. 160 mg or 320 mg). He may also combine Valsartan with
an additional medicine (e.g. a diuretic).
You can take Valsartan with or without food. Swallow Valsartan with a glass of
water.
Take Valsartan at about the same time each day.
If you take more Valsartan than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor
immediately. If you have accidentally taken too many capsules, contact your doctor,
pharmacist, or hospital.
If you forget to take Valsartan
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you remember. However, if it is almost
time for your next dose, skip the dose you missed.
If you stop taking Valsartan
Stopping your treatment with Valsartan may cause your disease to get worse. Do not
stop taking your medicine unless your doctor tells you to.
If you have further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as
• swollen face, lips, tongue or throat

Jubilant Pharmaceuticals nv

Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 6/9
November 2014

• difficulty in breathing or swallowing
• hives, itching
Frequency: uncommon (may affect up to 1 in 100 people).
If you get any of these, see a doctor immediately.
Other side effects include:
Common (may affect up to 1 in 10 people):
• dizziness, postural dizziness
• low blood pressure with symptoms such as dizziness
• decreased kidney function (signs of renal impairment)
Uncommon (may affect up to 1 in 100 people):
• signs of angioedema (see section “Some symptoms need immediate medical
attention”)
• sudden loss of consciousness
• spinning sensation
• severely decreased kidney function (signs of acute renal failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
• breathlessness, difficulty breathing when lying down, swelling of the feet or legs
(signs of cardiac failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• tiredness
• weakness
Not known (frequency cannot be estimated from the available data):
• rash, itching together with some of the following signs or symptoms: fever, joint
pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum
sickness)
• purple-red spots, fever, itching (signs of inflammation of blood vessels also called
vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low level of
white blood cells also called neutropenia)
• decrease of level of haemoglobin and decrease of the percentage of red blood cells
in the blood (which can, in severe cases, lead to anaemia)
• increase of level of potassium in the blood (which can, in severe cases, trigger
muscle spasms, abnormal heart rhythm)

Jubilant Pharmaceuticals nv





Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 7/9
November 2014

elevation of liver function values (which can indicate liver damage) including an
increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin
and eyes)
increase of level of blood urea nitrogen and increase of level of serum creatinine
(which can indicate abnormal kidney function)
low level of sodium in the blood (which can trigger tiredness, confusion, muscle
twitching and/or convulsions in severe cases)

The frequency of some side effects may vary depending on your condition. For
example, side effects such as dizziness, and decreased kidney function, were seen less
frequently in adult patients treated with high blood pressure than in adult patients
treated for heart failure or after a recent heart attack.
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.
If any of the side effects gets serious, or if you get any side effects talk to your doctor
or pharmacist. This includes any possible side effects not listed in this leaflet. Your
doctor may then decide to reduce your dose or stop treatment.
You can also report side effects directly via the Yellow Card Scheme Website:
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 Valsartan







Al/PVC/PE/PVdC blister: Store below 30°C. Store in the original package in
order to protect from moisture.
Al/OPA/Al/PVC blister: This medicinal product does not require any special
storage conditions.
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 pack after
EXP. The expiry date refers to the last day of that month.
Do not use Valsartan if you notice that the pack is damaged or shows signs of
tampering.
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
What Valsartan 40 mg capsules contain
• The active substance is valsartan.
Each capsule contains 40 mg valsartan.

Jubilant Pharmaceuticals nv



Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 8/9
November 2014

The other ingredients are:
Microcrystalline cellulose (E460), povidone, crospovidone (E1202), sodium
laurilsulfate and magnesium stearate (E470b).

What Valsartan 40 mg capsules look like and contents of the pack
Valsartan 40 mg capsules consist of light grey coloured cap and body, size “3” hard
gelatin capsules, printed in black ink with “40” on cap, containing white to off white
granular powder.
The capsules are available in blister packs of 7 or 28 capsules.
Not all pack sizes may be marketed.
What Valsartan 80 mg capsules contain

The active substance is valsartan.
Each capsule contains 80 mg valsartan.

The other ingredients are:
Microcrystalline cellulose (E460), povidone, crospovidone (E1202), sodium
laurilsulfate and magnesium stearate (E470b).
What Valsartan 80 mg capsules look like and contents of the pack
Valsartan 80 mg capsules consist of light grey coloured cap and flesh opaque
coloured body, size “2” hard gelatin capsules, printed in black ink with “80” on cap,
containing white to off white granular powder.
The capsules are available in blister packs of 7, 28 or 98 capsules.
Not all pack sizes may be marketed.
What Valsartan 160 mg capsules contains
• The active substance is valsartan.
Each capsule contains 160 mg valsartan.
• The other ingredients are:
Microcrystalline cellulose (E460), povidone, crospovidone (E1202), sodium
laurilsulfate and magnesium stearate (E470b).
What Valsartan 160 mg capsules look like and contents of the pack
Valsartan 160 mg capsules consist of dark grey coloured cap and flesh opaque
coloured body, size “1” hard gelatin capsules, printed in white ink with “160” on cap,
containing white to off white granular powder.
The capsules are available in blister packs of 7, 28 or 98 capsules.
Not all pack sizes may be marketed.

Jubilant Pharmaceuticals nv

Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
PILE – p. 9/9
November 2014

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Distributed by
Aspire Pharma Ltd,
Antrobus House,
18 College Street,
Petersfield, Hampshire,
GU31 4AD,
United Kingdom
For any information about this medicine, please contact the Marketing Authorisation
Holder.

This leaflet was last revised in 11/2014.

Expand Transcript

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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