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VALSARTAN 40MG CAPSULES

Active substance: VALSARTAN

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T00074-01 Malta Zejtun 190x345 PIL

Package leaflet: Information for the user

Valsartan 40mg, 80mg and 160mg Capsules
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.
•  you have any further questions, ask your doctor or pharmacist.
If
•  medicine has been prescribed for you only. Do not pass it
This
on to others. It may harm them, even if their signs of illness are
the same as yours.
•  you get any side effects, talk to your doctor or pharmacist. This
If
includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet
1  hat Valsartan Capsules are and what they are used for
W
2  hat you need to know before you take Valsartan
W
Capsules
3  ow to take Valsartan Capsules
H
4  ossible side effects
P
5  ow to store Valsartan Capsules
H
6  ontents of the pack and other information
C
1  hat Valsartan Capsules are and what they are used
W

for

Valsartan Capsules contain the active ingredient valsartan.
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 the blood vessels to
tighten, causing your blood pressure to increase.
Valsartan Capsules work by blocking the effect of angiotensin II. As a
result, blood vessels relax and blood pressure is lowered.
Valsartan 40mg Capsules can be used to:
• reat high blood pressure in children and adolescents 6 to 18
t
years of age. 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.
• reat adult patients after a recent heart attack (myocardial
t
infarction). “Recent” means the patient had a heart attack at least
12 hours ago but no more than 10 days ago.
• reat symptomatic heart failure in adult patients. Valsartan 40mg
t
Capsules are 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 medications 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.
Valsartan 80mg and 160mg Capsules can be used to:
• reat high blood pressure in adults and in children and
t
adolescents 6 to 18 years of age. 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.
• reat adult patients after a recent heart attack (myocardial
t
infarction). “Recent” means the patient had a heart attack at least
12 hours ago but no more than 10 days ago.
• reat symptomatic heart failure in adult patients. Valsartan 80mg
t
and 160mg Capsules 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 medications 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.

2  hat you need to know before you take Valsartan
W

Capsules

Do not take Valsartan Capsules if you:

• are allergic to valsartan or any of the other ingredients of this
medicine (listed in section 6).
• have severe liver disease.
• are more than 3 months pregnant (it is also better to avoid Valsartan
Capsules in early pregnancy - see pregnancy section).
• have diabetes or impaired kidney function and you are treated with
a blood pressure lowering medicine containing aliskiren.

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AAAH6757

Warnings and precautions

Talk to your doctor before taking Valsartan Capsules
•  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 blood vessel to the
if
kidney.
•  you have recently undergone kidney transplantation (received a
if
new kidney).
•  you have severe heart disease other than heart failure or heart
if
attack.
•  you are treated after a heart attack or for heart failure, your
if
doctor may check your kidney function.
•  you are taking medicines that increase the amount of potassium
if
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.
•  you suffer from aldosteronism. This is a disease in which your
if
adrenal glands make too much of the hormone aldosterone. If this
applies to you, the use of Valsartan Capsules is not recommended.
•  you have lost a lot of fluid (dehydration) caused by diarrhoea,
if
vomiting, or high doses of water pills (diuretics).
•  must tell your doctor if you think you are (or might become)
you
pregnant. Valsartan Capsules are not recommended in early
pregnancy, and must not be taken if you are more than 3 months
pregnant, as they may cause serious harm to your baby if used at that
stage (see pregnancy section).
•  you have history of angioedema
if
• f you are taking any of the following medicines used to treat high
i
blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in
particular if you have diabetes-related kidney problems.
- aliskiren
•  you are being treated with an ACE-inhibitor together with
if
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 Capsules
if you“

Other medicines and Valsartan Capsules
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 Capsules are
taken together with certain other medicines. Your doctor may need to
change your dose and/or 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 tablets”
(diuretics).
• 
medicines that increase the amount of potassium in your blood.
These include potassium supplements or salt substitutes containing
potassium, potassium-sparing medicines and heparin.
• 
certain type of pain killers called non-steroidal
anti-inflammatory medicines (NSAIDs).
• 
lithium, a medicine used to treat some types of psychiatric illness.
•  you are taking an ACE-inhibitor or aliskiren (see also information
if
under the headings “Do not take Valsartan Capsules if you” and
“Warnings and precautions”.

In addition:

•  you are being treated with an ACE-inhibitor together with
if
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).
•  you are being treated after a heart attack, a combination with
if
medicines known as ACE inhibitors (medicines to treat heart attack) is
not recommended.

Valsartan Capsules with food and drink

You can take Valsartan Capsules with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this 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 Capsules
before you become pregnant or as soon as you know you are pregnant,
and will advise you to take another medicine instead of Valsartan
Capsules.
Valsartan Capsules are not recommended in early pregnancy, and must
not be taken when more than 3 months pregnant, as they may cause
serious harm to your baby if they are used after the third month of
pregnancy.

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T00074-01 Malta Zejtun 190x345 PIL

Tell your doctor if you are breast-feeding or about to start
breast-feeding.

Valsartan Capsules are not recommended if you are breast-feeding. 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 Capsules affect you. Like many other medicines used to
treat high blood pressure, Valsartan Capsules may in rare cases cause
dizziness and affect the ability to concentrate.

3  ow to take Valsartan Capsules
H

Always take this medicine exactly as your doctor has told you in order to
get the best results and reduce the risk of side effects. 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.
Take Valsartan Capsules at about the same time each day. Swallow the
capsules with a glass of water. You can take the capsules with or without
food.

Dosage:

Children and adolescents (6 to 18 years of age) with high blood
pressure
In patients who weigh less than 35kg the usual dose is 40mg of
valsartan once daily. In patients who weigh 35kg or more the usual
starting dose is 80mg of valsartan once daily. In some cases your doctor
may prescribe higher doses (the dose can be increased to 160mg and to
a maximum of 320mg).
Adult patients with high blood pressure:
The recommended dose is one 80mg capsule daily. In some cases your
doctor may prescribe higher doses (e.g. 160mg or 320mg). You may
also be prescribed an additional medicine to take e.g. “water tablets” (a
diuretic).
Adult patients 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 20mg twice daily. You obtain the 20mg
dose by dividing a 40mg tablet (obtained from a different source).
Your doctor will increase this dose gradually over several weeks to a
maximum of 160mg twice daily. The final dose depends on what you as
an individual patient can tolerate.
Valsartan Capsules can be given together with certain other treatments
for heart attack, and your doctor will decide which treatment is suitable
for you.
Adult patients with heart failure:
Treatment starts generally with one 40mg capsule twice daily. Your
doctor will increase the dose gradually over several weeks to a
maximum of one 160mg capsule twice daily. The final dose depends on
what you as an individual patient can tolerate.
Valsartan Capsules can be given together with other treatments for
heart failure, and your doctor will decide which treatment is suitable for
you.

If you take more Valsartan Capsules than you should

If you experience severe dizziness and/or fainting, contact your doctor
immediately and lie down. If you have accidentally taken too many
tablets, contact your doctor, pharmacist or hospital.

If you forget to take Valsartan Capsules

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

If you stop taking Valsartan Capsules

Stopping your treatment with Valsartan Capsules may cause your
disease to get worse. Do not stop taking your medicine unless your
doctor tells you to.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4  ossible side effects
P

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
• difficulty in breathing or swallowing
• hives, itching
If you get any of these, see a doctor immediately.
Other side-effects include:
Common (may affect up to 1 in 10 people):
• dizziness
•  blood pressure with or without symptoms such as dizziness and
low
fainting when standing up
• 
decreased kidney function (signs of renal impairment)
Uncommon side effects (may affect up to 1 in 100 people):
• 
angioedema (see section “Some symptoms need immediate medical
attention”)
• 
sudden loss of consciousness (syncope)
• 
spinning sensation (vertigo)
• 
severely decreased kidney function (signs of acute kidney 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

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• nausea
• diarrhoea
• tiredness
• weakness
Not known (frequency cannot be estimated from the available data):
• blistering skin (sign of dermatitis bullous)
• 
allergic reactions with rash, itching and hives; symptoms of fever,
swollen joints and joint pain, muscle pain, swollen lymph nodes and/
or flu-like symptoms may occur (signs of serum sickness)
• 
purplish-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 in level of haemoglobin and decrease of the percentage
of red blood cells in the blood (which can, in severe cases, lead to
anaemia)
• 
increase in level of potassium in the blood (which can, in severe cases,
trigger muscle spasms, abnormal heart rhythm), decrease in blood
sodium
• 
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 in level of blood urea nitrogen and increase of level of serum
creatinine (which can indicate abnormal kidney function)
•  level of sodium in the blood (which can trigger tiredness,
low
confusion, muscle twitching and/or convulsions in severe cases)
• rash
• itching
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.
Side effects in children and adolescents are similar to those seen in
adults.
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 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  ow to store Valsartan Capsules
H

Store below 30oC.
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 this medicine 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  ontents of the pack and other information
C
What Valsartan Capsules contain

The active substance is Valsartan.
Each capsule contains 40mg valsartan.
Each capsule contains 80mg valsartan.
Each capsule contains 160mg valsartan.
The other ingredients in capsules are Microcrystalline cellulose
(101), Croscarmellose Sodium, Sodium laurilsulfate, Povidone (K30),
Magnesium stearate, Gelatin, Titanium dioxide (E171), Red iron oxide
(E172(ii)) and Black iron oxide (E172(i)).
The black printing ink contains Shellac, Ethanol, Isopropanol, butanol,
propylene glycol, purified water, strong ammonia solution, potassium
hydroxide and black iron oxide (E172).
What Valsartan Capsules look like and contents of the pack
Valsartan 40mg Capsules are a hard gelatin, light grey opaque / light
grey opaque capsule with ‘VS3’ over ‘ ’ on the cap and no markings on
the body.
Valsartan 80mg Capsules are a hard gelatin, light grey opaque / flesh
opaque capsule with ‘VS2’ over ‘ ’ on the cap and no markings on the
body.
Valsartan 160mg Capsules are a hard gelatin, dark grey opaque / flesh
opaque capsule with ‘VS1’ over ‘ ’ on the cap and no markings on the
body.
The capsules are packed in aluminium foil blisters.
Pack sizes: 7, 28, 98
Not all pack sizes may be marketed
Marketing Authorisation Holder
Arrow Generics Limited
Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom
Manufacturer
Actavis Ltd
BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta
This leaflet was last revised in February 2015

If you would like a
leaflet with larger
text, please contact
01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

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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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