VALSARTAN 40MG CAPSULES

Active substance: VALSARTAN

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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.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your doctor or
I
pharmacist.
•  his medicine has been prescribed for you only. Do not pass
T
it on to others. It may harm them, even if their signs of illness
are the same as yours.
• f you get any side effects, talk to your doctor or pharmacist.
I
This 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
W
used for
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
W

used 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
t
40mg 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 beta blockers (another 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.
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.
 igh blood pressure increases the risk of heart attacks. Lowering
H
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
t
80mg 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 beta blockers (another
medication to treat heart failure) cannot be used.
 eart failure symptoms include shortness of breath, and swelling
H
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:

•  re allergic to valsartan or any of the other ingredients of this
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medicine (listed in section 6).
•  ave severe liver disease.
h
•  re more than 3 months pregnant (it is also better to avoid
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Valsartan Capsules in early pregnancy - see pregnancy section).
•  re taking aliskiren and you have diabetes or severe kidney
a
disease.

Warnings and precautions

Talk to your doctor before taking Valsartan Capsules
• f you have liver disease.
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• f you have severe kidney disease or if you are undergoing
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dialysis.
• f you are suffering from a narrowing of the blood vessel to the
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kidney.
• f you have recently undergone kidney transplantation
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(received a new kidney).
• f you have severe heart disease other than heart failure or heart
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attack.
• f you are treated after a heart attack or for heart failure, your
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doctor may check your kidney function.
• f you are taking medicines that increase the amount of
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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.
• f you take Valsartan Capsules in combination with other
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medicines that inhibit the renin angiotensin aldosterone system
(medicines that lower blood pressure), your doctor may check
your kidney function and the amount of potassium in your blood
at regular intervals.
• f you suffer from aldosteronism. This is a disease in which your
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adrenal glands make too much of the hormone aldosterone.
If this applies to you, the use of Valsartan Capsules is not
recommended.
• f you have lost a lot of fluid (dehydration) caused by diarrhoea,
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vomiting, or high doses of water pills (diuretics).
•  ou must tell your doctor if you think you are (or might become)
y
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).
• f you have history of angioedema.
i
If any of these apply to you, tell your doctor before you take
Valsartan Capsules.

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. 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:
•  ther medicines that lower blood pressure, especially “water
o
tablets” (diuretics).
•  edicines that increase the amount of potassium in your
m
blood. These include potassium supplements or salt substitutes
containing potassium, potassium-sparing medicines and heparin.
•  ertain type of pain killers called non-steroidal
c
anti-inflammatory medicines (NSAIDs).
• ithium, a medicine used to treat some types of psychiatric illness.
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•  liskiren, a medicine used to treat essential hypertension. Do
a
not take Valsartan Capsules with aliskiren if you have diabetes or
severe kidney impairment.

In addition:

• f you are being treated after a heart attack, a combination with
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medicines known as ACE inhibitors (medicines to treat heart
attack) is not recommended.
• f you are being treated for heart failure, triple combination with
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ACE inhibitors and beta blockers (medicines to treat heart failure)
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.

Continued over page

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AAAG9413

Valsartan 40mg, 80mg, 160mg Capsules PIL - UK

colours/plates:
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origination date:

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DR

revision date:

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Technical Approval
date sent:

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technically app. date:

12.06.14

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

•  ausea
n
•  iarrhoea
d
•  iredness
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•  eakness
w
•  ot known (frequency cannot be estimated from the available
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data): 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)
•  urplish-red spots, fever, itching (signs of inflammation of blood
p
vessels also called vasculitis)
•  nusual bleeding or bruising (signs of thrombocytopenia)
u
•  uscle pain (myalgia)
m
• ever, sore throat or mouth ulcers due to infections (symptoms of
f
low level of white blood cells also called neutropenia)
•  ecrease in level of haemoglobin and decrease of the percentage
d
of red blood cells in the blood (which can, in severe cases, lead to
anaemia)
• ncrease in level of potassium in the blood (which can, in severe
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cases, trigger muscle spasms, abnormal heart rhythm), decrease
in blood sodium
•  levation of liver function values (which can indicate liver
e
damage) including an increase of bilirubin in the blood (which
can, in severe cases, trigger yellow skin and eyes)
• ncrease in level of blood urea nitrogen and increase of level of
i
serum creatinine (which can indicate abnormal kidney function)
• ow level of sodium in the blood (which can trigger tiredness,
l
confusion, muscle twitching and/or convulsions in severe cases)
•  ash
r
• tching
i
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.
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 internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays)
or fill in a paper form available from your local pharmacy.
By reporting side effects you can help provide more information on
the safety of this medicine

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 other treatment
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.

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.

If you take more Valsartan Capsules than you should

6  ontents of the pack and other information
C
What Valsartan Capsules contain

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.

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
Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, U.K.
Manufacturer
Arrow Pharm (Malta) Limited
HF 62, Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta

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):
•  izziness
d
• ow blood pressure with or without symptoms such as dizziness
l
and fainting when standing up
•  ecreased kidney function (signs of renal impairment)
d
Uncommon side effects (may affect up to 1 in 100 people):
•  ngioedema (see section “Some symptoms need immediate
a
medical attention”)
•  udden loss of consciousness (syncope)
s
•  pinning sensation (vertigo)
s
•  everely decreased kidney function (signs of acute kidney failure)
s
•  uscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
m
•  reathlessness, difficulty breathing when lying down, swelling of
b
the feet or legs (signs of cardiac failure)
•  eadache
h
•  ough
c
•  bdominal pain
a

This leaflet was last revised in June 2014

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

Continued top of next column
AAAG9413

Actavis, Barnstaple, EX32 8NS, UK

Valsartan 40mg, 80mg, 160mg Capsules PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAG9413
4
10.06.14

originated by:
approved for print/date

01.07.14

190x345

min pt size:

revised by:
supplier:

DR
Malta Hal Far

2.
3.

pharmacode:

4.
8.5pt

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

10.06.14

technically app. date:

12.06.14

1.
2.
3.

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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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