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VALSARTAN 160 MG CAPSULES

Active substance(s): VALSARTAN

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• 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 a low level of white blood cells also
called neutropenia)
• decrease of the level of haemoglobin and decrease
of the percentage of red blood cells in the blood
(which can lead to anaemia in severe cases)
• increase in the level of potassium in the blood
(which can trigger muscle spasms and abnormal
heart rhythm in severe cases)
• elevation of liver function values (which can
indicate liver damage) including an increase of
bilirubin in the blood (which can, trigger yellow
skin and eyes in severe cases)
• increase of the level of blood urea nitrogen and
increase of the 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 for 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 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.
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 H
 OW TO STORE VALSARTAN
CAPSULES
Keep this medicine out of the sight and
reach of children.
Do not use Valsartan Capsules after the expiry date
which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original
package in order to protect from 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.

88360-B
AAAF6350

6 C
 ONTENTS OF THE PACK AND
OTHER INFORMATION
What Valsartan Capsules contain:

PACKAGE LEAFLET: INFORMATION FOR THE USER

• T he active substance is valsartan.
40 mg: E ach hard capsule contains 40 mg of
valsartan.
80 mg: E ach hard capsule contains 80 mg of
valsartan.
160 mg: E ach hard capsule contains 160 mg of
valsartan.

Valsartan 40mg, 80mg
and 160mg Capsules

• The other ingredients are silica colloidal
anhydrous, sodium starch glycolate (type A),
crospovidone, cellulose microcrystalline, maize
starch and magnesium stearate inside the capsule.
The capsule shell is made of titanium dioxide,
gelatin, black iron oxide, 80 mg and 160 mg
strengths only: red iron oxide, 160 mg strength
only: yellow iron oxide. The printing ink contains
shellac, propylene glycol and black iron oxide.

What Valsartan Capsules look like and
contents of the pack
•C
 apsule, hard
•4
 0 mg strength: Hard-gelatin capsule with grey
opaque body and cap, filled with off-white to
yellowish powder with small agglomerates,
imprinted V40 on body and cap.
•8
 0 mg strength: Hard-gelatin capsule with
grey opaque body and flesh opaque cap, filled
with off-white to yellowish powder with small
agglomerates, imprinted V80 on body and cap.
•1
 60 mg strength: Hard-gelatin capsule with
grey opaque body and flesh opaque cap, filled
with off-white to yellowish powder with small
agglomerates, imprinted V160 on body and cap.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

It is caused when the heart muscle cannot pump
blood strongly enough to supply all the blood
needed throughout the body.

• 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.
This includes any possible side effects not listed
in this leaflet.

Valsartan 80 mg capsules can be used for
three different conditions:

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 W
 HAT VALSARTAN IS AND WHAT IT IS
USED FOR

Transparent PVC/PE/PVdC – Aluminium blister
packs:

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
and blood pressure is lowered.

Pack sizes:
40 mg capsules: 1, 7, 14, 15, 28, 30, 56, 84, 90, 98,
100 and 280 capsules.
80 & 160 mg capsules: 1, 14, 15, 28, 30, 56, 84, 90,
98, 100 and 280 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, United
Kingdom

Valsartan 40 mg capsules can be used for
three different conditions:
• t o treat high blood pressure in children and
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.
• to treat adult patients after a recent heart
attack (myocardial infarction). “Recent” here
means between 12 hours and 10 days ago.
• 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 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 owing
to fluid build-up.

This leaflet was last revised in June 2013

PL 00289/1122-1124

If you would like a
leaflet with larger
text, please contact
01271 311257.

• 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 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 owing
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 160 mg Capsules can be used for three
different conditions:
• to treat high blood pressure in adults and in
children and 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.
• 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 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.

Continued over page

Actavis, Barnstaple, EX32 8NS, UK

AAAF6350

Valsartan 40mg, 80mg & 160mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAF6350

dimensions:

print proof no:

5

pharmacode:

origination date: 11.07.13
approved for print/date

• to treat high blood pressure in adults and in
children and 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
reduces the risk of developing these disorders.
• to treat adult patients after a recent heart
attack (myocardial infarction). “Recent” here
means between 12 hours and 10 days ago.

min pt size:

323 x 320

2.
3.
4.

8, 9 & 10

5.
6.

originated by:

jh

revision date:

19.08.13

Technical Approval

revised by:

jh

date sent:

supplier:

TEVA

technically app. date: 29.07.13

11.07.13

Non Printing Colours
1.
2.
3.

2 W
 HAT YOU NEED TO KNOW BEFORE
YOU TAKE VALSARTAN CAPSULES
Do NOT take Valsartan Capsules if you:
• are allergic (hypersensitive) to valsartan or any of
the other ingredients of Valsartan Capsules (listed
in section 6).
• have severe liver disease.
• are more than 3 months pregnant (it is better to
avoid Valsartan Capsules in early pregnancy - see
pregnancy section).
• if you have diabetes mellitus or impaired kidney
function and taking aliskiren (a class of medicines
called renin inhibitors that helps to lower high
blood pressure in adult patients).
If any of these apply to you, do not take
Valsartan Capsules.

Warnings and precautions:
Talk to your doctor before taking Valsartan if you
• have liver disease.
• have severe kidney disease or if you are
undergoing dialysis.
• are suffering from a narrowing of the kidney
artery.
• have recently undergone kidney transplantation
(received a new kidney).
• are treated after a heart attack or for heart failure,
your doctor may check your kidney function.
• have severe heart disease other than heart
failure or heart attack.
• are taking medicines that increase the
amount of potassium in your blood. These
include potassium supplements, 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.
•a
 re below 18 years of age and you take Valsartan
in combination with other 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.
• 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 Capsules is not recommended.
• have lost a lot of fluid (dehydration) caused by
diarrhoea, vomiting, or high doses of water tablets
(diuretics).
• 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
Valsartan immediately and never take it again.
(See also section 4, “Possible side effects”).
• you must tell your doctor if you think you are (or
might become) pregnant. Valsartan Capsules
are 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 section Pregnancy,
breast-feeding and fertility).

If any of these apply to you, tell your
doctor before you take Valsartan Capsules.

Other medicines and Valsartan

3 H
 OW TO TAKE VALSARTAN
CAPSULES

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

Always take Valsartan Capsules exactly as your
doctor has told you. 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. For doses not realisable/
practicable with this strength, other strengths and
pharmaceutical forms of this medicinal product are
available.

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:
•a
 liskiren (a medicine that lower blood pressure),
particularly if you suffer from diabetes mellitus or
impaired kidney function.
•o
 ther medicines that lower blood pressure,
especially water tablets (diuretics).
•m
 edicines that increase the amount of
potassium in your blood. These include
potassium supplements, potassium‑sparing
medicines and heparin.
• c ertain type of pain killers called non-steroidal
anti-inflammatory medicines (NSAIDs).
• l ithium, a medicine used to treat some types of
psychiatric illness.

If you forget to take Valsartan Capsules
If you forget to take a dose then 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 further questions on the
use of this product, ask your doctor or
pharmacist.

Valsartan 80 mg and 160 mg capsules:
• Adults with high blood pressure:
The recommended dose is 80 mg daily. In some
cases your doctor may prescribe higher doses
(e.g. 160mg or 320mg). He/she may also combine
Valsartan Capsules with an additional medicine
(e.g. a diuretic).

Valsartan 40 mg, 80 mg and 160 mg
capsules:
•U
 se in children and adolescents (6 to 18 years
of age) with high blood pressure:
In patients who weigh less than 35 kg the usual
dose is 40 mg of valsartan once daily. In patients
who weigh 35 kg or more the usual starting dose
is 80 mg of valsartan once daily. In some cases
your doctor may prescribe higher doses (the dose
can be increased to 160 mg and to a maximum of
320 mg).

In addition:
• if you are being treated after a heart attack, a
combination with ACE inhibitors (medicines used
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 also used to treat heart
failure) is not recommended.

Valsartan Capsules with food and drink

• 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 20 mg twice daily. You may obtain the
20 mg dose by dividing a 40 mg valsartan tablet.
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.

You can take Valsartan Capsules with or without
food.

Pregnancy, breast-feeding and fertility
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
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
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 Capsules are
not recommended for mothers who are breastfeeding, 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.

Valsartan Capsules can be given together with
other treatment for heart attack: your doctor will
decide which treatment is suitable for you.
• Adult patients with 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 Capsules can be given together with
other treatment for heart failure: your doctor will
decide which treatment is suitable for you.
You can take Valsartan Capsules with or without
food. Swallow Valsartan Capsules with a glass of
water. Take Valsartan Capsules at about the same
time each day.

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 affects you. Like many other medicines
used to treat high blood pressure, Valsartan
Capsules may cause dizziness and affect the ability
to concentrate.

If you take more Valsartan Capsules than
you should
If you experience dizziness and/or fainting, contact
your doctor immediately and lie down. If you have
accidentally taken too many capsules then contact
your doctor, pharmacist or hospital.

Continued top of next column
AAAF6350

4 POSSIBLE SIDE EFFECTS
Like all medicines, Valsartan Capsules can cause
side effects, although not everybody gets them.
These side effects may occur with certain
frequencies, which are defined as follows:
Very common: may affect more than 1 in 10 people
Common:
may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1000 people
Very rare:
may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated
from the available data

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.
Side effects include:
Common
• dizziness
• low blood pressure with or without symptoms
such as dizziness and fainting when standing up
• decreased kidney function (signs of renal
impairment)
Uncommon
• angioedema (see section “Some symptoms need
immediate medical attention”)
• sudden loss of consciousness (syncope)
• spinning sensation (vertigo)
• 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
Frequency not known:
• 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).
Continued over page
AAAF6350

Valsartan 40mg, 80mg & 160mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAF6350

dimensions:

print proof no:

5

pharmacode:

origination date: 11.07.13
approved for print/date

min pt size:

323 x 320

2.
3.
4.

8, 9 & 10

5.
6.

originated by:

jh

revision date:

19.08.13

Technical Approval

revised by:

jh

date sent:

supplier:

TEVA

technically app. date: 29.07.13

11.07.13

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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