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VALSARTAN 80 MG CAPSULES HARD

Active substance(s): VALSARTAN

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Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
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.
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 capsules belong 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 capsules work by blocking the effect of angiotensin II. As
a result, blood vessels relax and blood pressure is lowered.
Valsartan 40 mg capsules can be used for three different
conditions:

to 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.

to treat symptomatic heart failure in adult patients.
Valsartan 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 capsules 80 and 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 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.
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 capsules in early pregnancy - see pregnancy
section).

if you suffer from diabetes and are taking a medicine called
aliskiren, you should not take Valsartan.

if you have severe kidney disease and are taking a medicine
called aliskiren, you should not take Valsartan.
If any of these apply to you, speak to your doctor.
Warnings and precautions
You must be especially careful and talk to your doctor before
taking Valsartan capsules if any of the following apply to you.

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 Valsartan immediately and never take it again. See also
section 4, “Possible side effects”.

if you are taking medicines that increase the amount of

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Valsartan capsules, hard

Package leaflet: Information for the user

Black

Valsartan capsules, hard

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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 are 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.

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
capsules is not recommended.

if you have lost a lot of fluid (dehydration) caused by diarrhoea,
vomiting, or high doses of water pills (diuretics).

You must tell your doctor if you think you are (or might
become) pregnant. Valsartan capsules 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 any of these apply to you, tell your doctor before you take
Valsartan.
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 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:









other medicines that lower blood pressure, especially
water pills (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 antiinflammatory 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.
aliskiren, a medicine used to treat high blood pressure, in
patients with diabetes and/or moderate to severe kidney
disease.

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.
Valsartan with food and drink
You can take Valsartan capsules with or without food.
Pregnancy, breast-feeding and fertility
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 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 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 capsules 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 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. How to take Valsartan
Always take this medicine exactly as described in this leaflet or 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.
Adult patients with 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).
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).
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 obtain the 20 mg dose by
dividing the 40 mg 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.

Valsartan capsules can be given together with other treatment for
heart attack, and your doctor will decide which treatment is suitable
for you.

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.

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.

Side effects in children and adolescents are similar to those seen in
adults.

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.
If you take more Valsartan 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 capsules, contact your
doctor, pharmacist or hospital.
If you forget to take Valsartan
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
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. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
These side effects may occur with certain frequencies, which are
defined as follows:
• very common:
affects more than 1 user in 10
• common:
affects 1 to 10 users in 100
• uncommon:
affects 1 to 10 users in 1,000
• rare:
affects 1 to 10 users in 10,000
• very rare:
affects less than 1 user in 10,000
• 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 symptoms, stop taking Valsartan and
contact your doctor straight away (see also section 2
“Warnings and precautions”).
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
Not known:
• allergic reactions with rash 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 of level of haemoglobin and decrease of the
percentage of red blood cells in the blood (which can lead
to anaemia in severe cases)
• increase of 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 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

5. How to store Valsartan
Keep this medicine out of the sight and reach of children.
Store below 30oC.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on
the label, carton, bottle after EXP. The expiry date refers to the last
day of that month.
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 contains
-

The active substance is valsartan. Each hard capsule contains
40 mg/ 80 mg/ 160 mg of valsartan.
The other ingredients are
Capsule content: Cellulose microcrystalline, silica colloidal
anhydrous, crospovidone (Type- B), povidone (K 30), sodium
lauryl sulphate, magnesium stearate.
Capsule shell: Iron oxide black (E172), titanium dioxide (E171),
gelatin, sodium lauryl sulfate.
Printing ink: Shellac (E904), propylene glycol, black iron oxide,
titanium dioxide (for 160 mg capsules only), potassium
hydroxide.

What Valsartan looks like and contents of the pack
Capsule, hard
Valsartan 40 mg Capsules:
Opaque light grey cap/Opaque light grey body, size '4' hard gelatin
capsules imprinted in black ink with ‘I’ on cap and '70' on body,
filled with white to off white granular powder.
Valsartan 80 mg Capsules:
Opaque light grey cap / Flesh opaque body, size '3' hard gelatin
capsules imprinted in black ink with ‘I’ on cap and '71' on body,
filled with white to off white granular powder.
Valsartan 160 mg Capsules:
Opaque dark grey cap/Flesh opaque body, size '1' hard gelatin
capsules imprinted in white ink with ‘I’ on cap and '72' on body with
black ink, filled with white to off white granular powder.
Pack size:
Clear PVC/Aclar –Aluminium blister:
28 capsules, hard
HDPE container with Polypropylene closure containing silica gel
desiccant:
30 and 500 capsules, hard
Not all pack sizes may be marketed
Marketing Authorization Holder
UK _ Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
MT_

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
Italy:
Valsartan Aurobindo Pharma Italia 80 mg/ 160 mg
capsule rigide
Malta:
Valsartan 40 mg/ 80 mg/ 160 mg capsules, hard
Portugal:
Valsartan Aurobindo
United Kingdom: Valsartan 40 mg/ 80 mg/ 160 mg capsules, hard
This leaflet was last revised in 08/2013.

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Valsartan capsules can be given together with other treatment for
heart failure, and your doctor will decide which treatment is suitable
for you.

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 (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
Malta
The United Kingdom
ADR Reporting
Yellow Card Scheme
The Medicines Authority
Website:
Post-Licensing Directorate
www.mhra.gov.uk/yellowcard
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website:
www.medicinesauthority.gov.mt.
e-mail:
postlicensing.medicinesauthority@gov.mt.

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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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