VALSARTAN 80MG FILM-COATED TABLET

Active substance: VALSARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Valsartan 40 mg film-coated tablets
Valsartan 80 mg film-coated tablets
Valsartan 160 mg film-coated tablets
Valsartan

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 nonprescription medicines, especially:
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Read all of this leaflet carefully before you start taking this medicine.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you. Do not pass it on to others. It may harm
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them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
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leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Valsartan is and what it is used for
2. Before you take Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Further information

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medicines that lower blood pressure, especially “water tablets” (diuretics).
medicines that increase the amount of potassium in your blood. These include
potassium supplements, potassium-sparing medicines and heparin.
certain type of pain killers called non-steroidal anti-inflammatory medicines
(NSAIDs).
lithium, a medicine used to treat mental health.

In addition:
if you are being treated for heart failure, a triple combination with ACE inhibitors
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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.

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1.

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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.

WHAT VALSARTAN ISAND WHAT IT IS USED FOR

The active ingredient of Valsartan is valsartan.
Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”.
Valsartan helps blood vessels relax and so reduces strain on the heart.
Valsartan 40 mg, 80 mg & 160 mg film-coated tablets can be used to treat:
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high blood pressure in children and adolescents aged 6 to 18 years.
High blood pressure may damage the body's blood vessels and may result in a stroke,
heart failure or kidney failure. Lowering blood pressure reduces the risk of developing
these disorders.
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.
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symptomatic heart failure in adults.
Heart failure occurs when the heart muscle cannot pump blood strongly enough to
supply all the blood needed throughout the body. Heart failure symptoms include
shortness of breath and swelling of the feet and legs owing to fluid build-up.
Valsartan is used for heart failure when a group of medicines called Angiotensin
Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be
used or Valsartan may be used in addition to ACE inhibitors when beta blockers
(another medication to treat heart failure) cannot be used.
Valsartan 80 mg & 160 mg film-coated tablets can also be used to treat:
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high blood pressure in adults.
High blood pressure may damage the body's blood vessels and may result in a stroke,
heart failure or kidney failure. Lowering blood pressure reduces the risk of developing
these disorders.
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.
2.

BEFORE YOU TAKE VALSARTAN

Do not take Valsartan if you:
are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan .
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have severe liver disease.
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are more than 3 months pregnant (it is also better to avoid Valsartan in early
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pregnancy - see pregnancy section).

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 cause dizziness and affect the
ability to concentrate.
Important information about some ingredients of Valsartan
This medicine contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.

HOW TO TAKE VALSARTAN

Always take Valsartan exactly as your doctor 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.
Adults
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 treatment for heart failure: 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. 160mg or 320mg). He may also combine Valsartan with an
additional medicine e.g. a diuretic (“water tablet”).
Children and adolescents (ages 6 to 18yrs) 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).

If any of these apply to you, do not take Valsartan
Take special care with Valsartan if you:
have liver disease.
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have severe kidney disease or if you are undergoing dialysis.
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are known to have narrowing of the kidney arteries.
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have recently had a kidney transplant.
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are receiving treatment after a heart attack or for heart failure then your doctor may
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check how your kidneys are working.
have severe heart disease other than heart failure or heart attack.
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are taking medicines that increase the amount of potassium in your blood: these
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include potassium supplements, potassium-sparing medicines and heparin. It may be
necessary to check the amount of potassium in your blood at regular intervals.
are known to have “primary aldosteronism”, a hormone imbalance. If this applies to
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you then the use of Valsartan is not recommended.
have lost a lot of fluid by diarrhoea, vomiting, or high doses of water pills (diuretics).
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In addition:
if you are below the age of 18 years and you take Valsartan with other medicines then
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your doctor may check request tests to check your salt balance and how your kidneys
are working.
you must tell your doctor if you think you are (or might become) pregnant. Valsartan is
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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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

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 tablets, 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, Valsartan can cause side effects, although not everybody gets them. The
frequency of some side effects may vary depending on your condition.
The following side effects are important and will require immediate action if you
experience them. You should stop taking Valsartan and see your doctor immediately if the
following symptoms occur:
Frequency not known:
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swelling of the face, tongue and windpipe which can cause great difficulty in
breathing

The following side-effects have also been reported:
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Common, affecting up to 1 in 10 people:
dizziness, dizziness on standing
low blood pressure
kidney problems that may become severe
changes in blood test results that show how the kidneys are working

What Valsartan 160 mg film-coated tablets looks like and contents of the pack
Valsartan 160 mg film-coated tablets are yellow coloured, oval shaped, biconvex filmcoated tablets, scored on one side and debossed with '160' on scored side and 'J' on the
other.
The score line is only to facilitate breaking for ease of swallowing and not to divide into
equal halves.
The tablets are available in blister packs of 7, 14, 28, 30, 56, 90 or 98 tablets.

Uncommon, affecting less than 1 in 100 people:
Fainting, spinning sensation
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heart failure (causing breathlessness, fluid retention)
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headache
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cough
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abdominal pain, nausea, diarrhoea
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Tiredness, fatigue
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Increase in blood potassium (may affect the heart and cause muscle symptoms)
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Frequency not known:
Allergic reaction with skin rash, itch, joint pains and swollen glands and/or flu-like
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symptoms
Anaemia causing shortness of breath or looking pale
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Increased susceptibility to infection such as fever, sore throat or mouth ulcers
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Bleeding or bruising more easily than normal
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changes in blood test results that show how the liver is working
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low blood sodium (may cause nausea, tiredness, confusion, malaise, convulsions)
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muscle pain
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inflammation of small blood vessels
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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.
5.

HOW TO STORE VALSARTAN

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This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
Keep out of the reach and sight of children.
Do not use Valsartan after the expiry date which is stated on the pack. 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.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.

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6.

FURTHER INFORMATION

What Valsartan 40 mg film-coated tablets contains
The active substance is valsartan.
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Each tablet contains 40 mg valsartan.
? The other ingredients are:
? for the tablet core:
Microcrystalline cellulose (E460), crospovidone (E1202), silica, magnesium
stearate (E470b) and anhydrous lactose.
? for the tablet coating:
Hypromellose (E464), titanium dioxide (E171), macrogol and iron oxide yellow
(E172).

Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
Marketing Authorisation Holder
Jubilant Pharmaceuticals 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
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
For any information about this medicine, please contact the Marketing Authorisation
Holder.
This medicinal product is authorized in the Member States of the EEA under the
following names:
Valsartan 40 mg film-coated tablets
Sweden: Valsartan Jubilant 40 mg Filmdragerade Tabletter
Belgium: Valsartan Jubilant, 40 mg filmomhulde tabletten
France: Valsartan Jubilant 40 mg comprimés pelliculés
Germany: Valsartan Jubilant 40 mg Filmtabletten
Italy: Kerval
Spain: Valsartán Jubilant 40 mg comprimidos recubiertos con película
The Netherlands: Valsartan Jubilant 40 mg filmomhulde tabletten
United Kingdom: Valsartan 40 mg film-coated tablets
Valsartan 80 mg film-coated tablets

The tablets are available in blister packs of 7, 14, 28, 30, 56, 90 or 98 tablets.

Sweden: Valsartan Jubilant 80 mg Filmdragerade Tabletter
Belgium: Valsartan Jubilant, 80 mg filmomhulde tabletten
France: Valsartan Jubilant 80 mg comprimés pelliculés
Germany: Valsartan Jubilant 80 mg Filmtabletten
Italy: Kerval
Spain: Valsartán Jubilant 80 mg comprimidos recubiertos con película
The Netherlands: Valsartan Jubilant 80 mg filmomhulde tabletten
United Kingdom: Valsartan 80 mg film-coated tablets

Not all pack sizes may be marketed.

Valsartan 160 mg film-coated tablets

What Valsartan 80 mg film-coated tablets contains
? The active substance is valsartan.
Each tablet contains 80 mg valsartan.
The other ingredients are:
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for the tablet core:
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Microcrystalline cellulose (E460), crospovidone (E1202), silica, magnesium
stearate (E470b) and anhydrous lactose.
for the tablet coating:
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Hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide yellow
(E172) and iron oxide red (E172)

Sweden: Valsartan Jubilant 160 mg Filmdragerade Tabletter
Belgium: Valsartan Jubilant, 160 mg filmomhulde tabletten
France: Valsartan Jubilant 160 mg comprimés pelliculés
Germany: Valsartan Jubilant 160 mg Filmtabletten
Italy: Kerval
Spain: Valsartán Jubilant 160 mg comprimidos recubiertos con película
The Netherlands: Valsartan Jubilant 160 mg filmomhulde tabletten
United Kingdom: Valsartan 160 mg film-coated tablets

What Valsartan 40 mg film-coated tablets looks like and contents of the pack
Valsartan 40 mg film-coated tablets are yellow coloured, round, biconvex, film-coated
tablets, debossed with 'J' on one side and '40' on the other.

What Valsartan 80 mg film-coated tablets looks like and contents of the pack
Valsartan 80 mg film-coated tablets are peach coloured, round, biconvex film-coated
tablets, scored on one side and debossed with '80' on scored side and 'J' on the other.
The score line is only to facilitate breaking for ease of swallowing and not to divide into
equal halves.
The tablets are available in blister packs of 7, 14, 28, 30, 56, 90 or 98 tablets.
Not all pack sizes may be marketed.
What Valsartan 160 mg film-coated tablets contains
? The active substance is valsartan.
Each tablet contains 160 mg valsartan.
? The other ingredients are:
? for the tablet core:
Microcrystalline cellulose (E460), crospovidone (E1202), silica, magnesium
stearate (E470b) and anhydrous lactose.
? for the tablet coating:
Hypromellose (E464), titanium dioxide (E171), macrogol, and iron oxide yellow
(E172).

This leaflet was last approved in 03/2011

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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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