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VALSARTAN 40MG FILM-COATED TABLETS

Active substance(s): VALSARTAN

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1959
14.06.16[7]

Diovan® 40 mg Film-Coated Tablets
Valsartan 40 mg Film-Coated Tablets
(valsartan)
PATIENT INFORMATION LEAFLET

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
include any possible side effects not listed in this leaflet. See section
4.
Your medicine is available using any one of the above names but will be
referred to as Diovan throughout this leaflet.
Other strengths are also available.
What is in this leaflet:
1. What Diovan is and what it is used for
2. What you need to know before you take Diovan
3. How to take Diovan
4. Possible side effects
5. How to store Diovan
6. Content of the pack and other information
1. WHAT DIOVAN IS AND WHAT IT IS USED FOR
Diovan contains the active substance: valsartan and belongs to a class of
medicines known as angiotensin II receptor antagonist, 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. Diovan
works by blocking the effect of angiotensin II. As a result, blood vessels
relax and blood pressure is lowered.
Diovan 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. Diovan 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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIOVAN
Do not take Diovan:
- if you are allergic (hypersensitive) 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
Diovan in early pregnancy - see pregnancy section).
- if you have diabetes or impaired kidney function and you are treated with
a blood pressure lowering medicine containing aliskiren
If any of the above apply to you, tell to your doctor do not take Diovan.
Warnings and precautions:
Talk to your doctor
- 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 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 Diovan, stop taking Diovan immediately and never take it
again. See also section 4, “Possible side effects”.

- if you are taking medicines that increase the amount of 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 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 Diovan is not recommended.
- if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting,
or high doses of water tablets (diuretics).
- if you are taking any of the following medicines used to treat high blood
pressure:
- an ACE inhibitors (for example enalapril, lisinopril, Ramipril), in
particular if you have diabetes-related kidney problems.
- aliskiren
- if you are being treated with a ACE inhibitor together with 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 Diovan”
You must tell your doctor if you think you are (or might become) pregnant.
Diovan 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).
Other medicines and Diovan
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 Diovan 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 non-prescription medicines, especially:
- other medicines that lower blood pressure, especially water tablets
(diuretics), ACE inhibitors (such as enalapril, lisinopril, etc) or aliskiren
(see also information under the headings “Do not take Diovan” and
“Warnings and precautions”).
- 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).
- 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
Diovan.
- lithium, a medicine used to treat some types of psychiatric illness.
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 other medicines to treat your heart failure which are
known as mineralocorticoid receptor antagonists (MRA) (for
example spironolactone, epleronone) or beta blockers (for example
metoprolol) is not recommended.
Pregnancy, breast-feeding and fertility
- You must tell your doctor if you think that you are (or might
become) pregnant. Your doctor will normally advise you to stop taking
Diovan before you become pregnant or as soon as you know you are
pregnant, and will advise you to take another medicine instead of Diovan.
Diovan 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 breastfeeding. Diovan is 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.
- Patients who are concerned about their fertility while taking Diovan are
advised to consult with their doctor.
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 Diovan
affects you. Like many other medicines used to treat high blood pressure,
Diovan may in rare cases cause dizziness and affect the ability to
concentrate.

3. HOW TO TAKE DIOVAN
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.
Children and adolescents (6 to 18 years of age) with high blood
pressure
In patients who weigh less than 35 kg the recommended dose is 40 mg of
valsartan once daily.
In patients who weigh 35 kg or more the recommended 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.
Diovan 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 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.
Diovan can be given together with other treatment for heart failure, and your
doctor will decide which treatment is suitable for you.
You can take Diovan with or without food. Swallow Diovan with a glass of
water.
Take Diovan at about the same time each day.
If you take more Diovan 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 Diovan
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 Diovan
Stopping your treatment with Diovan 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 medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Some side effects can be serious and 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 Diovan and contact your
doctor straight away (see also section 2 “Warnings and precautions”).
Other side effects include:
Common (may affect up to 1 in 10 people):
- dizziness
- low blood pressure with or without symptoms such as dizziness and
fainting when standing up
- decreased kidney function (signs of renal impairment)
Uncommon (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 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 (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 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 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. HOW TO STORE DIOVAN
- Do not store above 30°C. Store in the original package. Protect from
moisture.
- Keep out of the sight and reach of children.
- Do not use Diovan after the expiry date, which is stated on the pack. The
expiry date refers to the last day of that month.
- Do not use Diovan if you notice that the pack is damaged or shows signs
of tampering.
- If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- 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.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Diovan contains
Each film-coated tablet contains 40mg valsartan.
They also contain the following inactive ingredients: microcrystalline
cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate,
hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide
(E172), yellow iron oxide (E172) and black iron oxide (E172).
What Diovan looks like and contents of the pack
Diovan are yellow, ovaloid, film-coated tablet with bevelled edges, slightly
convex, scored on one side, with debossing “D” on one side of the score
and “O” on the other side of the score and “NVR” on the reverse side of the
tablet.
Supplied in calendar blister packs containing 14 and 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Novartis Farma S.p.A., Via Provinciale Schito 131, 80058
Torre Annunziata (NA) , Italy and procured from the EU by Product Licence
holder Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repacked by Servipharm Ltd.
POM

PL 30900/1959

Leaflet revision and issue date: 16.06.16[7]
Diovan is a trademark of Novartis AG.

1959
14.06.16[7]

Valsartan 40 mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
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. See section 4.
Your medicine is available using any one of the above names but will be
referred to as Valsartan throughout this leaflet.
Other strengths are also available.
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 contains the active substance: valsartan and belongs to a class of
medicines known as angiotensin II receptor antagonist, 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 blood pressure is lowered.
Valsartan 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 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 other medications 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 (hypersensitive) 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 in early pregnancy - see pregnancy section).
- if you have diabetes or impaired kidney function and you are treated with
a blood pressure lowering medicine containing aliskiren
If any of the above apply to you, tell to your doctor do not take
Valsartan.
Warnings and precautions:
Talk to your doctor
- 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 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 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 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 is not recommended.
- if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting,
or high doses of water tablets (diuretics).
- if you are taking any of the following medicines used to treat high blood
pressure:
- an ACE inhibitors (for example enalapril, lisinopril, Ramipril), in
particular if you have diabetes-related kidney problems.
- aliskiren
- if you are being treated with an ACE inhibitor together with 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”
You must tell your doctor if you think you are (or might become) pregnant.
Valsartan 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).
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 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 non-prescription medicines, especially:
- other medicines that lower blood pressure, especially water tablets
(diuretics). ACE inhibitors (such as enalapril, lisinopril, etc) or aliskiren
(see also information under the headings “Do not take Valsartan” and
“Warnings and precautions”).
- 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).
- 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.
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 other medicines to treat your heart failure which are
known as mineralocorticoid receptor antagonists (MRA) (for
example spironolactone, epleronone) or beta blockers (for example
metoprolol) is not recommended.
Pregnancy, breast-feeding and fertility.
- 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.
- Tell your doctor if you are breast-feeding or about to start breastfeeding. Valsartan is 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.
- Patients who are concerned about their fertility while taking Valsartan are
advised to consult with their doctor.
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 in rare cases cause dizziness and affect the ability to
concentrate.

3. HOW TO TAKE VALSARTAN
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.
Children and adolescents (6 to 18 years of age) with high blood
pressure
In patients who weigh less than 35 kg the recommended dose is 40 mg of
valsartan once daily.
In patients who weigh 35 kg or more the recommended 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 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 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, and
your doctor will decide which treatment is suitable for you.
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, 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
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 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 medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Some side effects can be serious and 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”).
Other side effects include:
Common (may affect up to 1 in 10 people):
- dizziness
- low blood pressure with or without symptoms such as dizziness and
fainting when standing up
- decreased kidney function (signs of renal impairment)
Uncommon (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 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 (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 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 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. HOW TO STORE VALSARTAN
- Do not store above 30°C. Store in the original package. Protect from
moisture.
- Keep out of the sight and reach 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.
- If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Valsartan contains
Each film-coated tablet contains 40mg valsartan.
They also contain the following inactive ingredients: microcrystalline
cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate,
hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide
(E172), yellow iron oxide (E172) and black iron oxide (E172).
What Valsartan looks like and contents of the pack
Valsartan are yellow, ovaloid, film-coated tablet with bevelled edges, slightly
convex, scored on one side, with debossing “D” on one side of the score
and “O” on the other side of the score and “NVR” on the reverse side of the
tablet.
Supplied in calendar blister packs containing 14 and 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Novartis Farma S.p.A., Via Provinciale Schito 131, 80058
Torre Annunziata (NA) , Italy and procured from the EU by Product Licence
holder Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repacked by Servipharm Ltd.
POM

PL 30900/1959

Leaflet revision and issue date: 16.06.16[7]

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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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