VALSARTAN 40 mg Фильм-Coated Таблетки

Содержание инструкции

1. Valsartan Pensa 40 mg film-coated tablets
   1. What Valsartan Pensa is and what it is used for
   2. Before taking Valsartan Pensa
   3. HOW TO TAKE VALSARTAN PENSA
   4. Possible side effects
   5. HOW TO STORE VALSARTAN PENSA
   6. Package contents and other information
2. Valsartan Pensa 80 mg film-coated tablets
   1. What is Valsartan Pensa and what is it used for
   2. Before taking Valsartan Pensa
   3. HOW TO TAKE VALSARTAN PENSA
   4. Possible side effects
   5. HOW TO STORE VALSARTAN PENSA
   6. Package Contents and Other Information
3. Valsartan Pensa 160 mg film-coated tablets
   1. What Valsartan Pensa is and what it is used for
   2. Before taking Valsartan Pensa
   3. HOW TO TAKE VALSARTAN PENSA
   4. Possible side effects
   5. HOW TO STORE Valsartan Pensa
   6. Package contents and other information
4. Valsartan Pensa 320 mg film-coated tablets
   1. What Valsartan Pensa is and what it is used for
   2. Before taking Valsartan Pensa
   3. HOW TO TAKE VALSARTAN PENSA
   4. Possible side effects
   5. HOW TO STORE Valsartan Pensa
   6. Contents of the pack and other information
5. Valsartan Vir 80 mg film-coated tablets, Vir 160 mg film-coated tablets, VIr 320 mg film-coated tablets

INFORMATION FOR THE PATIENT

Valsartan Pensa 40 mg film-coated tablets

Valsartan

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

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
• If you experience any side effects, inform your doctor or pharmacist. This includes any

Contents of this leaflet:

• 1. What Valsartan Pensa is and what it is used for
• 2. What you need to know before you take Valsartan Pensa
• 3. How to take Valsartan Pensa
• 4. Possible side effects
• 5. How to store Valsartan Pensa
• 6. Contents of the pack and other information

1. What Valsartan Pensa is and what it is used for

Valsartan Pensa belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan Pensa works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
Valsartan Pensa 40 mg film-coated tablets can be used to treat different conditions:

• in the treatment of high blood pressure in children and adolescents between 6 and 18 years of age.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the blood vessels in the brain, heart and kidneys and can lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. By lowering blood pressure to normal values, the risk of developing these diseases is reduced.
• in the treatment of adults who have recently had a heart attack(myocardial infarction).“Recently” means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adults.Valsartan Pensa is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used or can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid buildup. It is caused when the heart muscle fails to pump blood forcefully enough to provide all the blood needed to every part of the body.

2. Before taking Valsartan Pensa

Do not take Valsartan Pensa:

• if you are allergic(hypersensitive) to valsartan or to any of the excipients of Valsartan Pensa (listed in section 6).
• if you suffer from a severe liver disease.
• if you are pregnant for more than 3 months(it is advisable to avoid the use of Valsartan Pensa even in the early stages of pregnancy - see the section on pregnancy).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, called aliskiren.

If any of these conditions apply to you, do not take Valsartan Pensa
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Pensa:

• if you have liver diseases.
• if you have severe kidney diseases or if you are undergoing dialysis .
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated after a heart attack or for heart failure, the doctor may check your kidney function.
• if you have serious heart problems that are not heart failure or a heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while you are taking Valsartan Pensa, stop taking Valsartan Pensa immediately and do not take it again. See also section 4 "Possible side effects".
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium or potassium-sparing drugs and heparin. It may be necessary to check your blood potassium level at regular intervals.
• if you are less than 18 years old and use Valsartan Pensa together with other medicines that inhibit the renin angiotensin aldosterone system (medicines for blood pressure) the doctor may periodically have blood tests to check your kidney function and potassium levels.
• if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this is the case, the use of Valsartan Pensa is not recommended.
• if you have experienced a loss of fluids (dehydration) caused by diarrhea, vomiting, or high doses of diuretics.
• you must inform the doctor if you think you may be pregnant (or planning to become pregnant). Valsartan Pensa is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken during that period (see the section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol). The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is reported under "Do not take Valsartan Pensa”.

If any of these conditions apply to you, inform your doctor before taking Valsartan
Pensa.
Other medicines and Valsartan Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
The effect of the treatment may be affected if Valsartan Pensa is taken with some other medicines. It may
be necessary to change the dosage, take other precautions, or, in some cases, stop taking
one of the medicines. This applies to both prescription and over-the-counter medicines, and especially:

• other medicines that lower blood pressure, especially diuretics, ACE inhibitors(such as enalapril, lisinopril, etc.,) or aliskiren.
• medicines that increase potassium levelsin the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs and heparin.
• some types of pain relieverscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medicine used in transplant rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines can increase the effect of Valsartan Pensa.
• lithium, a medicine used to treat some types of mental illness.

In addition:

• if you are being treated after a heart attack, the association with ACE inhibitors(medicines for the treatment of a heart attack) is not recommended.
• if you are being treated for heart failure, the triple combination with ACE inhibitors and beta-blockers(medicines for the treatment of heart failure) is not recommended.

The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not take
Valsartan Pensa" and "Warnings and precautions”).
If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone,
eplerenone) or beta-blockers (for example metoprolol).

Taking Valsartan Pensa with food and drink
Valsartan Pensa can be taken with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

• You must inform the doctor if you think you may be pregnant (or if there is a possibility of becomingpregnant). As a rule, the doctor will advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valsartan Pensa. Valsartan Pensa is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or planning to start breastfeeding.Valsartan Pensa is not recommended during breastfeeding and the doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Before driving a vehicle, using machines or performing other activities that require concentration, it is
advisable that you know your reaction to Valsartan Pensa. Like many other medicines used in the treatment
of high blood pressure, Valsartan Pensa can rarely cause dizziness and affect your ability to
concentrate.

Valsartan Pensa contains lactose and sorbitol
If your doctor has told you that you have intolerance to some sugars, consult him before taking
this medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as your doctor has instructed to obtain the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
Those who suffer from high blood pressure often do not notice any signs of this problem and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

Children and adolescents (6 to 18 years) with high blood pressure:in patients weighing less than 35
kg, the usual dose is 40 mg per day. In patients weighing 35 kg or more, the usual starting dose is 80
mg per day. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160
mg and a maximum of 320 mg)

In adult patients after a recent heart attack:After a heart attack, treatment is generally started as soon as possible after 12 hours, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose
over a few weeks up to a maximum of 160 mg twice a day. The final dose depends on the
dose you tolerate individually.
Valsartan Pensa can be administered together with other treatments for heart attack and the doctor will decide
which treatment is suitable for you.

Adult patients with heart failure:treatment generally starts with 40 mg twice a day. The doctor will gradually increase the dose over a few weeks up to a maximum of 160
mg twice a day. The final dose depends on the dose you tolerate individually.
Valsartan Pensa can be administered together with other treatments for heart failure and the
doctor will decide which treatment is suitable for you.
You can take Valsartan Pensa with or without food. The tablet must be swallowed with a glass
of water.
Take Valsartan Pensa at about the same time each day.

If you take more Valsartan Pensa than you should
In case of severe dizziness and/or fainting, it is good to 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 Pensa
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next tablet,
skip the missed dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa may cause your condition to worsen. Do not
stop using the medicine unless you have been told to do so by your doctor.
If you have any doubts about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everybody gets them.
manifest.

Some symptoms require immediate medical attention:
Consult your doctor immediately if you have symptoms of angioedema (a specific adverse reaction) such as

• swelling of the face, lips, tongue or throat
• difficulty breathing and swallowing
• urticaria and itching

If you have any of these symptoms, contact a doctor immediately.
Other side effectsinclude:
Common (occur in up to 1 in 10 people):

• dizziness,
• Low blood pressure associated with or without symptoms such as dizziness and fainting when getting up
• reduced kidney function (signs of kidney dysfunction)

Uncommon(occur in up to 1 in 100 people) :

• angioedema (see section “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (vertigo)
• severely reduced kidney function (signs of acute renal failure)
• muscle cramps, irregular heartbeat (signs of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

Not known(frequency cannot be estimated based on available data):

• allergic reaction such as skin rashes, itching, urticaria, symptoms such as fever, swelling and pain in the joints, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of the blood vessels also called vasculitis)
• bleeding or bruising more easily than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decrease in hemoglobin levels and decrease in the percentage of red blood cells in the blood (which in severe cases can lead to anemia)
• increased levels of potassium in the blood (which in severe cases can cause muscle cramps and heart rhythm abnormalities)
• increased liver function values (which may indicate liver damage) including increased bilirubin in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased levels of azotemia and serum creatinine (which may indicate an abnormality of kidney function)
• low level of sodium in the blood (which can cause fatigue, confusion, spasms and/or muscle convulsions in the most severe cases).

The frequency of some of the side effects may vary depending on your condition. For example
effects such as dizziness and decreased kidney function values have been observed less
frequently in patients treated for high blood pressure compared to patients treated for heart failure or
after a recent heart attack.
Adverse reactions in children and adolescents are similar to those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through your national pharmacovigilance system. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE VALSARTAN PENSA

Store at a temperature below 30ºC. Store in the original packaging to protect it
from moisture.

• Keep out of sight and reach of children.
• Do not use Valsartan Pensa after the expiry date which is reported on the packaging. The expiry date refers to the last day of the month.
• Do not use Valsartan Pensa if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan Pensa contains

• The active ingredient is valsartan. Valsartan Pensa 40 mg,each film-coated tablet contains 40 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized corn starch, povidone K-25 (E 1201), sodium stearylfumarate, sodium lauryl sulfate, crospovidone type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

Description of the appearance of Valsartan Pensa and package contents
Valsartan pensa 40 mg:are yellow, cylindrical, film-coated tablets, marked on one side.
Pack sizes of 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano

Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
and
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), SPAIN

This medicinal product is authorised in the Member States of the EEC with the following names:
Netherlands:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet
Germany:Valsartan Heumann 40 mg Filmtabletten
Valsartan Heumann 80 mg Filmtabletten
Valsartan Heumann 160 mg Filmtabletten
Valsartan Heumann 320 mg Filmtabletten
France:Vagrecor 40 mg coated tablet
Vagrecor 80 mg coated tablet
Vagrecor 160 mg coated tablet
Vagrecor 320 mg coated tablet
Italy:Valsartan Pensa 40 mg film-coated tablets
Valsartan Pensa 80 mg film-coated tablets
Valsartan Pensa 160 mg film-coated tablets
Valsartan Pensa 320 mg film-coated tablets
Spain:Valsartan Vir 40 mg film-coated tablets
Valsartan Vir 80 mg film-coated tablets
Valsartan Vir 160 mg film-coated tablets
Valsartan Vir 320 mg film-coated tablets
Portugal: Vagrecor
Vagrecor
Vagrecor
Vagrecor
United Kingdom:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

INFORMATION FOR THE PATIENT

Valsartan Pensa 80 mg film-coated tablets

Valsartan

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never pass it on to others. Even if they have the same symptoms as you, this medicine may be dangerous for others.
• If you get any side effects, talk to your doctor or pharmacist. This includes any .

Contents of this leaflet:

• 7. What Valsartan Pensa is and what it is used for
• 8. What you need to know before you take Valsartan Pensa
• 9. How to take Valsartan Pensa
• 10. Possible side effects
• 11. How to store Valsartan Pensa
• 12. Contents of the pack and other information

1. What is Valsartan Pensa and what is it used for

Valsartan Pensa 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 blood vessels to narrow, thereby increasing pressure. Valsartan Pensa works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
Valsartan Pensa 80 mg film-coated tablets can be used to treat three different conditions:

• in the treatment of high blood pressure in adults, children and adolescents between the ages of 6 and 18.When blood pressure is high, the workload on the heart and arteries increases. If left untreated, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke, heart failure and kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these conditions.
• in the treatment of adults who have recently had a heart attack(myocardial infarction) .“Recently” means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adults.Valsartan Pensa is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used or can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. The symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It is caused when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body.

2. Before taking Valsartan Pensa

Do not take Valsartan Pensa:

• if you are allergic(hypersensitive) to valsartan or to any of the excipients of Valsartan Pensa (listed in section 6).
• if you suffer from a severe liver disease.
• if you are pregnant for more than 3 months(it is advisable to avoid the use of Valsartan Pensa even in the early stages of pregnancy - see the section on pregnancy).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, called aliskiren.

If any of these conditions apply to you, do not take Valsartan Pensa
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Pensa:

• if you have liver diseases.
• if you have severe kidney diseases or if you are undergoing dialysis .
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated after a heart attack or for heart failure, your doctor may check your kidney function.
• if you have serious heart problems that are not heart failure or a heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Valsartan Pensa, stop taking Valsartan Pensa immediately and do not take it again. See also section 4, "Possible side effects".
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium or potassium-sparing drugs and heparin. It may be necessary to check your blood potassium level at regular intervals.
• if you are less than 18 years old and use Valsartan Pensa together with other medicines that inhibit the renin angiotensin aldosterone system (medicines for blood pressure) the doctor may periodically have blood tests done to check your kidney function and potassium.
• if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this is the case, the use of Valsartan Pensa is not recommended.
• if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting or high doses of diuretics.
• you must inform the doctor if you think you may be pregnant (or planning to become pregnant). Valsartan Pensa is not recommended in early pregnancy and must not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken during that period (see the section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also what is reported under "Do not take Valsartan Pensa”.

If any of these conditions apply to you, tell your doctor before taking Valsartan
Pensa.
Other medicines and Valsartan Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The effect of the treatment may be affected if Valsartan Pensa is taken with some other medicines. It may
be necessary to change the dosage, take other precautions or, in some cases, stop taking
one of the medicines. This applies to both prescription and over-the-counter
medicines, and especially:

• other medicines that lower blood pressure, especially diuretics, ACE inhibitors(such as enalapril, lisinopril, etc.,) or aliskiren.
• medicines that increase potassium levelsin the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs and heparin.
• some types of pain relieverscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medicine used in transplant rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines can increase the effect of Valsartan Pensa
• lithium, a medicine used to treat some types of mental illness.

In addition:

• if you are being treated after a heart attack, the association with ACE inhibitors(medicines for the treatment of a heart attack) is not recommended.
• if you are being treated for heart failure, the triple association with ACE inhibitors and beta-blockers(medicines for the treatment of heart failure) is not recommended. The doctor may need to adjust the dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also what is reported under "Do not take
Valsartan Pensa" and "Warnings and precautions”).
If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone,
eplerenone) or beta-blockers (for example metoprolol).

Taking Valsartan Pensa with food and drink
Valsartan Pensa can be taken with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valsartan Pensa. Valsartan Pensa is not recommended in early pregnancy and must not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Tell your doctor if you are breastfeeding or planning to start breastfeeding.Valsartan Pensa is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newly born or premature.

Driving and using machines
Before driving a vehicle, using machines or performing other activities that require concentration, it is
advisable that you know your reaction to Valsartan Pensa. Like many other medicines used in the treatment
of high blood pressure, Valsartan Pensa can rarely cause dizziness and affect your ability to
concentrate.

Valsartan Pensa contains lactose and sorbitol
If your doctor has told you that you have intolerance to some sugars, consult him before taking this
medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as your doctor has instructed to obtain the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People who suffer from high blood pressure often do not notice any signs of this problem and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your
doctor, even when you feel well.

Adult patients with hypertension:the usual dose is 80 mg per day. In some cases, your doctor may prescribe
higher doses (e.g. 160 mg or 320 mg) or combine Valsartan Pensa with another medicine (e.g. a
diuretic).

Children and adolescents (from 6 to 18 years) with high blood pressure:in patients weighing less than 35
kg, the usual dose is 40 mg per day. In patients weighing 35 kg or more, the usual starting dose is 80
mg per day. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160
mg and a maximum of 320 mg).

Adult patients after a recent heart attack:after a heart attack, treatment is generally started as soon as
possible after 12 hours, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose
over a few weeks up to a maximum of 160 mg twice a day. The final dose depends on the
dose you tolerate individually.
Valsartan Pensa can be given with other treatments for heart attack and your doctor will decide
which treatment is right for you.

Adult patients with heart failure:treatment usually starts with 40 mg twice a day. The doctor will gradually increase this dose over a few weeks up to a maximum of
160 mg twice a day. The final dose depends on the dose you tolerate individually.
Valsartan Pensa can be given with other treatments for heart failure and the
doctor will decide which treatment is right for you.
You can take Valsartan Pensa with or without food. The tablet should be swallowed with a glass
of water.
Take Valsartan Pensa at about the same time each day.

If you take more Valsartan Pensa than you should
In case of severe dizziness and/or fainting, it is good to 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 Pensa
.
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next tablet,
skip the missed dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa can worsen your condition. Do not
stop using the medicine unless your doctor has told you to.
If you have any questions about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everybody gets them.
manifest.

Some symptoms require immediate medical attention:
Consult a doctor immediately if you have symptoms of angioedema (a specific adverse reaction), such as

• swelling of the face, lips, tongue or throat
• difficulty breathing and swallowing
• urticaria and itching

If you have any of these symptoms, contact a doctor immediately.
Other side effectsinclude:
Common (occur in up to 1 in 10 people):

• dizziness,
• Low blood pressure associated with or without symptoms such as dizziness and fainting when getting up
• reduced kidney function (signs of kidney dysfunction)

Uncommon (occur in up to 1 in 100 people ):

• angioedema (see section “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of dizziness (vertigo)
• severely reduced kidney function (signs of acute renal failure)
• muscle cramps, abnormal heart rhythm (signs of hyperkalaemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

Not known(frequency cannot be estimated from available data):

• allergic reaction such as skin rashes, itching, urticaria, symptoms such as fever, swelling, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of the vessels also called vasculitis)
• bleeding or bruising more easily than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decrease in haemoglobin levels and decrease in the percentage of red blood cells in the blood (which in severe cases can lead to anaemia)
• increased levels of potassium in the blood (which in severe cases can cause muscle cramps and heart rhythm abnormalities)
• increased values of liver function (which may indicate liver damage) including increased bilirubin in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased levels of azotaemia and serum creatinine levels (which may indicate an abnormality of kidney function)
• low level of sodium in the blood (which can cause fatigue, confusion, spasms and/or muscle convulsions in the most severe cases).

The frequency of some of the side effects may vary depending on your condition. For example
effects such as dizziness and decreased kidney function values have been observed less
frequently in patients treated for high blood pressure compared to patients treated for heart failure or
after a recent heart attack.
Adverse reactions in children and adolescents are similar to those observed in adults.

.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national pharmacovigilance system. By reporting side
effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE VALSARTAN PENSA

Store at a temperature below 30ºC. Keep in the original packaging to protect it
from humidity.

• Keep out of sight and reach of children.
• Do not use Valsartan Pensa after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
• Do not use Valsartan Pensa if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Valsartan Pensa contains

• The active ingredient is valsartan. Valsartan Pensa 80 mg,each film-coated tablet contains 80 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized corn starch, povidone K-25 (E 1201), sodium stearylfumarate, sodium lauryl sulfate, crospovidone type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, red iron oxide (E 172).

Description of Valsartan Pensa and package contents
Valsartan Pensa 80 mg:are pink, cylindrical, film-coated tablets, coated, marked on one side.
Pack sizes of 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan

Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), SPAIN
and
ZENTIVA k.s.

• U. Kabelovny 130, 102 37, Praha 10 Czech Republic

This medicinal product is authorised in the Member States of the EEC with the following names:
Netherlands:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

Germany:Valsartan Heumann 40 mg Filmtabletten
Valsartan Heumann 80 mg Filmtabletten
Valsartan Heumann 160 mg Filmtabletten
Valsartan Heumann 320 mg Filmtabletten

France:Vagrecor 40 mg comprimé pelliculé
Vagrecor 80 mg comprimé pelliculé
Vagrecor 160 mg comprimé pelliculé
Vagrecor 320 mg comprimé pelliculé

Italy:Valsartan Pensa 40 mg film-coated tablets
Valsartan Pensa 80 mg film-coated tablets
Valsartan Pensa 160 mg film-coated tablets
Valsartan Pensa 320 mg film-coated tablets

Spain:Valsartan Vir 40 mg comprimidos recubiertos con película
Valsartan Vir 80 mg comprimidos recubiertos con película
Valsartan Vir 160 mg comprimidos recubiertos con película
Valsartan Vir 320 mg comprimidos recubiertos con película

Portugal: Vagrecor
Vagrecor
Vagrecor
Vagrecor

United Kingdom:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

This leaflet was last updated on….
INFORMATION FOR PATIENTS

Valsartan Pensa 160 mg film-coated tablets

Valsartan

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. Even if they have the same symptoms as you, this medicine may be dangerous for others.
• If you get any side effects, speak to your doctor or pharmacist. This includes any

Contents of this leaflet:

• 13. What Valsartan Pensa is and what it is used for
• 14. What you need to know before you take Valsartan Pensa
• 15. How to take Valsartan Pensa
• 16. Possible side effects
• 17. How to store Valsartan Pensa
• 18. Contents of the pack and other information

1. What Valsartan Pensa is and what it is used for

Valsartan Pensa 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 blood vessels to narrow, thereby increasing blood pressure. Valsartan Pensa works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
Valsartan Pensa 160 mg film-coated tablets can be used to treat three different conditions:

• in the treatment of high blood pressure in adults, children and adolescents between 6 and 18 years of age.High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these diseases.
• in the treatment of adults who have recently had a heart attack(myocardial infarction).“Recently” means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adults.Valsartan Pensa is used when a group of medicines called angiotensin converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used or can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. It is caused when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body.

2. Before taking Valsartan Pensa

Do not take Valsartan Pensa:

• if you are allergic(hypersensitive) to valsartan or any of the excipients of Valsartan Pensa (listed in section 6).
• if you suffer from a severe liver disease.
• if you are pregnant for more than 3 months(it is advisable to avoid using Valsartan Pensa even in the early stages of pregnancy - see the section relating to pregnancy)
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, called aliskiren.

If any of these conditions apply to you, do not take Valsartan Pensa
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Pensa:

• if you have liver diseases.
• if you have severe kidney diseases or if you are undergoing dialysis .
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated after a heart attack or for heart failure, the doctor may check your kidney function.
• if you have serious heart problems that are not heart failure or a heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valsartan Pensa, stop taking Valsartan Pensa immediately and do not take it again. See also section 4 "Possible side effects".
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium or potassium-sparing drugs and heparin. It may be necessary to check your blood potassium levels regularly.
• if you are less than 18 years old and use Valsartan Pensa together with other medicines that inhibit the renin angiotensin aldosterone system (medicines for blood pressure) the doctor may periodically have your blood tested to check kidney function and potassium.
• if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this is the case, the use of Valsartan Pensa is not recommended.
• if you have experienced a loss of fluids (dehydration) caused by diarrhea, vomiting, or high doses of diuretics.
• you must inform your doctor if you think you are pregnant (or planning to become pregnant). Valsartan Pensa is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken during that period (see the section relating to pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol). The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is reported under "Do not take Valsartan Pensa”.

If any of these conditions apply to you, tell your doctor before taking Valsartan
Pensa.
Other medicines and Valsartan Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
The effect of the treatment may be affected if Valsartan Pensa is taken with some other medicines. It may
be necessary to change the dosage, take other precautions, or, in some cases, stop taking
one of the medicines. This applies to both prescription and over-the-counter medicines,
and especially:

• other medicines that lower blood pressure, especially diuretics, ACE inhibitors(such as enalapril, lisinopril, etc.) or aliskiren. .
• medicines that increase potassium levelsin the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs and heparin.
• some types of pain medicationscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics(of the rifampicin group), a medicine used in transplant rejection (cyclosporine) or an antiretroviral medicine used to treat HIV / AIDS infection (ritonavir). These medicines can increase the effect of Valsartan Pensa.
• lithium, a medicine used to treat some types of mental illness.

In addition:

• if you are being treated after a heart attack, the combination with ACE inhibitors(medicines for the treatment of a heart attack) is not recommended.
• if you are being treated for heart failure, the triple combination with ACE inhibitors and beta-blockers(medicines for the treatment of heart failure) is not recommended.

The doctor may need to adjust the dose and / or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not take
Valsartan Pensa" and "Warnings and precautions”).
If you are being treated with an ACE inhibitor together with other medicines used to treat heart
failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone,
eplerenone) or beta-blockers (for example metoprolol).

Taking Valsartan Pensa with food and drink
Valsartan Pensa can be taken with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

• You must inform your doctor if you think you are pregnant (or planning to become pregnant ). As a rule, your doctor will advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valsartan Pensa. Valsartan Pensa is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Tell your doctor if you are breastfeeding or planning to start breastfeeding.Valsartan Pensa is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery
Before driving a vehicle, using machinery or performing other activities that require concentration, it
is good to know your reaction to Valsartan Pensa. Like many other medicines used to treat
high blood pressure, Valsartan Pensa can rarely cause dizziness and affect the ability to
concentrate.

Valsartan Pensa contains lactose and sorbitol
If your doctor has told you that you are intolerant to any sugars, consult him before taking this
medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as your doctor has instructed to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People who suffer from high blood pressure often do not notice any signs of this problem and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your
doctor, even when you feel well.

Adult patients with hypertension:the usual dose is 80 mg per day. In some cases your doctor may
prescribe higher doses (e.g. 160 mg or 320 mg). The doctor may combine Valsartan Pensa with another
medicine (e.g. a diuretic).

Children and adolescents (from 6 to 18 years) with high blood pressure:in patients weighing less than 35
kg, the usual dose is 40 mg per day. In patients weighing 35 kg or more the usual starting dose is 80
mg per day. In some cases the doctor may prescribe higher doses (the dose may be increased to 160
mg and a maximum of 320 mg)

Adult patients after a recent heart attack:after a heart attack, treatment is generally started as soon as
possible after 12 hours, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose
over several weeks up to a maximum of 160 mg twice a day. The final dose depends on the
dose you tolerate individually.
Valsartan Pensa can be given together with other treatments for heart attack and the doctor will decide
which treatment is suitable for you.

Adult patients with heart failure:treatment generally starts with 40 mg twice a day. The doctor will gradually increase this dose over several weeks up to a maximum of
160 mg twice a day. The final dose depends on the dose you tolerate individually.
Valsartan Pensa can be given together with other treatments for heart failure and the
doctor will decide which treatment is suitable for you.
You can take Valsartan Pensa with or without food. The tablet should be swallowed with a glass
of water.
Take Valsartan Pensa at about the same time each day.

If you take more Valsartan Pensa than you should
In case of severe dizziness and/or fainting, it is good to 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 Pensa
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next tablet,
skip the missed dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa can worsen your condition. Do not
stop using the medicine unless you have been told to do so by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everybody gets them.
manifest.

Some symptoms require immediate medical attention:
Consult your doctor immediately if you have symptoms of angioedema (a specific adverse reaction) such as

• swelling of the face, lips, tongue or throat
• difficulty breathing and swallowing
• urticaria and itching

If you have any of these symptoms, contact a doctor immediately.
Other side effectsinclude:
Common (occur in up to 1 in 10 people):

• dizziness,
• Low blood pressure associated with or without symptoms such as dizziness and fainting when getting up
• reduced kidney function (signs of kidney dysfunction)

Uncommon(occur in up to 1 in 100 people) :

• angioedema (see section “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of dizziness (vertigo)
• severely reduced kidney function (signs of acute renal failure)
• muscle cramps, irregular heartbeat (signs of hyperkalaemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

Not known(frequency cannot be estimated from available data):

• allergic reaction such as skin rashes, itching, urticaria, symptoms such as fever, joint pain and swollen joints, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of the vessels also called vasculitis)
• bleeding or bruising more easily than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decrease in haemoglobin levels and decrease in the percentage of red blood cells in the blood (which in severe cases can lead to anaemia)
• increased levels of potassium in the blood (which in severe cases can cause muscle cramps and irregular heartbeat)
• increased values of liver function (which may indicate liver damage) including increased bilirubin in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased levels of azotaemia and serum creatinine levels (which may indicate an abnormality of kidney function)
• low level of sodium in the blood (which can cause fatigue, confusion, spasms and/or muscle convulsions in the most severe cases).

The frequency of some of the side effects may vary depending on your condition. For example
effects such as dizziness and decreased kidney function values have been observed less
frequently in patients treated for high blood pressure compared to patients treated for heart failure or
after a recent heart attack.
Adverse reactions in children and adolescents are similar to those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through your national pharmacovigilance system. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE Valsartan Pensa

Store at a temperature below 30ºC. Keep in the original packaging to protect it
from humidity.

• Keep out of sight and reach of children.
• Do not use Valsartan Pensa after the expiry date which is reported on the packaging. The expiry date refers to the last day of the month.
• Do not use Valsartan Pensa if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan Pensa contains

• The active ingredient is valsartan. Valsartan Pensa 160 mg, each film-coated tablet contains 160 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized corn starch, povidone K-25 (E 1201), sodium stearylfumarate, sodium lauryl sulfate, crospovidone type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172) and brown iron oxide (E 172).

Description of the appearance of Valsartan Pensa and package contents
Valsartan Pensa 160 mg:are ochre, cylindrical, film-coated tablets, marked on one side.
Pack sizes of 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan

Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), SPAIN
and
ZENTIVA k.s.

• U. Kabelovny 130, 102 37, Praha 10 Czech Republic

This medicinal product is authorised in the Member States of the EEC with the following names:
Netherlands:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

Germany:Valsartan Heumann 40 mg Filmtabletten
Valsartan Heumann 80 mg Filmtabletten
Valsartan Heumann 160 mg Filmtabletten
Valsartan Heumann 320 mg Filmtabletten

France:Vagrecor 40 mg comprimé pelliculé
Vagrecor 80 mg comprimé pelliculé
Vagrecor 160 mg comprimé pelliculé
Vagrecor 320 mg comprimé pelliculé

Italy:Valsartan Pensa 40 mg film-coated tablets
Valsartan Pensa 80 mg film-coated tablets
Valsartan Pensa 160 mg film-coated tablets
Valsartan Pensa 320 mg film-coated tablets

Spain:Valsartan Vir 40 mg comprimidos recubiertos con película
Valsartan Vir 80 mg comprimidos recubiertos con película
Valsartan Vir 160 mg comprimidos recubiertos con película
Valsartan Vir 320 mg comprimidos recubiertos con película

Portugal: Vagrecor
Vagrecor
Vagrecor
Vagrecor

United Kingdom:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

INFORMATION FOR PATIENTS

Valsartan Pensa 320 mg film-coated tablets

Valsartan

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. Even if they have the same symptoms as you, this medicine may be dangerous for others.
• If you get any side effects, talk to your doctor or pharmacist. This includes any

Contents of this leaflet:

• 19. What Valsartan Pensa is and what it is used for
• 20. What you need to know before you take Valsartan Pensa
• 21. How to take Valsartan Pensa
• 22. Possible side effects
• 23. How to store Valsartan Pensa
• 24. Contents of the pack and other information

1. What Valsartan Pensa is and what it is used for

Valsartan Pensa 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 narrowing of the blood vessels, thereby increasing blood pressure. Valsartan Pensa works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
Valsartan Pensa 320 mg film-coated tablets can be used:

• in the treatment of high blood pressure in adults, children and adolescents between 6 and 18 years of age.High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these conditions.

2. Before taking Valsartan Pensa

Do not take Valsartan Pensa:

• if you are allergic(hypersensitive) to valsartan or any of the excipients of Valsartan Pensa (listed in section 6).
• if you suffer from a severe liver disease.
• if you are pregnant for more than 3 months(it is advisable to avoid using Valsartan Pensa even in the early stages of pregnancy - see the section on pregnancy).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, called aliskiren.

If any of these conditions apply to you, do not take Valsartan Pensa
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Pensa:

• if you have liver diseases.
• if you have severe kidney diseases or if you are undergoing dialysis .
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated after a heart attack or for heart failure, your doctor may check your kidney function.
• if you have serious heart problems that are not heart failure or a heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valsartan Pensa, stop taking Valsartan Pensa immediately and do not take it again. See also section 4, "Possible side effects".
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium or potassium-sparing drugs and heparin. It may be necessary to check your blood potassium level at regular intervals.
• if you are under 18 years of age and use Valsartan Pensa together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines for blood pressure) the doctor may periodically have blood tests done to check kidney function and potassium.
• if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this is the case, the use of Valsartan Pensa is not recommended.
• if you have experienced a loss of fluids (dehydration) caused by diarrhea, vomiting or high doses of diuretics.
• you must inform your doctor if you think you may be pregnant (or planning to become pregnant). Valsartan Pensa is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken during that period (see the section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol). The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. o See also what is reported under "Do not take Valsartan Pensa”.

If any of these conditions apply to you, inform your doctor before taking Valsartan Pensa.
Other medicines and Valsartan PensaTell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines.
The effect of the treatment may be affected if Valsartan Pensa is taken with certain other medicines. It may
be necessary to change the dosage, take other precautions or, in some cases, stop taking
one of the medicines. This applies to both prescription and over-the-counter medicines,
especially:

• other medicines that lower blood pressure, especially diuretics, ACE inhibitors(such as enalapril, lisinopril, etc.,) or aliskiren.
• medicines that increase potassium levelsin the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs and heparin.
• some types of pain relieverscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medicine used in transplant rejection (cyclosporine) or an antiretroviral medicine used to treat HIV / AIDS infection (ritonavir). These medicines can increase the effect of Valsartan Pensa.
• lithium, a medicine used to treat some types of mental illness.

The doctor may need to change the dose and / or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not take
Valsartan Pensa" and "Warnings and precautions”).
If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure,
known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone,
eplerenone) or beta-blockers (for example metoprolol).

Taking Valsartan Pensa with food and drink
Valsartan Pensa can be taken with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

• You must inform your doctor if you think you may be pregnant (or planning to become pregnant ). As a rule, your doctor will advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valsartan Pensa. Valsartan Pensa is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or planning to start breastfeeding.Valsartan Pensa is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Before driving a vehicle, using machines or performing other activities that require concentration, it is
advisable to know your reaction to Valsartan Pensa. Like many other medicines used to treat
high blood pressure, Valsartan Pensa can rarely cause dizziness and affect the ability to
concentrate.

Valsartan Pensa contains lactose and sorbitol
If your doctor has told you that you have intolerance to some sugars, consult him before taking this
medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as your doctor has instructed to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People who suffer from high blood pressure often do not notice any signs of this problem and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your
doctor, even when you feel well.

Adult patients with hypertension:the usual dose is 80 mg per day. In some cases, your doctor may prescribe
higher doses (e.g. 160 mg or 320 mg). Your doctor may combine Valsartan Pensa with another medicine (e.g.
a diuretic).

Children and adolescents (from 6 to 18 years) with high blood pressure:in patients weighing less than
35 kg, the usual dose is 40 mg per day. In patients weighing 35 kg or more, the usual starting dose is
80 mg per day. In some cases, your doctor may prescribe you higher doses (the dose may be increased to
160 mg and a maximum of 320 mg).
You can take Valsartan Pensa with or without food. The tablet should be swallowed with a glass
of water.
Take Valsartan Pensa at approximately the same time each day.

If you take more Valsartan Pensa than you should
In case of severe dizziness and/or fainting, it is good to 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 Pensa
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next tablet,
skip the missed dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa may worsen your condition. Do not
stop using the medicine unless your doctor has told you to.
If you have any doubts about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everybody gets them.
manifest.

• .

Some symptoms require immediate medical attention:
Consult a doctor immediately if you have symptoms of angioedema (a specific adverse reaction) such as

• swelling of the face, lips, tongue or throat
• difficulty breathing and swallowing
• urticaria and itching

If you have any of these symptoms, contact a doctor immediately.
Other side effectsinclude:
Common (occur in up to 1 in 10 people):

• dizziness,
• Low blood pressure associated with or without symptoms such as dizziness and fainting when getting up
• reduced kidney function (signs of kidney dysfunction)

Uncommon(occur in up to 1 in 100 people) :

• angioedema (see section “Symptoms requiring medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (vertigo)
• severely reduced kidney function (signs of acute renal failure)
• muscle cramps, irregular heartbeat (signs of hyperkalaemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

Not known(frequency cannot be estimated based on available data):

• allergic reaction such as skin rashes, itching, urticaria, symptoms such as fever, joint pain and swollen joints, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of the vessels also called vasculitis)
• bleeding or bruising more easily than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decrease in haemoglobin levels and decrease in the percentage of red blood cells in the blood (which in severe cases can lead to anaemia)
• increased levels of potassium in the blood (which in severe cases can cause muscle cramps and heart rhythm abnormalities)
• increased values of liver function (which may indicate liver damage) including increased bilirubin in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased levels of azotaemia and serum creatinine levels (which may indicate an abnormality of kidney function)
• low level of sodium in the blood (which can cause fatigue, confusion, spasms and/or muscle convulsions in the most severe cases).

The frequency of some of the side effects may vary depending on your condition. For example
effects such as dizziness and decreased kidney function values have been observed less
frequently in patients treated for high blood pressure compared to patients treated for heart failure or
after a recent heart attack.
Adverse reactions in children and adolescents are similar to those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national pharmacovigilance system. By reporting side
effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE Valsartan Pensa

Store at a temperature below 30ºC. Keep in the original packaging to protect it
from humidity.

• Keep out of sight and reach of children.
• Do not use Valsartan Pensa after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
• Do not use Valsartan Pensa if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan Pensa contains

• The active ingredient is valsartan. Valsartan Pensa 320 mg, each film-coated tablet contains 320 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized corn starch, povidone K-25 (E 1201), sodium stearylfumarate, sodium lauryl sulfate, crospovidone type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, red iron oxide (E 172) and brown iron oxide (E 172), indigo carmine aluminum lake (E132).

Description of the appearance of Valsartan Pensa and contents of the pack
Valsartan Pensa 320 mg:are ochre, cylindrical, film-coated tablets, marked on one side.
Pack sizes of 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan

Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), SPAIN

This medicinal product is authorised in the Member States of the EEC with the following names:
Netherlands:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

Germany:Valsartan Heumann 40 mg Filmtabletten
Valsartan Heumann 80 mg Filmtabletten
Valsartan Heumann 160 mg Filmtabletten
Valsartan Heumann 320 mg Filmtabletten

France:Vagrecor 40 mg comprimé pelliculé
Vagrecor 80 mg comprimé pelliculé
Vagrecor 160 mg comprimé pelliculé
Vagrecor 320 mg comprimé pelliculé

Italy:Valsartan Pensa 40 mg film-coated tablets
Valsartan Pensa 80 mg film-coated tablets
Valsartan Pensa 160 mg film-coated tablets
Valsartan Pensa 320 mg film-coated tablets

Spain:Valsartan Vir 40 mg comprimidos recubiertos con película

Valsartan Vir 80 mg film-coated tablets, Vir 160 mg film-coated tablets, VIr 320 mg film-coated tablets

Portugal: Vagrecor
Vagrecor
Vagrecor
Vagrecor

United Kingdom:Vagrecor 40 mg film-coated tablet
Vagrecor 80 mg film-coated tablet
Vagrecor 160 mg film-coated tablet
Vagrecor 320 mg film-coated tablet

This leaflet was updated on……