Valsartan PensA

PATIENT INFORMATION

PACKAGE LEAFLET: INFORMATION FOR THE USER

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. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, inform your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Valsartan Pensa is and what it is used for
2. What you need to know 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

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 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. As a result, blood vessels relax and blood pressure decreases.
Valsartan Pensa 40 mg film-coated tablets can be used to treat different conditions:

• for the treatment of high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. By lowering blood pressure to normal levels, the risk of developing these conditions is reduced.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for 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 may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. It occurs when the heart muscle is unable to pump blood strongly enough to supply sufficient blood to all parts 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 have severe liver disease.
• if you are more than 3 months pregnant (use of Valsartan Pensa is also advised to be avoided during early pregnancy – see section on pregnancy).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 disease.
• if you have severe kidney disease or are on dialysis.
• if you have renal artery stenosis (narrowing of the artery to the kidney).
• 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 monitor your kidney function.
• if you have serious heart problems other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan Pensa, stop taking it 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 potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need regular blood tests to monitor your potassium levels.
• if you are under 18 years of age and are using Valsartan Pensa together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines for blood pressure), your doctor may periodically perform blood tests to monitor kidney function and potassium levels.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In such cases, use of Valsartan Pensa is not recommended.
• if you have experienced fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
• you must inform your doctor if you think you may be pregnant (or planning to become pregnant). Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have 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) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol). Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

See also the section "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 treatment may be affected if Valsartan Pensa is taken with certain other medicines. It may be necessary to adjust the dose, take additional 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, particularly diuretics, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Pensa.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

In addition:

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

Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also section: "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) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).
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). Your doctor will usually advise you to stop taking Valsartan Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartan Pensa. Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken after this time.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Pensa is not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing any activity requiring concentration, you should be aware of how you react to Valsartan Pensa. Like many other medicines used to treat high blood pressure, Valsartan Pensa may rarely cause dizziness and affect your ability to concentrate.
Valsartan Pensa contains lactose and sorbitol
If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as directed by your doctor in order to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not experience any symptoms and may 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 (aged 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the usual dose is 40 mg once daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

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

Adult patients with heart failure: Treatment usually starts with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate.
Valsartan Pensa may be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

Valsartan Pensa can be taken with or without food. Swallow the tablet with a glass of water.
Take Valsartan Pensa at approximately the same time each day.

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

If you forget to take Valsartan Pensa
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 missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa may cause your condition to worsen. Do not stop taking this medicine unless instructed by your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everyone experiences them.
Some symptoms require immediate medical attention:
Consult your doctor immediately if you experience symptoms of angioedema (a specific adverse reaction) such as:

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

If you have any of these symptoms, contact a doctor immediately.
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 upon standing
• reduced kidney function (signs of renal dysfunction)

Uncommon (may affect up to 1 in 100 people):

• angioedema (see section “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (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
• diarrhoea
• fatigue
• weakness

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

• allergic reactions such as skin rashes, itching, hives, or symptoms such as fever, joint swelling and pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red skin nodules, fever, itching (signs of inflammation of blood vessels also known as vasculitis)
• increased tendency to bleed or bruise (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)
• decreased haemoglobin levels and reduced percentage of red blood cells in the blood (which in severe cases may lead to anaemia)
• increased potassium levels in the blood (which in severe cases may cause muscle cramps and irregular heartbeat)
• increased liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms and/or seizures in more severe cases)

The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function have been observed less frequently in patients treated for high blood pressure than in 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 experience any side effect, talk to your doctor, pharmacist or nurse. This includes any side effect 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 below 30°C. Keep in the original packaging to protect from moisture.

• Keep out of the sight and reach of children.
• Do not use Valsartan Pensa after the expiry date stated on the pack. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Valsartan Pensa contains

• The active substance 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 maize starch, povidone K-25 (E 1201), sodium stearyl fumarate, sodium lauryl sulfate, crospovidone type A (E 1202). Coating: monohydrate lactose, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

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

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

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 authorized in the EEA Member States under the following names:
Netherlands: Vagrecor 40 mg filmomhulde tablet
Vagrecor 80 mg filmomhulde tablet
Vagrecor 160 mg filmomhulde tablet
Vagrecor 320 mg filmomhulde 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 compresse rivestite con film
Valsartan Pensa 80 mg compresse rivestite con film
Valsartan Pensa 160 mg compresse rivestite con film
Valsartan Pensa 320 mg compresse rivestite con film
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 THE PATIENT

PATIENT LEAFLET: INFORMATION FOR THE USER

Valsartan Pensa 80 mg film-coated tablets

Valsartan
Please 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. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Valsartan Pensa is and what it is used for
2. What you need to know 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

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 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. As a result, blood vessels relax and blood pressure decreases.
Valsartan Pensa 80 mg film-coated tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in adults, children and adolescents aged between 6 and 18 years. When blood pressure is high, the workload on the heart and arteries increases. If left untreated, this can damage the blood vessels in the brain, heart and kidneys, leading to stroke, heart failure and kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adults who have recently had a heart attack (myocardial infarction). “Recently” means within 12 hours to 10 days.
• for 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 may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the required amount of blood.

2. Before taking Valsartan Pensa

Do not take Valsartan Pensa:

• if you are allergic (hypersensitive) to valsartan or to any of the excipients in Valsartan Pensa (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (use of Valsartan Pensa is also advised to be avoided during early pregnancy – see section on pregnancy).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 disease.
• if you have severe kidney disease or are on dialysis.
• if you have renal artery stenosis (narrowing of the artery to the kidney).
• if you have recently had a kidney transplant (received a new kidney).
• if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function.
• if you have serious heart problems other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan Pensa, stop taking it 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 potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need regular blood tests to monitor your potassium levels.
• if you are under 18 years of age and using Valsartan Pensa together with other medicines that inhibit the renin-angiotensin-aldosterone system (blood pressure medicines), your doctor may periodically perform blood tests to monitor kidney function and potassium levels.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Pensa is not recommended.
• if you have fluid loss (dehydration) due to diarrhea, vomiting, or high-dose diuretics.
• you must inform your doctor if you think you may be pregnant (or are planning to become pregnant). Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have 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) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may regularly monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.
See also the information under the heading "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 treatment may be altered if Valsartan Pensa is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, particularly diuretics, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Pensa.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

In addition:

• if you are being treated after a heart attack, concomitant use with ACE inhibitors (medicines for treating heart attack) is not recommended.
• if you are being treated for heart failure, triple combination therapy with ACE inhibitors and beta-blockers (medicines for treating heart failure) is not recommended. Your doctor may consider it necessary to adjust the dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the sections: "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) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).
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). Your doctor will usually advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken after this time.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Pensa is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing any activity requiring concentration, you should be aware of how you react to Valsartan Pensa. Like many other medicines used to treat high blood pressure, Valsartan Pensa may rarely cause dizziness and affect your ability to concentrate.
Valsartan Pensa contains lactose and sorbitol
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as directed by your doctor to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms and may feel just 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 once daily. 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 (aged 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the usual dose is 40 mg once daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg once daily. 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: Treatment is generally started as soon as possible within 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. This 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you can individually tolerate.
Valsartan Pensa may be given together with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure: Treatment is generally started with 40 mg twice daily. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you can individually tolerate.
Valsartan Pensa may be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You may take Valsartan Pensa with or without food. Swallow the tablet with a glass of water.
Take Valsartan Pensa at approximately the same time each day.

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

If you forget to take Valsartan Pensa
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 missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa may cause your condition to worsen. Do not discontinue use of this medicine unless instructed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everyone experiences them.
Some symptoms require immediate medical attention:
Consult your doctor immediately if you experience symptoms of angioedema (a specific adverse reaction), such as:

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

If you experience any of these symptoms, contact a doctor immediately.
Other side effects include:
Common ( occurring in up to 1 in 10 patients):

• dizziness
• low blood pressure, with or without symptoms such as dizziness and fainting upon standing
• reduced kidney function (signs of renal dysfunction)

Uncommon ( occurring in up to 1 in 100 patients):

• angioedema (see section "Symptoms requiring immediate medical attention")
• sudden loss of consciousness (syncope)
• sensation 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 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 reactions such as skin rashes, itching, hives, or 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 blood vessels known as vasculitis)
• increased tendency to bleed or bruise easily (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)
• decreased haemoglobin levels and reduced percentage of red blood cells in the blood (which in severe cases may lead to anaemia)
• increased potassium levels in the blood (which in severe cases may cause muscle cramps and heart rhythm abnormalities)
• increased liver function test values (indicating possible liver damage), including increased bilirubin in the blood (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms and/or seizures in more severe cases)

The frequency of some of these side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function have been observed less frequently in patients treated for high blood pressure than in 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 experience any side effect, talk to your doctor, pharmacist or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly via 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 below 30°C. Keep in the original packaging to protect from moisture.

• Keep out of the sight and reach of children.
• Do not use Valsartan Pensa after the expiry date 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 substance is valsartan. Valsartan Pensa 80 mg: each film-coated tablet contains 80 mg of valsartan.
• The other components 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 stearyl fumarate, 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 the appearance of Valsartan Pensa and contents of the pack
Valsartan Pensa 80 mg: pink, cylindrical, film-coated tablets, coated and marked on one side.
Pack sizes: 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

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

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 authorized in the EEA Member States under the following names:
Netherlands: Vagrecor 40 mg filmomhulde tablet
Vagrecor 80 mg filmomhulde tablet
Vagrecor 160 mg filmomhulde tablet
Vagrecor 320 mg filmomhulde 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 compresse rivestite con film
Valsartan Pensa 80 mg compresse rivestite con film
Valsartan Pensa 160 mg compresse rivestite con film
Valsartan Pensa 320 mg compresse rivestite con film

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 THE PATIENT

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan Pensa 160 mg film-coated tablets

Valsartan
Please 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. It could be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, inform your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

13. What Valsartan Pensa is and what it is used for
14. What you need to know before taking 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 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. As a result, blood vessels relax and blood pressure decreases.
Valsartan Pensa 160 mg film-coated tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in adults, children and adolescents aged between 6 and 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage blood vessels in the brain, heart and kidneys, and may lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for 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 may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with adequate blood flow.

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 have severe liver disease.
• if you are more than 3 months pregnant (use of Valsartan Pensa is not recommended even in early pregnancy – see section on pregnancy).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 disease.
• if you have severe kidney disease or are on dialysis.
• if you have renal artery stenosis (narrowing of the artery to the kidney).
• 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 monitor your kidney function.
• if you have serious heart problems other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan Pensa, stop taking it 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 potassium-containing salt substitutes, potassium-sparing drugs, and heparin. Regular monitoring of your blood potassium levels may be necessary.
• if you are under 18 years of age and are using Valsartan Pensa together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines for blood pressure), your doctor may periodically perform blood tests to monitor kidney function and potassium levels.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Pensa is not recommended.
• if you have had fluid loss (dehydration) caused by diarrhea, vomiting, or high-dose diuretics.
• you must inform your doctor if you think you may be pregnant (or plan to become pregnant). Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially if you have 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) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol). Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

See also the section "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 treatment may be affected if Valsartan Pensa is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, particularly diuretics, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren.
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Pensa.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

In addition:

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

Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: "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) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).
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 plan to become pregnant). Your doctor will usually advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken after the third month.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Pensa is not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing other activities requiring concentration, you should know how you react to Valsartan Pensa. Like many other medicines used to treat high blood pressure, Valsartan Pensa may rarely cause dizziness and affect your ability to concentrate.
Valsartan Pensa contains lactose and sorbitol
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as directed by your doctor to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any signs of this condition 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 once daily. 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 (aged 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the usual dose is 40 mg once daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

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

Adult patients with heart failure: Treatment usually starts with 40 mg twice daily. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate.
Valsartan Pensa may be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You may take Valsartan Pensa with or without food. Swallow the tablet with a glass of water.
Take Valsartan Pensa at approximately the same time each day.

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

If you forget to take Valsartan Pensa
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 missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa may cause your condition to worsen. Do not stop using this medicine unless instructed by your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

If you have any of these symptoms, contact a doctor immediately.

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 upon standing
• reduced kidney function (signs of renal dysfunction)

Uncommon (may affect up to 1 in 100 people):

• angioedema (see section “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (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 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 reactions such as skin rashes, itching, hives, or symptoms such as fever, joint pain and swollen joints, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red skin papules, fever, itching (signs of inflammation of blood vessels also known as vasculitis)
• more frequent bleeding or bruising than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)
• decreased haemoglobin levels and decreased percentage of red blood cells in the blood (which in severe cases may lead to anaemia)
• increased potassium levels in the blood (which in severe cases may cause muscle cramps and irregular heartbeat)
• increased liver function test values (which may indicate liver damage), including increased bilirubin in the blood (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms and/or seizures in more severe cases)

The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function have been observed less frequently in patients treated for high blood pressure than in 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 experience any side effect, talk to your doctor, pharmacist or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly via 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 not exceeding 30°C. Keep in the original packaging to protect from moisture.

• Keep out of the sight and reach of children.
• Do not use Valsartan Pensa after the expiry date 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Valsartan Pensa contains

• The active substance is valsartan. Valsartan Pensa 160 mg: each film-coated tablet contains 160 mg of valsartan.
• The other components 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 stearyl fumarate, 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 contents of the pack
Valsartan Pensa 160 mg: are orange, cylindrical, film-coated tablets marked on one side.
Available in packs of 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

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

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 authorized in the EEA Member States under the following names:
Netherlands: Vagrecor 40 mg filmomhulde tablet
Vagrecor 80 mg filmomhulde tablet
Vagrecor 160 mg filmomhulde tablet
Vagrecor 320 mg filmomhulde 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 THE PATIENT

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Valsartan Pensa 320 mg film-coated tablets

Valsartan
Please 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. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

19. What Valsartan Pensa is and what it is used for
20. What you need to know before taking 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 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. As a result, blood vessels relax and blood pressure decreases.
Valsartan Pensa 320 mg film-coated tablets can be used:

• for the treatment of high blood pressure in adults, and in children and adolescents aged 6 to 18 years. 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, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels 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 to any of the excipients of Valsartan Pensa (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (use of Valsartan Pensa is advised against even in early pregnancy – see section on pregnancy).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 disease.
• if you have severe kidney disease or are on dialysis.
• if you suffer from renal artery stenosis (narrowing of the artery to the kidney).
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated following a heart attack or for heart failure, your doctor may monitor your kidney function.
• if you have serious heart problems other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to 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 it 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 potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need regular blood tests to monitor your potassium levels.
• if you are under 18 years of age and are taking Valsartan Pensa together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines for blood pressure), your doctor may periodically perform blood tests to monitor kidney function and potassium levels.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Pensa is not recommended.
• if you have experienced fluid loss (dehydration) caused by diarrhoea, vomiting, or high-dose diuretics.
• you must inform your doctor if you think you may be pregnant (or are planning a pregnancy). Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have 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) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol). Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "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 Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan Pensa is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, particularly diuretics, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren.
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Pensa.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections: "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) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprololo).
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 are planning a pregnancy). Your doctor will usually advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Valsartan Pensa. Valsartan Pensa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken after this time.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Pensa is not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing other activities requiring concentration, make sure you know how you react to Valsartan Pensa. Like many other medicines used to treat high blood pressure, Valsartan Pensa may rarely cause dizziness and affect your ability to concentrate.
Valsartan Pensa contains lactose and sorbitol
If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. HOW TO TAKE VALSARTAN PENSA

Always take Valsartan Pensa exactly as directed by your doctor in order to achieve the best results and reduce the risk of side effects. If you have any doubts, you should consult your doctor or pharmacist.
People with high blood pressure often do not notice any signs of this condition and many feel just 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 daily. 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 (aged 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the usual dose is 40 mg daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).
You may take Valsartan Pensa with or without food. Swallow the tablet with a glass of water.
Take Valsartan Pensa at approximately the same time each day.
If you take more Valsartan Pensa than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan Pensa
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 missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Valsartan Pensa
Stopping treatment with Valsartan Pensa may cause your condition to worsen. Do not stop using this medicine unless your doctor tells you to.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everyone experiences them.

• .

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

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

If you experience any of these symptoms, contact a doctor immediately.
Other side effects include:
Common ( occurring in up to 1 in 10 people):

• dizziness,
• low blood pressure, with or without symptoms such as dizziness and fainting upon standing
• reduced kidney function (signs of renal dysfunction)

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

• angioedema (see section “Symptoms requiring medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (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 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 reactions such as skin rashes, itching, hives, or 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 blood vessels also known as vasculitis)
• increased tendency to bleed or bruise (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)
• decreased haemoglobin levels and reduced percentage of red blood cells in the blood (which in severe cases may lead to anaemia)
• increased potassium levels in the blood (which in severe cases may cause muscle cramps and irregular heartbeat)
• increased liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms and/or seizures in more severe cases).

The frequency of some of these side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function have been observed less frequently in patients treated for high blood pressure than in those 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 experience any side effects, talk to your doctor, pharmacist or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly via 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 not exceeding 30°C. Keep in the original packaging to protect from moisture.

• Keep out of the sight and reach of children.
• Do not use Valsartan Pensa after the expiry date stated on the pack. 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 Packaging and Other Information

What Valsartan Pensa Contains

• The active substance is valsartan. Valsartan Pensa 320 mg: each film-coated tablet contains 320 mg of valsartan.
• The other components 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 stearyl fumarate, 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), aluminium lake indigo carmine (E132).

Description of the Appearance of Valsartan Pensa and Contents of the Packaging
Valsartan Pensa 320 mg: orange, cylindrical, film-coated tablets, coated and marked on one side.
Pack sizes: 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be commercialized.

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

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 authorized in the Member States of the EEA under the following names:
Netherlands: Vagrecor 40 mg filmomhulde tablet
Vagrecor 80 mg filmomhulde tablet
Vagrecor 160 mg filmomhulde tablet
Vagrecor 320 mg filmomhulde 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

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