Valpression

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valpression 80 mg capsules, 160 mg capsules

valsartan
Please read this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms seem identical to yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT VALPRESSION IS AND WHAT IT IS USED FOR

Valpression 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. Valpression works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valpression 80 mg hard capsules can be used to treat three different conditions:

• in 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, it can damage blood vessels in the brain, heart, and kidneys, leading 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.
• in the treatment of people who have recently had a heart attack (myocardial infarction). “Recently” means within 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adult patients. Valpression 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 retention. 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.

Valpression 160 mg hard capsules can be used to treat three different conditions:

• in 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, it can damage blood vessels in the brain, heart, and kidneys, leading 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.
• in the treatment of people who have recently had a heart attack (myocardial infarction). “Recently” means within 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adult patients. Valpression 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 accumulation. 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. WHAT YOU SHOULD KNOW BEFORE TAKING VALPRESSION

Do not take Valpression

• if you are allergic (hypersensitive) to valsartan or to any of the excipients in Valpression listed at the end of this leaflet
• if you have severe liver disease
• if you are more than three months pregnant (it is better to avoid taking Valpression even in the early stages of pregnancy – see the Pregnancy section)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If any of these conditions apply to you, do not take Valpression.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valpression
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 when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valpression, stop taking Valpression immediately and never take it again. See 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 medicines, and heparin. Regular monitoring of your blood potassium levels may be necessary;
if you are under 18 years of age and are taking Valpression in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and blood potassium levels at regular intervals;
if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valpression is not recommended;
if you have fluid loss (dehydration) caused by diarrhoea, vomiting, or high-dose diuretics;
you must inform your doctor if you think you may be pregnant (or planning to become pregnant). Valpression is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see the Pregnancy section);
if you are taking any of the following medicines used to treat high blood pressure:
an “ACE inhibitor” (for example 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) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).
Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take Valpression”.
If any of these conditions apply to you, inform your doctor before taking Valpression.
Other medicines and Valpression
Tell 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 Valpression is taken with certain other medicines. Your doctor may need to adjust the dose and/or take additional precautions if you are taking:

• an ACE inhibitor or aliskiren (see also the sections: “Do not take Valpression” and “Warnings and precautions”)
• an ACE inhibitor and other medicines used to treat heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol)
• medicines that increase potassium levels in the blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparine
• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs)
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valpression.
• lithium, a medicine used to treat certain psychiatric conditions.

In addition:
if you are being treated after a heart attack, concomitant use with ACE inhibitors (medicines for treating heart attack) is not recommended.
Taking Valpression with food and drink
Valpression may 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 you are planning to become pregnant). Your doctor will normally advise you to stop taking Valpression before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valpression. Valpression is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valpression is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
  Driving and using machines
  Before driving, operating tools or machinery, or performing other activities requiring concentration, you should be aware of how you react to Valpression. Like many other medicines used to treat high blood pressure, Valpression may rarely cause dizziness and affect your ability to concentrate.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE VALPRESSION

Always take Valpression 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 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 high blood pressure: The usual dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg) or combine it 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 of valsartan once daily.
In patients weighing 35 kg or more, the usual dose is 80 mg of valsartan 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 beginning with a low dose of 20 mg twice daily. The 20 mg dose is obtained by splitting 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.
Valpression may be given together with other treatments for heart attack, and your doctor will decide which treatment is most 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 individually tolerate.
Valpression may be given together with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

The 40 mg and 320 mg strengths of Valpression are available in film-coated tablet formulation

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

If you take more Valpression than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately. If you have accidentally taken too many capsules, contact your doctor, pharmacist, or hospital.

If you forget to take Valpression
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 the forgotten dose.

If you stop taking Valpression
Stopping treatment with Valpression may cause your condition to worsen. Do not discontinue use of 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 ADVERSE REACTIONS

Like all medicines, Valpression can cause adverse reactions, although not everyone experiences them.
These adverse reactions may occur with certain frequencies, defined as follows:

• very common: affects more than 1 in 10 people
• common: affects 1 to 10 in 100 people
• uncommon: affects 1 to 10 in 1,000 people
• rare: affects 1 to 10 in 10,000 people
• very rare: affects less than 1 in 10,000 people
• not known: frequency cannot be estimated from the available data.

Some symptoms require immediate medical attention:
You may experience symptoms of angioedema (a specific type of allergic reaction), such as:

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

If you experience any of these symptoms, stop taking Valpression and contact your doctor
immediately (see also section 2 “Take special care with Valpression”).

Adverse reactions include:
Common adverse reactions:

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

Uncommon adverse reactions:

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (vertigo)
• severely reduced kidney function (sign of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of high potassium levels in the blood)
• 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

Frequency not known

• formation of blisters on the skin (sign of bullous dermatitis)
• allergic reactions with skin rashes, itching, or hives, feverish symptoms, swollen joints and 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)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
• decreased hemoglobin levels and decreased percentage of red blood cells in the blood (which may lead to anemia in severe cases)
• increased potassium levels in the blood (which may cause muscle cramps and heart rhythm abnormalities in severe cases)
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases)
• increased blood urea nitrogen (BUN) and increased serum creatinine levels (which may indicate kidney dysfunction)
• low sodium levels in the blood (which may cause fatigue, mental confusion, muscle twitching and/or seizures in severe cases)

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE VALPRESSION

• Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
• Keep out of the reach and sight of children.
• Do not use Valpression after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Do not use Valpression if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Valpression contains

• The active substance is valsartan.
• Each hard capsule contains 80 mg or 160 mg of valsartan.
• The excipients are: microcrystalline cellulose, povidone, sodium lauryl sulfate, crospovidone type A, magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172).

Description of the appearance of Valpression and packaging contents
Valpression 80 mg hard capsules are opaque pink and light grey opaque capsules, with the letters “CG FZF” printed on one side or without any marking.
Valpression 160 mg hard capsules are opaque pink and dark grey opaque capsules, with the letters “CG GOG” printed on one side or without any marking.
The capsules are available in blisters of 28 capsules.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 - Florence
Responsible manufacturer for batch release
DELPHARM L'Aigle
Zone industrielle N°1, Route de Crulai
61300 L'Aigle
France
SPECIAL PRODUCT’S LINE S.P.A.
Via Fratta Rotonda Vado Largo, 1,
03012 Anagni (FR)
Italy
For further information on this medicinal product, please contact the Marketing Authorization Holder.
This Patient Information Leaflet was last approved on
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Valpression 40 mg film-coated tablets, 320 mg film-coated tablets

valsartan
Please read this leaflet carefully before taking this medicine.

• 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT VALPRESSION IS AND WHAT IT IS USED FOR

Valpression 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. Valpression works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valpression 40 mg film-coated tablets can be used to treat three 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 increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these diseases.

• 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 adult patients. Valpression 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 accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with adequate blood flow.

Valpression 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, it 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.

2. WHAT YOU SHOULD KNOW BEFORE TAKING VALPRESSION

Do not take Valpression

• if you are allergic (hypersensitive) to valsartan or to any of the excipients in Valpression listed at the end of this leaflet.
• if you have severe liver disease.
• if you are more than three months pregnant (it is better to avoid taking Valpression even in the early stages of pregnancy – see section on Pregnancy).
• if you have diabetes, or impaired kidney function, and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

• if you have liver disease;

• if you have severe kidney disease or are on dialysis;

• if you suffer from 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 monitor your kidney function;

• if you have serious heart problems other than heart failure or heart attack;

• if you have previously had swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valpression, stop taking Valpression immediately and never take it again. See 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 medicines, and heparin. Your blood potassium levels may need to be checked regularly;

• if you are under 18 years of age and are taking Valpression in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and blood potassium levels at regular intervals;

• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valpression is not recommended;

• if you have fluid loss (dehydration) caused by diarrhea, vomiting, or high-dose diuretics;

• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Valpression is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe 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 monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under the heading “Do not take Valpression”.
If any of these conditions apply to you, inform your doctor before taking Valpression.

Other medicines and Valpression
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be altered if Valpression is taken with certain other medicines. Your doctor may need to adjust the dose and/or take additional precautions if you are taking:

• an ACE inhibitor or aliskiren (see also information under “Do not take Valpression” and “Warnings and precautions”).
• an ACE inhibitor and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
• medicines that increase potassium levels in the blood, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valpression.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (medicines for treating heart attack) is not recommended.

Taking Valpression with food and drink
Valpression 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 normally advise you to stop taking Valpression before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valpression. Valpression is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valpression is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, you should be aware of how you react to Valpression. Like many other medicines used to treat high blood pressure, Valpression may in rare cases cause dizziness and affect your ability to concentrate.

3. HOW TO TAKE VALPRESSION

Always take Valpression exactly as prescribed 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 experience any symptoms 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 high blood pressure: The usual dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg) or combine it 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 of valsartan once daily.
In patients weighing 35 kg or more, the usual dose is 80 mg of valsartan 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 usually started as soon as possible within 12 hours after the heart attack, generally 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.

Valpression may be given together with other treatments for heart attack, and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: Treatment is usually 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 individually tolerate.

Valpression may be given together with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

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

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

If you forget to take Valpression
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 the forgotten dose.

If you stop taking Valpression
Stopping treatment with Valpression may cause your condition to worsen. Do not stop taking 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 ADVERSE REACTIONS

Like all medicines, Valpression may cause adverse reactions, although not everyone experiences them.
These adverse reactions may occur with certain frequencies, defined as follows:

• very common: affects more than 1 in 10 people
• common: affects 1 to 10 in 100 people
• uncommon: affects 1 to 10 in 1,000 people
• rare: affects 1 to 10 in 10,000 people
• very rare: affects fewer than 1 in 10,000 people
• not known: frequency cannot be estimated from the available data.

Some symptoms require immediate medical attention:
You may experience symptoms of angioedema (a specific type of allergic reaction), such as:

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

If you experience any of these symptoms, stop taking Valpression and contact your doctor
immediately (see also section 2 “Take special care with Valpression”).
The adverse reactions include:
Common adverse reactions:

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

Uncommon adverse reactions:

• angioedema (see the section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (vertigo)
• severely reduced kidney function (sign of acute renal failure)
• muscle cramps, irregular heartbeat (signs of high potassium levels in the blood), 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

Frequency not known

• blistering of the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, hives, fever, swollen joints and 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)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which may lead to anemia in severe cases)
• increased potassium levels in the blood (which may cause muscle cramps and heart rhythm abnormalities in severe cases)
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases)
• increased blood urea nitrogen (azotemia) and increased serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, mental confusion, muscle twitching and/or seizures in severe cases)

The frequency of some adverse reactions may vary depending on your condition. For example, adverse reactions such as dizziness and decreased liver function have been observed less frequently in adult patients treated for high blood pressure compared to adult patients treated for heart failure or after a recent heart attack.
In children and adolescents, adverse reactions are similar to those observed in adults.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE VALPRESSION

• Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
• Keep out of the reach and sight of children.
• Do not use Valpression after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Do not use Valpression if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of 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 PACKAGE AND OTHER INFORMATION

What Valpression contains

• The active substance is valsartan.
• One film-coated tablet contains 40 mg or 320 mg of valsartan.
• The excipients are: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silicon dioxide, magnesium stearate.
• The tablet coating contains hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172, only in 40 mg and 320 mg tablets).

Description of the appearance of Valpression and contents of the pack
Valpression 40 mg film-coated tablets are yellow, ovaloid tablets with a score line on one side. The letters “D/O” are engraved on one side and “NVR” on the opposite side of the tablet, or only the score line on one side with the letters “D” and “O” printed on either side of the score. The tablet may be divided into two equal parts.
Valpression 320 mg film-coated tablets are grey-purple, ovaloid tablets with bevelled edges and a score line on one side. Adjacent to the score line are the letters “DC” on one side and “DC” on the other side of the score, and “NVR” on the opposite side of the tablet, or only the score line on one side with the letters “DC” and “DC” printed on either side of the score. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
The tablets are available in blisters of 7, 14, 28, 30, 56, 90 or 98 tablets, and in calendar blisters of 14, 28, 56, 98 and 280 tablets. Additionally, there are unit-dose divisible blisters containing 56x1, 98x1 or 280x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 - Florence, Italy

Responsible manufacturer for batch release
DELPHARM L'Aigle
Zone industrielle N°1, Route de Crulai
61300 L'Aigle
France

For further information about this medicinal product, please contact the Marketing Authorization Holder.

This patient information leaflet was last approved on