VALPRESSION 80 мг Капсулы

Содержание инструкции

1. Valpression 80 mg capsule, 160 mg capsule
   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
2. Valpression 40 mg film-coated tablets
   1. WHAT IS VALPRESSION 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. PACKAGE CONTENTS AND OTHER INFORMATION

Valpression 80 mg capsule, 160 mg capsule

valsartan

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. Never give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell 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 you take 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 to control high blood pressure. Angiotensin II is a substance in the body that causes the blood vessels to narrow, thereby increasing blood pressure. Valpression works by blocking the effect of angiotensin II. The result is that the 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 adolescentsaged between 6 and 18 years.High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal reduces the risk of developing these conditions.
• in the treatment of people who have recently had a heart attack(myocardial infarction). “Recently” means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in 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 can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. The symptoms of heart failure include shortness of breath and swelling of the feet and legs, due to fluid accumulation. It is caused when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body.

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 adolescentsaged between 6 and 18 years.. High blood pressure increases the workload

on the heart and arteries. If left untreated, it can damage the blood vessels of
brain, heart and kidneys and can lead to stroke, heart failure or kidney failure.
High blood pressure increases the risk of heart attack. Bringing blood
pressure back to normal reduces the risk of developing these conditions.

• in the treatment of people who have recently had a heart attack(myocardial infarction). “Recently” means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in 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 can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. The symptoms of heart failure include shortness of breath and swelling of the feet and legs, due to fluid accumulation. It is caused when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VALPRESSION

Do not take Valpression

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of Valpression
• if you have a severe liver disease
• if you are pregnant for more than three months(it is best to avoid taking Valpression even in the early stages of pregnancy - see the pregnancy section).
• if you have diabetes or your kidney function is impaired and you are being treated with aliskiren, a medicine that lowers blood pressure.

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 diseases;
if you have severe kidney diseases or if you are on dialysis;
if you suffer from a narrowing of the renal artery;
if you have recently undergone a kidney transplant (received a new kidney);
if you are being treated after a heart attack or for heart failure, your doctor may
check your kidney function;
if you have serious heart problems that are not heart failure or a heart attack;
if you have previously experienced swelling of the tongue and face caused by an allergic
reaction called angioedema when taking other medicines (including ACE inhibitors), inform your
doctor. If these symptoms occur while taking Valpression, stop taking it 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 salt substitutes containing potassium or potassium-sparing medicines
and heparin. It may be necessary to check your potassium level in the blood at regular intervals;
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
check your kidney function and potassium levels in the blood at regular intervals
if you suffer from aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone.
In this case, the use of Valpression is not recommended;
if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting, or high doses of
diuretics;
you must inform your doctor if you think you may be pregnant (or planning to become
pregnant). Valpression is not recommended in early pregnancy and should not be
taken if you are pregnant for more than three months, as it can cause serious harm to the
baby 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), especially if you suffer from
kidney problems related to diabetes
aliskiren
if you are being treated with an ACE inhibitor together with other medicines used to treat
heart failure, known as mineralocorticoid receptor antagonists (MRA)
(for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).
Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under “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 the treatment may be affected if Valpression is taken with certain other medicines. Your
doctor may need to adjust the dose and/or take other precautions if you are
taking:

• an ACE inhibitor or aliskiren(see also what is stated under: “Do not take Valpression” and “Warnings and precautions”). an ACE inhibitorand other medicines used to treat heart failure known asmineralocorticoid receptor antagonists (MRA)(for example spironolactone, eplerenone) or beta-blockers(for example metoprolol). medicines that increase potassium levelsin the blood such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines and heparin. some types of pain medicationscalled non-steroidal anti-inflammatory drugs (NSAIDs).some antibiotics (rifampicin group), a medicine used against rejection after transplantation (cyclosporine) and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines can increase the effect of Valpression. lithium, a medicine used to treat some types of mental illness.

In addition:
if you are being treated after a heart attack, the combination with ACE
inhibitors (medicines for the treatment of a heart attack) is not recommended.

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). As a rule, your doctor will advise you to stop taking Valpression before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valpression. Valpression is not recommended in early pregnancy and should not be taken if you are pregnant for more than three months as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding, or planning to start breastfeeding. 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 newborn or premature. Driving and operating machineryBefore driving a vehicle, using tools or machinery, or performing other activities that require concentration, you should know how you react to Valpression. Like many other medicines used to treat high blood pressure, Valpression can 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 your doctor has instructed to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
Those who suffer from high blood pressure often do not notice any signs of this problem and many feel 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 a day. 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 between 6 and 18 years) with high blood pressure:
In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once a day.
In patients weighing 35 kg or more, the usual dose is 80 mg of valsartan once a day.
In some cases, the 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 from the heart attack, usually with a low dose of 20 mg twice a day.
The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice a day. The final dose depends on the dose you tolerate individually.
Valpression can be administered together with other treatments for heart attack and the doctor will decide which treatment is most suitable for you.

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

Dosages of 40 mg and 320 mg are available, for Valpression, in film-coated tablet formulation
You can take Valpression with or without food. The capsule should be swallowed with a glass of water.
Take Valpression at about the same time each day.

If you take more Valpression than you should
In case of severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have inadvertently 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 the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Valpression can cause side effects, although not everybody gets them.
These side effects can occur with certain frequencies, defined as follows:

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

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

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

If you experience any of these symptoms, stop taking Valpression and contact your doctor immediately (see also section 2 “Pay particular attention with Valpression”).
Side effects include:
Common side effects:

• dizziness.
• low blood pressure accompanied or not by symptoms such as dizziness and fainting when getting up
• reduced kidney function (sign of kidney impairment)

Uncommon side effects:

• angioedema (see the paragraph “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (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
• diarrhoea
• fatigue
• weakness

Frequency not known

• formation of blisters on the skin (sign of bullous dermatitis)
• allergic reactions with skin rashes, itching or urticaria, symptoms: 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 the blood vessels also known as vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decreased levels of hemoglobin and decreased percentage of red blood cells in the blood (which can lead to anemia in severe cases)
• increased levels of potassium in the blood (which can cause muscle cramps and irregular heartbeat in severe cases)
• increased liver function values (which may be an indication of liver damage) including increased levels of bilirubin in the blood (which can cause a yellowing of the skin and eyes in severe cases)
• increased levels of azotemia and increased serum creatinine levels (which may indicate a kidney function abnormality)
• low levels of sodium in the blood (which can cause fatigue, confusion, muscle contractions and/or seizures in severe cases)

The frequency of some side effects may vary depending on your condition. For example
side effects 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, side effects are similar to those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the safety of
this medicine.

5. HOW TO STORE VALPRESSION

• Do not store at a temperature above 30°C. Store 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 which is reported 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 should 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 PACK AND OTHER INFORMATION

What Valpression contains

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

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 - Florence

Manufacturer responsible 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, contact the marketing authorisation holder.

Valpression 40 mg film-coated tablets

Valpression 320 mg film-coated tablets
valsartan

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell 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 you take 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 IS VALPRESSION AND WHAT IT IS USED FOR

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

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

High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these diseases.

• in the treatment of adult patients who have recently had a heart attack(myocardial infarction). "Recently" means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in 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 can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs, due to fluid accumulation. It is caused when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body.

Valpression 320 mg film-coated tablets can be used

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

2. WHAT YOU NEED TO KNOW BEFORE TAKING VALPRESSION

Do not take Valpression

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of Valpression
• if you suffer from severe liver disease
• if you are pregnant for more than three months(it is best to avoid taking Valpression even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from diabetes, or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure 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 diseases;
if you have severe kidney diseases or are undergoing dialysis;
if you suffer from a narrowing of the renal artery;
if you have recently undergone a kidney transplant (received a new kidney);
if you are being treated after a heart attack or for heart failure, your doctor may
check your kidney function;
if you have serious heart problems that are not heart failure or a heart attack;
if you have previously experienced swelling of the tongue and face caused by an allergic
reaction called angioedema when taking other medicines (including ACE inhibitors), inform your
doctor. If these symptoms occur when you take 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 salt substitutes containing potassium or potassium-sparing medicines
and heparin. It may be necessary to check your potassium level in the blood at regular intervals;
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 check your kidney function and your potassium levels in the
blood at regular intervals;
if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Valpression is not recommended;
if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting or high doses of
diuretics;

• you must inform your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Valpression is not recommended in early pregnancy and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby 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), especially if you suffer from kidney problems related to diabetes
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

The doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in
your blood at regular intervals.
See also what is stated under “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 the treatment may be affected if Valpression is taken with certain other medicines. Your
doctor may need to adjust the dose and/or take other precautions if you are
taking:

• an ACE inhibitoror aliskiren(see also what is stated under: “Do not take Valpression” and “Warnings and precautions”).
• an ACE inhibitorand other medicines used to treat heart failure, known asmineralocorticoid receptor antagonists (MRAs)(for example spironolactone, eplerenone) or beta-blockers(for example metoprolol). medicines that increase potassium levelsin the blood such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. some types of pain relieverscalled non-steroidal anti-inflammatory drugs (NSAIDs).some antibiotics (rifampicin group), a medicine used against rejection after transplantation (cyclosporine) and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines can increase the effect of Valpression. lithium, a medicine used in the treatment of some types of mental illness.

In addition:
if you are being treated after a heart attack, the combination with ACE
inhibitors(medicines for the treatment of a heart attack) is not recommended.

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 bepregnant( or if there is apossibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Valpression before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valpression. Valpression is not recommended in early pregnancy and should not be taken if you are pregnant for more than three months as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding, or are about to start breastfeeding. 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 newborn or premature.

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

3. HOW TO TAKE VALPRESSION

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

Adult patients with high blood pressure:the usual dose is 80 mg once a day. 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 between 6 and 18 years) with high blood pressure:In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once a day. In patients weighing 35 kg or more, the usual dose is 80 mg of valsartan once a day. In some cases, the 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 from the heart attack, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice a day. The final dose depends on the dose you tolerate individually. Valpression can be administered together with other treatments for heart attack and the doctor will decide which treatment is most suitable for you.

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

If you take more Valpression than you should
In case of severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have inadvertently taken too many tablets, 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 the next tablet, skip the forgotten dose. Do not take a double dose to make up for the forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Valpression can cause side effects, although not everybody gets them.
These side effects can occur with certain frequencies, defined as follows:

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

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

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

If you experience any of these symptoms, stop taking Valpression and contact
your doctor immediately (see also section 2 “Pay particular attention with
Valpression”).
Side effects include:
Common side effects:

• dizziness.
• low blood pressure accompanied or not by symptoms such as dizziness and fainting when getting up
• reduced kidney function (sign of kidney impairment)

Uncommon side effects:

• angioedema (see the paragraph “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (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
• diarrhoea
• fatigue
• weakness

Frequency not known

• formation of blisters on the skin (sign of bullous dermatitis)
• allergic reactions with skin rashes, itching and urticaria, 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 the blood vessels also known as vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decreased levels of haemoglobin and decreased percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
• increased levels of potassium in the blood (which can cause muscle cramps and irregular heartbeat in severe cases)
• increased liver function values (which may be indicative of liver damage) including increased levels of bilirubin in the blood (which can cause yellowing of the skin and eyes in severe cases)
• increased levels of azotaemia and increased levels of serum creatinine (which may indicate impaired kidney function)
• low levels of sodium in the blood (which can cause fatigue, confusion, muscle contractions and/or convulsions in severe cases)

The frequency of some side effects may vary depending on your condition. For example
side effects such as dizziness and decreased 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, side effects are similar to those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the safety of
this medicine.

5. HOW TO STORE VALPRESSION

• Do not store at a temperature above 30°C. Store 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 which is 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 should 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Valpression contains

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

Description of the appearance of Valpression and package contents
Valpression 40 mg film-coated tablets are yellow, ovoid tablets with a notch on one side.
They have the letters “D/O” engraved on one side and “NVR” on the opposite side of the tablet or
only the notch on one side and the letters “D” and “O” imprinted on either side of the notch. The
tablet can be divided into two equal halves.
Valpression 320 mg film-coated tablets are grey-violet, ovoid tablets with beveled edges and a notch on one side.
Next to the notch are the letters “DC” on one side and “DC” on the other side of the notch and “NVR” on the opposite side of the tablet or only
the notch on one side and the letters “DC” and “DC” imprinted on either side of the notch. The notch on the
tablet is intended to facilitate breaking for easier swallowing and
not for dividing 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. There are also unit-dose divisible blisters of 56x1, 98x1 or
280x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 - Florence

Manufacturer responsible for batch release
DELPHARM L'Aigle
Zone industrielle N°1, Route de Crulai
61300 L'Aigle
France
For further information on this medicinal product, contact the marketing authorisation holder.