Pressloval

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pressloval 40 mg Film-coated Tablets, 80 mg Film-coated Tablets, 160 mg Film-coated Tablets

Valsartan
Generic medicine
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 only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What this leaflet contains:

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

1. WHAT PRESSLOVAL IS AND WHAT IT IS USED FOR

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

Pressloval 40mg Film-coated Tablets can be used to treat different conditions:

• for the treatment of high blood pressure in children and adolescents aged between 6 and 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, this condition can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. 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 adult patients. Pressloval can be 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. Heart failure means that the heart muscle is unable to pump blood strongly enough to supply sufficient blood to all parts of the body.

Pressloval 80mg Film-coated Tablets can be used to treat 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 condition can damage blood vessels in the brain, heart, and kidneys, leading to heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. 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 adult patients. Pressloval can be 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. Heart failure means that the heart muscle is unable to pump blood strongly enough to supply sufficient blood to all parts of the body.

Pressloval 160mg Film-coated Tablets can be used to treat 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 condition can damage blood vessels in the brain, heart, and kidneys, leading to heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. 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 adult patients. Pressloval can be 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. Heart failure means that the heart muscle is unable to pump blood strongly enough to supply sufficient blood to all parts of the body.

2. WHAT YOU NEED TO KNOW BEFORE TAKING PRESSLOVAL

Do not take Pressloval:

• if you are allergic (hypersensitive) to valsartan or to any of the excipients of this medicine (listed in section 6).
• if you suffer from severe liver disease.
• if you are more than 3 months pregnant. It is advisable to avoid Pressloval even in the early stages of pregnancy (see 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 Pressloval.
Warnings and precautions
Inform your doctor or pharmacist before taking Pressloval:

• if you have liver disease;
• if you have severe kidney disease or are on dialysis;
• if you suffer from renal artery stenosis;
• 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 ever 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 Pressloval, stop taking Pressloval 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 monitoring of your blood potassium levels;
• if you are under 18 years of age and taking Pressloval 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 Pressloval is not recommended;
• if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting, or high-dose diuretics;
• use of Pressloval is not recommended in children and adolescents (under 18 years of age);
• you must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Pressloval 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 baby if taken during this period (see 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 check 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 PRESSLOVAL”
If any of these conditions apply to you, inform your doctor before taking PRESSLOVAL.
Other medicines and PRESSLOVAL
Inform 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 PRESSLOVAL is taken with certain other medicines. It may be necessary to adjust the dosage, take additional precautions, or in some cases, stop taking one of the medicines. This applies to all medicines, including those without a prescription, especially:

• other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics);
• medicines that increase potassium levels in the blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin;
• some types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs);
• lithium, a medicine used in the treatment of certain psychiatric disorders;
• some antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may enhance the effect of PRESSLOVAL.

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 Pressloval" and "Talk to your doctor before taking PRESSLOVAL");
• 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).

Additionally:

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

Pressloval with food and drinks
Pressloval can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Pressloval before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Pressloval. Pressloval 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 baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed.
Pressloval is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you 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 Pressloval. Like many other medicines used to treat high blood pressure, Pressloval may rarely cause dizziness and affect your ability to concentrate.
Pressloval contains lactose
If your doctor has informed you that you are intolerant to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE PRESSLOVAL

Always take Pressloval exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure. People with high blood pressure often do not notice 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.

Children and adolescents (aged 6 to 18 years) with high blood pressure: In patients with body weight below 35 kg, the usual dose of valsartan is 40 mg once daily. In patients with body weight equal to or above 35 kg, the usual initial dose of valsartan 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 from 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.

Pressloval may be administered 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 dosage depends on the dose you individually tolerate.

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

Adult patients with high blood pressure: The usual dose is 80 mg daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg), or may combine Pressloval with other medicines (e.g. a diuretic).

Children and adolescents (aged 6 to 18 years) with high blood pressure: In patients with body weight below 35 kg, the usual dose of valsartan is 40 mg daily. In patients with body weight equal to or above 35 kg, the usual initial dose of valsartan 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 from 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.

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

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.

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

You may take Pressloval with or without food. Pressloval tablets should be swallowed with a glass of water. Take Pressloval approximately at the same time each day.

If you take more Pressloval 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 Pressloval

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 Pressloval

Stopping treatment with Pressloval may cause your condition to worsen. Do not discontinue use of this medicine unless instructed by your doctor.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

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

• swelling of the face, lips, tongue, or pharynx;
• difficulty breathing or swallowing;
• hives, itching.

If you have any of these conditions, contact your doctor immediately.
The adverse reactions are:
Common adverse reactions (may affect up to 1 in 10 people):

• dizziness
• low blood pressure, with or without symptoms such as dizziness or feeling faint when standing up
• reduced kidney function test values (a sign of renal dysfunction)

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

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (vertigo)
• severely reduced kidney function (a 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 (frequency cannot be estimated from available data):

• allergic reactions with skin rash, itching, and hives: symptoms of fever, joint swelling and 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, also known as vasculitis)
• bleeding or bruising more easily 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 known as 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 severe cases)

The frequency of some of these adverse reactions may vary depending on your condition. For example, effects such as dizziness and reduced kidney function test values have been observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those observed in adults.
Reporting of adverse reactions
If you experience any of the adverse reactions, inform your doctor, pharmacist, or nurse. This includes any possible adverse reaction not listed in this leaflet. You can also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PRESSLOVAL

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

6. OTHER INFORMATION

What Pressloval Film-coated Tablets contain
The active substance is valsartan.
Pressloval 40 mg Film-coated Tablets: each film-coated tablet contains 40 mg of valsartan.
Pressloval 80 mg Film-coated Tablets: each film-coated tablet contains 80 mg of valsartan.
Pressloval 160 mg Film-coated Tablets: each film-coated tablet contains 160 mg of valsartan.

The excipients are:
Tablet core:
anhydrous lactose, monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, colloidal silicon dioxide, magnesium stearate.

Tablet film coating:
hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

Pressloval 40 mg Film-coated Tablets also contain black iron oxide.
Pressloval 160 mg Film-coated Tablets also contain black iron oxide.

Description of the appearance of Pressloval Film-coated Tablets and contents of the pack
Pressloval 40 mg Film-coated Tablets are film-coated tablets.
Pressloval 80 mg Film-coated Tablets are film-coated tablets.
Pressloval 160 mg Film-coated Tablets are film-coated tablets.

Pressloval 40 mg Film-coated Tablets are yellow, oblong and biconvex. They are marked with the letters “VLS” on one side and the number “40” and a score line on the other. They can be divided into two equal parts.

Pressloval 80 mg Film-coated Tablets are pink, round and biconvex. They are marked with the letters “VLS” on one side and the number “80” and a score line on the other. They can be divided into two equal parts.

Pressloval 160 mg Film-coated Tablets are dark yellow, oblong and biconvex. They are marked with the letters “VLS” on one side and the number “160” and a score line on the other. They can be divided into two equal parts.

Pressloval Film-coated Tablets are available in the following pack sizes:
Pressloval 40 mg Film-coated Tablets:
PVC/PVDC/aluminum blister packs containing 14, 28, 56 or 98 film-coated tablets.

Pressloval 80 mg Film-coated Tablets:
PVC/PVDC/aluminum blister packs containing 14, 28, 56 or 98 film-coated tablets.

Pressloval 160 mg Film-coated Tablets:
PVC/PVDC/aluminum blister packs containing 14, 28, 56 or 98 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (Roma)
Italy

Manufacturer
Special Product’s Line S.p.A.
Strada Paduni, 240
03012 Anagni (FR)
Italy

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

This summary of product characteristics was last approved on