PRESSLOVAL 40 мг Фильм-coated таблетки

Содержание инструкции

1. Pressloval 40 mg Film-coated Tablets, 80 mg Film-coated Tablets, 160 mg Film-coated Tablets
   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. OTHER INFORMATION

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

Valsartan
Generic medicine

Read this leaflet carefully before you start taking this medicine. 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

• 1. What Pressloval is and what it is used for
• 2. What you need to know before you take 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 to 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. The result is that blood vessels relax and blood pressure decreases.

Pressloval 40mg film-coated tablets can be used to treat different conditions:

• in 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 and cause stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure 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.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 can be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. Heart failure means that the heart muscle is unable to pump blood forcefully enough to provide enough blood to every part of the body.

Pressloval 80mg film-coated tablets can be used to treat different conditions:

• in 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 and cause heart attack, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure 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.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 can be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. Heart failure means that the heart muscle is unable to pump blood forcefully enough to provide enough blood to every part of the body.

Pressloval 160mg film-coated tablets can be used to treat different conditions:

• in 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 and cause heart attack, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure 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.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 can be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. Heart failure means that the heart muscle is unable to pump blood forcefully enough to provide enough blood to every part of the body.

2. WHAT YOU NEED TO KNOW BEFORE TAKING PRESSLOVAL

Do not take Pressloval:

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

• if you have liver diseases;
• if you have severe kidney diseases or if you are undergoing dialysis;
• if you suffer from a narrowing of the renal artery;
• if you have recently undergone a kidney transplant (received a new kidney);
• if you are being treated after a heart attack or for heart failure, your doctor may check your kidney function;
• if you have serious heart problems that are not heart failure or a heart attack;
• If you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking 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 salt substitutes containing potassium or potassium-sparing drugs and heparin. It may be necessary to check your blood potassium level at regular intervals;
• if you are less than 18 years old and are taking Pressloval 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 the amount of potassium in your 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 Pressloval is not recommended;
• if you have experienced a loss of fluids (dehydration) caused by diarrhea, vomiting, or high doses of diuretics;
• Pressloval is not recommended for use in children and adolescents (under 18 years of age);
• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Pressloval 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 Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes;
• aliskiren;
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.

See also the section “Do not take PRESSLOVAL”
If any of these conditions apply to you, tell your doctor before taking PRESSLOVAL.
Other medicines and PRESSLOVAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The effect of the treatment may be affected if PRESSLOVAL is taken with some other medicines. It may
be necessary to change the dosage, take other precautions or, in some cases, stop taking
one of the medicines. This applies to any medicine, even those available without a prescription,
especially:

• other medicines that lower blood pressure, especially those that increasefluid elimination(diuretics);
• medicines that increase potassium levelsin the blood such as potassium supplements, substitutes

for salt containing potassium, potassium-sparing drugs and heparin;

• some types of pain relieverscalled non-steroidal anti-inflammatory drugs (NSAIDs);
• lithium, a medicine used in the treatment of some mental illnesses;
• some antibiotics(rifamycin group), a medicine used to prevent rejection after transplantation (cyclosporine) or an antiretroviral medicine used to treat HIV / AIDS infection (ritonavir). These medicines can enhance the effect of PRESSLOVAL.
• The doctor may need to change the dose and / or take other precautions:
• If you are taking an ACE inhibitor or aliskiren (see also the section: "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) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

In addition:

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

Pressloval with food and drink
Pressloval can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist before taking this medicine.

Pregnancy
You must tell 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 Pressloval before
starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Pressloval. Pressloval 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.

Breastfeeding
Tell your doctorif you are breastfeeding or if you intend to start breastfeeding.
Pressloval is not recommended for mothers who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newly born or premature.

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

Pressloval contains lactose
If your doctor has told you that you are intolerant to some sugars, contact him before taking this
medicine.

3. HOW TO TAKE PRESSLOVAL

Always take Pressloval this medicine exactly as your doctor has instructed you. Consult your
doctor or pharmacist if you are unsure. People who suffer from high blood pressure often do not
notice any signs of this problem and many feel as well as usual. For this reason, it is
very important that you keep regular appointments with your doctor, even when you feel well.

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

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

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

Children and adolescents (aged 6 to 18 years) with high blood pressure:in patients with a body
weight less than 35 kg, the usual dose of valsartan is 40mg per day. In patients with a body weight
equal to or greater than 35 kg, the usual initial dose of valsartan is 80mg once a day. In some cases, the
doctor may prescribe higher doses (the dose may be increased to 160mg and up to a maximum of
320mg).

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

Heart failure:treatment is generally started with 40mg twice a day. The doctor
will gradually increase this dose over a few weeks, up to a maximum of 160mg twice
a day. The final dose depends on the dose that you tolerate individually.
Pressloval 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 Pressloval with or without food. The tablets of Pressloval must be swallowed with a
glass of water. Take Pressloval at about the same time each day.

If you take more Pressloval than you should
In case of severe dizziness and/or fainting, it is good to lie down and contact your doctor immediately. If you have
accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Pressloval
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 Pressloval
Stopping treatment with Pressloval 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

• dizziness
• low blood pressure with or without symptoms such as dizziness and feeling faint when getting up
• reduced values of renal function tests (sign of renal dysfunction)

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

• angioedema (see the paragraph “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of dizziness (vertigo)
• severely reduced renal function (sign of acute renal failure)
• muscle cramps, abnormal heart rhythm (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 (the frequency cannot be estimated from the available data):

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

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also
report side effects directly through the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help to
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 which is stated on the packaging after the wording EXP. The expiry date refers to the last day of the month.
• Do not store at a temperature 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 in waste water 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 contains
The active ingredient is valsartan.
Pressloval 40 mg Film-Coated Tablets: each film-coated tablet contains 40mg of
valsartan.
Pressloval 80 mg Film-Coated Tablets: each film-coated tablet contains 80mg of
valsartan.
Pressloval 160 mg Film-Coated Tablets: each film-coated tablet contains 160mg of
valsartan.
The excipients are:

Tablet core:
anhydrous lactose, lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, silicone
colloidal dioxide and magnesium stearate

Tablet film coating:
hypromellose, macrogol 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 contains black iron oxide.
Pressloval 160 mg Film-Coated Tablets also contains black iron oxide.

Description of the appearance of Pressloval Film-Coated Tablets and contents of the pack
Pressloval 40 mg Film-Coated Tablets presents as a film-coated core.
Pressloval 80 mg Film-Coated Tablets presents as a film-coated core.
Pressloval 160 mg Film-Coated Tablets presents as a film-coated core.
Pressloval 40 mg Film-Coated Tablets are yellow, oblong and biconvex.
They bear the letters “VLS” on one side and the number “40” and the score line on the other. They can be
divided into two equal halves.
Pressloval 80 mg Film-Coated Tablets are pink, round and biconvex.
They bear the letters “VLS” on one side and the number “80” and the score line on the other. They can be
divided into two equal halves.
Pressloval 160 mg Film-Coated Tablets are dark yellow, oblong and
biconvex. They bear the letters “VLS” on one side and the number “160” and the score line.
They can be divided into two equal halves.
Pressloval Film-Coated Tablets is available in the following packs:
Pressloval 40 mg Film-Coated Tablets:
PVC/PVDC/aluminium blisters with 14, 28, 56 or 98 film-coated tablets
Pressloval 80 mg Film-Coated Tablets:
PVC/PVDC/aluminium blisters with 14, 28, 56 or 98 film-coated tablets
Pressloval 160 mg Film-Coated Tablets:
PVC/PVDC/aluminium blisters with 14, 28, 56 or 98 film-coated tablets
Not all pack sizes may be marketed in your country.

Marketing Authorisation 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, contact the marketing authorisation holder.