Valsartan Alter: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan Alter 40 mg film-coated tablets, 80 mg film-coated tablets, 160 mg film-coated tablets, 320 mg film-coated tablets

Generic medicine
Valsartan
Please read all of 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Valsartan Alter is and what it is used for
What you need to know before taking Valsartan Alter
How to take Valsartan Alter
Possible side effects
How to store Valsartan Alter
Contents of the pack and other information

1. WHAT VALSARTAN ALTER IS AND WHAT IT IS USED FOR

Valsartan Alter belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan Alter works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartan Alter 40 mg film-coated tablets can be used to treat three different conditions:

in 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, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. By lowering blood pressure to normal levels, the risk of developing these conditions is reduced.
in the treatment of adult patients 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. Valsartan Alter is used when medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or it may be used in addition to ACE inhibitors when beta-blockers (other medicines for treating heart failure) cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with adequate blood flow.

Valsartan Alter 80 mg film-coated tablets 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 also increases the risk of heart attacks. By lowering blood pressure to normal levels, the risk of developing these conditions is reduced.
in the treatment of adult patients 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. Valsartan Alter is used when medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or it may be used in addition to ACE inhibitors when beta-blockers (other medicines for treating heart failure) cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with adequate blood flow.

Valsartan Alter 160 mg film-coated tablets 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 also increases the risk of heart attacks. By lowering blood pressure to normal levels, the risk of developing these conditions is reduced.
in the treatment of adult patients 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. Valsartan Alter is used when medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or it may be used in addition to ACE inhibitors when other medicines used 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 retention. This occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with adequate blood flow.

Valsartan Alter 320 mg film-coated tablets can be used

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 also increases the risk of heart attacks. By lowering blood pressure to normal levels, the risk of developing these conditions is reduced.

2. WHAT YOU SHOULD KNOW BEFORE TAKING VALSARTAN ALTER

Do not take Valsartan Alter

if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6).
if you have severe liver disease.
if you are more than 3 months pregnant (it is nevertheless better to avoid Valsartan Alter even in early pregnancy – see the 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 Valsartan Alter.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Alter
Take particular care with Valsartan Alter:

if you have liver disease.
if you have severe kidney disease or are on dialysis.
if you suffer from renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant (received a new kidney).
if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function.
if you have serious heart problems other than heart failure or heart attack.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan Alter, stop taking Valsartan Alter immediately and never 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 medicines, and heparin. It may be necessary to check your blood potassium levels at regular intervals.
if you are under 18 years of age and taking Valsartan Alter in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to 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 Valsartan Alter is not recommended.
if you have experienced fluid loss (dehydration) caused by diarrhoea, vomiting, or high-dose diuretics.
you must inform your doctor if you think you are (or may become) pregnant. Valsartan Alter is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see section on pregnancy).
if you are taking any of the following medicines used to treat high blood pressure:
- An "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- Aliskiren.
if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol). Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the section "Do not take Valsartan Alter".
If any of these conditions apply to you, inform your doctor before taking Valsartan Alter.
Other medicines and Valsartan Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The effect of treatment may be affected if Valsartan Alter is taken with certain other medicines. Your doctor may consider it necessary to adjust the dose, take additional precautions, or in some cases, discontinue one of the medicines. This applies to all medicines, even those without a prescription, especially:

if you are taking other medicines that lower blood pressure, particularly diuretics (medicines that increase fluid elimination), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the sections: "Do not take Valsartan Alter" and "Warnings and precautions").
if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprololo).
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.
if you are taking certain types of pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used in the treatment of HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan Alter.
if you are taking 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 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.

Valsartan Alter with food and drink
Valsartan Alter may be taken with or without food.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant (or are planning to become pregnant). Your doctor will usually advise you to stop taking Valsartan Alter before you become pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valsartan Alter. Valsartan Alter is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to start breast-feeding. Valsartan Alter is not recommended during breast-feeding. Your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is 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 Valsartan Alter. Like many other medicines used to treat high blood pressure, Valsartan Alter may rarely cause dizziness and affect your ability to concentrate.

3. HOW TO TAKE VALSARTAN ALTER

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms and may feel perfectly well. 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 higher doses (for example, 160 mg or 320 mg). Your doctor may also combine Valsartan Alter with another medicine (for example, a diuretic).

Use in children and adolescents (aged 6–18 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 starting 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 within 12 hours after a heart attack, generally at a low dose of 20 mg twice daily. A 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 how well you, as an individual patient, can tolerate the medicine.

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

Adult patients with heart failure: Treatment is usually started at 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on how well you, as an individual patient, can tolerate the medicine.

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

Swallow Valsartan Alter with a glass of water.

Take Valsartan Alter approximately at the same time each day.

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

If you forget to take Valsartan Alter
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

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

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
These adverse effects 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 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 Valsartan Alter immediately and seek medical
attention straight away (see also section 2 “Warnings and precautions”).
The adverse effects include:
Common :

dizziness
low blood pressure with or without symptoms such as dizziness and fainting when standing up
reduced kidney function (a sign of kidney damage)

Uncommon :

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 kidney failure)
muscle cramps, irregular heartbeat (signs of high potassium levels in the blood)
shortness of breath (dyspnea), 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

blisters on the skin (a sign of bullous dermatitis)
allergic reactions with skin rash, itching, and hives; fever, swollen joints, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
red-purple spots, 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)
reduced 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 may cause muscle cramps and heart rhythm abnormalities in severe cases)
increased liver function test values (which may indicate liver damage), including increased bilirubin in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle twitching (muscle cramps) and/or seizures)

The frequency of some of these adverse effects may vary depending on your condition. For example,
effects such as dizziness and reduced kidney function have been observed less frequently in patients
treated for high blood pressure than in patients treated for heart failure or after a recent heart attack.
Adverse effects in children and adolescents are similar to those observed in adults.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You may also report adverse effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VALSARTAN ALTER

Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use this medicine 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 no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Valsartan Alter contains
The active substance is valsartan.
One film-coated tablet contains 40 mg, 80 mg, 160 mg or 320 mg of valsartan.
The other components are microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silicon dioxide,
magnesium stearate; the tablet coating contains hypromellose, titanium dioxide (E171),
triacetin.

Description of the appearance of Valsartan Alter and pack sizes
VALSARTAN ALTER 40 mg: White, round, biconvex, film-coated tablet with a score line on one side, 6 mm in diameter. The tablet can be divided into equal parts. The tablets are packaged in PVC/PE/PVDC/Al blisters containing 14 or 28 tablets.
VALSARTAN ALTER 80 mg: White, round, biconvex, film-coated tablet, 8 mm in diameter. The tablets are packaged in PVC/PE/PVDC/Al blisters containing 14 or 28 tablets.
VALSARTAN ALTER 160 mg: White, round, biconvex, film-coated tablet, 11 mm in diameter. The tablets are packaged in PVC/PE/PVDC/Al blisters containing 14 or 28 tablets.
VALSARTAN ALTER 320 mg: White, oblong, biconvex, film-coated tablet, 21.7 x 7.5 mm in size. The tablets are packaged in PVC/PE/PVDC/Al blisters containing 7, 14 or 28 tablets.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
LABORATORI ALTER S.R.L.
Via Egadi, 7, 20144 - MILAN (MI), Italy

MANUFACTURER
Laboratorios Alter S.A.
C/Mateo Inurria n. 30, 28036 - Madrid, Spain

This patient information leaflet was last approved on