Valsartan Sandoz: detailed information

Patient Information Leaflet

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

Generic medicine
Please read this entire leaflet carefully before taking this medicine, as 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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan Sandoz is and what it is used for

Valsartan Sandoz contains the active substance valsartan and 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 Sandoz works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

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

for the treatment of high blood pressure in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these diseases.
for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
for the treatment of symptomatic heart failure in adult patients. Valsartan Sandoz is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for the treatment of heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the blood they need.

Valsartan Sandoz 80 mg film-coated tablets can be used to treat three different conditions:

for the treatment of high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these diseases.
for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
for the treatment of symptomatic heart failure in adult patients. Valsartan Sandoz may 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 the treatment of heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the blood they need.

Valsartan Sandoz 160 mg film-coated tablets can be used to treat three different conditions:

for the treatment of high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these diseases.
for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
for the treatment of symptomatic heart failure in adult patients. Valsartan Sandoz may be used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for the treatment of heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for the treatment of heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the blood they need.

Valsartan Sandoz 320 mg film-coated tablets can be used

for the treatment of high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these diseases.

2. What you need to know before taking Valsartan Sandoz

Do not take Valsartan Sandoz

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 three months pregnant (it is better to avoid taking Valsartan Sandoz even in the early stages of pregnancy – see section on Pregnancy).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Valsartan Sandoz if any of the above conditions apply to you. If you are in doubt,
consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before taking Valsartan Sandoz:

if you have liver disease.
if you have severe kidney disease or are on dialysis.
if you suffer from narrowing of the renal artery.
if you have recently undergone a kidney transplant (received a new kidney).
if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function.
if you have serious heart problems other than heart failure or heart attack.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking other medicines (including ACE inhibitors). If these symptoms occur while you are taking Valsartan Sandoz, stop taking it 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 drugs, and heparin. You may need regular monitoring of your blood potassium levels.
if you are under 18 years of age and are taking Valsartan Sandoz 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. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Valsartan Sandoz is not recommended.
if you have fluid loss (dehydration) caused by diarrhoea, vomiting, or high-dose diuretic tablets (medicines that increase fluid elimination).
you must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan Sandoz is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see 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 levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information in the section “Do not take Valsartan Sandoz”.
If any of these conditions apply to you, inform your doctor before taking Valsartan Sandoz.
Contact your doctor if, after taking Valsartan Sandoz, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Valsartan Sandoz on your own.

Other medicines and Valsartan Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment may be affected if Valsartan Sandoz is taken with certain other medicines. Your doctor may need to adjust the dose and/or take other precautions, or in some cases discontinue treatment with one of the medicines. This applies to all medicines, including those not requiring a prescription, especially:

other medicines that lower blood pressure, particularly tablets that increase fluid elimination (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under “Do not take Valsartan Sandoz” and “Warnings and precautions”).
medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Sandoz.
lithium, a medicine used in the treatment of certain psychiatric disorders.

In addition:

if you are being treated after a heart attack, combination with ACE inhibitors (medicines for treating heart attack) is not recommended.
if you are being treated for heart failure, triple combination therapy with ACE inhibitors and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo), is not recommended.

Valsartan Sandoz with food and drink
Valsartan Sandoz can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Valsartan Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valsartan Sandoz. Valsartan Sandoz is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Sandoz is not recommended for women who are breastfeeding, and your doctor may choose a different treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

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

3. How to take Valsartan Sandoz

Always take this medicine exactly as instructed by your doctor in order to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms. Many may feel just 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 recommended dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg), or may combine Valsartan Sandoz with another medicine (e.g. a diuretic).

Children and adolescents aged 6 to less than 18 years with high blood pressure
Valsartan Sandoz is not available as an oral solution.
For oral solutions, refer to other products available on the market.
In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily.
In patients weighing 35 kg or more, the usual dose is 80 mg of valsartan once daily.
In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).
For children who are unable to swallow tablets, use of an oral solution of valsartan is recommended.

Adult patients after a recent heart attack: Treatment is usually started as soon as possible after 12 hours from the heart attack, typically 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.

Valsartan Sandoz 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 usually started with 40 mg twice daily. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate.

Valsartan Sandoz 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 Valsartan Sandoz with or without food. Swallow the tablet with a glass of water.

Take Valsartan Sandoz at approximately the same time each day.

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

If you forget to take Valsartan Sandoz
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 a forgotten dose.

If you stop taking Valsartan Sandoz
Stopping treatment with Valsartan Sandoz may cause your condition to worsen. Do not stop using this medicine unless instructed by your doctor.

If you have any 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 everyone gets them.
Some side effects may be serious and require immediate medical attention:
You may experience symptoms of angioedema (a specific type of allergic reaction), such as:

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

If you experience any of these symptoms, stop taking Valsartan Sandoz immediately and contact your doctor
straight away (see also section 2 “Warnings and precautions”).
Other side effects include:
Common (may affect up to 1 in 10 people):

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

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

angioedema (see section “Some side effects may be serious and require immediate medical attention”)
sudden loss of consciousness (syncope)
sensation of dizziness (vertigo)
severely reduced kidney function (sign of acute kidney failure)
muscle cramps, irregular heartbeat (signs of hypercalcemia)
shortness of breath, difficulty breathing when lying flat, swelling of the feet or legs (signs of heart failure)
headache
cough
abdominal pain
nausea
diarrhoea
fatigue
weakness

Very rare (may affect up to 1 in 10,000 people):

intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Not known (frequency cannot be estimated from the available data):

skin blisters (signs of bullous dermatitis)
allergic reactions with skin rashes, itching and hives; feverish symptoms, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
red papules, fever, itching (signs of inflammation of blood vessels also known as vasculitis)
unusual bleeding or bruising (signs of thrombocytopenia)
muscle pain (myalgia)
fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
decreased haemoglobin levels and decreased percentage of red blood cells in the blood (which may lead to anaemia in severe cases)
increased potassium levels in the blood (which may cause muscle cramps and heart rhythm abnormalities in severe cases)
increased liver function values (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases)
increased blood urea nitrogen and increased serum creatinine levels (which may indicate abnormal kidney function)
low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching 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 reduced 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, the side effects are similar to those observed in adults.
Reporting of adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box/blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
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. 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 Valsartan Sandoz contains
The active substance is valsartan.
Each film-coated tablet contains 40 mg of valsartan.
Each film-coated tablet contains 80 mg of valsartan.
Each film-coated tablet contains 160 mg of valsartan.
Each film-coated tablet contains 320 mg of valsartan.

The other components are:
Tablet core:
microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate.
Film coating:
hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172); additionally for 40 mg/160 mg/320 mg: black iron oxide (E172).

Description of the appearance of Valsartan Sandoz and contents of the pack
Valsartan Sandoz 40 mg film-coated tablets:
Yellow, oval, film-coated tablet with bevelled edges, slightly convex, with a breakline on one side, the letter “D” engraved on one side of the line, the letter “O” on the other, and the code “NVR” on the opposite side of the tablet.
The tablet can be divided into equal doses.

Valsartan Sandoz 80 mg film-coated tablets:
Light red, round, film-coated tablet with bevelled edges, with a breakline on one side, the letter “D” engraved on one side of the line, the letter “V” on the other, and the code “NVR” on the opposite side of the tablet.
The breakline is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Valsartan Sandoz 160 mg film-coated tablets:
Grey-orange, oval, film-coated tablet, slightly convex, with a breakline on one side, the letters “DX” engraved on one side of the line, the letters “DX” on the other, and the code “NVR” on the opposite side of the tablet.
The breakline is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Valsartan Sandoz 320 mg film-coated tablets:
Dark grey-violet, oval, film-coated tablet with bevelled edges, slightly convex, with a breakline on one side, the letters “DC” engraved on one side of the line, the letters “DC” on the other, and the code “NVR” on the opposite side of the tablet.
The breakline is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Valsartan Sandoz 40 mg film-coated tablets
Pack size: pack containing 14 film-coated tablets.

Valsartan Sandoz 80 mg film-coated tablets
Pack size: pack containing 28 film-coated tablets.

Valsartan Sandoz 160 mg film-coated tablets
Pack size: pack containing 28 film-coated tablets.

Valsartan Sandoz 320 mg film-coated tablets
Pack size: pack containing 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers responsible for batch release
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben (Germany)
LEK S.A. - Ul. Podlipie 16, 95010 Strykow (Poland) Manufacturing site: UI: Domaniewska 50 C, 02-672 Warsaw, Poland
Lek Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana (Slovenia)
Lek Pharmaceuticals d.d. Trimlini 2 D, 9220 Lendava (Slovenia)
Novartis Farmaceutica S.A. - Gran Vía de les Corts Catalanes 764, 08013 Barcelona (Spain)
S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540 472 Targu-Mures (Romania)
Novartis Farma S.p.A - via Provinciale Schito 131 - 80058 Torre Annunziata, Naples (Italy)

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: VALSARTAN SANDOZ 40 mg film-coated tablets
VALSARTAN SANDOZ 80 mg film-coated tablets
VALSARTAN SANDOZ 160 mg film-coated tablets
VALSARTAN SANDOZ 320 mg film-coated tablets