Valsartan HCS

Package leaflet: Information for the user

Valsartan HCS 320 mg film-coated tablets

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

Contents of this leaflet

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

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

Valsartan HCS 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 HCS works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan HCS 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 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 may lead 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.

2. What you need to know before taking Valsartan HCS

Do not take Valsartan HCS

• if you are allergic to valsartan or to any of the excipients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan HCS at the beginning of 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 situations apply to you, do not take Valsartan HCS.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan HCS:

• If you have liver disease.
• If you have severe kidney disease or are undergoing dialysis.
• If you suffer from renal artery stenosis.
• If you have recently undergone a kidney transplant (you have 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 previously had a serious heart condition 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 HCS, stop taking Valsartan HCS 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. Regular monitoring of blood potassium levels may be necessary.
• If you have aldosteronism, a condition in which your adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan HCS is not recommended.
• If you have lost a significant amount of fluids (dehydration) due to diarrhea, vomiting, or high doses of diuretics.
• You must inform your doctor if you think you are (or might become) pregnant. Valsartan HCS is not recommended at the beginning of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see the 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

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 Valsartan HCS".
If any of these situations apply to you, inform your doctor before taking Valsartan HCS.
Children and adolescents
If you are under 18 years of age and are taking Valsartan HCS in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may regularly monitor your kidney function and blood potassium levels.
Other medicines and Valsartan HCS
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 HCS is taken together with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, discontinue one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, particularly diuretics
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• Certain types of painkillers called 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 infections (ritonavir). These medicines may increase the effect of Valsartan HCS.
• Lithium, a medicine used to treat certain psychiatric disorders.
• If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Valsartan HCS" and “Warnings and precautions”).

Taking Valsartan HCS with food and drink
You may take Valsartan HCS 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 are (or might become) pregnant. Normally, your doctor will advise you to stop taking Valsartan HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartan HCS. Valsartan HCS is not recommended at the beginning of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.
• Inform your doctor if you are breastfeeding or starting to breastfeed. Valsartan HCS is not recommended for breastfeeding mothers and your doctor may choose another treatment for you if you wish to breastfeed, particularly 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, make sure you are aware of how Valsartan HCS affects you. Like many other medicines used to treat high blood pressure, Valsartan HCS may rarely cause dizziness and affect your ability to concentrate.
Valsartan HCS contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Valsartan HCS

Take Valsartan HCS exactly as directed by your doctor or pharmacist. This will help you achieve the best results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms of this condition, and many may feel quite well. Therefore, it is important to attend all your medical appointments regularly, even if 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 (e.g. 160 mg or 320 mg). Your doctor may also combine Valsartan HCS with another medicine (e.g. a diuretic).

Children and adolescents (6–18 years of age) 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).
Doses lower than 160 mg are not possible with Valsartan HCS 320 mg film-coated tablets.

You may take Valsartan HCS with or without food. Swallow the tablet with a glass of water. Take Valsartan HCS at approximately the same time each day.

If you take more Valsartan HCS 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 go to the hospital.

If you forget to take Valsartan HCS
Do not take a double dose to make up for the missed dose.
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.

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

If you have any questions about how to use 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:
You may develop the following 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 HCS and seek immediate medical
attention (see also section 2 "Warnings and precautions").
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
• reduced kidney function (signs of kidney impairment) Uncommon (may affect up to 1 in 100 people):
• angioedema (see section “Symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of confusion (vertigo)
• severely reduced kidney function (signs of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of hyperkalaemia)
• 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 Not known (frequency cannot be estimated from the available data):
• blisters on the skin (signs of bullous dermatitis)
• allergic reactions with rash, itching and hives; symptoms such as fever, joint swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may develop (signs of serum sickness)
• red-purple spots, 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)
• reduction in haemoglobin levels and reduction in the percentage of red blood cells in the blood (which, in severe cases, may lead to anaemia)
• increased potassium levels in the blood (which may trigger muscle pain and irregular heartbeat in severe cases)
• low sodium levels in the blood (which may trigger fatigue, confusion, muscle cramps and/or seizures in severe cases)
• increased liver function test values (which may indicate liver damage), including increased bilirubin in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate abnormal kidney function)

The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function 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.
Additional side effects in children and adolescents
Side effects in children and adolescents are similar to those observed in adults.
Reporting of side effects
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 national reporting system at 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 HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blisters 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 from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Valsartan HCS contains

• The active substance is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other ingredients (excipients) are: monohydrate lactose, microcrystalline cellulose, povidone, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate in the tablet core; hypromellose,
  titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172) and red iron oxide (E172) in the coating.

Description of the appearance of Valsartan HCS and contents of the pack
The 320 mg film-coated tablets are light brown, capsule-shaped, biconvex tablets, marked on one side. The tablet can be divided into equal doses.
For the 320 mg strength, packs containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90 and 98 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local representative for Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milan, Italy

Responsible manufacturer for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information on this product, please contact the local representative of the Marketing Authorization Holder.

This medicinal product is authorized in the European Economic Area countries under the following names:

Package leaflet: Information for the user

Valsartan HCS 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 could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Valsartan HCS 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 HCS works by blocking the effects of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan HCS 40 mg film-coated tablets can be used for three different conditions:

• for 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, this may damage the blood vessels in the brain, heart, and kidneys, potentially leading 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 after a recent heart attack (myocardial infarction). "Recent" here means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. Valsartan HCS is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a drug for treating heart failure) cannot be used, or it may be used in addition to ACE inhibitors when other heart failure medications cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. It occurs when the heart muscle is unable to pump blood strongly enough to supply the body's needs.

Valsartan HCS 80 mg and 160 mg film-coated tablets can be used for three different conditions:

• for 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 may damage the blood vessels in the brain, heart, and kidneys, and may lead 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 disorders.
• for the treatment of adult patients after a recent heart attack (myocardial infarction). "Recent" here means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. Valsartan HCS is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a drug for treating heart failure) cannot be used, or it may be used in addition to ACE inhibitors when other heart failure medications cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. It occurs when the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartan HCS

Do not take Valsartan HCS

• 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 also advisable to avoid Valsartan HCS 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 apply to you, do not take Valsartan HCS.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan HCS.

• If you have liver disease.
• If you have severe kidney disease or are undergoing dialysis.
• If you suffer from narrowing of the renal artery.
• If you have recently undergone a kidney transplant (you have 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 had a serious heart disease 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 HCS, stop taking Valsartan HCS immediately and never take it again. See also section 4 “Possible side effects”.
• If you are taking medicines that increase the amount of potassium 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 regularly.
• If you are under 18 years of age and are taking Valsartan HCS in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor will monitor your kidney function and blood potassium levels at regular intervals.
• If you have aldosteronism, a condition in which your adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan HCS is not recommended.
• If you have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics.
• You must inform your doctor if you think you are (or may become) pregnant. Valsartan HCS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see the 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 certain other medicines known as mineralocorticoid receptor antagonists (MRAs), for the treatment of your heart failure (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

Your doctor may monitor 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 Valsartan HCS”.
If any of these apply to you, inform your doctor before taking Valsartan HCS.
Other medicines and Valsartan HCS
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 HCS is taken together with certain other
medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, stop
taking one of the two medicines. This applies both to prescription and non-prescription medicines, particularly:

• other medicines that lower blood pressure, especially diuretics
• medicines that increase the amount of potassium in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, 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 in the treatment of HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan HCS.
• lithium, a medicine used to treat certain psychiatric disorders.
• if you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Valsartan HCS” and “Warnings and precautions”).
• if you are being treated with an ACE inhibitor together with certain other medicines known as mineralocorticoid receptor antagonists (MRAs), for the treatment of your heart failure (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

Additionally (Valsartan HCS 40 mg):

• 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 with ACE inhibitors and beta-blockers (medicines for treating heart failure) is not recommended.

Additionally (Valsartan HCS 80 mg and 160 mg):

• 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 with ACE inhibitors and beta-blockers (medicines for treating heart failure) is not recommended.

Valsartan HCS with food and drink
You may take Valsartan HCS with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• You must inform your doctor if you think you are (or may become) pregnant. Normally, your doctor will advise you to stop taking Valsartan HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartan HCS. Valsartan HCS is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.
• Inform your doctor if you are breastfeeding or starting to breastfeed. Valsartan HCS is not recommended for breastfeeding mothers, and if you wish to breastfeed, your doctor may choose another treatment for you, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Before driving, operating tools or machinery, or performing activities requiring concentration, make
sure you are aware of how Valsartan HCS affects you. Like many other medicines used to treat
high blood pressure, Valsartan HCS may rarely cause dizziness and affect your ability to
concentrate.
Valsartan HCS contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this
medicine.

3. How to take Valsartan HCS

Take Valsartan HCS exactly as directed by your doctor or pharmacist. This will help you achieve the best results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms of this condition. Many may feel quite well. For this reason, it is important that you attend all your medical appointments even if you feel well.

Children and adolescents (aged 6 to 18 years) with high blood pressure (Valsartan HCS 40 mg)
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 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 (Valsartan HCS 40 mg)
After a heart attack, treatment is usually started within 12 hours, typically 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 your individual tolerance.

Valsartan HCS 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 (Valsartan HCS 40 mg)
Treatment usually starts with 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 your individual tolerance.

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

Adult patients with high blood pressure (Valsartan HCS 80 mg and 160 mg)
The usual dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Your doctor may also combine Valsartan HCS with another medicine (e.g. a diuretic).

Children and adolescents (aged 6 to 18 years) with high blood pressure (Valsartan HCS 80 mg and 160 mg)
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 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 (Valsartan HCS 80 mg and 160 mg)
After a heart attack, treatment is usually started within 12 hours, typically 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 your individual tolerance.

Valsartan HCS 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 (Valsartan HCS 80 mg and 160 mg)
Treatment usually starts with 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 your individual tolerance.

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

You may take Valsartan HCS with or without food. Swallow Valsartan HCS with a glass of water. Take Valsartan HCS at approximately the same time each day.

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

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

If you have any questions about how to use this medicine, consult 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:
You may develop the following 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 HCS and seek medical help immediately
(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 (signs of kidney impairment)

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

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of spinning (vertigo)
• severely reduced kidney function (signs of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of hyperkalaemia)
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

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

• blisters on the skin (signs of bullous dermatitis)
• allergic reactions with skin rash, itching and hives; fever, joint pain and swelling, 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 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)
• reduction in haemoglobin levels and reduction in the percentage of red blood cells in the blood (which may, in severe cases, lead to anaemia)
• increased potassium levels in the blood (which may, in severe cases, trigger muscle cramps and irregular heartbeat)
• decreased sodium levels in the blood (which may cause fatigue and confusion, muscle twitching, seizures or coma)
• increased liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which may, in severe cases, cause yellowing of the skin and eyes)
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate abnormal kidney function)

The frequency of some side effects may vary depending on your condition. For example, side 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.
Side effects in children and adolescents are similar to those observed in adults.
Reporting of side effects
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 national reporting system at 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 HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Valsartan HCS contains

• The active substance is valsartan. Each tablet contains 40 mg, 80 mg or 160 mg of valsartan.
• The excipients in the tablet core are: monohydrate lactose, microcrystalline cellulose, povidone, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate.
• The excipients in the film coating of the 40 mg tablet are: hypromellose, titanium dioxide (E171), macrogol 4000 and yellow iron oxide (E172).
• The excipients in the film coating of the 80 mg tablet are: hypromellose, titanium dioxide (E171), macrogol 4000 and red iron oxide (E172).
• The excipients in the film coating of the 160 mg tablet are: hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Valsartan HCS and contents of the pack
The 40 mg film-coated tablets are slightly biconvex, round, yellow-brown film-coated tablets, marked on one side.
The 80 mg film-coated tablets are biconvex, round, pink film-coated tablets, marked on one side.
The 160 mg film-coated tablets are biconvex, oval, yellow-brown film-coated tablets, marked on one side.
Tablets of all three strengths can be divided into two equal doses.
For each strength, packs of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120 and 180 film-coated tablets in blister packs are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local representative in Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milan, Italy

Responsible manufacturer for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

This medicinal product is authorized in the European Economic Area Member States under the following names: