Valsartan Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

VALSARTAN DOC Generici 40 mg film-coated tablets, 80 mg film-coated tablets, 160 mg film-coated tablets

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 other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What VALSARTAN DOC Generici is and what it is used for

VALSARTAN DOC Generici 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 DOC Generici works by blocking the effects of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

VALSARTAN DOC Generici 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 between 6 and 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may 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 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 DOC Generici 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 heart failure medications cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply the body's needs.

VALSARTAN DOC Generici 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 between 6 and 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may 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 attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. VALSARTAN DOC Generici 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 heart failure medications cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply the body's needs.

VALSARTAN DOC Generici 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 between 6 and 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may 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 attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. VALSARTAN DOC Generici 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 heart failure medications cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. What you should know before taking VALSARTAN DOC Generici

Do not take VALSARTAN DOC Generici:

• 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 VALSARTAN DOC Generici even in the early stages of pregnancy – see section 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 DOC Generici
Warnings and precautions
Talk to your doctor or pharmacist before taking VALSARTAN DOC Generici

• if you have liver disease.
• if you have severe kidney disease or are on dialysis.
• if you have 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 are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin. It may be necessary to regularly monitor your blood potassium levels.
• if you are under 18 years of age and are taking VALSARTAN DOC Generici in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and blood potassium levels at regular intervals.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of VALSARTAN DOC Generici is not recommended.
• if you have experienced fluid loss (dehydration) due to diarrhea, vomiting, or high-dose diuretics.
• you must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). VALSARTAN DOC Generici 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 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 DOC Generici"
If any of these conditions apply to you, inform your doctor before taking
VALSARTAN DOC Generici.
Other medicines and VALSARTAN DOC Generici
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 DOC Generici is taken together with other medicines. It may be necessary to adjust the dosage, take additional precautions, or in some cases, stop taking one of the medicines. This applies to all medicines, including those not requiring a prescription, especially:

• other medicines that lower blood pressure, particularly tablets that increase fluid elimination (diuretics),
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• some types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• lithium, a medicine used in the treatment of certain psychiatric conditions.
  Additionally:

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take VALSARTAN DOC Generici" 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).

VALSARTAN DOC Generici with food and drink
VALSARTAN DOC Generici can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

• You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking VALSARTAN DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. VALSARTAN DOC Generici 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 start breastfeeding. VALSARTAN DOC Generici is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment 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 DOC Generici. Like many other medicines used to treat high blood pressure, VALSARTAN DOC Generici may rarely cause dizziness and affect your ability to concentrate.
VALSARTAN DOC Generici contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
VALSARTAN DOC Generici contains soybean oil. If you are allergic to peanuts or soy, do not take this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take VALSARTAN DOC Generici

Take this medicine exactly as directed by your doctor. 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 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.

Use in children and adolescents (aged 6 to 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 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 generally started as soon as possible,
within 12 hours after the heart attack, usually with a low starting dose of 20 mg twice daily. The
20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase
this dose over several weeks, up to a maximum of 160 mg twice daily. The final dose depends on the dose
you individually tolerate.
VALSARTAN DOC Generici may be given together with other treatments for heart attack,
and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: treatment is generally started with 40 mg twice daily. Your
doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice
daily. The final dose depends on the dose you individually tolerate.
VALSARTAN DOC Generici may be given together with other treatments for
heart failure, and your doctor will decide which treatment is most suitable for you.

Adult patients with high blood pressure: the usual dose is 80 mg once daily. In
some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg) or combine it
with another medicine (e.g. a diuretic).

Use in children and adolescents (aged 6 to 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 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 generally started as soon as possible,
within 12 hours after the heart attack, usually with a low starting dose of 20 mg twice daily. The
20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase
this dose over several weeks, up to a maximum of 160 mg twice daily. The final dose depends on the dose
you individually tolerate.
VALSARTAN DOC Generici may be given together with other treatments for heart attack,
and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: treatment is generally started with 40 mg twice daily. Your
doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice
daily. The final dose depends on the dose you individually tolerate.
VALSARTAN DOC Generici may be given together with other treatments for
heart failure, and your doctor will decide which treatment is most suitable for you.

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

If you take more VALSARTAN DOC Generici 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 DOC Generici
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 DOC Generici
Stopping treatment with VALSARTAN DOC Generici may cause your condition to worsen.
Do not stop using this medicine unless instructed by your doctor.

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.
These side 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 less 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 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, contact your doctor immediately.
The side effects include:
Common:

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

Uncommon:

• angioedema (see the section “Some symptoms 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 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
• diarrhoea
• fatigue
• weakness

Not known:

• 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 (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 proportion 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 irregular heartbeat in severe cases)
• increased liver function test 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 (azotemia) and increased serum creatinine levels (which may indicate kidney dysfunction)
• low sodium levels in the blood (which may cause tiredness, confusion, muscle spasms and/or seizures in more severe cases)

The frequency of some of these side effects may vary depending on your condition. For example, side effects such as dizziness and decreased 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 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 the website
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 DOC Generici

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

6. Package Contents and Other Information

What VALSARTAN DOC Generici 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.
• The other components are: tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silica; tablet coating: polyvinyl alcohol, macrogol 3350, talc, lecithin (contains soybean oil) (E322), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) [Only for 80 mg and 160 mg].

Description of the appearance of VALSARTAN DOC Generici and the contents of the pack
VALSARTAN DOC Generici 40 mg film-coated tablets: film-coated, yellow, oval, biconvex tablets, 9 x 4.5 mm, with a score line on one side and a "V" on the other.
VALSARTAN DOC Generici 80 mg film-coated tablets: film-coated, pink, round, biconvex tablets, 8 mm in diameter, with a score line on both sides and a "V" on one side.
VALSARTAN DOC Generici 160 mg film-coated tablets: film-coated, yellow, oval, biconvex tablets, 15 x 6.5 mm, with a score line on one side and a "V" on the other.
Pack sizes
PVC/PE/PVDC/aluminum blisters: 7, 14 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Manufacturer
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
Iceland: Docartan
Italy: VALSARTAN DOC Generici

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

VALSARTAN DOC Generici 320 mg film-coated tablets

Generic medicine
Please read this 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What VALSARTAN DOC Generici is and what it is used for

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

VALSARTAN DOC Generici 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 may damage the blood vessels of the brain, heart, and kidneys, 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 conditions.

2. What you should know before taking VALSARTAN DOC Generici

Do not take VALSARTAN DOC Generici:

• if you are allergic to valsartan or to any of the other ingredients of this medicine
• if you have severe liver disease
• if you are more than three months pregnant (it is better to avoid VALSARTAN DOC Generici even in the early stages of pregnancy – see section 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 DOC Generici.

Warnings and precautions
Talk to your doctor or pharmacist before taking VALSARTAN DOC Generici

• 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 had a kidney transplant
• 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 are taking medicines that increase potassium levels in the blood. These include potassium supplements, 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 DOC Generici in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and blood potassium levels at regular intervals
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of VALSARTAN DOC Generici is not recommended
• if you have fluid loss (dehydration) caused by diarrhoea, vomiting, or high-dose diuretics
• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). VALSARTAN DOC Generici 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 baby if taken during this period (see section Pregnancy)
• if you are taking any of the following medicines for 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 DOC Generici"
If any of these conditions apply to you, inform your doctor before taking
VALSARTAN DOC Generici.
Other medicines and VALSARTAN DOC Generici
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 DOC Generici is taken together with other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases stop taking 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)
• medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin
• some types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs)
• lithium, a medicine used in the treatment of certain psychiatric disorders

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take VALSARTAN DOC Generici" 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).

VALSARTAN DOC Generici with food and drink
VALSARTAN DOC Generici can be taken with or without food.

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

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking VALSARTAN DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. VALSARTAN DOC Generici 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 baby if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or are planning to breastfeed. VALSARTAN DOC Generici is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing any activity requiring concentration, you should be aware of how you react to VALSARTAN DOC Generici. Like many other medicines used to treat high blood pressure, VALSARTAN DOC Generici may rarely cause dizziness and affect your ability to concentrate.

VALSARTAN DOC Generici contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

VALSARTAN DOC Generici contains soya oil.
If you are allergic to peanuts or soya, do not take this medicine.

VALSARTAN DOC Generici contains Sunset Yellow FCF (E110) which may cause allergic reactions.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.

3. How to take VALSARTAN DOC Generici

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
People who suffer from high blood pressure often do not experience any symptoms and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

Adult patients with high blood pressure: the usual 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 it with another medicine (e.g. a diuretic).

Use in children and adolescents (aged between 6 and 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 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).

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

If you take more VALSARTAN DOC Generici 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 DOC Generici
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 DOC Generici
Stopping treatment with VALSARTAN DOC Generici may cause your condition to worsen. Do not discontinue use of this medicine unless instructed by your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side 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 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, seek medical advice immediately.
The side effects include:
Common:

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

Uncommon:

• angioedema (see section “Some symptoms 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 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

Not known:

• allergic reactions with skin rash, itching, and hives, fever, swollen joints and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of blood vessels 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 test values (which may indicate liver damage), including increased levels of bilirubin in the blood (which may cause yellowing of the skin and eyes in severe cases)
• increased blood urea nitrogen (BUN) and increased serum creatinine levels (which may indicate kidney dysfunction)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms and/or seizures in more severe cases)

The frequency of some of these side effects may vary depending on your condition. For example, side effects such as dizziness and decreased 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 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 DOC Generici

• Do not store above 30°C.
• 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 on the blister after "Exp". The expiry date refers to the last day of that month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VALSARTAN DOC Generici contains

• The active substance is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other components are: tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silica; tablet coating: polyvinyl alcohol, macrogol 3350, talc, lecithin (contains soybean oil) (E322), titanium dioxide (E171), black iron oxide (E172), sunset yellow FCF aluminium lake (E110).

Description of the appearance of VALSARTAN DOC Generici and contents of the pack
VALSARTAN DOC Generici 320 mg film-coated tablets: film-coated tablets, brown, oval, biconvex, 19 x 8.2 mm, with a score line on one side and a score line and a "V" imprinted on the other side.
Packs
PVC/PE/PVDC/aluminium blister: 28 tablets.
Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy
Manufacturer:
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This medicinal product is authorized in the European Economic Area countries under the
following names:
Iceland: Docartan
Italy: VALSARTAN DOC Generici