Tareg

Package leaflet: Information for the user

Tareg 3 mg/ml oral solution

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 other people, even if their symptoms are the same as yours, because it may 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 Tareg is and what it is used for
2. What you need to know before taking Tareg
3. How to take Tareg
4. Possible side effects
5. How to store Tareg
6. Contents of the pack and other information Instructions for use of the oral administration syringe and dosing cup

1. What Tareg is and what it is used for

Tareg 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. Tareg works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Tareg 3 mg/ml oral solution can be used for the treatment of high blood pressure in children and adolescents aged 6 to 18 years. When blood pressure is high, the workload on the heart and arteries increases. Over time, this may damage the blood vessels of the brain, heart, and kidneys, potentially leading 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 conditions.

2. What you should know before taking Tareg

Do not take Tareg

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of Tareg listed at the end of this leaflet.
• if you have a severe liver disease.
• if you are more than three months pregnant (it is better to avoid taking Tareg 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. If any of the above conditions apply to you, consult your doctor and do not take Tareg.

Warnings and precautions
Talk to your doctor

• 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 have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Tareg, stop taking Tareg 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 have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Tareg is not recommended.
• if you have fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
• 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 Tareg”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Tareg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section on Pregnancy).

Other medicines and Tareg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be altered if Tareg is taken with certain 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, even those not requiring a prescription, especially:

• other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also sections “Do not take Tareg” and “Warnings and precautions”).
• medicines that increase potassium levels in the blood, such as potassium supplements, 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 drug used to prevent transplant rejection (cyclosporine), and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Tareg.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

Pregnancy and breastfeeding

• Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Tareg before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Tareg. Tareg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Tareg is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing other activities requiring concentration, make sure you know how Tareg affects you. Like many other medicines used to treat high blood pressure, Tareg may rarely cause dizziness and affect your ability to concentrate.

Tareg contains sucrose, methyl parahydroxybenzoate, and a poloxamer

• Tareg solution contains 0.3 g of sucrose per millilitre. Take this into account if you have diabetes mellitus. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking Tareg solution. The amount of sucrose in Tareg solution may be harmful to the teeth.
• Tareg solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions, even some time after taking the solution. Signs may include skin rash, itching, or hives. If any of these side effects worsen, inform your doctor.
• Tareg solution contains a poloxamer (188), which may cause soft stools.

3. How to take Tareg

Take Tareg exactly as directed by your doctor 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 notice any symptoms and many 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.

Read the instructions at the end of this leaflet before using the oral syringe or dosing cup.

How much Tareg to take

Tareg solution should be taken once daily.

• If you weigh less than 35 kg: the usual dose is 20 mg of valsartan (corresponding to 7 ml of solution).
• If you weigh 35 kg or more: the usual dose is 40 mg of valsartan (corresponding to 13 ml of solution).

In some cases, your doctor may instruct you to take:

• up to 40 mg of valsartan (corresponding to 13 ml of solution) for those weighing less than 35 kg;
• up to 80 mg of valsartan (corresponding to 27 ml of solution) for those weighing 35 kg or more.

You may take Tareg with or without food.
Take Tareg at approximately the same time each day.

If you take more Tareg than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too much Tareg solution, contact your doctor, pharmacist, or hospital.

If you forget to take Tareg

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 the forgotten dose.

If you stop taking Tareg

Stopping treatment with Tareg may cause your condition to worsen. Do not stop using this medicine unless instructed by your doctor.

If you have any doubts 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
everyone experiences them.
Some side effects can 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 pharynx
• difficulty breathing or swallowing
• hives, itching
  If you experience any of these symptoms, stop taking Tareg and contact your doctor
  immediately (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 upon standing
• reduced kidney function test values (sign of kidney dysfunction)

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 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 feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

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

• formation of blisters on the skin (sign of bullous dermatitis)
• allergic reactions such as 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 known as vasculitis)
• bleeding or bruising more easily than usual (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 irregular heartbeat 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 serum creatinine levels (which may indicate abnormal kidney function)

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 values 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, 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,
please inform your doctor or pharmacist. You may also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you
can help provide more information on the safety of this medicine.

5. How to store Tareg

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
• Do not store above 30°C. After opening, the bottle may be stored for up to 3 months at temperatures below 30°C.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tareg contains

• The active substance is valsartan.
• 1 ml of oral solution contains 3 mg of valsartan.
• The other components are sucrose, methyl 4-hydroxybenzoate (E218), potassium sorbate, poloxamer (188), anhydrous citric acid, sodium citrate, artificial blueberry flavour, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water.

Description of the appearance of Tareg and contents of the pack
Tareg 3 mg/ml oral solution is a clear, colourless to pale yellow solution.

• The solution is supplied in a pack containing an amber glass bottle of 180 ml with a child-resistant screw cap and a yellow tamper-evident ring. The bottle contains 160 ml of solution. It is available with a kit containing a press-in adapter for the bottle, a 5 ml oral dosing syringe made of polypropylene, and a 30 ml dosing cup made of polypropylene.

Marketing Authorization Holder
NOVARTIS FARMA S.P.A.
LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO, VARESE,
Manufacturer responsible for batch release
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
For further information on this medicinal product, please contact the Marketing Authorization Holder.
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

INSTRUCTIONS FOR USE OF THE ORAL DOSING SYRINGE AND DOSING CUP
Read these instructions carefully before taking the medicine. They will help you to
use the oral dosing syringe and dosing cup correctly.

What you will use

A bottle adapter:

• which must be inserted into the neck of the bottle.
• once inserted, it must not be removed.

A bottle containing the medicine:

• which has a child-resistant screw cap.
• Always replace and tighten the screw cap after use.

An oral dosing syringe:

• consisting of a transparent plastic tube with a plunger inside.
• The oral dosing syringe is inserted into the bottle adapter and is used to measure the required amount of medicine from the bottle. Use a new bottle adapter and a new oral dosing syringe each time

a new bottle of
medicine is started.

A dosing cup:

• which may be used if the prescribed dose requires filling the syringe more than once.
• After use and cleaning, always place the dosing cup back on top of the screw cap.

Inserting the bottle adapter into a new medicine bottle

1. Remove the screw cap by pressing down firmly and turning counterclockwise (as indicated above the screw cap).
2. Hold the open bottle upright on a table and press the bottle adapter firmly into the neck of the bottle until fully seated.

Note: You may not be able to push the adapter all the way in at this stage, but this is not a problem, as it will be fully secured when you replace and tighten the screw cap.

3. Replace and tighten the screw cap on the bottle.

Preparing a dose of the medicine

4. Remove the screw cap by pressing down firmly and turning counterclockwise (as indicated above the screw cap).
5. Check that the plunger is fully pushed into the oral dosing syringe.
6. Holding the bottle upright, insert the oral dosing syringe firmly into the bottle adapter.
7. While keeping the syringe in place, carefully invert the bottle and syringe.
8. Before measuring the dose, any large air bubble trapped in the oral dosing syringe must be removed. To do this:
   • slowly pull the plunger down to completely fill the oral dosing syringe with medicine;
   • then push the plunger back up to completely empty the syringe.

Measuring the dose of medicine
Note: The maximum volume that can be measured in the oral dosing syringe is 5 ml. Depending on the prescribed dose, steps 10 to 16 may need to be repeated several times. For example, if the prescribed dose is 13 ml, the solution must be measured in three separate steps: 5 ml + 5 ml + 3 ml.

9. Identify on the oral dosing syringe the mark corresponding to the required amount of medicine.
10. Slowly pull the plunger until the top edge of the black ring inside aligns exactly with the mark.
11. Carefully return the bottle and oral dosing syringe to an upright position.
12. Remove the oral dosing syringe from the bottle adapter with a gentle rotating motion.

Taking the medicine

13. Sit or stand upright.
14. Place the tip of the oral dosing syringe into the mouth.
15. Slowly push the plunger and swallow the medicine directly from the oral dosing syringe.
16. If the prescribed dose requires multiple fillings of the syringe, you may pour the measured doses of medicine from the syringe into the dosing cup and then check the total volume of the solution.
17. Drink all the solution immediately.
18. Replace and tighten the child-resistant screw cap after use.
19. Cleaning the oral dosing syringe

• Wipe the outside of the oral dosing syringe with a clean, dry cloth.
• Do this every time after using the oral dosing syringe.

20. Cleaning the dosing cup

• Rinse the dosing cup with water.
• Dry the dosing cup with a clean cloth and place it back on top of the bottle cap.

Instructions for the user: package leaflet

Tareg 40 mg film-coated tablets, 80 mg film-coated tablets, 160 mg film-coated tablets, 320 mg film-coated tablets

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 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 Tareg is and what it is used for
2. What you need to know before taking Tareg
3. How to take Tareg
4. Possible side effects
5. How to store Tareg
6. Package contents and other information

1. What Tareg is and what it is used for

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

Tareg 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 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, 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. Tareg 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 treating heart failure 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 all parts of the body with the required amount of blood.

Tareg 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 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, leading 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 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. Tareg 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 treating heart failure 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 all parts of the body with the required amount of blood.

Tareg 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 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, leading 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 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. Tareg 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 treating heart failure 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 all parts of the body with the required amount of blood.

Tareg 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 in the brain, heart, and kidneys, leading 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 conditions.

2. What you should know before taking Tareg

Do not take Tareg

• if you are allergic (hypersensitive) 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 Tareg 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 the above conditions apply to you, consult your doctor and do not take Tareg.

Warnings and precautions
Consult your doctor

• 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 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 when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Tareg, stop taking Tareg immediately and never take it again. See 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 the adrenal glands produce too much aldosterone hormone. In this case, the use of Tareg is not recommended.
• if you have experienced fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
• 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 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 Tareg”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Tareg is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section Pregnancy).

Other medicines and Tareg
Inform 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 Tareg is taken with certain 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 obtained without 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 the sections “Do not take Tareg” and “Warnings and precautions”).
• medicines that increase potassium levels in the blood, such as 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), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Tareg.
• 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 used to treat heart attack) is not recommended.
• if you are being treated for heart failure, the triple combination 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.

Pregnancy and breastfeeding

• 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 Tareg before becoming pregnant or as soon as you learn you are pregnant, and will recommend an alternative medicine to Tareg. Tareg is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe 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. Tareg 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 Tareg. Like many other medicines used to treat high blood pressure, Tareg may rarely cause dizziness and affect your ability to concentrate.

3. How to use Tareg

Take this medicine exactly as your doctor has instructed you,
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 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.

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 combine it with another medicine (e.g. a diuretic).

Children and adolescents (aged between 6 and 18 years) with high blood pressure
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 recommended 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
after 12 hours from 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.

Tareg 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 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.

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

Take Tareg at approximately the same time each day.

If you take more Tareg 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 Tareg
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 the forgotten dose.

If you stop taking Tareg
Stopping treatment with Tareg may cause your condition to worsen.
Do not discontinue the medicine unless instructed by your doctor.

If you have any doubts 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 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 Tareg and contact your doctor 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 upon standing
• reduced kidney function (a sign 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 dizziness (vertigo)
• severely reduced kidney function (a sign of acute kidney injury)
• 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 (frequency cannot be estimated from the available data)

• formation of blisters on the skin (a sign of bullous dermatitis)
• 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 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 blood bilirubin levels (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, mental 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 decreased liver 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.
In children and adolescents, 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/it/responsabili. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store Tareg

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton. 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 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 Tareg contains

• The active substance is valsartan.
• Each film-coated tablet contains 40 mg, 80 mg, 160 mg or 320 mg of valsartan.
• The other components are: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate.
• The tablet coating contains: hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172, only in 40 mg, 160 mg and 320 mg tablets).

Description of the appearance of Tareg and contents of the pack
Tareg 40 mg film-coated tablets are yellow, ovaloid tablets with a score line on one side. The letters “D/O” are engraved on one side and “NVR” on the opposite side of the tablet. The tablet can be divided into two equal halves.
Tareg 80 mg film-coated tablets are light red, round tablets with a score line on one side. The letters “D/V” are engraved on one side and “NVR” on the opposite side of the tablet. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and is not intended to allow division into equal doses.
Tareg 160 mg film-coated tablets are orange-grey, ovaloid tablets with a score line on one side. The letters “DX/DX” are engraved on one side and “NVR” on the opposite side of the tablet. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and is not intended to allow division into equal doses.
Tareg 320 mg film-coated tablets are grey-violet, ovaloid tablets with bevelled edges and a score line on one side. On either side of the score line, the letters “DC” appear, one on each side of the line, and “NVR” on the opposite side of the tablet. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and is not intended to allow division into equal doses.
The tablets are available in blisters of 7, 14, 28, 30, 56, 90 or 98 tablets, and in calendar blisters of 14, 28, 56, 98 and 280 tablets. Additionally, there are divisible unit-dose blisters containing 56x1, 98x1 or 280x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
NOVARTIS FARMA S.P.A.
LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO, VARESE, Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy

For further information about this medicinal product, please contact the Marketing Authorization Holder.

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tareg 80 mg capsule, 160 mg capsule

Valsartan
Read this leaflet carefully before taking this medicine.

• 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. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tareg is and what it is used for

Tareg 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. Tareg works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Tareg 80 mg hard capsules can be used to treat three different conditions:

• in the treatment of high blood pressure. High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage blood vessels in the brain, heart, and kidneys, leading 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 conditions.
• in the treatment of people who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• in the treatment of symptomatic heart failure. Tareg 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 treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. Heart failure means that the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the blood they need.

Tareg 160 mg hard capsules can be used to treat three different conditions:

• in the treatment of high blood pressure. High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage blood vessels in the brain, heart, and kidneys, leading 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 conditions.

• in the treatment of people who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.

• in the treatment of symptomatic heart failure. Tareg 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 treating heart failure 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 all parts of the body with the blood they need.

2. What you should know before taking Tareg

Do not take Tareg

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from severe liver disease.
• if you are more than three months pregnant (it is better to avoid using Tareg even during the first months 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 the above conditions apply to you, consult your doctor and do not take Tareg.

Warnings and precautions
Consult your doctor

• 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 have serious heart problems other than heart failure or myocardial infarction.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Tareg, stop taking Tareg immediately and never take it again. See section 4, “Possible side effects”.
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly monitor your blood potassium levels.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Tareg is not recommended.
• if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting, or high-dose diuretics.
• use of Tareg is not recommended in children and adolescents (under 18 years of age).
• if you are taking any of the following classes of 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,
  • or 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 check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the section “Do not take Tareg”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Tareg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child if taken during this period (see section on Pregnancy).

Other medicines and Tareg
Inform 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 Tareg is taken with certain 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, even those without a prescription, especially:

• other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the sections “Do not take Tareg” and “Warnings and precautions”).
• medicines that increase potassium levels in the blood, such as potassium supplements, 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), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Tareg.
• 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., metoprolol), is not recommended.

Pregnancy and breastfeeding

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Tareg before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Tareg. Tareg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.

• Inform your doctor if you are breastfeeding or planning to breastfeed. Tareg is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

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

3. How to use Tareg

Take this medicine exactly as prescribed 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 noticeable symptoms and may feel perfectly well. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

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 combine it with another medicine (e.g. a diuretic).

After a recent heart attack: Treatment is generally started as soon as possible after 12 hours from the heart attack, usually with a low starting dose of 20 mg twice daily. The 20 mg dose is obtained by splitting 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.

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

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.

Tareg 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 Tareg with or without food. Swallow the capsule with a glass of water.

Take Tareg at approximately the same time each day.

If you take more Tareg 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 capsules, contact your doctor, pharmacist, or hospital.

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

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 everyone gets them.
Some side effects may be serious and require immediate medical attention:
If you experience symptoms of angioedema, such as:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives and breathing difficulties
  If you experience any of these symptoms, stop taking Tareg immediately and contact your doctor (see also section 2 “Warnings and precautions”).

Other side effects include:
Common (may affect up to 1 in 10 people):

• dizziness, postural dizziness (related to position, e.g. lying down or sitting)
• low blood pressure accompanied by symptoms such as dizziness
• reduced kidney function (sign of renal dysfunction)

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

• allergic reaction with symptoms such as skin rash, itching, dizziness, swelling of the face or lips, tongue or throat, difficulty breathing or swallowing (signs of angioedema)
• sudden loss of consciousness
• sensation of dizziness
• severely reduced kidney function (sign of acute renal failure)
• muscle cramps, irregular heartbeat (signs of high potassium levels in the blood)
• 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 available data)

• formation of blisters on the skin (sign of bullous dermatitis)
• skin rash, itching, associated with one or more of the following signs or symptoms: fever, 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 percentage of red blood cells in the blood (which, in severe cases, may lead to anaemia)
• increased potassium levels in the blood (which, in severe cases, may cause muscle cramps and irregular heartbeat)
• increased liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and serum creatinine levels (which may indicate kidney dysfunction)
• low sodium levels in the blood (which may cause fatigue, mental confusion, muscle twitching and/or seizures in 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 patients treated for high blood pressure than in patients treated for heart failure or after a recent heart attack.

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/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tareg

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original packaging to protect the medicine from moisture and heat.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of 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 Tareg contains

• The active substance is valsartan. Each capsule contains 80 mg or 160 mg of valsartan.
• The other components are: microcrystalline cellulose, povidone, sodium lauryl sulfate, crospovidone type A and magnesium stearate.
• The capsule shell contains gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172).
• The printing ink contains lacquer, industrial denatured alcohol 74 OP, black iron oxide (E172, 80 mg only) and titanium dioxide (E171, 160 mg only).

Marketing Authorization Holder
NOVARTIS FARMA S.P.A.
LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO, VARESE
Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
For further information about this medicinal product, please contact the Marketing Authorization Holder.
This medicinal product is authorized in the European Economic Area Member States under the
following names: