Valsartan Tecnigen: detailed information

Package leaflet: Information for the user

Valsartan TecniGen 40 mg film-coated tablets

Generic medicine
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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Valsartan TecniGen 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 TecniGen works by blocking the effects of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartan TecniGen 40 mg film-coated tablets can be used for three different conditions:

treatment of high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these complications.
treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
treatment of symptomatic heart failure in adult patients. Valsartan TecniGen is used when medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for treating heart failure) cannot be used, or it may be used in addition to ACE inhibitors when other heart failure treatments cannot be used.

Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This occurs when the heart muscle is unable to pump blood strongly enough to supply adequate blood flow to all parts of the body.

2. What you need to know before taking Valsartan TecniGen

Do not take Valsartan TecniGen

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 (use of Valsartan TecniGen is advised against even in early 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 these conditions apply to you, do not take Valsartan TecniGen.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Valsartan TecniGen

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 (if 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 serious heart problems other than heart failure or heart attack.
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur when taking Valsartan TecniGen, stop taking it immediately and do not 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 drugs, and heparin. Regular monitoring of blood potassium levels may be necessary.
if you are under 18 years of age and taking Valsartan TecniGen in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
if you have aldosteronism, a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. In this case, use of Valsartan TecniGen is not recommended.
if you have fluid loss (dehydration) caused by diarrhea, vomiting, or high-dose diuretics.
you must inform your doctor if you think you are pregnant (or planning to become pregnant). Valsartan TecniGen is not recommended in early pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the baby if taken during this period (see section on pregnancy).
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren
if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section "Do not take Valsartan TecniGen".
Other medicines and Valsartan TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 TecniGen" 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., metoprolol).
The effect of treatment may be affected if Valsartan TecniGen 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 both to prescription and non-prescription medicines, particularly:

other medicines that lower blood pressure, especially those that increase fluid elimination (diuretics).
medicines that increase potassium levels in the blood, including potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
some antibiotics (such as rifampicin), cyclosporine (a medicine used to prevent transplant rejection), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan TecniGen.
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 with ACE inhibitors and beta-blockers (medicines for treating heart failure) is not recommended.

Valsartan TecniGen with food, drinks, and alcohol
Valsartan TecniGen can be taken with or without food.
Pregnancy, breastfeeding, and fertility
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 planning to become pregnant). Normally, your doctor will advise you to stop taking Valsartan TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valsartan TecniGen. Valsartan TecniGen is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken after this time.
Inform your doctor if you are breastfeeding or planning to start breastfeeding. The use of Valsartan TecniGen is not recommended during 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 a vehicle, operating tools or machinery, or performing other activities requiring concentration, make sure you know how Valsartan TecniGen affects you.
Like many other medicines used to treat high blood pressure, Valsartan TecniGen may, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan TecniGen

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often
do not experience any symptoms and usually feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, 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 a higher dose (e.g. 160 mg or 320 mg) or may combine it with another medicine, for example a diuretic.
Children and adolescents (aged 6 to 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 starting dose is 80 mg of valsartan once daily.
In some cases, your doctor may prescribe higher doses (the dose may be increased up to a maximum of 160 mg or 320 mg).
Adult patients after a recent heart attack
After a heart attack, treatment is usually started within 12 hours of the event, typically with a low starting dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you can individually tolerate.
Valsartan TecniGen 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 the dose over several weeks up to a maximum of 160 mg twice daily.
The final dose depends on the dose you can individually tolerate.
Valsartan TecniGen 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 TecniGen with or without food. Swallow the tablet with a glass of water.
Take Valsartan TecniGen at approximately the same time each day.
The tablet may be divided into equal parts.
If you take more Valsartan TecniGen 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 TecniGen
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 Valsartan TecniGen
Stopping treatment with Valsartan TecniGen may cause your condition to worsen. Do not discontinue the medicine unless your doctor tells you to do so.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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
urticaria (itchy rash), itching

If you experience any of these symptoms, consult your doctor immediately (see section 2 “Warnings and precautions”).

The side effects include:

Common

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

Uncommon

angioedema (see section “Some symptoms require immediate medical attention”)
sudden loss of consciousness (syncope)
sensation of dizziness (vertigo)
severely reduced kidney function (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

Frequency not known

formation of blisters on the skin (sign of bullous dermatitis)
allergic reactions with rash, itching and urticaria (itchy rash); symptoms such as fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
red papules, fever, itching (signs of inflammation of blood vessels 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 bilirubin in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle spasms and/or seizures)

The frequency of some of these 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 compared to 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 Valsartan TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines 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 TecniGen contains

The active substance is valsartan 40 mg.
The other components are: microcrystalline cellulose, crospovidone (Type A) and magnesium stearate.
The tablet coating contains hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Valsartan TecniGen and contents of the pack
Valsartan TecniGen 40 mg film-coated tablets are yellow, round, biconvex, film-coated tablets with a score on one side.
Pack containing 14 film-coated tablets.

Marketing Authorization Holder
Tecnimede - Sociedade Técnico Medicinal S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra
Portugal

Marketing Authorization Sub-licensee
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus nº11, Venda Nova
2700-486 Amadora
Portugal

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande nº 2, Abrunheira
2710 – 089 Sintra
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Valsartan Coratenz
Italy: Valsartan TecniGen 40 mg film-coated tablets

Package leaflet: Information for the user

Valsartan TecniGen 80 mg film-coated tablets

Equivalent 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, pharmacist, or nurse.
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 effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Valsartan TecniGen 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 TecniGen works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Valsartan TecniGen 80 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 of the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart and kidneys, and may lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. By lowering blood pressure to normal levels, the risk of developing these disorders is reduced.
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 TecniGen is used when medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (medicines for the treatment of heart failure) cannot be used, or it may be used in addition to ACE inhibitors when other medicines for the treatment of heart failure cannot be used.

2. What you need to know before taking Valsartan TecniGen

Do not take Valsartan TecniGen

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 advisable to avoid using Valsartan TecniGen even in early pregnancy – see the section on pregnancy).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, do not take Valsartan TecniGen.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Valsartan TecniGen

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 (if 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 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 Valsartan TecniGen, stop taking it 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 drugs, and heparin. You may need to have your blood potassium levels checked regularly.
if you are under 18 years of age and taking Valsartan TecniGen in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
if you have aldosteronism, a condition in which the adrenal glands produce excess aldosterone hormone. In this case, use of Valsartan TecniGen 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 planning to become pregnant). Valsartan TecniGen 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 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 other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section "Do not take Valsartan TecniGen"
Other medicines and Valsartan TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 TecniGen" 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).

The effect of treatment may be affected if Valsartan TecniGen 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 both to prescription and non-prescription medicines, especially:

other medicines that lower blood pressure, particularly those that increase fluid elimination ( diuretics ).
medicines that increase potassium levels in the blood, including potassium supplements or 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.

In addition:

if you are being treated after a heart attack, concomitant use with ACE inhibitors (medicines for treating heart attack) is not recommended.
certain 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 Valsartan TecniGen.

Valsartan TecniGen with food, drinks and alcohol
Valsartan TecniGen can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, 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 are pregnant (or planning to become pregnant). Usually, your doctor will advise you to stop taking Valsartan TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartan TecniGen. Valsartan TecniGen 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 after the third month.
Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Valsartan TecniGen is not recommended during 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 tools or machinery, or performing other activities requiring concentration, make sure you are aware of how Valsartan TecniGen affects you.
Like many other medicines used to treat high blood pressure, Valsartan TecniGen may, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan TecniGen

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often
do not notice any signs of this condition and usually feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, 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 a higher dose (e.g. 160 mg or 320 mg) or combine it with another medicine (e.g. a diuretic).

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

Children and adolescents (aged 6 to 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 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, up to a maximum of 320 mg).

Adult patients after a recent heart attack
Treatment is usually started within 12 hours after the heart attack, generally 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 can individually tolerate.

Valsartan TecniGen 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 at 40 mg twice daily. Your doctor will gradually increase the dose over several weeks, up to a maximum of 160 mg twice daily.
The final dose depends on the dose you can individually tolerate.
Valsartan TecniGen 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 TecniGen with or without food. Swallow the tablet with a glass of water.
Take Valsartan TecniGen at approximately the same time each day.
The tablet may be divided into equal parts.

If you take more Valsartan TecniGen 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 TecniGen
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 TecniGen
Stopping treatment with Valsartan TecniGen may cause your condition to worsen. Do not discontinue use of this medicine unless your doctor tells you to do so.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
These side effects may occur at certain frequencies, defined as follows:
very common: affects more than 1 in 10 people
common: affects 1 to 10 in 100 people
uncommon: affects 1 to 10 in 1,000 people
rare: affects 1 to 10 in 10,000 people
very rare: affects fewer than 1 in 10,000 people
not known: frequency cannot be estimated from the available data.

Some symptoms require immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as:

swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives (itchy rash), itching

If you experience any of these symptoms, contact your doctor immediately (see section 2 “Warnings and precautions”).

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 damage)

Uncommon

angioedema (see section “Some symptoms require immediate medical attention”)
sudden loss of consciousness (syncope)
feeling 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

Frequency not known

formation of blisters on the skin (sign of bullous dermatitis)
allergic reactions with rash, itching and hives (itchy rash); fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
red spots (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, 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 bilirubin in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle spasms and/or seizures)

The frequency of some of these 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 compared to adult 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, pharmacist or nurse.
You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan TecniGen

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 packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from light.
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 Valsartan TecniGen contains

The active substance is valsartan 80 mg.
The other components are: microcrystalline cellulose, crosspovidone (Type A) and magnesium stearate.
The tablet coating contains hypromellose, titanium dioxide (E171), polyethylene glycol 8000, red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Valsartan TecniGen and package contents
Valsartan TecniGen 80 mg film-coated tablets are pink, round, biconvex, film-coated tablets with a score on one side.
Pack size: 28 film-coated tablets.
Marketing Authorization Holder
Tecnimede - Sociedade Técnico Medicinal S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra
Portugal
Marketing Authorization Holder's Representative for Sale
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy
Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus nº11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande nº 2, Abrunheira
2710 – 089 Sintra
Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Valsartan Coratenz
Italy: Valsartan TecniGen

Package leaflet: Information for the user

Valsartan TecniGen 160 mg film-coated tablets

Valsartan
Generic medicine
Please read this entire 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, consult your doctor, pharmacist, or nurse.
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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Valsartan TecniGen is and what it is used for
What you need to know before taking Valsartan TecniGen
How to take Valsartan TecniGen
Possible side effects
How to store Valsartan TecniGen
Package contents and other information

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

Valsartan TecniGen 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 TecniGen works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Valsartan TecniGen 160 mg film-coated tablets can be used for three different conditions:

in the treatment of high blood pressure in adults and 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 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 adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
in the treatment of symptomatic heart failure in adult patients. Valsartan TecniGen is used when medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for the treatment of heart failure) cannot be used, or it may be used in addition to ACE inhibitors.

when other medicines for the treatment of heart failure cannot be used.
Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This occurs when the heart muscle is unable to pump blood strongly enough to supply adequate blood flow to all parts of the body.

2. What you need to know before taking Valsartan TecniGen

Do not take Valsartan TecniGen

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 (use of Valsartan TecniGen is not recommended even in early pregnancy – see the section on pregnancy).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, do not take Valsartan TecniGen.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Valsartan TecniGen

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 (if 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 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 Valsartan TecniGen, stop taking Valsartan TecniGen 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. You may need to have your blood potassium levels checked at regular intervals.
if you are under 18 years of age and taking Valsartan TecniGen in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to lower blood pressure), your doctor may monitor 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 TecniGen 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 may be pregnant (or are planning to become pregnant). Valsartan TecniGen is not recommended in 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 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 other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section "Do not take Valsartan TecniGen".
Other medicines and Valsartan TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Valsartan TecniGen" 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., metoprolol).
The effect of treatment may be affected if Valsartan TecniGen 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 both prescription and non-prescription medicines, particularly:

other medicines that lower blood pressure, especially those that increase fluid elimination (diuretics).
medicines that increase potassium levels in the blood, including 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 disorders.

In addition:

if you are being treated after a heart attack, concomitant use with ACE inhibitors (medicines used to treat heart attack) is not recommended.
certain 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 Valsartan TecniGen.

You must inform your doctor if you think you are pregnant (or planning to become pregnant). Your doctor will usually advise you to stop taking Valsartan TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Valsartan TecniGen. Valsartan TecniGen is not recommended in 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 after this time.
Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Valsartan TecniGen is not recommended during 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 tools or machinery, or performing other activities requiring concentration, make sure you are aware of how Valsartan TecniGen affects you. Like many other medicines used to treat high blood pressure, Valsartan TecniGen may, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan TecniGen

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often
do not notice any symptoms and usually feel just as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, 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 a higher dose (e.g. 160 mg or 320 mg), or may combine it with another medicine (e.g. a diuretic).

Children and adolescents (aged 6 to 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 initial 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, up to a maximum of 320 mg).

If you stop taking Valsartan TecniGen
Stopping treatment with Valsartan TecniGen may cause your condition to worsen. Do not stop using this medicine unless your doctor tells you to.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 allergic reaction), such as:

swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives (itchy rash), itching

If you experience any of these symptoms, consult your doctor immediately (see section 2 “Warnings and precautions”).

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 damage)

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 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

Frequency not known

formation of blisters on the skin (sign of bullous dermatitis)
allergic reactions with skin rash, itching and hives (itchy rash); symptoms such as fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
red papules, fever, itching (signs of inflammation of blood vessels 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 bilirubin in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle spasms and/or seizures)

The frequency of some of these 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 compared to adult 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, pharmacist or nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan TecniGen

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. Store in the original packaging to protect the medicine from light.
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 Valsartan TecniGen contains

The active substance is valsartan 160 mg.
The other components are: microcrystalline cellulose, crospovidone (Type A) and 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).

Description of the appearance of Valsartan TecniGen and pack contents
Valsartan TecniGen 160 mg film-coated tablets are film-coated, yellow to orange in colour, oblong-shaped tablets with a score on one side.
Pack size: 28 film-coated tablets.

Marketing Authorisation Holder
Tecnimede - Sociedade Técnico Medicinal S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra
Portugal

Supplier for sale
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy

Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus nº11, Venda Nova
2700-486 Amadora
Portugal

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande nº 2, Abrunheira
2710 – 089 Sintra
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Valsartan Coratenz
Italy: Valsartan TecniGen

Package leaflet: Information for the user

Valsartan TecniGen 320 mg film-coated tablets

Valsartan
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, consult your doctor, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Valsartan TecniGen 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 TecniGen works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Valsartan TecniGen 320 mg film-coated tablets can be used:

for the treatment of high blood pressure in adults and in children and adolescents from 6 to 18 years of age. 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. By lowering blood pressure to normal levels, the risk of developing these conditions is reduced.

2. What you need to know before taking Valsartan TecniGen

Do not take Valsartan TecniGen

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 (use of Valsartan TecniGen is also not recommended in early 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 these conditions apply to you, do not take Valsartan TecniGen.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Valsartan TecniGen

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 (if 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 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 Valsartan TecniGen, stop taking it 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 drugs, and heparin. Regular monitoring of blood potassium levels may be necessary.
if you are under 18 years of age and taking Valsartan TecniGen in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
if you suffer from aldosteronism, a condition in which the adrenal glands produce excess aldosterone hormone. In this case, use of Valsartan TecniGen 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 planning to become pregnant). Valsartan TecniGen is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken during this period (see section on pregnancy).
If you are taking any of the following medicines used to treat high blood pressure:
An "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren

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 TecniGen".
Other medicines and Valsartan TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
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 TecniGen" and "Warnings and precautions").
The effect of treatment may be altered if Valsartan TecniGen 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 both prescription and over-the-counter medicines, especially:

other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics).
medicines that increase potassium levels in the blood, including potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
some types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
certain 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 Valsartan TecniGen.
lithium, a medicine used in the treatment of certain psychiatric disorders.

Valsartan TecniGen with food, drinks and alcohol
Valsartan TecniGen can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.

You must inform your doctor if you think you are pregnant (or planning to become pregnant). Your doctor will usually advise you to stop taking Valsartan TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan TecniGen is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken beyond the third month of pregnancy.
Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Valsartan TecniGen is not recommended during 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 a vehicle, operating tools or machinery, or performing other activities requiring concentration, make sure you are aware of how Valsartan TecniGen affects you.
Like many other medicines used to treat high blood pressure, Valsartan TecniGen may, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan TecniGen

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. People with 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 if you feel well.

You may take Valsartan TecniGen with or without food. Swallow the tablet with a glass of water.
Take Valsartan TecniGen at approximately the same time each day.
The break line on the tablet is intended to facilitate splitting the tablet if you have difficulty swallowing it whole.

If you stop taking Valsartan TecniGen
Stopping treatment with Valsartan TecniGen may cause your condition to worsen. Do not discontinue use of this medicine unless your doctor tells you to do so.

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

4. Possible side effects

Some symptoms require immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as:

swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives (itchy rash), itching

If you experience any of these symptoms, consult your doctor immediately (see section 2 “Warnings and precautions”).

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 damage)

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
diarrhoea
fatigue
weakness

Frequency not known

blistering of the skin (sign of bullous dermatitis)
allergic reactions with rash, itching and hives (itchy rash); symptoms such as fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
red papules, fever, itching (signs of inflammation of blood vessels 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 reduced 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 bilirubin in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle spasms and/or seizures)

The frequency of some of these 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan TecniGen

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. Store in the original packaging to protect the medicine from light.
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 Valsartan TecniGen contains

The active substance is valsartan 320 mg.
The other components are: microcrystalline cellulose, crospovidone (Type A) and 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).

Description of the appearance of Valsartan TecniGen and package contents
Valsartan TecniGen 320 mg film-coated tablets are brownish, oblong, biconvex film-coated tablets with a score on one side.
Pack size: 28 film-coated tablets.

Marketing Authorization Holder
Tecnimede - Sociedade Técnico Medicinal S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra
Portugal

Marketing Authorization Holder's Representative for Sale
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Italy

Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus nº11, Venda Nova
2700-486 Amadora
Portugal

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande nº 2, Abrunheira
2710 – 089 Sintra
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Valsartan Coratenz
Italy: Valsartan TecniGen