Patient Information Leaflet

Valsartan Mylan Generics 40mg Film-coated Tablets

Generic medicine
valsartan
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan Mylan Generics is and what it is used for

Valsartan Mylan Generics 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 Mylan Generics works by blocking the effect of angiotensin II. As a result, blood vessels widen and blood pressure decreases.

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

Treatment of high blood pressure 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 blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
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 Mylan Generics 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 buildup. This condition occurs when the heart muscle is unable to pump blood strongly enough to supply adequate blood to all parts of the body.

2. What you need to know before taking Valsartan Mylan Generics

Do not take Valsartan Mylan Generics

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 Mylan Generics is not recommended 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 Mylan Generics
Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan Mylan Generics:

if you have liver disease.
if you have severe kidney problems or are undergoing dialysis.
if you suffer from renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant (received a new kidney).
if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function.
if you have serious heart problems other than heart failure or heart attack.
if you are taking medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need regular monitoring of your blood potassium levels.
if you are under 18 years of age and are taking Valsartan Mylan Generics in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and blood potassium levels at regular intervals.
if you have aldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Mylan Generics is not recommended.
if you have experienced significant fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
you must inform your doctor if you think you are pregnant (or planning to become pregnant). Valsartan Mylan Generics 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 baby if taken during this period (see section on pregnancy).
inform your doctor if you have ever had swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors). If these symptoms occur while you are taking

Valsartan Mylan Generics, stop taking Valsartan Mylan Generics immediately
and do not take it again. See also section 4 "Possible side effects".

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 for 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 information in the section “Do not take Valsartan Mylan Generics”.
If any of these conditions apply to you, inform your doctor before taking
Valsartan Mylan Generics.
Other medicines and Valsartan Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
The effect of treatment may be affected if Valsartan Mylan Generics is taken with certain
other medicines. It may be necessary to adjust the dose, take additional precautions, or, in
some cases, discontinue one of the medicines. This applies to both prescription and
non-prescription medicines, especially:

other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics).
medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
certain types of pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
lithium, a medicine used in the treatment of certain psychiatric disorders.
certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Mylan Generics.

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 beta-blockers (medicines for treating heart failure) is not recommended.

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 Mylan Generics" and "Warnings and precautions").

If you are being treated with an ACE inhibitor together with other medicines used for
treating heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g.,
spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).

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

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Valsartan Mylan Generics before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan Mylan Generics 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 baby if taken after this time.
Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Mylan Generics is not recommended for women who are breastfeeding, and your doctor may choose a different treatment 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 Valsartan Mylan Generics affects you. Like many
other medicines used to treat high blood pressure, Valsartan Mylan Generics may rarely
cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist 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 may feel just as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

Use in 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 usual starting dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Use in adult patients after a recent heart attack: Treatment is generally started within 12 hours after a heart attack, usually at a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. 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 individual patient's tolerance.

Valsartan Mylan Generics may be administered together with other treatments for heart attack; your doctor will decide which treatment is suitable for you.

Use in 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 can tolerate individually.

Valsartan Mylan Generics may be administered together with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

You may take Valsartan Mylan Generics with or without food. Swallow the tablet with a glass of water.

Take Valsartan Mylan Generics at approximately the same time each day.

The tablet may be divided into equal parts.

If you take more Valsartan Mylan Generics than you should

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

If you forget to take Valsartan Mylan Generics

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 Mylan Generics

Stopping treatment with Valsartan Mylan Generics may cause your condition to worsen. Do not discontinue use of this 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.
STOP taking this medicine and contact your doctor or go immediately to the
nearest hospital emergency department if you experience any of the following side effects:
Uncommon (may affect up to 1 in 100 people)

Angioedema (a specific type of allergic reaction), with symptoms such as:
Swelling of the face, lips, tongue or throat
Difficulty breathing or swallowing
Hives, itching
Shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
Not known (frequency cannot be estimated from the available data) severe blistering of the skin (bullous dermatitis)

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

Dizziness
Low blood pressure, with or without symptoms such as dizziness and fainting when standing up
Reduced kidney function (sign of kidney failure)

Uncommon (may affect up to 1 in 100 people)

Sudden loss of consciousness (syncope)
Feeling of dizziness (vertigo)
Severely reduced kidney function (sign of acute kidney failure)
Muscle spasms, irregular heartbeat (signs of hyperkalaemia)
Headache
Cough
Abdominal pain
Nausea
Diarrhoea
Fatigue
Weakness

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

Allergic reactions with irritation, itching and hives: symptoms of fever, joint swelling, joint pain, muscle pain; swelling of lymph nodes and/or flu-like symptoms (signs of serum sickness)
Red-violet skin spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
Unusual bleeding or bruising (signs of thrombocytopenia)
Muscle pain (myalgia)
Fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
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, irregular heartbeat)
Increased liver function test values (which may indicate liver damage), including increased levels of 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 may cause fatigue, confusion, muscle twitching and, in severe cases, 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 than in patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those seen in adults.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. 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 Mylan Generics

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack/bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Mylan Generics contains
The active substance is valsartan.
Each film-coated tablet contains 40 mg of valsartan.
The other components are microcrystalline cellulose, crospovidone, povidone, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Valsartan Mylan Generics and package contents
Valsartan 40 mg film-coated tablets are yellow, oval-shaped, biconvex tablets, marked with "VN" and "1" on both sides separated by the breakline, and "M" on the other side.
The breakline allows the tablet to be divided into two equal doses.
Valsartan Mylan Generics is available in blister packs containing 7, 10, 14, 28, 30, 56, 98, 100 tablets and in HDPE bottles containing 500 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20 – 20124 Milan, Italy

Responsible manufacturer for batch release
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland

Generics UK Ltd
Station Close
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom

Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary

This leaflet was last approved on

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: Valsartan Arcana
Belgium: Valsartan Mylan
Cyprus: Valsartan Generics
France: Valsartan Mylan Pharma
Germany: Valsartan dura
Greece: Valsartan / Generics
Ireland: Valsartan Mylan
Italy: Valsartan Mylan Generics
Luxembourg: Valsartan Mylan
Netherlands: Valsartan Mylan
Portugal: Valsartan Mylan
United Kingdom: Valsartan
Spain: Valsartan Mylan

Package leaflet: information for the patient

Valsartan Mylan Generics 80 mg film-coated tablets

Equivalent medicine
valsartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan Mylan Generics is and what it is used for

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

in the treatment of high blood pressure in adults, and in children and adolescents from 6 to 18 years of age. When blood pressure is high, the workload on the heart and arteries increases. 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 attacks. Bringing blood pressure back 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 Mylan Generics is used either when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for the treatment of heart failure) cannot be used, or 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 condition occurs when the heart muscle is unable to pump blood strongly enough to supply the required amount of blood to all parts of the body.

2. What you should know before taking Valsartan Mylan Generics

Do not take Valsartan Mylan Generics

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 Mylan Generics is also not recommended during 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 Mylan Generics
Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan Mylan Generics

if you have liver disease.
if you have severe kidney disease or are undergoing dialysis.
if you have renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant (received a new kidney).
if you are being treated for heart attack or heart failure, your doctor may monitor your kidney function.
if you have serious heart problems other than heart failure or heart attack.
if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need regular monitoring of your blood potassium levels.
if you are under 18 years of age and are taking Valsartan Mylan Generics in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor your kidney function and blood potassium levels at regular intervals.
if you have aldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Valsartan Mylan Generics is not recommended.
if you have experienced significant fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
you must inform your doctor if you think you are pregnant (or planning to become pregnant). Valsartan Mylan Generics 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).
inform your doctor if you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors). If these symptoms occur while you are taking Valsartan Mylan Generics, stop taking it immediately and do not take it again. See also section 4 "Possible side effects".
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 for 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 information under “Do not take Valsartan Mylan Generics”.
If any of these conditions apply to you, inform your doctor before taking Valsartan Mylan Generics.
Other medicines and Valsartan Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan Mylan Generics is taken together with other medicines. It may be necessary to adjust the dosage, take additional precautions, or in some cases, stop taking one of the medicines. This applies to both 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. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
some types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
lithium, a medicine used in the treatment of certain psychiatric disorders.
certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Mylan Generics.

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, triple combination therapy with ACE inhibitors and beta-blockers (medicines used to treat heart failure) is not recommended.

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 Mylan Generics" 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).

Pregnancy and breastfeeding
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 if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Valsartan Mylan Generics before you become pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valsartan Mylan Generics. Valsartan Mylan Generics 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 this time.
Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Mylan Generics is not recommended for women who are breastfeeding. 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 any activity requiring concentration, make sure you know how Valsartan Mylan Generics affects you. Like many other medicines used to treat high blood pressure, Valsartan Mylan Generics may rarely cause dizziness and may affect your ability to concentrate.

3. How to take Valsartan Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist,
in order to get 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. Many feel as well as usual. For this reason, it is very
important that you keep regular appointments with your doctor, even when you feel well.
Use in adult patients with high blood pressure: The usual dose is 80 mg once daily. In
some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Your doctor may also
combine Valsartan Mylan Generics with another medicine (e.g. a diuretic).
Use in children and adolescents (aged 6 to 18 years) with high blood pressure: In
patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).
Use in adult patients after a recent heart attack: Treatment is usually started within 12 hours after a heart attack, generally at a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. 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 individual patient's tolerance.
Valsartan Mylan Generics may be given together with other treatments for heart attack; your doctor will decide which treatment is suitable for you.
Use in adult patients with heart failure: Treatment is generally started at 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 can individually tolerate.
Valsartan Mylan Generics 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 Mylan Generics with or without food. Valsartan Mylan Generics
should be swallowed with a glass of water.
Take Valsartan Mylan Generics at approximately the same time each day.
The tablet may be divided into two equal halves.
If you take more Valsartan Mylan Generics than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan Mylan Generics
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 Mylan Generics
Stopping treatment with Valsartan Mylan Generics 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking this medicine and contact your doctor or go immediately to the
nearest hospital emergency department if you experience any of the following side effects:
Uncommon (may affect up to 1 in 100 people)

Angioedema (a specific type of allergic reaction), such as
Swelling of the face, lips, tongue or throat
Difficulty breathing or swallowing
Hives, itching
Shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).

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

Severe blistering rash (bullous dermatitis)

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

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

Uncommon (may affect up to 1 in 100 people)

Sudden loss of consciousness (syncope)
Feeling of dizziness (vertigo)
Severely reduced kidney function (sign of acute kidney failure)
Muscle spasms, irregular heartbeat (signs of hyperkalaemia)
Headache
Cough
Abdominal pain
Nausea
Diarrhoea
Tiredness
Weakness

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

Allergic reactions with irritation, itching and hives, fever symptoms, joint swelling and joint pain, muscle pain; swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
Red-purple spots, fever, itching (signs of inflammation of blood vessels 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, irregular heartbeat)
Increased liver function test values (which may indicate liver damage), including increased levels of 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 may cause tiredness, confusion, muscle twitching and/or, in severe cases, 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.
Side effects in children and adolescents are similar to those seen 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 [national reporting system].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan Mylan Generics

Keep out of the sight and reach of children
Do not use this medicine after the expiry date stated on the packaging/bottle after EXP. The expiry date refers to the last day of that month
This medicine does not require any special storage conditions
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 Valsartan Mylan Generics contains
The active substance is valsartan.
Each film-coated tablet contains 80 mg of valsartan.
The other components are microcrystalline cellulose, crospovidone, povidone, sodium
croscarmellose, anhydrous colloidal silica, magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Valsartan Mylan Generics and contents of the pack
Valsartan Mylan Generics 80 mg film-coated tablets are light red, round, bevelled-edged, biconvex tablets, with a score line on one side and engraved "M" on one side and "VN2" on the other side. The score line allows the tablet to be divided into two equal doses.
Valsartan Mylan Generics is available in blister packs containing 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets and in HDPE bottles containing 500 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer responsible for batch release
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland
Generics UK Ltd
Station close
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary

This medicinal product is authorised in the European Economic Area Member States under the
following names:
Austria: Valsartan Arcana
Belgium: Valsartan Mylan
Cyprus: Valsartan Generics
France: Valsartan Mylan Pharma
Germany: Valsartan dura
Greece: Valsartan / Generics
Ireland: Valsartan Mylan
Italy: Valsartan Mylan Generics
Luxembourg: Valsartan Mylan
Netherlands: Valsartan Mylan
Portugal: Valsartan Mylan
United Kingdom: Valsartan
Spain: Valsartan Mylan

Patient information leaflet

Valsartan Mylan Generics 160 mg film-coated tablets

Equivalent medicine
valsartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan Mylan Generics is and what it is used for

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

Treatment of high blood pressure in adults, and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
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 Mylan Generics is used when a group of 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 medications cannot be used.

Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. This condition 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 should know before taking Valsartan Mylan Generics

Do not take Valsartan Mylan Generics

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 Mylan Generics 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 Mylan Generics.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan Mylan Generics

if you have liver disease.
if you have severe kidney disease or are undergoing dialysis.
if you suffer from renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant (received a new kidney).
if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function.
if you have serious heart problems other than heart failure or heart attack.
if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin. You may need regular monitoring of your blood potassium levels.
if you are under 18 years of age and taking Valsartan Mylan Generics in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
if you have aldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Mylan Generics is not recommended.
if you have experienced significant fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
you must inform your doctor if you think you may be pregnant (or planning to become pregnant). Valsartan Mylan Generics 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 during this period (see the section on pregnancy).
inform your doctor if you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors). If these symptoms occur while you are taking Valsartan Mylan Generics, stop taking it immediately and do not take it again. See also section 4 "Possible side effects".
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 for 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 Mylan Generics”.
If any of these conditions apply to you, inform your doctor before taking Valsartan Mylan Generics.
Other medicines and Valsartan Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan Mylan Generics is taken together with other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases stop taking one of the medicines. This applies to both 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. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin.
certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
lithium, a medicine used in the treatment of certain psychiatric disorders.
certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Mylan Generics.

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.
if you are being treated for symptomatic heart failure, triple combination therapy with ACE inhibitors and beta-blockers (medicines used to treat heart failure) is not recommended.

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 Mylan Generics" 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).

Pregnancy and breastfeeding
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 may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Valsartan Mylan Generics before you become pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valsartan Mylan Generics. Valsartan Mylan Generics 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 after this time.
Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Mylan Generics 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 any activity requiring concentration, make sure you know how you react to Valsartan Mylan Generics. Like many other medicines used to treat high blood pressure, Valsartan Mylan Generics may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist 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 signs of this condition 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.

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

Use in children and adolescents (aged 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Use in adult patients after a recent heart attack: Treatment is usually started within 12 hours after a heart attack, generally at a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. 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 individual patient's tolerance.

Valsartan Mylan Generics may be given together with other treatments for heart attack; your doctor will decide which treatment is suitable for you.

Use in 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 can individually tolerate.

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

Take Valsartan Mylan Generics at approximately the same time each day.

The tablet may be divided into two equal halves.

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking this medicine and contact your doctor or go immediately to the
nearest hospital emergency department if you experience any of the
following side effects:
Uncommon (may affect up to 1 in 100 people):

angioedema (a specific type of allergic reaction), with symptoms such as:
swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives, itching
shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).

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

severe blistering of the skin (bullous dermatitis).

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

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

Uncommon (may affect up to 1 in 100 people)

sudden loss of consciousness (syncope)
sensation of dizziness (vertigo)
severely reduced kidney function (a sign of acute kidney failure)
muscle cramps, irregular heartbeat (signs of hyperkalaemia)
headache
cough
abdominal pain
nausea
diarrhoea
fatigue
weakness

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

allergic reactions with irritation, itching and hives, fever symptoms, joint swelling and joint pain, muscle pain; may include swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
red-purple spots, fever, itching (signs of inflammation of blood vessels also known as vasculitis)
unusual bleeding or bruising (signs of thrombocytopenia)
muscle pain (myalgia)
fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
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 heart rhythm)
increased liver function test values (which may indicate liver damage, including increased levels of 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 may lead to fatigue, confusion, muscle twitching and, in severe cases, 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 than in patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those seen 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan Mylan Generics

Keep out of the sight and reach of children
Do not use this medicine after the expiry date stated on the pack/bottle after EXP. The expiry date refers to the last day of that month
This medicine does not require any special storage conditions
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. PACK CONTENTS AND OTHER INFORMATION

What Valsartan Mylan Generics contains
The active substance is valsartan.
Each film-coated tablet contains 160 mg of valsartan.
The other components are microcrystalline cellulose, crospovidone, povidone, sodium croscarmellose,
anhydrous colloidal silica, magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, yellow iron oxide (E172),
black iron oxide (E172), red iron oxide (E172).

Description of the appearance of Valsartan Mylan Generics and pack contents
Valsartan Mylan Generics 160 mg film-coated tablets are orange-grey in colour, round, with bevelled edges, biconvex, marked with "M" to the left of the score on one side and "VN3" on the other side. The score line allows the tablet to be divided into two equal doses.
Valsartan Mylan Generics is available in blister packs of 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets and in HDPE bottles containing 500 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer responsible for batch release
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland
Generics UK Ltd
Station Close
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Valsartan Arcana
Belgium: Valsartan Mylan
Cyprus: Valsartan / Generics
France: Valsartan Mylan Pharma
Germany: Valsartan dura
Greece: Valsartan / Generics
Ireland: Valsartan Mylan
Italy: Valsartan Mylan Generics
Luxembourg: Valsartan Mylan
Netherlands: Valsartan Mylan
Portugal: Valsartan Mylan
United Kingdom: Valsartan
Spain: Valsartan Mylan

Patient Information Leaflet

Valsartan Mylan Generics 320 mg film-coated tablets

Equivalent medicine
valsartan
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan Mylan Generics is and what it is used for

Valsartan Mylan Generics 320 mg film-coated tablets can be used:

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

2. What you need to know before taking Valsartan Mylan Generics

Do not take Valsartan Mylan Generics

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 Mylan Generics is also not recommended during 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 Mylan Generics
Warnings and precautions:
Talk to your doctor or pharmacist before taking Valsartan Mylan Generics.

if you have liver disease.
if you have severe kidney disease or are undergoing dialysis.
if you suffer from renal artery stenosis (narrowing of the artery to the kidney).
if you have recently undergone a kidney transplant (received a new kidney).
if you are being treated following a heart attack or for heart failure, your doctor may monitor your kidney function.
if you have serious heart problems other than heart failure or heart attack.
if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need to have your blood potassium levels checked regularly.
if you are under 18 years of age and are taking Valsartan Mylan Generics in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
if you have aldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Mylan Generics is not recommended.
if you have experienced significant 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 Mylan Generics 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).
inform your doctor if you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors). If these symptoms occur while you are taking Valsartan Mylan Generics, stop taking it immediately and do not take it again. See also section 4 "Possible side effects".
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 (such as potassium) in your blood at regular intervals.
See also the section “Do not take Valsartan Mylan Generics”.
If any of these conditions apply to you, inform your doctor before taking
Valsartan Mylan Generics.
Other medicines and Valsartan Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan Mylan Generics is taken together with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, stop taking one of the 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. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
certain types of pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
lithium, a medicine used in the treatment of certain psychiatric disorders.
certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Mylan Generics. Your doctor may consider it necessary to adjust the dose and/or take other precautions.
if you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan Mylan Generics" and "Warnings and precautions").

Pregnancy and breastfeeding
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 may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Valsartan Mylan Generics before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan Mylan Generics 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 of pregnancy.
Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan Mylan Generics is not recommended for women who are breastfeeding. 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 machinery, or performing any activity requiring concentration, make sure you know how you react to Valsartan Mylan Generics. Like many other medicines used to treat high blood pressure, Valsartan Mylan Generics may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist
to achieve the best results and reduce the risk of unwanted side effects. If you have any doubts,
consult your doctor or pharmacist. People with high blood pressure often do not notice any
symptoms. Many feel just as usual. For this reason, it is very
important that you keep regular appointments with your doctor, even when you feel well.
Use in adult patients with high blood pressure: the usual dose is 80 mg once daily. In
some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Your doctor may also
combine Valsartan Mylan Generics with another medicine (e.g. a diuretic).
Use in children and adolescents (aged 6 to 18 years) with high blood pressure: in
patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, the doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).
You may take Valsartan Mylan Generics with or without food. Valsartan Mylan Generics should
be swallowed with a glass of water.
Take Valsartan Mylan Generics at approximately the same time each day.
If you take more Valsartan Mylan Generics than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.
If you forget to take Valsartan Mylan Generics
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 Mylan Generics
Stopping treatment with Valsartan Mylan Generics may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking this medicine and contact your doctor or go immediately to the
nearest hospital emergency department if you experience any of the
following side effects:
Uncommon (may affect up to 1 in 100 people)

angioedema (a specific type of allergic reaction), with symptoms such as:
swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives, itching
shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).

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

severe blistering rash (bullous dermatitis).

Other side effects:
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 (sign of kidney failure)

Uncommon (may affect up to 1 in 100 people)

sudden loss of consciousness (syncope)
sensation of dizziness (vertigo)
severely reduced kidney function (sign of acute kidney injury)
muscle cramps, irregular heartbeat (signs of hyperkalaemia)
headache
cough
abdominal pain
nausea
diarrhoea
fatigue
weakness

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

Allergic reactions with irritation, itching and hives; symptoms of fever, joint swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
Red-purple skin spots, 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, irregular heartbeat)
increased liver function test values (which may indicate liver damage), including increased levels of 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 may lead to fatigue, confusion, muscle twitching and, in severe cases, 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 than in patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those seen 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan Mylan Generics

Keep out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the packaging/bottle after EXP. The expiry date refers to the last day of that month
This medicine does not require any special storage conditions
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering
Do not dispose of any 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 Mylan Generics contains
The active substance is valsartan.
Each film-coated tablet contains 320 mg of valsartan.
The other ingredients are: microcrystalline cellulose, crospovidone, povidone, sodium
croscarmellose, anhydrous colloidal silica, magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).
Description of the appearance of Valsartan Mylan Generics and the contents of the pack
Valsartan Mylan Generics 320 mg film-coated tablets are dark violet-grey, oval-shaped, with bevelled edges, biconvex, marked with "VN4" on one side and "M" on the other.
Valsartan Mylan Generics is available in blister packs containing 7, 10, 14, 28, 30, 56, 90, 98, 100 tablets and in HDPE bottles containing 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturer responsible for batch release
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Generics UK Ltd
Station close
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Valsartan Arcana
Belgium: Valsartan Mylan
Cyprus: Valsartan Generics
France: Valsartan Mylan Pharma
Germany: Valsartan dura
Greece: Valsartan / Generics
Ireland: Valsartan Mylan
Italy: Valsartan Mylan Generics
Luxembourg: Valsartan Mylan
Netherlands: Valsartan Mylan
Portugal: Valsartan Mylan
United Kingdom: Valsartan
Spain: Valsartan Mylan