Valsartan Mylan Generics Italia: detailed information

Package leaflet: Information for the user

Valsartan Mylan Generics Italia 40 mg hard capsules, 80 mg hard capsules, 160 mg hard capsules

Equivalent medicine
valsartan
Please read all of this leaflet carefully before you start 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 effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Valsartan Mylan Generics Italia 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 Italia works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Valsartan Mylan Generics Italia 40 mg hard capsules can be used to treat three
different conditions:

for the treatment of children and adolescents aged 6 to 18 years with high blood pressure. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
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 Mylan Generics Italia is used when 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 heart failure treatments cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid retention. Heart failure means that the heart muscle is unable to pump blood strongly enough to supply adequate blood to all parts of the body.

Valsartan Mylan Generics Italia 80 mg and 160 mg hard capsules can be used to treat three
different conditions:

for the treatment of high blood pressure in adults, and in children and adolescents aged 6 to 18 years. When blood pressure is high, the workload on the heart and arteries increases. Over time, this may damage blood vessels in the brain, heart, and kidneys, and may lead to heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal levels reduces the risk of developing these conditions.
for the treatment of adult patients who have recently had a heart attack (myocardial infarction). “Recently” means within 12 hours to 10 days.
for the treatment of symptomatic heart failure in adult patients. Valsartan Mylan Generics Italia is used when 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 heart failure treatments cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid retention. Heart failure means that 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 Italia

Do not take Valsartan Mylan Generics Italia

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 Italia is also not recommended during the first months of pregnancy – see section on pregnancy).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, do not take Valsartan Mylan Generics Italia
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Mylan Generics Italia if any of the
following apply to you.

If you have liver disease.
If you have kidney disease or are on dialysis.
If you have renal artery stenosis (narrowing of the artery to the kidney).
If you have recently undergone a kidney transplant (received a new kidney).
If you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function.
If you have serious heart problems other than heart failure or heart attack.
If you have ever experienced swelling of the tongue, throat, or face due to an allergic reaction called angioedema while taking another medicine (including “ACE inhibitors”), inform your doctor. If these symptoms occur while you are taking valsartan, stop taking valsartan immediately and do not take it again. See also section 4 of this leaflet, “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.
If you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Mylan Generics Italia is not recommended.
If you have fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
If you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
aliskiren
You must inform your doctor if you think you are pregnant (or planning to become pregnant). Valsartan Mylan Generics Italia 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).

Talk to your doctor if, after taking Valsartan Mylan Generics Italia, you experience abdominal pain,
nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do
not stop taking Valsartan Mylan Generics Italia on your own.
Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the information in the section “Do not take Valsartan Mylan Generics Italia”
Children and adolescents
If you are under 18 years of age and are taking Valsartan Mylan Generics Italia 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.
Other medicines and Valsartan Mylan Generics Italia
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 Italia is taken with certain other
medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, stop taking one of the medicines. This applies to all medicines, including those without a prescription, especially:

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

In addition:

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

Your doctor may need to adjust your dose and/or take other precautions:

if you are taking an ACE inhibitor or aliskiren (see also information in the sections “Do not take Valsartan Mylan Generics Italia” and “Warnings and precautions”).
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).

Valsartan Mylan Generics Italia with food and drink
Valsartan Mylan Generics Italia can be taken with or without food.
Pregnancy and 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 Italia before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartan Mylan Generics Italia. Valsartan Mylan Generics Italia 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 Italia 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 machinery, or performing other activities requiring concentration, you should
know how you react to Valsartan Mylan Generics Italia. Like many other medicines used to treat high
blood pressure, Valsartan Mylan Generics Italia may in rare cases cause dizziness and affect your
ability to concentrate.
Valsartan Mylan Generics Italia 40 mg hard capsules contain sodium
Valsartan Mylan Generics Italia 80 mg hard capsules contain sodium
Valsartan Mylan Generics Italia 160 mg hard capsules contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to take Valsartan Mylan Generics Italia

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

Use in children and adolescents (aged 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the usual 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 cannot be obtained with Valsartan Mylan Generics Italia hard capsules. The 20 mg dose is achieved by splitting 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 your individual tolerance.

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

Use in adult patients with arterial hypertension: the usual dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Valsartan Mylan Generics Italia may also be combined with another medicine (e.g. a diuretic). You may take Valsartan Mylan Generics Italia with or without food. Swallow with a glass of water. Take Valsartan Mylan Generics Italia at approximately the same time each day.

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

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

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

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 everyone gets them.
These side effects may occur with certain frequencies, defined as follows:
very common: may affect more than 1 in 10 people
common: may affect up to 1 in 10 people
uncommon: may affect up to 1 in 100 people
rare: may affect up to 1 in 1,000 people
very rare: may affect up to 1 in 10,000 people
not known: frequency cannot be estimated from the available data.

Some symptoms require immediate medical attention:
Consult your doctor immediately if you have symptoms of angioedema (a specific allergic reaction), such as:

swelling of the face, lips, tongue or throat
difficulty swallowing
hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan Mylan Generics Italia and contact your doctor immediately (see also section 2 “What you need to know before taking Valsartan Mylan Generics Italia”)

Other side effects include:

Common side effects:

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

Uncommon side effects:

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

Very rare side effects:

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Frequency not known:

Blisters on the skin (signs of bullous dermatitis)
allergic reactions with skin rash, itching, hives, fever symptoms, joint swelling, joint pain, muscle pain; lymph node swelling and/or flu-like symptoms may occur (signs of serum sickness)
red-purple papules, fever, itching (signs of blood vessel inflammation known as vasculitis)
bleeding or bruising more easily than usual (signs of thrombocytopenia)
muscle pain (myalgia)
fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
decreased haemoglobin levels and 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 levels 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/or seizures in severe cases)

The frequency of some of these side effects may vary depending on your condition. For example, side effects such as dizziness and reduced liver function test values 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan Mylan Generics Italia

Do not store above 30 °C. Keep in the original packaging to
protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of the month.
Do not use this medicine if the packaging is damaged or shows any signs of deterioration.
Do not dispose of medicines 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 Italia contains
The active substance is valsartan.
Each capsule contains 40 mg/80 mg/160 mg of valsartan.
The other components are microcrystalline cellulose, crospovidone (type A), sodium lauryl sulfate,
povidone, anhydrous colloidal silicon dioxide, magnesium stearate.
Capsule shell composition: black iron oxide (E172), titanium dioxide (E171), gelatin,
sodium lauryl sulfate, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol,
concentrated ammonium solution, potassium hydroxide.

Description of the appearance of Valsartan Mylan Generics Italia and the contents of the pack
Valsartan 40 mg hard capsules have a light grey cap and a light grey hard gelatin body, imprinted with “M40” on both cap and body in black ink, and are filled with white to off-white granules.
Valsartan 80 mg hard capsules have a light grey cap and an opaque beige hard gelatin body, imprinted with “M80” on both cap and body in black ink, and are filled with white to off-white granules.
Valsartan 160 mg hard capsules have a dark grey cap and an opaque beige hard gelatin body, imprinted with “M160” on both cap and body in black ink, and are filled with white to off-white granules.
Valsartan capsules are available in blisters of 14 and 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., via Vittor Pisani 20 – 20124 Milano, Italy

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Valsartan Mylan Generics Italia 40 mg capsules, Valsartan Mylan
Generics Italia 80 mg capsules, Valsartan Mylan Generics Italia 160
mg capsules

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