Valsartan Almus

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan Almus 40 mg Film-coated Tablets, 80 mg Film-coated Tablets, 160 mg Film-coated Tablets

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

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

Contents of this leaflet:

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

1. WHAT IS VALSARTAN ALMUS AND WHAT IS IT USED FOR?

Valsartan Almus 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 Almus works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Valsartan Almus 40 mg Film-coated Tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in children and adolescents aged 6 to 18 years. 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 attack. Lowering blood pressure to normal levels reduces the risk of developing these diseases.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. Valsartan Almus is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat 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 buildup. This occurs when the heart muscle is unable to pump blood strongly enough to supply adequate blood to all parts of the body.

Valsartan Almus 80 mg Film-coated Tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in adults and in children and adolescents aged 6 to 18 years. 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 attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. Valsartan Almus is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat 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 occurs when the heart muscle is unable to pump blood strongly enough to supply adequate blood to all parts of the body.

Valsartan Almus 160 mg Film-coated Tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in adults and in children and adolescents aged 6 to 18 years. 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 attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. Valsartan Almus is used when angiotensin-converting enzyme (ACE) inhibitors (ACE inhibitors, medicines for the treatment of heart failure) cannot be used, or it may be used in addition to ACE inhibitors when beta-blockers (other medicines for the treatment of heart failure) cannot be used. Symptoms of heart failure include shortness of breath and swelling in 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 to all parts of the body.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VALSARTAN ALMUS

Do not take Valsartan Almus:

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is best to avoid taking Valsartan Almus in the early stages of pregnancy – see section "Pregnancy").
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

• you have liver disease.

• you have severe kidney disease or are on dialysis.

• you suffer from renal artery stenosis (narrowing of the artery to the kidney).

• you have recently undergone a kidney transplant (received a new kidney).

• you are being treated after a heart attack or for heart failure, as your doctor may monitor your kidney function.

• you have serious heart problems other than heart failure or heart attack.

• you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), consult your doctor.
  If these symptoms occur while you are taking Valsartan Almus, stop taking it immediately and never take it again. See also section 4 "Possible side effects".

• you are taking medicines used to treat high blood pressure such as angiotensin receptor antagonists, including Valsartan Almus, or ACE inhibitors and aliskiren.

• 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 your blood potassium levels may be necessary.

• you are under 18 years of age and are taking Valsartan Almus in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor will regularly monitor your kidney function and blood potassium levels.

• you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Valsartan Almus is not recommended.

• 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 if there is a possibility of becoming pregnant). Valsartan Almus 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 "Pregnancy").

• you are taking any of the following medicines for high blood pressure: or an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes or are taking aliskiren.

• you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol). Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the section “Do not take Valsartan Almus”.
If any of these conditions apply to you, inform your doctor before taking Valsartan Almus.
Other medicines and Valsartan Almus
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 Almus is taken with certain types of medicines.
Dosage adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be required. This applies to all medicines, including those not requiring a prescription, especially:

• other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics).
• medicines that increase potassium levels in the blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (rifamycin group), a medicine used in organ transplants to prevent rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan Almus.
• medicines used to treat high blood pressure such as angiotensin receptor antagonists, including Valsartan Almus, or ACE inhibitors and aliskiren.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

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 sections: “Do not take Valsartan Almus” 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).

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 symptomatic heart failure, triple combination with ACE inhibitors and beta-blockers (medicines for treating heart failure) is not recommended.

Valsartan Almus with food and drink
Valsartan Almus can be taken with or without food.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Valsartan Almus before you become pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Valsartan Almus. Valsartan Almus 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 Almus 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 be aware of how you react to Valsartan Almus. Like many other medicines used to treat high blood pressure, Valsartan Almus may rarely cause dizziness and affect your ability to concentrate.
Valsartan Almus contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE VALSARTAN ALMUS

Take this medicine exactly as directed by your doctor, in order to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not experience any 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.

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

Adult patients after a recent heart attack: treatment is usually started as soon as possible, 12 hours after the heart attack, 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 individually tolerate.

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

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

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

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

Adult patients after a recent heart attack: treatment is usually started as soon as possible, 12 hours after the heart attack, 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 individually tolerate.
Valsartan Almus may be administered together with other treatments for heart attack, and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: treatment is usually started with 40 mg twice daily. Your doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate.
Valsartan Almus 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 Almus with or without food. Swallow the tablet with a glass of water. Take Valsartan Almus approximately at the same time each day.

If you take more Valsartan Almus 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 immediately.

If you forget to take Valsartan Almus
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 Almus
Stopping treatment with Valsartan Almus 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 ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
These adverse effects may occur with certain frequencies defined as follows:

• very common: occurs in more than 1 in 10 patients
• common: occurs in 1 to 10 in 100 patients
• uncommon: occurs in 1 to 10 in 1,000 patients
• rare: occurs in 1 to 10 in 10,000 patients
• very rare: occurs in fewer than 1 in 10,000 patients
• not known: frequency cannot be estimated from the available data.

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

• swelling of the face, lips, tongue or throat
• difficulty breathing or swallowing
• hives, itching
  If you experience any of these symptoms, stop taking Valsartan Almus and contact your doctor immediately (see also section 2 Warnings and precautions).

The adverse effects are:
Common:

• 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:

• 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 spasms, irregular heartbeat (signs of high potassium levels in the blood)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

Not known:

• blisters on the skin (sign of a condition called bullous dermatitis)
• allergic reactions such as skin rashes, itching, hives, fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of blood vessels known as vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
• decreased haemoglobin levels and decreased percentage of red blood cells in the blood (which may lead to anaemia in severe cases)
• increased potassium levels in the blood (which may cause muscle cramps and heart rhythm abnormalities in severe cases)
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases)
• increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)

The frequency of some of these adverse effects may vary depending on your condition. For example, effects such as dizziness and reduced kidney function test values have been observed less frequently in adult patients treated for high blood pressure compared to adult patients treated for heart failure or after a recent heart attack.
In children and adolescents, adverse effects are similar to those in adults.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VALSARTAN ALMUS

• 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 the month.
• Do not store above 30°C.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Valsartan Almus contains
The active substance is valsartan.
Valsartan Almus 40 mg film-coated tablets: each film-coated tablet contains 40 mg of valsartan.
Valsartan Almus 80 mg film-coated tablets: each film-coated tablet contains 80 mg of valsartan.
Valsartan Almus 160 mg film-coated tablets: each film-coated tablet contains 160 mg of valsartan.

The excipients are:
Tablet core:
anhydrous lactose, monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, colloidal silicon dioxide, magnesium stearate.
Tablet film coating:
hypromellose, macrogol 8000, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
Valsartan Almus 40 mg also contains black iron oxide.
Valsartan Almus 160 mg also contains black iron oxide.

Description of the appearance of Valsartan Almus and pack contents
Valsartan Almus 40 mg film-coated tablets are presented as film-coated tablets.
Valsartan Almus 80 mg film-coated tablets are presented as film-coated tablets.
Valsartan Almus 160 mg film-coated tablets are presented as film-coated tablets.

Valsartan Almus 40 mg tablets are yellow, oblong and biconvex. They have a score line on one side and can be divided into two equal parts.
Valsartan Almus 80 mg tablets are pink, round and biconvex. They have a score line on one side and can be divided into two equal parts.
Valsartan Almus 160 mg tablets are dark yellow, oblong and biconvex. They have a score line on one side and can be divided into two equal parts.

Valsartan Almus is available in the following pack sizes:
Valsartan Almus 40 mg:
PVC/PVDC/aluminium blisters containing 14, 28, 56 or 98 film-coated tablets.
Valsartan Almus 80 mg:
PVC/PVDC/aluminium blisters containing 14, 28, 56 or 98 film-coated tablets.
Valsartan Almus 160 mg:
PVC/PVDC/aluminium blisters containing 14, 28, 56 or 98 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Responsible Person for Batch Release
Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa - Italy
Responsible Person for Batch Release
Special Product's Line S.p.A - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) - Italy

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