Rixil

Rixil 40 mg film-coated tablets
Rixil 80 mg film-coated tablets
Rixil 160 mg film-coated tablets
Rixil 320 mg film-coated tablets
Valsartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of this leaflet:

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

1. What Rixil is and what it is used for

Rixil contains the active substance valsartan, which 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. Rixil works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Rixil 40 mg film-coated tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these 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. Rixil is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the required amount of blood.

Rixil 80 mg film-coated tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these 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. Rixil is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the required amount of blood.

Rixil 160 mg film-coated tablets can be used to treat three different conditions:

• for the treatment of high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these 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. Rixil is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid accumulation. It occurs when the heart muscle is unable to pump blood strongly enough to supply all parts of the body with the required amount of blood.

Rixil 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 blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you should know before taking Rixil

Do not take Rixil

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are more than three months pregnant (it is best to avoid taking Rixil even in the early stages of pregnancy – see section on Pregnancy).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above conditions apply to you, consult your doctor and do not take Rixil.

Warnings and precautions
Consult your doctor

• if you have liver disease.
• if you have severe kidney disease or are on dialysis.
• if you have narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have serious heart problems other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Rixil, stop taking Rixil immediately and never take it again. See section 4, "Possible side effects".
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. You may need regular monitoring of potassium levels in your blood.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Rixil is not recommended.
• if you have experienced fluid loss (dehydration) due to diarrhea, vomiting, or high-dose diuretics.
• if you are taking any of the following medicines used to treat high blood pressure:
  • an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol). Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Rixil”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Rixil is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby if taken during this period (see section on Pregnancy).

Other medicines and Rixil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Rixil is taken with certain other medicines.
It may be necessary to adjust the dose, take additional precautions, or, in some cases, stop taking one of the medicines. This applies to all medicines, even those without a prescription, especially:

• other medicines that lower blood pressure, particularly tablets that increase fluid elimination (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under “Do not take Rixil” and “Warnings and precautions”).
• medicines that increase potassium levels in the blood, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Rixil.
• lithium, a medicine used in the treatment of certain psychiatric disorders.

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (medicines for treating heart attack) is not recommended.
• if you are being treated for heart failure, triple combination with ACE inhibitors and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol) is not recommended.

Pregnancy and breastfeeding

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Rixil before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Rixil. Rixil is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Rixil 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 a newborn or was born prematurely.

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

3. How to take Rixil

Take this medicine exactly as your doctor has told you to, in order to achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any signs of this condition and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

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

Children and adolescents (aged 6 to 18 years) with high blood pressure
In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily.
In patients weighing 35 kg or more, the recommended 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 after 12 hours from the heart attack, generally with a low starting dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate.

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

Adult patients with heart failure: Treatment is 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.

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

Take Rixil at approximately the same time each day.

If you take more Rixil 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 Rixil
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 Rixil
Stopping treatment with Rixil may cause your condition to worsen. Do not stop taking 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 experiences them.
Some side effects may be serious and require immediate medical attention:
You may experience symptoms of angioedema (a specific type of allergic reaction), such as:

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

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

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

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

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

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (vertigo)
• severely reduced kidney function (sign of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of high potassium levels in the blood)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

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

• blistering of the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching and hives, fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• red spots (papules), fever, itching (signs of inflammation of blood vessels known as vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
• decreased haemoglobin levels and reduced percentage of red blood cells in the blood (which may lead to anaemia in severe cases)
• increased potassium levels in the blood (which may cause muscle cramps and irregular heartbeat in severe cases)
• increased liver function 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 (azotemia) and increased serum creatinine levels (which may indicate kidney dysfunction)
• low sodium levels in the blood (which may cause fatigue, mental confusion, muscle twitching and/or seizures in severe cases)

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

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

5. How to store Rixil

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Rixil and package contents
Rixil 40 mg film-coated tablets are yellow, ovaloid tablets with a score line on one side. The letters "D" are engraved on one side of the score line and "O" on the other side of the score line, and "NVR" on the opposite side of the tablet. The tablet can be divided into two equal halves.

Rixil 80 mg film-coated tablets are light red, round tablets with a score line on one side. The letters "D" are engraved on one side of the score line and "V" on the other side of the score line, and "NVR" on the opposite side of the tablet. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Rixil 160 mg film-coated tablets are orange-grey, ovaloid tablets with a score line on one side. The letters "DX" are engraved on both sides of the score line, and "NVR" on the opposite side of the tablet. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Rixil 320 mg film-coated tablets are grey-violet, ovaloid tablets with bevelled edges and a score line on one side. The letters "DC" are engraved on both sides of the score line, and "NVR" on the opposite side of the tablet. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

The tablets are available in blisters of 7, 14, 28, 30, 56, 90, or 98 tablets, and in calendar blisters of 14, 28, 56, 98, and 280 tablets. Additionally, there are unit-dose divisible blisters containing 56x1, 98x1, or 280x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Largo Boccioni, 1
21040 Origgio VA
Italy

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

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

This medicinal product is authorized in the European Economic Area countries
under the following names: