Diovan

Leaflet accompanying the packaging: information for the user

Diovan, 80 mg, film-coated tablets

Diovan, 160 mg, film-coated tablets

Valsartan

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Diovan and what is it used for
• 2. Important information before taking Diovan
• 3. How to take Diovan
• 4. Possible side effects
• 5. How to store Diovan
• 6. Contents of the packaging and other information

1. What is Diovan and what is it used for

Diovan contains the active substance: valsartan and belongs to a group of medicines called angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Diovan works by blocking the action of angiotensin II. As a result, blood vessels dilate and blood pressure decreases. Diovan 80 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and children and adolescents from 6 to less than 18 years of age.High blood pressure increases the strain on the heart and arteries. If left untreated, it may lead to damage to the blood vessels in the brain, heart, and kidneys, which may result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level reduces the risk of these disorders.
• to treat adult patients after a recent heart attack(myocardial infarction). "Recent" means a period of 12 hours to 10 days.
• to treat symptomatic heart failure in adult patients.Diovan is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or as additional treatment with ACE inhibitors if other medicines used to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. They are caused by the heart muscle not being able to pump blood with sufficient force to supply the amount of blood required by the body.

Diovan 160 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and children and adolescents from 6 to less than 18 years of age.High blood pressure increases the strain on the heart and arteries. If left untreated, it may lead to damage to the blood vessels in the brain, heart, and kidneys,

which may result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level reduces the risk of these disorders.

• to treat adult patients after a recent heart attack(myocardial infarction). "Recent" means a period of 12 hours to 10 days.
• to treat symptomatic heart failure in adult patients.Diovan is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or as additional treatment with ACE inhibitors if other medicines used to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. They are caused by the heart muscle not being able to pump blood with sufficient force to supply the amount of blood required by the body.

2. Important information before taking Diovan

When not to take Diovan:

• if the patient has been diagnosed with hypersensitivity(allergy) to valsartan or any of the other ingredients of Diovan listed in section 6;
• if the patient has severe liver disease;
• if the patient is pregnant over 3 months(it is also not recommended to take Diovan in early pregnancy - see the section on pregnancy).
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions are met, Diovan should not be taken.

Warnings and precautions

You should inform your doctor if:

• you have liver disease;
• you have severe kidney disease or are undergoing dialysis;
• you have narrowing of the renal artery;
• you have recently had a kidney transplant (you have received a new kidney);
• you have severe heart disease other than heart failure or heart attack;
• you have ever had swelling of the tongue and face caused by an allergic reaction after taking another medicine (including ACE inhibitors), you should tell your doctor. If such symptoms occur while taking Diovan, you should stop taking Diovan immediately and never take it again. See also section 4, "Possible side effects";
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Diovan, you should discuss this with your doctor. The doctor will decide on further treatment. You should not stop taking Diovan on your own;
• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. Regular monitoring of potassium levels in your blood may be necessary;
• if you have aldosteronism (a disease in which the adrenal glands produce too much of a hormone called aldosterone), you should not take Diovan;
• in case of significant fluid loss (dehydration) due to diarrhea, vomiting, or the use of high doses of diuretics (water pills);
• if you are taking any of the following medicines for high blood pressure: an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under "When not to take Diovan" and "Warnings and precautions").

if you are being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol). Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood at regular intervals. See also the information under "When not to take Diovan". You should tell your doctor if you suspect you are pregnant (or plan to become pregnant). It is not recommended to take Diovan in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken at this stage (see the section on pregnancy).

Diovan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Taking Diovan with certain other medicines may affect your treatment. A dose change, other precautions, or discontinuation of one of the medicines may be necessary. This applies to both prescription and non-prescription medicines, in particular:

• other blood pressure-lowering medicines, especially diuretics(water pills), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under "When not to take Diovan" and "Warnings and precautions");
• medicines that increase the amount of potassium in your blood; including potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• certain types of painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (such as rifampicin), a medicine used to prevent transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Diovan;
• lithium(a medicine used to treat certain types of mental illness).

In addition:

• after a heart attack, it is not recommended to take ACE inhibitors (medicines used to treat heart attack) in combination with Diovan;
• in the treatment of heart failure, it is not recommended to take Diovan with ACE inhibitors, other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone), and beta-blockers (such as metoprolol).

Pregnancy and breastfeeding

• You should tell your doctor if you suspect you are pregnant (or plan to become pregnant).Your doctor will usually advise you to stop taking Diovan before you become pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine instead of Diovan. It is not recommended to take Diovan in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken at this stage.
• You should inform your doctor if you are breastfeeding or plan to breastfeed.It is not recommended to take Diovan while breastfeeding; your doctor may choose an alternative treatment for you if you plan to breastfeed. This is especially important for breastfeeding newborns or premature babies.

if you are breastfeeding, you should not take Diovan. Your doctor may choose an alternative treatment for you if you plan to breastfeed. This is especially important for breastfeeding newborns or premature babies.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, each patient should find out how Diovan affects them. Like many other medicines used to treat high blood pressure, Diovan may cause dizziness and affect concentration.

3. How to take Diovan

This medicine should always be taken exactly as prescribed by your doctor to achieve the best results and minimize the risk of side effects. If you have any doubts, you should consult your doctor or pharmacist again. People with high blood pressure often do not notice any symptoms of this problem. Many of them feel quite well. Therefore, it is especially important to attend doctor's appointments, even if you feel well.

High blood pressure in adult patients:

The recommended dose of Diovan 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 prescribe Diovan in combination with another medicine (e.g., a diuretic).

Children and adolescents (from 6 to less than 18 years of age) with high blood pressure

In patients with a body weight below 35 kg, the recommended initial dose of Diovan is 40 mg once daily. In patients with a body weight of 35 kg or more, the recommended initial dose of Diovan is 80 mg once daily. In some cases, your doctor may prescribe higher doses (the dose can be increased to 160 mg, and up to a maximum of 320 mg). For children who cannot swallow tablets, an oral solution of Diovan is recommended.

Condition after a recent heart attack in adult patients:

Treatment usually starts 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. The patient receives a dose of 20 mg, obtained by dividing a 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine. Diovan can be given with other medicines used to treat heart attack, and your doctor will decide which treatment is suitable in a particular case.

Heart failure in adult patients:

The usual starting dose is 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine. Diovan can be given with other medicines used to treat heart failure, and your doctor will decide which treatment is suitable in a particular case. Diovan can be taken with or without food. Diovan should be swallowed with a glass of water. Diovan should be taken every day at approximately the same time.

Taking a higher dose of Diovan than recommended

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

Missing a dose of Diovan

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose. You should not take a double dose to make up for a missed dose.

Stopping treatment with Diovan

Stopping treatment with Diovan may worsen your condition. You should not stop taking Diovan unless your doctor advises you to do so. If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

There may be symptoms of angioedema (a specific 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, you should stop taking Diovan immediately and contact your doctor (see also section 2, "Warnings and precautions").

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

• dizziness,
• low blood pressure with symptoms such as dizziness and fainting when standing up or without these symptoms,
• kidney problems (symptoms of kidney problems).

Uncommon(may affect up to 1 in 100 people)

• angioedema (see "Some side effects may be serious and require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (vertigo),
• severe kidney problems (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• feeling of tiredness,
• weakness.

Rare(may affect up to 1 in 10,000 people)

• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown(frequency cannot be estimated from the available data)

• blisters on the skin (symptoms of bullous dermatitis),
• allergic reactions with rash, itching, and hives; symptoms such as fever, swelling, and joint or muscle pain, swelling of lymph nodes, and/or flu-like symptoms (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of vasculitis, also known as inflammation of blood vessels),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia),
• decreased hemoglobin and decreased red blood cell count in the blood (which may lead to anemia in severe cases),
• increased potassium levels in the blood (which may cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver enzyme 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 urea and creatinine levels in the blood (which may indicate kidney problems),
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and/or seizures in severe cases).

The frequency of some side effects may vary depending on the disease. For example, such side effects as dizziness and kidney problems are observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack. The side effects observed in children and adolescents are similar to those observed in adult patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diovan

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
• Do not use Diovan after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Do not use Diovan if you notice damage to the packaging or signs of attempted opening.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diovan contains

• The active substance of Diovan is valsartan.
• Each film-coated tablet contains 80 mg or 160 mg of valsartan.
• Other ingredients of Diovan are: microcrystalline cellulose, crospovidone type A, colloidal silicon dioxide, magnesium stearate. The ingredients of the tablet coating are: hypromellose, titanium dioxide (E171), macrogol 8000, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E172, only Diovan 160 mg)

What Diovan looks like and contents of the pack

Diovan 80 mg is a light red, round, film-coated tablet with a score line on one side, slightly convex, with the imprint "D" on one side of the score line and "V" on the other side of the score line and "NVR" on the other side of the tablet. The score line is only to facilitate breaking, to make swallowing easier, but not to divide into equal doses. Available packs: 28 or 56 tablets. Diovan 160 mg is a gray-orange, oval, film-coated tablet with a score line on one side, with the imprint "DX" on both sides of the score line and "NVR" on the other side of the tablet. The score line is only to facilitate breaking, to make swallowing easier, but not to divide into equal doses. Available packs: 14, 28, or 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, tel. (22) 375 48 88

Manufacturer/Importer

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany, Novartis Pharma GmbH, Sophie-Germain-Strasse 10, 90443 Nuremberg, Germany, Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain, Novartis Pharma GmbH, Jakov-Lind-Straβe 5, Top 3.05, 1020 Wien, Austria, Novartis Pharma B.V., Haaksbergweg 16, 1101 BX Amsterdam, Netherlands, Novartis Sverige AB, Torshamnsgatan 48, 164 40 Kista, Sweden, Novartis Farma-Produtos Farmacêuticos S.A., Avenida Professor Doutor Cavaco Silva, nº10E, Taguspark, Porto Salvo, 2740-255, Portugal, Novartis Farma S.p.A., Viale Luigi Sturzo 43

• 20154 - Milano MI Italy

Novartis Farma S.p.A., Via Provinciale Schito, 131-80058 Torre Annunziata (NA), Italy, Novartis Pharma NV, Medialaan 40 bus 1, Vilvoorde, 1800, Belgium, Novartis Finland Oy, Metsänneidonkuja 10, FI-02130 Espoo, Finland, Novartis Pharma S.A.S., 8-10 rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France, Novartis Hellas S.A.C.I, 12th km National Road Athens-Lamia, 14451, Metamorfosi, Greece, Novartis Hungária Kft.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the leaflet: 04/2025