DIOVAN 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Diován 80mg film-coated tablets

valsartan

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Diován and what is it used for

Diován contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Diován works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Diován 80 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adults and in children and adolescents from6 toless than 18years of age.High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and can lead to a 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 disorders.
• to treat adult patients after a recent heart attack(myocardial infarction). “Recent” means here between 12 hours and 10 days.
• to treat symptomatic heart failure in adult patients.Diován is used when it is not possible to use a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication for treating heart failure), or it can be used in addition to ACEIs when it is not possible to use other medications for the treatment of heart failure. Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to provide all the blood needed for the body.

2. What you need to know before you take Diován

Do not take Diován:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease.
• if you are pregnantfor more than 3 months(it is also better to avoid Diován during the first months of pregnancy – see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of the above applies to you, tell your doctor and do not takeDiován.

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have narrowing of the kidney artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have severe heart disease other than heart failure or heart attack.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACEIs), inform your doctor. If you have these symptoms when taking Diován, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Diován. Your doctor will decide whether to continue treatment. Do not stop taking Diován on your own.
• if you are taking medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. It may be necessary to regularly monitor the amount of potassium in the blood.
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Diován.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination).
• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
  • aliskiren
• if you are being treated with an ACEI along with other specific medications for the treatment of your 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 electrolyte levels (e.g., potassium) in the blood at regular intervals.

• See also the information under the heading “Do not take Diován”.

You must inform your doctor if you think you are (or might become) pregnant. Diován is not recommended at the start of pregnancy, and it must not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period (see the section on pregnancy).

Using Diován with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of treatment with Diován may be altered if taken with certain medicines. Your doctor may need to change your dose and/or take other precautions or, in some cases, stop treatment with one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure,especially diuretics(medicines to increase urine elimination), ACEIs (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Diován” and “Warnings and precautions”).
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (from the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Diován.
• lithium,a medicine used to treat certain types of psychiatric illnesses.

Additionally:

• if you are being treated after a heart attack,it is not recommended to combine with ACEIs(a medication for treating a heart attack).
• if you are being treated for heart failure,it is not recommended to combine with ACEIs and other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) orbeta-blockers(e.g., metoprolol).

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant(or if you think you might be).Your doctor will normally advise you to stop taking Diován before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Diován. Diován is not recommended during the first trimester of pregnancy, and it must not be taken during the second and third trimesters of pregnancy as it may cause serious harm to your baby.

• Tell your doctor if you are breastfeeding or about to start breastfeeding. Diován is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how Diován affects you. Like many other medicines used to treat high blood pressure, Diován can cause dizziness and affect your ability to concentrate.

3. How to take Diován

To get the best results and reduce the risk of side effects, always take this medicine exactly as your doctor tells you. If you are unsure, ask your doctor or pharmacist. People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to attend your doctor's appointments, even if you feel well.

Adult patients with high blood pressure:the recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Diován can also be taken in combination with another medicine (e.g., a diuretic).

Use in children and adolescents from6 to less than18years of age with high blood pressure:

In patients who weigh less than 35 kg, the recommended initial dose for Diován tablets is 40 mg once daily.

In patients who weigh 35 kg or more, the recommended initial dose for Diován tablets 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).

In children who have difficulty swallowing tablets, it is recommended to administer Diován oral solution.

Adult patients after a recent heart attack:after a heart attack, treatment is usually started at 12 hours, normally with a low dose of 20 mg, given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Diován can be taken with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:treatment is usually started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Diován can be taken with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take Diován with or without food. Swallow Diován with a glass of water.

Take Diován at approximately the same time each day.

If you take more Diován than you should

If you notice a strong 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. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Diován

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Diován

If you stop taking Diován, your disease may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of 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.

Some side effects can be serious and may need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

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

If you experience any of these symptoms, stop taking Diován and contact your doctor immediately (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 when standing up
• reduced kidney function (signs of kidney impairment)

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

• angioedema (see section “Some symptoms need immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (vertigo)
• marked reduction in kidney function (signs of acute kidney failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

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

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

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

• blisters on the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)
• purple spots, fever, itching (signs of vasculitis)
• bleeding or bruising more often 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 called neutropenia)
• reduction in hemoglobin level and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• increase in potassium level in the blood (which, in severe cases, can cause muscle spasms and an abnormal heart rhythm)
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• increase in blood urea nitrogen and increase in serum creatinine level (which may indicate kidney function abnormalities)
• low sodium level in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function 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.

Side effects in children and adolescents are similar to those observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Diován

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

6. Container Content and Additional Information

Composition ofDiován

• The active ingredient is valsartan. Each film-coated tablet contains 80 mg of valsartan.
• The other components are microcrystalline cellulose, type A crospovidone, anhydrous colloidal silica, magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E 171), macrogol 8000, red iron oxide (E 172), yellow iron oxide (E 172).

Appearance of the Product and Container Content

The film-coated tablets of Diován 80 mg are light red, round, with a notch on one side. They have the mark “D” on one side of the notch and “V” on the other side of the notch and “NVR” on the opposite face of the tablet. The notch is only to enable breaking and facilitate swallowing, but not to divide into equal doses.

The tablets are presented in blister packs with 7, 14, 28, 30, 56, 90 or 98 tablets and in calendar blister packs with 14, 28, 56, 98 and 280 tablets. Also available are single-dose precut blister packs of 56x1, 98x1 or 280x1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Tel: 93-306 42 00

Manufacturer

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Farma S.p.A.

Viale Luigi Sturzo 43

20154 Milano (MI)

Italy

Novartis Farma – Pharmaceutical Products, S.A.

Avenida Professor Doutor Cavaco Silva, n.° 10E (Taguspark, Porto Salvo).

Oeiras Parish. 2740 255.

Portugal

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma S.A.S.

8-10 rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

Novartis Pharma B.V.

Haaksbergweg 16

1101 BX Amsterdam

Netherlands

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

Novartis Farma S.p.A.

Via Provinciale, Schito131

80058 Torre Annunziata (NA)

Italy

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

Further information on this medicinal product can be obtained from the marketing authorization holder.

This medicinal product is authorized in theMember States of the European Economic Area underthe following names:

Date of the Last Revision of this Leaflet:06/2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/