Diovan 160 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diován 160mg film-coated tablets

valsartan

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Diován is and what it is used for

Diován contains the active substance: valsartan and 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, leading to increased blood pressure. Diován works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Diován 160 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years of age. High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the 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 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 a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors) (a medication used to treat heart failure) cannot be used, or may be used added to ACE inhibitors when other heart failure treatments cannot be used. Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This is due to the heart muscle being unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Diován

Do not take Diován:

• if you are allergic (hypersensitive) to valsartan or to any of the other components of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also advisable to avoid Diován during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor and do not take Diován.

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have renal artery stenosis (narrowing of the kidney artery).
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have a serious heart condition 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 while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking Diován, stop treatment immediately and never take Diován 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 medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin. Regular monitoring of blood potassium levels may be necessary.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking Diován is not recommended.
• if you have lost a significant amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine elimination).
• if you are taking any of the following medicines used to treat hypertension (high blood pressure):
  • an angiotensin-converting enzyme inhibitor (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 specific medicines for 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) at regular intervals.

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

You must inform your doctor if you think you are (or might be) pregnant. Diován is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Use of Diován with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of Diován treatment may be altered when taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions, or in some cases discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

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

Additionally:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medication used to treat heart attack) is not recommended.
• if you are being treated for heart failure, triple combination with ACE inhibitors and other specific medicines for 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 are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Diován before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Diován. The use of Diován is not recommended during early pregnancy, and it must not be administered from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

• Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Diován during breastfeeding is not recommended, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

3. How to take Diován

To achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as your doctor has instructed you. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms and may feel completely normal. This makes it very important to attend your medical appointments regularly, 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 may also be combined with another medicine (e.g. a diuretic).

Use in children and adolescents aged 6 to less than 18 years with high blood pressure:

In patients weighing less than 35 kg, the recommended starting dose of Diován tablets is 40 mg once daily.

In patients weighing 35 kg or more, the recommended starting dose of Diován tablets is 80 mg 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).

For children who have difficulty swallowing tablets, Diován oral solution is recommended.

Adult patients after a recent heart attack: treatment is usually started 12 hours after the heart attack, normally with a low starting dose of 20 mg twice daily. This 20 mg dose is obtained by dividing a 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 will depend on your individual tolerance.

Diován may be administered together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure: treatment is usually initiated with 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 will depend on your individual tolerance.

Diován may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

Diován may be taken with or without food. Swallow the tablet with a glass of water.

Take Diován at approximately the same time each day.

If you take more Diován 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. You may also call the Toxicology Information Service at telephone number 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 your next dose, skip the missed dose.

Do not take a double dose to make up for a missed dose.

If you stop taking Diován

If you discontinue treatment with Diován, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.

If you have any further questions about 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 everyone gets them.

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

You may experience 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, 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 upon standing
• reduced kidney function (signs 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 spinning (vertigo)
• marked reduction in kidney function (signs of acute renal failure)
• muscle cramps, irregular heartbeat (signs of hyperkalaemia)
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

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

• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• blisters on the skin (sign of blistering dermatitis)
• allergic reactions may occur with skin rash, itching and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
• purplish red spots, fever, itching (signs of blood vessel inflammation, also called 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 called neutropenia)
• reduction in haemoglobin level and reduction in the proportion of red blood cells in the blood (which, in severe cases, may lead to anaemia)
• increased blood potassium levels (which, in severe cases, may cause muscle cramps and irregular heartbeat)
• elevation of liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen levels and increased serum creatinine levels (which may indicate kidney function abnormalities)
• low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function were 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 type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diován

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C. Keep in the original packaging to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diován

• The active substance is valsartan. Each film-coated tablet contains 160 mg of valsartan.
• The other components are microcrystalline cellulose, crospovidone type A, 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), black iron oxide (E 172).

Appearance of the product and contents of the pack

Diován 160 mg film-coated tablets are greyish-orange in color, oval-shaped, with a score on one side. They are marked with “DX” on one side of the score and “DX” on the other side of the score, and “NVR” on the opposite face of the tablet. The score is intended only to facilitate tablet splitting and swallowing, but not to divide the tablet into equal doses.

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

Only certain 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 – Productos Farmacêuticos, 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
The 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

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

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

Date of the most recent review of this leaflet: 06/2020

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