Diovan

Package leaflet: Information for the user

Diovan 80 mg, film-coated tablets
Diovan 160 mg, film-coated tablets
Valsartanum
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Diovan is and what it is 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 narrow, thereby increasing blood pressure. Diovan works by blocking the effects of angiotensin II. As a result, blood vessels widen and blood pressure is lowered.

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

• Treatment of high blood pressure in adult patients and in children and adolescents aged 6 to below 18 years. High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart and kidneys, which may result in 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 complications.
• Treatment of adult patients after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients. Diovan is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or as additional treatment to ACE inhibitors when other types of medicines used in heart failure cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These are caused by the heart muscle being unable to pump blood strongly enough to supply the body's needs.

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

• Treatment of high blood pressure in adult patients and in children and adolescents aged 6 to below 18 years. High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may lead to damage of 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 normal levels reduces the risk of developing these complications.
• Treatment of adult patients after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients. Diovan is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or as additional treatment to ACE inhibitors when other types of medicines used in heart failure cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These are caused by the heart muscle being unable to pump blood strongly enough to supply the body's needs.

2. Important information before using Diovan

When not to use Diovan:

• if the patient has hypersensitivity (allergy) to valsartan or to any of the other ingredients of Diovan listed in section 6;
• if the patient has severe liver disease;
• if the patient is pregnant beyond the 3rd month (use of Diovan is also not recommended during early pregnancy – see Pregnancy section);
• if the patient has diabetes or kidney impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, Diovan must not be used.
Warnings and precautions
Tell your doctor if:

• the patient has liver disease;

• severe kidney disease has been diagnosed or if the patient is on dialysis;

• in case of renal artery stenosis;

• if the patient has recently received a kidney transplant (the patient has received a new kidney);

• if the patient has severe heart disease other than heart failure or a heart attack;

• if the patient has ever previously experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), this should be reported to the doctor. If such symptoms occur while taking Diovan, treatment with Diovan must be stopped immediately and must never be restarted. See also section 4, "Possible side effects";

• if the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Diovan, this should be discussed with the doctor. The doctor will decide on further treatment. Do not stop taking Diovan on your own initiative;

• if the patient is taking medicines that increase potassium levels in the blood. This includes potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparin. Regular monitoring of blood potassium levels may be necessary;

• if the patient has aldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone), Diovan must not be used;

• in case of significant fluid loss (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretic medicines (diuretics);

• if the patient is taking any of the following medicines used to treat high blood pressure: ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes; or aliskiren.

• if the patient is being treated with an ACE inhibitor in combination with other medicines used
  in the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g.
  spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).
  The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels
  (e.g. potassium) at regular intervals.
  See also information under the heading “When not to use Diovan”. Tell your doctor if the patient
  suspects she is pregnant (or plans to become pregnant). Use of Diovan is not recommended during
  early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm
  the unborn child if used at this stage (see Pregnancy section).
  Diovan and other medicines
  Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
  taken, as well as any medicines the patient plans to take.
  Taking Diovan together with certain other medicines may affect treatment. A dose adjustment,
  additional precautions, or in some cases discontinuation of one of the medicines may be necessary.
  This applies to both prescription and over-the-counter medicines, particularly:

• other medicines that lower blood pressure, especially diuretics, angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under the headings “When not to use Diovan” and “When to exercise special caution with Diovan”);

• medicines that increase potassium levels in the blood; including potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparin;

• certain types of painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs);

• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used in the treatment of HIV/AIDS (ritonavir). These medicines may enhance the effect of Diovan;

• lithium (a medicine used in the treatment of certain psychiatric disorders).

Additionally:

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

Pregnancy and breastfeeding

• Tell your doctor if the patient suspects she is pregnant (or plans to become pregnant). The doctor will usually advise stopping Diovan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Diovan. Use of Dio wan is not recommended during early pregnancy and must not be used in patients beyond the 3rd month of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.
• Inform your doctor if the patient is breastfeeding or intends to breastfeed. Use of Diovan is not recommended in breastfeeding mothers; the doctor may choose another treatment for the patient who plans to breastfeed. This particularly applies to feeding newborns or preterm infants.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any other activity requiring concentration, each patient should determine how Diovan affects them. Like many other medicines used to treat high blood pressure, Diovan may cause dizziness and affect the ability to concentrate.

3. How to take Diovan

This medicine should always be taken exactly as prescribed by your doctor in order to achieve the best results and minimize the risk of adverse effects. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not experience any symptoms and may feel quite well. For this reason, it is especially important to attend regular medical check-ups, even if you feel well.

High blood pressure in adult patients: The recommended dose 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 together with another medicine (e.g. a diuretic).

High blood pressure in children and adolescents (aged 6 to under 18 years)
For patients weighing less than 35 kg, the recommended initial dose of Diovan tablets is 40 mg once daily. For patients weighing 35 kg or more, the recommended initial dose of Diovan tablets is 80 mg once daily. In some cases, your doctor may recommend higher doses (the dose may be increased up to 160 mg, and a maximum of 320 mg). For children who cannot swallow tablets, Diovan oral solution is recommended.

Treatment following a recent heart attack in adult patients: Treatment usually begins within 12 hours after the heart attack, typically starting with a low dose of 20 mg twice daily. The 20 mg dose is obtained by splitting a 40 mg tablet. Your doctor will gradually increase the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose depends on the individual patient's tolerance to the medicine.

Diovan may be given together with other medicines used in the treatment of heart attack. Your doctor will decide which treatment is appropriate in each individual case.

Heart failure in adult patients: The usual initial dose is typically 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose depends on the individual patient's tolerance to the medicine.

Diovan may be given together with other medicines used in the treatment of heart failure. Your doctor will decide which treatment is appropriate in each individual case.

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

Diovan should be taken every day at approximately the same time.

If you take more Diovan than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In case of accidental overdose, contact your doctor, pharmacist, or go to a hospital immediately.

If you forget to take Diovan
If you miss a dose, take it as soon as possible. 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.

Stopping Diovan
Stopping treatment with Diovan may worsen your condition. Do not discontinue treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Some adverse effects may be serious and require immediate medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:

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

If any of these symptoms occur, stop taking Diovan immediately
and contact your doctor (see also section 2 "Warnings and precautions").
Other adverse effects:
Common (may affect up to 1 in 10 people)

• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting upon standing,
• kidney function disorders (symptoms of impaired kidney function).

Uncommon (may affect up to 1 in 100 people)

• angioedema (see "Some symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (dizziness),
• severe kidney function disorders (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalaemia),
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• feeling of fatigue,
• weakness.

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

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Unknown frequency (frequency cannot be estimated from available data)

• skin blisters (symptoms of bullous dermatitis),
• allergic reactions with rash, itching and hives; symptoms such as fever, swelling and joint pain, muscle pain, swollen lymph nodes and (or) flu-like symptoms may occur (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of inflammation of blood vessels, also known as vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat or mouth ulcers due to infection (symptoms of low white blood cell count, so-called neutropenia),
• reduced haemoglobin concentration and reduced proportion of red blood cells in blood (which may lead to anaemia in severe cases),
• increased potassium levels in blood (which may cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver function parameters (which may indicate liver damage), including increased bilirubin levels in blood (which may cause yellowing of the skin and eyes in severe cases),
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate impaired kidney function),
• low sodium concentration in blood (which may cause fatigue, disorientation, muscle twitching and (or) seizures in severe cases).

The frequency of some adverse effects may vary depending on the disease.
For example, adverse effects such as dizziness and kidney function disorders
have been 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.
Adverse effects observed in children and adolescents are similar to those occurring in adult
patients.
Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse effects helps gather more information on the safety of this medicine.

5. How to store Diovan

• Keep the medicine out of the sight and reach of children.
• Store below 30º C. Keep 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 stated month.
• Do not use Diovan if the packaging is damaged or shows any signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diovan contains

• The active substance in this medicine is valsartan.
• Each coated tablet contains 80 mg or 160 mg of valsartan.
• Other ingredients of the medicine are: microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate.
  Coating ingredients: hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172, only in Diovan 160 mg).

What Diovan looks like and contents of the pack
Diovan 80 mg are light red, round, film-coated tablets, with a score line on one side, slightly convex, marked with an embossed "D" on one side of the score line and "V" on the other side of the score line, and "NVR" on the reverse side of the tablet.
The break line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing when divided.
Available pack sizes: 28 or 56 tablets.

Diovan 160 mg are grey-orange, oval, film-coated tablets, with a score line on one side, marked with an embossed "DX" on both sides of the dividing score line and "NVR" on the reverse side of the tablet.
The break line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing when divided.
Available pack sizes: 14, 28 or 56 tablets.
Not all pack sizes may be marketed.

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

Manufacturer / Importer
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-Straße 5
1100 Vienna
Austria

Novartis Pharma B.V.
Haaksbergweg 16
1101 BX Amsterdam
The 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 Hungária Kft.
H-1114 Budapest
Bartók Béla út 43-47.
Hungary
This medicinal product is authorized for marketing in the Member States of the European
Economic Area under the following names: