Package Insert: Information for the Patient

Valsartán Krka 40 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Valsartán Krka belongs to a class of medications known as angiotensin II receptor antagonists that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartán Krka acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Krka 40 mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults and children and adolescents between 6 and under 18 years of age.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders,
• to treat people after a recent heart attack(myocardial infarction). “Recent” means here between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients.Valsartán Krka can be used to treat symptomatic heart failure in adult patients. Valsartán Krka is used when it is not possible to use a group of medications called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) or when it can be used together with ACE inhibitors when it is not possible to use other medications for the treatment of heart failure.
• Among the symptoms of heart failure are shortness of breath and swelling of feet and legs due to fluid retention. This is because the heart muscle is not strong enough to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Krka:

• if you areallergicto valsartán or to any of the other ingredients of this medicine (listed in section 6),
• if you havesevere liver disease,
• if you aremore than 3 months pregnant.(In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy - see Pregnancy section),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

If any of these situations affect you, do not take Valsartán Krka.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take valsartán:

• if you have liver disease,
• if you have severe kidney disease or if you are undergoing dialysis,
• if you have a narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (you received a new kidney),
• if you have a 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 medicines (including ACEIs), inform your doctor. If you have these symptoms when taking valsartán, stop taking valsartán immediately and never take it again. See also section 4 “Possible side effects”,
• if you are using medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines and heparin. You may need to control the amount of potassium in the blood regularly,
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán Krka is not recommended,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting or high doses of diuretics (medicines to increase urine production),
• if you are taking any of the following blood pressure-lowering medicines:
• • an ACE inhibitor (such as enalapril, lisinopril, etc.), particularly if you have diabetes-related kidney problems.
  • aliskirén.
• if you are being treated with an ACE inhibitor together with some other medicines for heart failure, which are 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 the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the title "Do not take Valsartán Krka".

You must inform your doctor if you think you are (or could be) pregnant. Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if you use it during this period (see Pregnancy section).

If any of these situations affect you, inform your doctor before taking Valsartán Krka.

Other medicines and Valsartán Krka

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

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

• other blood pressure-lowering medicines,especiallydiuretics (medicines to increase urine production), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskirén (see also the information under the headings “Do not take Valsartán Krka” 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 medicines, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (rifampicin group), a medicine used to protect against transplant rejection (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartán Krka,
• lithium,a medicine used to treat certain types of psychiatric diseases.

Additionally:

• if you are being treated after a heart attack,do not recommend the combination withACE inhibitors (a medication for treating a heart attack),
• if you are being treated for heart failure,do not recommend the triple combination withACE inhibitorsand other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Taking Valsartán Krka with food and drinks

You can take Valsartán Krka regardless of food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking Valsartán Krka before becoming pregnant or as soon as you become pregnant, and recommend taking another blood pressure-lowering medicine instead. Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if you use it during this period (see Pregnancy section).

• Inform your doctor if you are planning to start or are breastfeedingsince Valsartán Krka is not recommended during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or performing other activities that require concentration, make sure you know your reactions to the effects of Valsartán Krka. Like many other medicines used to treat high blood pressure, Valsartán Krka may cause dizziness and affect concentration.

Valsartán Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This will help you to obtain the best results and reduce the risk of adverse effects. People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your appointments with the doctor, even if you feel well.

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

In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once a day.

In patients weighing 35 kg or more, the initial usual dose is 80 mg of valsartan once a day.

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:after a heart attack, treatment is usually started at 12 hours, usually at a low dose of 20 mg administered twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance Valsartan Krka can be taken together with other treatments for heart attack, and your doctor will decide what treatment is suitable for you.

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

Valsartan Krka can be taken together with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartan Krka with or without food. Swallow Valsartan Krka with a glass of water. Take Valsartan Krka approximately at the same time every day.

If you take more Valsartan Krka than you should

If you experience a strong dizziness or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Valsartan Krka

Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Valsartan Krka

If you stop taking Valsartan Krka, your disease may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and may require 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,
• skin rash, itching.

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

Other side effects include:

Frequent(may affect up to 1 in 10 people):

• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting when standing up,
• reduction in kidney function (signs of renal deterioration).

Rare(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 insufficiency),
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia),
• shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• fatigue,
• weakness.

Unknown frequency(cannot be estimated from available data):

• blistering on the skin (sign of bullous dermatitis),
• allergic reaction with skin rash, itching, urticaria, symptoms of fever, joint pain, muscle pain, swelling of lymph nodes, and/or may occur symptoms similar to the flu (signs of serum disease),
• red purpuric spots, fever, itching (signs of inflammation of blood vessels, also called vasculitis),
• more frequent bleeding or bruising (signs of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also called neutropenia),
• reduction in hemoglobin level and reduction in 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 abnormal heart rhythm),
• decrease in sodium level in the blood (which can cause fatigue and confusion, muscle spasms, seizures, or coma),
• elevation of liver function values (which can 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 urea nitrogen level in the blood and increase in serum creatinine level (which can indicate renal anomalies).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction were observed less frequently in adult patients treated for hypertension 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from humidity.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Valsartán Krka

• The active ingredient is valsartan. Each tablet contains 40 mg of valsartan.
• The other components of the tablet core are lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.
• The other components of the tablet coating are hypromellose, titanium dioxide (E171), macrogol 4000, and yellow iron oxide (E172).

See section 2 “Valsartán Krka contains lactose and sodium”.

Appearance of Valsartán Krka and contents of the packaging

The film-coated tablets of 40 mg are yellow-brown, round, slightly biconvex, and marked on one of their parts.

The tablets of the three doses can be divided into equal doses.

The film-coated tablets are presented in blisters of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120, and 180 tablets, in a box.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warszawa, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Last review date of this leaflet: May 2021

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/