Package Leaflet: Information for the Patient

Valsartán Krka 320 mg Film-Coated Tablets

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

• Keep this package 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. 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 an increase in blood pressure. Valsartán Krka acts by blocking the effect of angiotensin II. As a consequence, blood vessels relax and blood pressure decreases.

Valsartán Krka 320 mg film-coated tabletscan be used to treat high blood pressure in adults and adolescents between 6 and less than 18 years of age.

Hypertension increases the load on 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 renal failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán Krka:

• if you areallergicto valsartán or to any of the other components of this medication (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 medication at the beginning of your pregnancy - see Pregnancy section),
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure 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 medications (including ACE inhibitors), 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 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. You may need to regularly check 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, Valsartán Krka is not recommended,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production),
• if you are taking any of the following medications used to treat high blood pressure:
• • a medication that inhibits the enzyme angiotensin-converting enzyme (ACE inhibitors) such as enalapril, lisinopril, etc., especially if you have diabetes-related kidney problems.
  • aliskirén.

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 should 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 the Pregnancy section).

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

Children and adolescents:

If you are under 18 years old and taking Valsartán Krka in combination with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor should regularly check your kidney function and the amount of potassium in the blood.

Other medications and Valsartán Krka:

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

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

• other medications that lower blood pressure,especiallydiuretics(medications 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”),
• medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• some pain medicationscalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (rifampicin group), a medication used to protect against transplant rejection (ciclosporina), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán Krka,
• lithium,a medication used to treat certain types of psychiatric disorders.

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 medication.

• You should 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 medication instead. Valsartán Krka is not recommended at the beginning of pregnancy, and it should not be administered after the third month of pregnancy as it may cause serious harm to your baby if administered from that point onwards.

• Inform your doctor if you plan to start or are breastfeedingas 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 machinery:

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 medications used to treat high blood pressure, Valsartán Krka may cause dizziness and affect concentration.

Valsartán Krka contains lactose and sodium:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This will help you achieve 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 doctor's appointments, even if you feel well.

Adults with High Blood Pressure

The usual dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). You may also combine Valsartán Krka with another medication (e.g., a diuretic).

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).

Doses less than 160 mg are not possible with Valsartán Krka 320 mg film-coated tablets.

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

If You Take More Valsartán Krka Than You Should

If you experience severe 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 Valsartán Krka

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

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 Treatment with Valsartán Krka

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

If you have any other questions 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 symptoms may be severe and require immediate medical attention:

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

• swelling in the face, tongue, or throat,
• difficulty breathing or swallowing,
• hives, 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, postural dizziness,
• low blood pressure with symptoms such as dizziness,
• 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 rotation (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(frequency cannot be estimated from available data)

• blistering on the skin (sign of bullous dermatitis),
• skin rash, itching, along with some of the following signs or symptoms: fever, joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu (signs of serum sickness),
• red purpuric patches, fever, itching (signs of vascular inflammation, also known as vasculitis),
• more frequent bleeding or bruising (signs of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as 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 that can cause fatigue and confusion, muscle contractions, convulsions, or coma,
• 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 yellowing of the skin and eyes),
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may 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 patients treated for hypertension than in patients treated for heart failure or after a recent heart attack.

Additional side effects in children and adolescents

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 above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Valsartán Krka

• The active ingredient is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), and red iron oxide (E172) in the coating.

See section 2 “Valsartán Krka contains lactose and sodium”

Appearance of Valsartán Krka and contents of the packaging

Film-coated tablets of 320 mg are slightly brown, capsule-shaped, biconvex, and marked on one part. The tablet can be divided into equal doses.

Film-coated tablets of 320 mg are presented in boxes with blisters of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, and 98 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorizationand manufacturer

Holder of the marketing authorization

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

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 Segura10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Last review date of this leaflet: May 2021

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/