Valsartan Krka 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartán Krka 160 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Valsartán Krka is and what it is used for
2. What you need to know before taking Valsartán Krka
3. How to take Valsartán Krka
4. Possible side effects
5. How to store Valsartán Krka

Contents of the pack and other information

1. What Valsartán Krka is and what it is used for

Valsartán Krka 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, resulting in increased blood pressure. Valsartán Krka works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Krka 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. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders,
• to treat people after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 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 a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication used to treat heart failure) cannot be used, or it may be used in combination with ACE inhibitors when other medications for treating heart failure cannot be used.

Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This is caused by the heart muscle being unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Krka

Do not take Valsartán Krka

• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver disease,
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also in early 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 these situations apply to you, do not take Valsartán Krka.

Warnings and precautions

Talk to your doctor or pharmacist before taking valsartan:

• if you have liver disease,
• if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the artery to the kidney (renal artery stenosis),
• if you have recently had 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 valsartan, stop taking valsartan immediately and never take it again. See also section 4 “Possible side effects”,
• if you are taking medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, 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, Valsartán Krka is not recommended,
• if you have lost a lot of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines to increase urine output),
• if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes related to kidney problems,
  • aliskiren.
• if you are being treated with an ACE inhibitor together with certain other medicines used to treat 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 levels of electrolytes (e.g., potassium) in your blood at regular intervals.

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

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

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

Other medicines and Valsartán Krka

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

The effect of treatment with valsartan may be altered if taken together with certain medicines. It may be necessary to adjust the dose, take additional 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 to increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartán Krka” and “Warnings and precautions”),
• medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin,
• certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartán Krka,
• lithium, a medicine used to treat certain psychiatric conditions.

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medicine used to treat heart attack) is not recommended,
• if you are being treated for heart failure, the triple combination with ACE inhibitors and other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol), is not recommended.

Taking Valsartán Krka with food and drink

You may take Valsartán Krka regardless of meals.

Pregnancy and breastfeeding

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

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking valsartan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from this stage.

• Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as administration of valsartan is not recommended during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the baby is a 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 are aware of how Valsartán Krka affects you. Like many other medicines used to treat high blood pressure, Valsartán Krka may cause dizziness and affect your ability to concentrate.

Valsartán Krka contains lactose and sodium

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

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

3. How to take Valsartán Krka

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in 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 symptoms of the condition; many feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

Adult patients with high blood pressure: the usual 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 combine Valsartán Krka with another medicine (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 daily.

In patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartan 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).

Adult patients after a recent heart attack: treatment is usually started within 12 hours after the heart attack, typically at 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 up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartán Krka 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 started at 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.

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

You may take Valsartán Krka with or without food. Swallow Valsartán Krka with a glass of water. Take Valsartán Krka at approximately the same time each 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartán Krka

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

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.

If you stop taking Valsartán Krka

If you stop treatment with Valsartán Krka, your condition may worsen. Do not stop taking this 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 adverse effects

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

Some adverse effects can 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 pharynx,
• difficulty breathing or swallowing,
• skin rash, itching.

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

Other adverse 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 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.

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

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

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

• blisters on the skin (signs of bullous dermatitis),
• allergic reaction with skin rash, itching, urticaria, fever symptoms, 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 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 levels and decreased proportion of red blood cells in the blood (which, in severe cases, may lead to anemia),
• increased blood potassium levels (which, in severe cases, may cause muscle cramps and irregular heartbeat),
• decreased sodium levels in the blood (which may cause fatigue and confusion, muscle spasms, seizures, or coma),
• elevated liver function test values (indicating possible liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes),
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities).

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and reduced kidney function were observed less frequently in adult patients treated for hypertension than in adult patients treated for heart failure or after a recent heart attack.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan Krka

• The active substance is valsartan. Each tablet contains 160 mg of valsartan.
• The other components of the tablet core are lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
• The other components of the tablet coating are hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), and red iron oxide (E172).

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

Appearance of Valsartan Krka and contents of the pack

The 160 mg film-coated tablets are yellow-brown, oval-shaped, biconvex, and marked on one side.

The tablets of all three strengths can be divided into equal doses.

Film-coated tablets are available in blisters containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120 and 180 tablets per box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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. Równoległa 5, 02-235 Warszawa, Poland

For more information about this medicine, you may contact the local representative of the Marketing Authorization Holder:

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

Date of the most recent revision of this leaflet: April 2025

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