Leaflet: Information for the user

Valsartán Kern Pharma 160 mg film-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Valsartán Kern Pharma belongs to a class of medications 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 constrict, resulting in increased blood pressure. Valsartán Kern Pharma acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Kern Pharma 160 mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents aged 6 to 18 years.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 adult patients after a recent heart attack(myocardial infarction).

“Recent” here means between 12 hours and 10 days,

• to treat symptomatic heart failure in adult patients.Valsartán Kern Pharma is used when it is not possible to use a group of medications called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication to treat heart failure), or it can be used in addition to ACEIs when other medications for heart failure treatment cannot be used.

Among the symptoms of heart failure are difficulty breathing 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 Kern Pharma:

• if you areallergic(hypersensitive) to valsartán or to any of the other components of Valsartán Kern Pharma, listed at the end of this prospectus,
• if you have aserious liver disease,
• if you aremore than 3 months pregnant(it is better to avoid Valsartán Kern Pharma during the first months of 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 Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán Kern Pharma.

• if you have liver disease,
• if you have a serious kidney disease or if you are undergoing dialysis,
• if you have a narrowing of the renal artery,
• if you have recently undergone a kidney transplant (you received a new kidney),
• if you are being treated for a heart attack or heart failure, your doctor may check your renal function,
• if you have a severe heart disease other than heart failure or heart attack,
• if you are using medications that increase the amount of potassium in the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to control your potassium levels regularly,
• if you are under 18 years of age and take Valsartán Kern Pharma with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may check your renal function and potassium levels periodically,
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartán Kern Pharma,
• 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 renin-angiotensin-aldosterone system inhibitor (RAAS inhibitor) (for example, enalapril, lisinopril, ramipril), especially if you have related diabetes problems
• aliskirén
• if you are being treated with a RAAS inhibitor along with other specific medications for your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

Your doctor may check your renal function, blood pressure, and electrolyte levels (such as potassium) regularly.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán Kern Pharma in monotherapy.

See also the information under the heading “Do not take Valsartán Kern Pharma”.

• inform your doctor if you are pregnant (or if you suspect you may be).Valsartán Kern Pharma is not recommended for use at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that moment on (see Pregnancy section).

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

Use of Valsartán Kern Pharma with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

The effect of Valsartán Kern Pharma treatment may be altered if taken with certain medications. Your doctor may need to change your dose and/or 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), RAAS inhibitors (such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take Valsartán Kern Pharma” and “Warnings and precautions”)
• medications that increase the amount of potassiumin the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• litium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withangiotensin-converting enzyme inhibitors (ACE inhibitors)(a medication for treating a heart attack),
• if you are being treated forheart failure,it is not recommended to combine withACE inhibitors and other specific treatments for your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers(for example, metoprolol).

Taking Valsartán Kern Pharma with food, drink, and alcohol

You can take Valsartán Kern Pharma with or without food.

Pregnancy and breastfeeding

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

• Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be).Your doctor will usually recommend that you stop taking Valsartán Kern Pharma before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Kern Pharma. Valsartán Kern Pharma is not recommended for use at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that moment on.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartán Kern Pharma is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machines, or performing other activities that require concentration, make sure you know how Valsartán Kern Pharma affects you. Like many other medications used to treat high blood pressure, Valsartán Kern Pharma may cause, in rare cases, dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take Valsartán Kern Pharma exactly as your doctor tells you to. Consult your doctor or pharmacist if you have any doubts. 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.

Adult patients 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 take Valsartán Kern Pharma with another medication (e.g. a diuretic).

Children and adolescents (6 to 18 years old) 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 usually starts at 12 hours, typically with 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 gradually increase this dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartán Kern Pharma can be taken with other treatments for heart attack, and your doctor will decide what treatment is suitable for you.

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

Valsartán Kern Pharma can be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartán Kern Pharma with or without food. Swallow Valsartán Kern Pharma with a glass of water.

Take Valsartán Kern Pharma approximately at the same time every day.

If you take more Valsartán Kern Pharma than you should

If you notice 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 can also call the Toxicological Information Service, phone 91-562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán Kern Pharma

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

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

If you interrupt treatment with Valsartán Kern Pharma

If you stop taking Valsartán Kern Pharma, 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 may cause side effects, although not everyone will experience them.

These side effects may occur at certain frequencies, which are defined below:

• Very common: may affect more than 1 in 10 people,
• Common: may affect up to 1 in 10 people,
• Uncommon: may affect up to 1 in 100 people,
• Rare: may affect up to 1 in 1,000 people,
• Very rare: may affect up to 1 in 10,000 people,
• Unknown frequency: the frequency cannot be estimated from the available data.

Some symptoms 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,
• Hives, itching.

If you experience any of these symptoms, consult a doctor immediately.

The side effects include:

Common

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

Uncommon

• 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.

Very rare

- Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency

• May occur allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu (signs of serum sickness),
• Reddish purple spots, fever, itching (signs of inflammation of blood vessels, also called vasculitis),
• Bleeding or bruising more frequently than usual (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, may cause anemia),
• Increased potassium level in the blood (which, in severe cases, may cause muscle spasms and abnormal heart rhythm),
• Elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, may cause the skin and eyes to turn yellow),
• Increased urea nitrogen level in the blood and increased 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 adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

The 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 86°F (30°C).

Do not use Valsartán Kern Pharma after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not use Valsartán Kern Pharma if you observe that the packaging is damaged or shows signs of deterioration.

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. If in doubt, 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 Kern Pharma

• The active ingredient is valsartan. Each film-coated tablet contains 160 mg of valsartan.
• The other components are: microcrystalline cellulose (E-460i), crospovidone, anhydrous colloidal silica, and magnesium stearate (E-470b). The components of the tablet coating are: hypromellose (E-464), titanium dioxide (E-171), macrogol, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

The film-coated tablets of Valsartán Kern Pharma 160 mg are yellow-coated, oval-shaped, scored tablets, biconvex, and with the mark “160” on the other side.

The score serves to divide the tablet into two equal halves.

The tablets are presented in blister packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2025

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