VALSARTAN KERN PHARMA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan Kern Pharma 160 mg film-coated tablets EFG

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

Keep this leaflet, you may need to read it again.

• 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Valsartan Kern Pharma and what is it used for
2. What you need to know before you take Valsartan Kern Pharma
3. How to take Valsartan Kern Pharma
4. Possible side effects
5. Storage of Valsartan Kern Pharma
6. Pack contents and further information

1. What is Valsartan Kern Pharma and what is it used for

Valsartan Kern Pharma belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsartan Kern Pharma works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Valsartan Kern Pharma 160 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adults and in children and adolescents from 6 to 18 years of age.High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels of the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels 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.Valsartan Kern Pharma is used when it is not possible to use a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication for treating heart failure), or it may be used in addition to ACEIs when it is not possible to use other medications for the treatment of heart failure.

Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to provide all the blood needed by the body.

2. What you need to know before you take Valsartan Kern Pharma

Do not take Valsartan Kern Pharma:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of Valsartan Kern Pharma, listed at the end of this leaflet,
• if you have severe liver disease,
• if you are pregnant for more than 3 months(it is also better to avoid Valsartan Kern Pharma during the first months of pregnancy – see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of these situations apply to you, do not take Valsartan Kern Pharma.

Warnings and precautions

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

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• if you are being treated for a heart attack or heart failure, your doctor may check your kidney function,
• if you have severe heart disease other than heart failure or heart attack,
• if you are taking 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. It may be necessary to regularly check the amount of potassium in the blood,
• if you are under 18 years of age and take Valsartan Kern Pharma with other medications that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure),your doctor may periodically check your kidney function and blood potassium levels,
• 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 Valsartan Kern Pharma,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination),
• if you are taking any of the following medications used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril),especially if you have diabetes-related problems
• aliskiren
• if you are being treated with an ACEI along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

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

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

• tell your doctor if you are pregnant (or think you might be).It is not recommended to use Valsartan Kern Pharma at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from that time on (see section Pregnancy).

If any of these situations apply to you, tell your doctor before taking Valsartan Kern Pharma.

Using Valsartan Kern Pharma with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

The effect of treatment with Valsartan Kern Pharma may be altered if taken with certain medicines. Your doctor may need to change your dose and/or take other precautions, or in some cases, stop treatment with one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure,especially diuretics(medicines to increase urine elimination), ACEIs (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Valsartan Kern Pharma” 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 medications, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• lithium,a medicine used to treat certain types of psychiatric illnesses.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack),
• if you are being treated for heart failure,it is not recommended to combine with ACE inhibitors and other specific treatments for your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers(e.g., metoprolol).

Taking Valsartan Kern Pharma with food, drink, and alcohol

You can take Valsartan Kern Pharma with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

Tell your doctor if you are pregnant (or think you might be).Your doctor will normally advise you to stop taking Valsartan Kern Pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Kern Pharma. It is not recommended to use Valsartan Kern Pharma at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from that time on.

• Breastfeeding

Tell your doctor if you are breastfeeding or will start breastfeeding.It is not recommended to use Valsartan Kern Pharma 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 using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how Valsartan Kern Pharma affects you. Like many other medicines used to treat high blood pressure, Valsartan Kern Pharma can cause, in rare cases, dizziness and affect your ability to concentrate.

3. How to take Valsartan Kern Pharma

To get the best results and reduce the risk of side effects, always take Valsartan Kern Pharma exactly as your doctor tells you. If you are unsure, ask your doctor or pharmacist. 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 once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan Kern Pharma may also be used in combination with another medicine (e.g., a diuretic).

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

In patients who weigh less than 35 kg, the usual dose is 40 mg of valsartan once daily.

In patients who weigh 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:after a heart attack, treatment is usually started at 12 hours, normally with 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 to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan Kern Pharma can be given 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 daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

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

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

Take Valsartan Kern Pharma at approximately the same time each day.

If you take more Valsartan Kern Pharma than you should

If you notice a strong 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 Toxicology Information Service, telephone 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan Kern Pharma

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.

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

If you stop taking Valsartan Kern Pharma

If you stop taking Valsartan Kern Pharma, your condition may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects may occur with 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,
• frequency not known: 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 of the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching.

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

The side effects include:

Common

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

Uncommon

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope),
• feeling of spinning (vertigo),
• marked reduction in kidney function (signs of acute kidney failure),
• muscle spasms, abnormal heart rhythm (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

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

Frequency not known

• 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 those of the flu (signs of serum sickness),
• purplish red spots, fever, itching (signs of inflammation of the blood vessels, also called vasculitis),
• bleeding or bruising more often 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 reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia),
• increase in blood potassium levels (which, in severe cases, can cause muscle spasms and an abnormal heart rhythm),
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow),
• increase in blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function 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.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Kern Pharma

Keep out of sight and reach of children.

Do not store at a temperature above 30°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartán Kern Pharma

• The active ingredient is valsartan. Each film-coated tablet contains 160 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E-460i), crospovidone, anhydrous colloidal silica, and magnesium stearate (E-470b). The ingredients 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 Package Contents

Valsartán Kern Pharma 160 mg film-coated tablets are yellow, oval, scored on one side, biconvex, and marked with "160" on the other side.

The score line is used to divide the tablet into two equal halves.

The tablets are presented in blister packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Leaflet: February 2025

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