Valsartan Kern Pharma 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Valsartan Kern Pharma 160 mg film-coated tablets EFG

Read the entire 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valsartan Kern Pharma is and what it is used for
2. What you need to know before taking Valsartan Kern Pharma
3. How to take Valsartan Kern Pharma
4. Possible side effects
5. How to store Valsartan Kern Pharma
6. Contents of the pack and other information

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

Valsartán Kern Pharma 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, leading to increased blood pressure. Valsartán Kern Pharma works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán 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 aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage the blood vessels of the brain, heart, and kidneys, and may lead to 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" means within 12 hours to 10 days,

• to treat symptomatic heart failure in adult patients. Valsartán Kern Pharma is used when a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors) (a medication used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure treatments cannot be used.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This is due to 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 Kern Pharma

Do not take Valsartán Kern Pharma:

• if you are allergic (hypersensitive) to valsartan or to any of the other components of Valsartán Kern Pharma listed at the end of this leaflet,
• if you have a severe liver disease,
• if you are more than 3 months pregnant (it is also advisable 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 blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartán Kern Pharma.

• if you have a liver disease,
• if you have a serious kidney disease or are undergoing dialysis,
• if you have narrowing of the artery supplying the kidney (renal artery stenosis),
• 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 monitor your kidney function,
• if you have a serious heart disease other than heart failure or heart attack,
• if you are taking medicines that increase potassium levels in the blood. 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 are under 18 years of age and are taking Valsartán Kern Pharma together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically monitor your kidney function and blood potassium levels,
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking Valsartán Kern Pharma is not recommended,
• if you have lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output),
• if you are taking any of the following medicines used to treat hypertension (high blood pressure):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related problems,
• aliskiren,
• if you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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

Contact 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 as monotherapy without medical advice.

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

• inform your doctor if you are pregnant (or suspect you may be pregnant). The use of Valsartán Kern Pharma is not recommended during early pregnancy, and it must not be administered after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward (see Pregnancy section).

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

Use of Valsartán Kern Pharma with other medicines

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 Valsartán Kern Pharma may be altered when taken together with certain medicines. Your doctor may need to adjust your dose and/or take other 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 that increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Valsartán Kern Pharma” and “Warnings and precautions”),
• medicines that increase potassium levels in the blood. 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),
• lithium, a medicine used to treat certain psychiatric conditions.

Additionally:

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

Taking Valsartán Kern Pharma with food, drink, and alcohol

You may take Valsartán Kern Pharma with or without 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.

• Pregnancy

You must inform your doctor if you are pregnant (or suspect you may be pregnant). Your doctor will usually advise you to stop taking Valsartán Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartán Kern Pharma is not recommended during early pregnancy, and must not be administered after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward.

• Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Valsartán Kern Pharma is not recommended during breastfeeding. Your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving, operating tools, or handling machinery, or engaging in other activities requiring concentration, make sure you know how Valsartán Kern Pharma affects you. Like many other medicines used to treat high blood pressure, Valsartán Kern Pharma may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Kern Pharma

To achieve the best results and reduce the risk of adverse effects, always take Valsartán Kern Pharma exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not experience any symptoms; many feel perfectly normal. Therefore, it is 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). Valsartán Kern Pharma may also be combined with another medicine (e.g. a diuretic).

Children and adolescents (6 to 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 with a low dose of 20 mg twice daily. The 20 mg dose is obtained by splitting 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 Kern Pharma 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 initiated with 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 Kern Pharma may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

Valsartán Kern Pharma may be taken with or without food. Swallow the tablet with a glass of water.

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

If you take more Valsartán Kern Pharma than you should

If you experience 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 may also call the Toxicology Information Service at telephone number 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 your next dose, skip the missed dose.

Do not take a double dose to make up for a missed dose.

If you stop taking Valsartán Kern Pharma

If you discontinue treatment with Valsartán Kern Pharma, your condition may worsen. Do not stop taking the 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 experiences them.

These adverse effects may occur with certain frequencies defined as follows:

• 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, consult a doctor immediately.

Adverse effects include:

Common

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

Uncommon

• 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 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 causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known

• allergic reactions may occur with skin rash, itching, and hives; symptoms of fever, swelling and pain in the joints, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness),
• purplish red 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 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, may lead to anemia),
• increased potassium levels in the blood (which, in severe cases, may cause muscle spasms and abnormal heart rhythm),
• elevated liver function test values (which may indicate 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 high blood pressure 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 type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Kern Pharma

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Valsartán Kern Pharma after the expiry date stated on the container. The expiry 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 must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Kern Pharma

• The active substance 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 contents of the pack

Valsartán Kern Pharma 160 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets with a score line on one side and the mark “160” on the other side.

The score line is intended to facilitate tablet splitting into equal halves.

The tablets are presented in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/