Valsartan Pharmakern 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartán Pharmakern 160 mg film-coated tablets EFG

Read the entire 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Valsartán Pharmakern

3. How to take Valsartán Pharmakern

4. Possible side effects

5. How to store Valsartán Pharmakern

6. Contents of the pack and other information

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

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

Valsartán Pharmakern 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 can 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 Pharmakern is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure treatments are not suitable.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This occurs because the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Pharmakern

Do not take Valsartán Pharmakern:

• if you are allergic (hypersensitive) 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 (Valsartán Pharmakern should also be avoided 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 the above situations apply to you, inform your doctor and do not take Valsartán Pharmakern.

Warnings and precautions

• Consult your doctor or pharmacist before starting Valsartán Pharmakern if you have liver disease,

• if you have severe kidney disease or are undergoing dialysis,

• if you have renal artery stenosis (narrowing of the artery to the kidney),

• if you have recently undergone 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 Valsartán Pharmakern, stop treatment 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 Pharmakern is not recommended,

• if you have lost a significant amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to 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 kidney problems related to diabetes,
  • aliskiren,

• if you are being treated with an ACE inhibitor together with other specific medicines for heart failure treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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

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

• You should inform your doctor if you think you are or could be pregnant. Valsartán Pharmakern 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).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan monotherapy without medical advice.

Other medicines and Valsartán Pharmakern

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

The effect of treatment with Valsartán Pharmakern 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 to increase urine output), angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartán Pharmakern” 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 valsartan,
• lithium, a medicine used to treat certain psychiatric conditions.

Additionally:

• 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, triple combination with ACE inhibitors and other specific medicines for heart failure treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol), is not recommended.

Pregnancy and breastfeeding

• Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Valsartán Pharmakern before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartán Pharmakern. Valsartán Pharmakern 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 that time.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of Valsartán Pharmakern during breastfeeding is not recommended, and your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

3. How to take Valsartán Pharmakern

To achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms and may feel perfectly well. Therefore, it is very important to attend your medical appointments regularly, even if you feel fine.

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 Pharmakern may also be combined with another medicine (e.g., a diuretic).

Use in 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 initiated within 12 hours after the heart attack, typically starting 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 Pharmakern may be administered together with other treatments for heart attack, and your doctor will determine 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 Pharmakern may be administered together with other treatments for heart failure, and your doctor will determine which treatment is appropriate for you.

Valsartan may be taken with or without food. Swallow the tablet with a glass of water.

Take valsartan at approximately the same time each day.

Dosage not covered by available Valsartán Pharmakern presentations

The available Valsartán Pharmakern strengths (80 mg, 160 mg, and 320 mg) do not allow administration of the recommended dose for the initial treatment of recent myocardial infarction or heart failure in adults, or for the treatment of arterial hypertension in children weighing < 35 kg. In such cases, alternative formulations from other valsartan-containing medicines allowing administration of 20 mg or 40 mg of valsartan should be used.

If you take more Valsartán Pharmakern 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 immediately. You may also call the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartán Pharmakern

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 Pharmakern

If you discontinue treatment with Valsartán Pharmakern, 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Some side effects may 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 throat,
• difficulty breathing or swallowing,
• hives, itching.

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

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

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

• blisters on the skin (sign of bullous dermatitis),
• allergic reactions may occur with skin rash, itching and hives; symptoms of fever, swelling and 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 easily 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 proportion of red blood cells in the blood (which, in severe cases, may lead to anemia),
• increased potassium levels in blood (which, in severe cases, may cause muscle cramps and irregular heartbeat),
• elevated liver function test values (which may indicate liver damage), 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),
• low sodium levels in blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures).

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 type of side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Pharmakern

• Store below 30°C. Keep in the original packaging to protect from moisture.

• Keep out of the reach and sight of children.

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

• Do not use Valsartán Pharmakern if you notice that the packaging is damaged or shows signs of tampering.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Valsartán Pharmakern

• The active substance is valsartan.
• One film-coated tablet contains 160 mg of valsartan.
• The other ingredients are microcrystalline cellulose, crospovidone, and magnesium stearate.
• The tablet coating contains hypromellose, titanium dioxide (E171), Macrogol PEG 8000, iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172).

Appearance of the product and contents of the package

Valsartán Pharmakern 160 mg film-coated tablets are orange-yellow in color, oblong-shaped, and scored on one side. The tablet can be divided into two equal halves.

The tablets are supplied in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

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

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