VALSARTAN PREMIUM PHARMA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan

Premium Pharma 160 mg film-coated tablets EFG

valsartan

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.
• 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:

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

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

Valsartan Premium 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 Premium Pharma works by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Valsartan Premium 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 in the brain, heart, and kidneys, and can 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" means here between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patientsValsartan Premium Pharma is used when it is not possible to use a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE inhibitors 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 for the body.

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

Do not take Valsartan Premium Pharma:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease,
• if you are pregnant for more than 3 months(it is also better to avoid Valsartan Premium 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 the above applies to you, tell your doctor and do not take Valsartan Premium Pharma.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Valsartan Premium Pharmaif you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have a narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• if you have severe heart disease other than heart failure or heart attack,
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Valsartan Premium Pharma, stop taking it immediately and never take it again. See also section 4 "Possible side effects".
• 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 have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartan Premium 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 (ACE inhibitor) (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes
  • aliskiren

• if you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.

See also the information under the heading "Do not take Valsartan Premium Pharma".

• You must inform your doctor if you think you are or might become pregnant. Valsartan Premium Pharma is not recommended at the start of pregnancy, and it must not be taken if you are pregnant for more than three months, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

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 on your own.

Other medicines and Valsartan Premium Pharma

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

The effect of treatment with Valsartan Premium 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), angiotensin-converting enzyme inhibitors(ACE inhibitors) (such as enalapril, lisinopril, etc.), or aliskiren(see also the information under the headings "Do not take Valsartan Premium 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),
• certain antibiotics (from the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan.
• lithium,a medicine used to treat certain types of psychiatric diseases.

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 medications for the treatment of your heart failure,known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Pregnancy and breastfeeding

• Pregnancy

You must inform your doctor if you are pregnant (or if you think you might be pregnant).Your doctor will normally advise you to stop taking Valsartan Premium 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 Premium Pharma. It is not recommended to use Valsartan Premium Pharma at the start of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken after this period.

• Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Valsartan Premium 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 machines, or carrying out other activities that require concentration, make sure you know how Valsartan Premium Pharma affects you. Like many other medicines used to treat high blood pressure, Valsartan Premium Pharma can cause, in rare cases, dizziness and affect your ability to concentrate.

3. How to take Valsartan Premium Pharma

To get the best results and reduce the risk of side effects, always take this medicine 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). You can also take Valsartan Premium Pharma in combination 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 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 can 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 Premium Pharma can be given with other treatments for heart attack, and your doctor will decide which 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 Premium Pharma can be given with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take valsartan with or without food. Swallow valsartan with a glass of water.

Take valsartan at approximately the same time each day.

Dosing not covered by the available presentations of Valsartan Premium Pharma

The available presentations of Valsartan Premium Pharma (80 mg, 160 mg, and 320 mg) do not allow for the administration of the recommended dose for the treatment of recent myocardial infarction or heart failure in adults, or for the treatment of high blood pressure in children <35 kg. in these cases, other medicinal products that allow for the administration of 20 mg or 40 valsartan should be used.< p>

If you take more Valsartan Premium 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 Premium 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 make up for missed doses.

If you stop taking Valsartan Premium Pharma

If you stop taking Valsartan Premium Pharma, your disease 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 in the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching.

If you experience any of these symptoms, stop taking Valsartan Premium Pharma and contact your doctor immediately (see also section 2 "Warnings and Precautions").

Adverse effects include:

Frequent(may affect up to 1 in 10 people):

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

Uncommon(may affect up to 1 in 100 people):

• angioedema (see section "Some symptoms require immediate medical attention")
• sudden loss of consciousness (syncope),
• feeling of rotation (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(may affect up to 1 in 10,000 people)

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

Frequency Not Known(cannot be estimated from the available data):

• blisters on the skin (sign of bullous dermatitis)
• 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),
• more frequent bleeding or bruising 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 serum creatinine levels (which may indicate kidney function abnormalities).
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

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 with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

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

5. Storage of Valsartan Premium Pharma

• Store below 30°C. Keep in the original packaging to protect it from moisture.
• Keep out of the reach and sight of children.
• Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.
• Do not use Valsartan Premium Pharma if you notice that the packaging is damaged or shows signs of tampering.

• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Valsartan Premium Pharma

• The active ingredient 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 PGE 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).

Appearance of the Product and Packaging Contents

The film-coated tablets of Valsartan Premium Pharma 160 mg are orange-yellow, oblong, and scored on one side. The tablet can be divided into two equal halves.

The tablets are presented in blister packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Premium Pharma SL

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

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/