VALSARTAN PREMIUM PHARMA 320 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Premium Pharma 320 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 and other information

1. What is Valsartan Premium Pharma and what is it 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

1. Contents of the pack and other information

1. What is Valsartan Premium Pharma and what is it 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, blood vessels relax and blood pressure decreases.

Valsartan Premium Pharma 320 mg film-coated tablets can be used

• to treat high blood pressure in adults and in children and adolescents from 6 to 18 years of age.High blood pressure increases the strain on the heart and arteries. If left uncontrolled, it can lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal reduces the risk of developing these disorders.

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

Do not take Valsartan:

• 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 treatment with Valsartan Premium 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 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Valsartan Premium Pharma, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.
• if you are taking medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, 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,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine production),

• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., 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 should not be taken if you are pregnant for more than three months, as it can 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 taking, have recently taken, or might take any other medicines.

The effect of treatment with Valsartan Premium Pharma may be altered if taken with certain medicines. It may be necessary to change the dose, 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 production), an angiotensin-converting enzyme inhibitor (ACE inhibitor)(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 containing potassium, potassium-sparing medicines, and heparin,

• certain pain 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.

Pregnancy and breastfeeding

• Pregnancy

You must inform your doctor if you are pregnant (or think you might be).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. Valsartan Premium Pharma is not recommended during the first trimester of pregnancy, and it must not be taken after the third month of pregnancy, as it can cause serious harm to your baby when used during this period (see section Pregnancy).

• Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding.Valsartan Premium Pharma is not recommended 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 performing 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, in rare cases, cause 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 symptoms; 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 may also be given 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).

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

Take valsartan at approximately the same time each day.

Dosage 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, nor 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, phone 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 forgotten doses.

If you stop taking Valsartan Premium Pharma

If you stop taking Valsartan Premium 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.

Some side effects can be serious and may need 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”).

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 when standing up,
• reduced kidney function (signs of kidney damage).

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

• angioedema (see section “Some symptoms need 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(may affect up to 1 in 10,000 people)

• Intestinal angioedema: swelling in the intestine that presents with 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),
• 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 and hematocrit levels in the blood (which, in severe cases, can cause anemia),
• increase in potassium levels in the blood (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 yellowing of the skin and eyes),
• 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 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 via 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 Valsartan Premium Pharma

• Store below 30°C. Store in the original package 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 package. The expiry date is the last day of the month indicated.
• Do not use Valsartan Premium Pharma if you notice that the package is damaged or shows signs of tampering.

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

6. Additional information

Composition of Valsartan Premium Pharma

• The active substance is valsartan.
• One film-coated tablet contains 320 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 package contents

The 320 mg Valsartan film-coated tablets are brown, oblong, convex, and scored on one side. The score line is intended to facilitate breaking the tablet to help with swallowing, but not to divide into equal doses.

The tablets are packaged 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/