VALSARTAN NORMON 40 mg FILM-COATED TABLETS

1. What is Valsartan Normon and what is it used for

Valsartan Normon belongs to a class of medications 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, resulting in increased blood pressure.

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

Valsartan40 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in 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 values 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 inadult patients. Valsartan is used when it is not possible to use a group of medications 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 treating heart failure.

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

2. What you need to know before taking Valsartan Normon

Do not take Valsartan Normon:

• if you are allergic(hypersensitive) to valsartan or any of the other components of this medication (listed in section 6).
• if you have a severe liver disease.
• if you are pregnant for more than 3 months(it is also recommended to avoid Valsartan Normon during the first months of pregnancy - see section Pregnancy).
• if you have diabetes or kidney failure and are being treated with a medication to reduce blood pressure that contains aliskiren.

If any of the above situations apply to you, inform your doctor and do not take Valsartan Normon.

Warnings and precautions:

Consult your doctor

• 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 medications (including ACEIs), inform your doctor. If you have these symptoms when taking Valsartan Normon, stop treatment with Valsartan Normon immediately and never take it again. See also section 4 "Possible side effects".
• if you are using 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 monitor 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 Normon.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production).
• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACEI) (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes
  • 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) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan Normon. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan Normon on your own.

Your doctor may monitor 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 Normon".

You must inform your doctor if you think you are (or might be) pregnant. Valsartan Normon 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 may cause serious harm to your baby if used during this period (see the section on pregnancy).

Using Valsartan Normon with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

• other medications that lower blood pressure,especially diuretics(medications to increase urine production), ACEIs (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings "Do not take Valsartan Normon" and "Warnings and precautions").
• medications 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 medicationscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (from the rifampicin group), a medication used to protect against rejection in a transplant (cyclosporine), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartan Normon.
• lithium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated after a heart attack,it is not recommended to combine with ACEIs(a medication for treating a heart attack),
• if you are being treated for heart failure,it is not recommended to combine with ACEIs 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

• You must inform your doctor if you are pregnant (or if you suspect you might be pregnant).Your doctor will generally recommend that you stop taking Valsartan Normon before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Valsartan Normon. Valsartan Normon 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 may cause serious harm to your baby if used during this period.

• Inform your doctor if you are breastfeeding or plan to start breastfeeding. Valsartan Normon 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 machines, or engaging in other activities that require concentration, make sure you know how Valsartan Normon affects you. Like many other medications used to treat high blood pressure, Valsartan Normon may cause dizziness and affect your ability to concentrate.

Valsartan Normon contains sorbitol

This medication contains 4.6 mg of sorbitol in each tablet.

Valsartan Normon contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Valsartan Normon contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Valsartan Normon

To get the best results and reduce the risk of side effects, always take this medication exactly as your doctor instructs. 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.

Use in children and adolescents from 6 to less than 18 years of age with high blood pressure

In patients who weigh less than 35 kg, the recommended starting dose is 40 mg of valsartan once a day.

In patients who weigh 35 kg or more, the recommended starting dose is 80 mg of valsartan once a day.

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 usually starts within 12 hours, normally with a low dose of 20 mg, given twice a day. 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 a day. The final dose will depend on your individual tolerance.

Valsartan 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 usually starts with 40 mg twice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

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

You can take this medication with or without food. Swallow valsartan with a glass of water. Take valsartan at approximately the same time each day.

If you take more Valsartan Normon than you should

If you notice 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 can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartan Normon

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 treatment with Valsartan Normon

If you stop your treatment with valsartan, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side 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 Normon and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other 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 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 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

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 available data):

• blistering of 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 purplish spots, fever, itching (signs of 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 level and reduction in red blood cell percentage in the blood (which, in severe cases, can lead to anemia)
• increase in potassium level in the blood (which, in severe cases, can lead to muscle spasms and abnormal heart rhythm)
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increase in blood urea nitrogen and increase in serum creatinine level (which may indicate kidney function abnormalities)
• low sodium level 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.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Valsartán Normon

Do not store above 30°C. Store 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 packaging. The expiry date is the last day of the month indicated.

Do not use this medicine 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 any unused medicines at the SIGRE Point in your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Valsartán Normon

• The active ingredient is valsartan.
• One film-coated tablet contains 40 mg of valsartan.
• The other ingredients are microcrystalline cellulose (E-460), anhydrous colloidal silica, sorbitol (E-420), magnesium carbonate (E-504), pregelatinized corn starch (corn starch), povidone (E-1201), sodium stearyl fumarate, and sodium lauryl sulfate (see section 2: 'Valsartán Normon contains sodium'), crospovidone.
• The tablet coating contains Opadry OY-L-28900 (lactose monohydrate(see section 2: 'Valsartán Normon contains lactose'), hypromellose (E-464), titanium dioxide (E-171), and macrogol 4000).

Valsartán Normon 40 mg contains yellow iron oxide (E-172).

Appearance and Packaging Contents

Yellow, cylindrical, and scored film-coated tablets.

The tablet can be divided into equal doses.

The tablets are presented in blister packs of 14 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid, Spain

Date of the Last Revision of this Leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70362/P_70362.html