User Information: Package Insert

Valsartán NORMON 160 mg Film-Coated Tablets.

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Valsartán 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 constrict, resulting in increased blood pressure.

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

Valsartán 160 mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years.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 cause a stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing blood pressure to normal values 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 patients.Valsartán is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure), or it may 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 feet and legs due to fluid retention. This is because the heart muscle is not able to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Normon:

• if you areallergic(hypersensitive) to valsartán or to any of the other components of this medication (listed in section 6).
• if you have aserious liver disease.
• if you aremore than 3 months pregnant(it is better to avoid Valsartán Normon during the first months of pregnancy - see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

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

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have a serious kidney disease or if you are undergoing dialysis.
• if you have a narrowing of the kidney artery.
• if you have recently undergone a kidney transplant (you received a new kidney).
• if you have a serious 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 Valsartán Normon, stop taking it 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. You may need to regularly control 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 Valsartán 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:
• • a medication that blocks the conversion of angiotensin (ACEI) (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes.
  • aliskirén
• if you are being treated with an ACEI along with other medications specifically used to treat 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 Valsartán Normon. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán Normon in monotherapy.

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

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

Inform your doctor if you think you are (or could be) pregnant. Valsartán Normon is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it could cause serious harm to your baby if used during this period (see Pregnancy section).

Use of Valsartán Normon with other medications

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

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

• other medications that lower blood pressure,especiallydiuretics(medications to increase urine production), ACEIs (such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take Valsartán 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 medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (in the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán Normon.
• lithium,a medication used to treat certain types of psychiatric diseases.

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withACEIs (a medication for heart attack treatment).
• if you are being treated forheart failure,it is not recommended to take a triple combination withACEIs and other medications specifically used to treat 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).Your doctor will usually recommend that you stop taking Valsartán Normon before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Normon. Valsartán Normon is not recommended at the beginning of pregnancy, and it should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you are breastfeeding or plan to start. Valsartán 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 operating machinery

Before driving a vehicle, using tools, or operating machines, or performing other activities that require concentration, make sure you know how Valsartán Normon affects you. Like many other medications used to treat high blood pressure, Valsartán Normon may cause dizziness and affect concentration.

Valsartán Normon contains sorbitol

This medication contains 18.5 mg of sorbitol in each tablet.

Valsartán Normon contains lactose

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

Valsartán Normon contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

To get the best results and reduce the risk of adverse effects, take this medication exactly as your doctor tells you to. If you are unsure, ask your doctor or pharmacist. People with high blood pressure often do not notice any symptoms 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 per day. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). You may also take valsartan with another medication (e.g. a diuretic).

Use in children and adolescents aged 6 to less than 18 years with high blood pressure

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

In patients weighing 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 at 12 hours, typically with a low dose of 20 mg, administered 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 taken with other treatments for a heart attack, and your doctor will decide what 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 taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

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

If you take more Valsartan Normon 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 can also call the Toxicological 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 the missed doses.

If you interrupt treatment with Valsartan Normon

If you stop taking 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 in the face, lips, tongue, or throat
• difficulty breathing or swallowing
• hives, itching

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

Other side 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
• reduction in kidney function (signs of renal deterioration)

Less frequent(may affect up to 1 in 100 people):

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of rotation (vertigo)
• marked reduction in kidney function (signs of acute renal insufficiency)
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia)
• shortness of breath, difficulty breathing while 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 presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• blistering of the skin (sign of dermatitis bullosa)
• may occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu
• red-purple patches, fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
• more frequent bleeding or bruising than usual (signs of thrombocytopenia),
• muscle pain (myalgia)
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia)
• reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• increase in potassium level in the blood (which, in severe cases, may cause 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, may cause the skin and eyes to turn yellow)
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies)
• low sodium level in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction 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, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from humidity.

Keep out of the reach and sight of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not use this medicine if you observe that the packaging is damaged or shows signs of manipulation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Valsartán Normon

• The active ingredient is valsartan.
• A film-coated tablet contains 160 mg of valsartan.
• The other components are microcrystalline cellulose (E-460), anhydrous colloidal silica, sorbitol (E-420), magnesium carbonate (E-504), pregelatinized cornstarch (cornstarch), povidone (E-1201), stearate fumarate and sodium, sodium lauryl sulfate (see section 2: 'Valsartán Normon contains sodium'), crospovidone.
• The tablet coating containsOpadry OY-L-28900 (Lactose monohydrate (see section 2: ‘Valsartán Normon contains lactose’), hypromellose (E-464), titanium dioxide (E-171) and macrogol 4000).

Valsartán Normon 160 mg contains iron oxide yellow/brown (E-172).

Appearance of the product and content of the container

Orange-coated, cylindrical, and scored tablets. The tablet can be divided into equal doses.

The tablets are presented in blister packs with 28, 56, and 280 tablets.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet:February 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70364/P_70364.html