PATIENT INFORMATION LEAFLET

Valsartan Normon 320 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Valsartan Normon

3.How to take Valsartan Normon

4.Possible side effects

5.Storage of Valsartan Normon

6.Contents of the pack and additional information

Valsartán Normon belongs to a class of medications known as angiotensin II receptor antagonists that 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 Normon acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

This medicationmay be used

• to treat high blood pressure in adults and in children and adolescents from6 toless 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 cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take ValsartánNormon:

• if you areallergic(hypersensitive) to valsartán or any of the other components of this medication (listed in section 6),
• if you have aserious liver disease,
• if you arepregnantover 3 months(it is better to avoid taking valsartán during the first months of pregnancy - see the 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 takeValsartánNormon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán Normon:

• if you have liver disease,
• if you have a serious 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 a 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 Valsartán Normon, stop taking it immediately and never take it again. See 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 containing potassium, potassium-sparing medications, and heparin. You may need to have your potassium levels in the blood checked regularly
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, valsartán is not recommended.
• 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 (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • Aliskirén
• if you are being treated with an ACE inhibitor along with other medications specifically used to treat 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 check your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

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

You should inform your doctor if you think you are (or could be) pregnant. Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it could cause serious harm to your baby if used during this period (see the Pregnancy section).

Other medications and Valsartán Normon

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), ACE inhibitors (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 containing potassium, potassium-sparing medications, and heparin,
• certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (of 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 disorders.

Your doctor may need to adjust your dose and/or take other precautions.

Taking ValsartánNormon with food and drinks

You can take Valsartán Normon with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

• You must inform your doctorif you are pregnant(or if you suspect you may be).Your doctor will usually recommend that you stop taking valsartán before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication to lower blood pressure instead of valsartán. Valsartán is not recommended at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered at that time.
  

• Inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartán Normon is not recommended during breastfeeding, and your doctor will choose another medication 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 machinery, or engaging in 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, in rare cases, dizziness and affect concentration.

Valsartán Normon contains sorbitol, lactose, and sodium

This medication contains 37.0 mg of sorbitol in each film-coated tablet.

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.

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; that is, 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, consult 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 appointments with your doctor, even if you feel well.

Adult patients with high blood pressure

The recommended 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 combine valsartan with another medication (e.g. a diuretic).

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

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

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

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).

For children who cannot swallow tablets, the use of valsartan oral solution is recommended.

Swallow Valsartan Normon with a glass of water.

Take this medication approximately at the same time every day.

If you take more Valsartán Normon than you should

If you experience severe dizziness or fainting, lie down and contact your doctor immediately.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately. You may also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán 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 Valsartán Normon

If you stop taking Valsartán Normon, 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 medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan 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 Valsartán Normon and consult a doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

Frequent(may affect up to1 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).

Rare(may affect up to1 in 100 people)

• angioedema (see section “Someside effects can be serious and may requireimmediate medical attention”)
• sudden loss of consciousness (syncope),
• sensation of spinning (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.

Very 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(the frequency cannot be estimated from the 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 pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu,
• red purpura 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, can cause anemia),
• increase in potassium level in the blood (which, in severe cases, can 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, can 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, can cause fatigue, confusion, muscle contraction, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduction in kidney function were observed less frequently in adult patients treated for hypertension 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 Vigilance of Medicinal Products for Human Use: https://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 86°F (30°C).Store in the original packaging to protect it from moisture.

Keep this medication out of the sight and reach of children.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofValsartán Normon

• The active ingredient is valsartán.Each tablet contains 320 mg of valsartán.
• The other components are:microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized cornstarch, povidone K-25 (E 1201), sodium esterfumarate, sodium lauryl sulfate, crospovidone Type A (E 1202).Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol.

This medicine contains red iron oxide (E 172) and brown iron oxide (E 172) colorant, and aluminium lake indigo carmine (E 132).

Appearance of the product and contents of the packaging

Valsartan Normon 320 mg:are oval-shaped, coated, grey-violet tablets with a notch on one face.

The tablets are presented in packaging of 7, 14, 28, 56, 98, and 280 coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

For more information about this medicine, please contact the holder of the marketing authorization.

Last review date of this leaflet:February 2025

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Valsartan Normon 320 mg coated tablets EFG

Detailed and updated 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/72917/P_72917.html