VALSARTAN NORMON 320 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan Normon 320 mg film-coated tablets EFG

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

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

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

This medicinecan 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 not treated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead to a 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 Normon

Do not take ValsartanNormon:

• 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 pregnantfor more than 3 months. (it is also better to avoid taking valsartan 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 takeValsartanNormon.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Valsartan Normon:

• if you have a liver disease,
• if you have a 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 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Valsartan Normon, stop taking it immediately and never take it again. See section 4, “Possible side effects”.
• if you are using 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
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., 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 check 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 Normon”.

You must inform your doctor if you think you are (or might become) pregnant. Valsartan is not recommended at the start of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

Other medicines and Valsartan Normon

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

The effect of treatment with Valsartan Normon may be affected 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 production), ACE inhibitors (e.g., enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan Normon” 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-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (of the rifampicin group), a medicine used to prevent rejection in a transplant (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Normon.
• lithium, a medicine used to treat certain types of psychiatric diseases.

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

Taking Valsartan Normon with food and drink

You can take Valsartan Normon with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another blood pressure-lowering medicine instead of valsartan. Valsartan Normon is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage.

• Tell your doctor if you are breast-feeding or will start breast-feeding. Valsartan Normon is not recommended during breast-feeding, and your doctor will choose another medicine for you if you want to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how Valsartan Normon affects you. Like many other medicines used to treat high blood pressure, Valsartan Normon may cause dizziness and affect your ability to concentrate.

Valsartan Normon contains sorbitol, lactose, and sodium

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated 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 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 recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Your doctor may also combine valsartan with another medicine (e.g., a diuretic).

Use in children and adolescents (from6 toless than 18years of age) with high blood pressure

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

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

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 the valsartan oral solution is recommended.

Swallow Valsartan Normon with a glass of water.

Take this medicine at approximately the same time each day.

If you take more Valsartan Normon than you should

If you notice a strong dizziness or fainting, lie down and contact your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist or hospital immediately. 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 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 taking Valsartan Normon

If you stop taking Valsartan Normon, 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 medicine, 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 Normon and consult a 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 side effects can be serious and may 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(frequency cannot be estimated from the available data)

• blistering of the skin (sign of bullous dermatitis),
• allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness),
• red spots on the skin, fever, itching (signs of 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 reduction in the percentage of red blood cells in the blood (which, in severe cases, can lead to anemia),
• increase in potassium levels 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 levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes),
• increase in urea nitrogen and creatinine levels in the blood (which may indicate kidney problems),
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle contractions, 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 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Normon

Do not store above 30°C. Store in the original package to protect from moisture.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. 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 deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Container Content and Additional Information

Composition ofValsartan Normon

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

This medication contains the colorants red iron oxide (E 172) and brown iron oxide (E 172), aluminum lake indigo carmine (E 132).

Appearance of the Product and Container Content

Valsartan Normon 320 mg: are oblong, film-coated tablets, gray-violet in color and with a score line on one side.

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

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

You can request more information about this medication by contacting the marketing authorization holder.

Date of the Last Revision of this Prospectus:February 2025

This Medication is Authorized in the Member States of the European Economic Area with the Following Names:

Spain:Valsartan Normon 320 mg film-coated tablets EFG

Detailed and updated information about this medication 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 medication by scanning the QR code included in the prospectus 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/72917/P_72917.html