Valsartan Normon 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan NORMON 80 mg film-coated tablets EFG.

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Valsartán Normon belongs to a class of medicines 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.

Valsartán 80 mg film-coated tablets can be used for 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 may damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels 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. Valsartan is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication used to treat heart failure) cannot be used, or may be used in addition to angiotensin-converting enzyme inhibitors when other heart failure medications cannot be used.

Symptoms of heart failure include difficulty breathing and swelling in the feet and legs due to fluid retention. This occurs because the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before starting to take Valsartán Normon

Do not take Valsartán Normon:

• if you are allergic (hypersensitive) to valsartan or to any of the other components of this medicine (listed in section 6).
• if you have a severe liver disease.
• if you are more than 3 months pregnant (it is also best 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 blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions:

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have narrowing of the artery supplying the kidney (renal artery stenosis).
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have a serious heart disease other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking Valsartán Normon, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.
• if you are taking medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking Valsartán Normon is not recommended.
• if you have lost a significant amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output).
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren
• if you are being treated with an ACEI together with other specific medicines for 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 Valsartán Normon. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán Normon when used as monotherapy without medical advice.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

You must inform your doctor if you think you are (or could be) pregnant. Valsartán Normon is not recommended in early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Use of Valsartán Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment with Valsartán Normon may be altered when taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions, or in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Valsartán Normon” and “Warnings and precautions”).
• medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartán Normon.
• lithium, a medicine used to treat certain psychiatric conditions.

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medicine used to treat heart attack) is not recommended.
• if you are being treated for heart failure, triple combination with ACE inhibitors and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol) is not recommended.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant (or suspect you might be pregnant). Your doctor will usually advise you to stop taking Valsartán Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartán Normon is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

• Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Valsartán Normon is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving, operating tools or machinery, or engaging in any activity requiring concentration, make sure you know how Valsartán Normon affects you. Like many other medicines used to treat high blood pressure, Valsartán Normon may cause dizziness and affect your ability to concentrate.

Valsartán Normon contains sorbitol

This medicine contains 9.25 mg of sorbitol in each tablet.

Valsartán Normon contains lactose

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

Valsartán Normon contains sodium

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

3. How to take Valsartán Normon

To achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms and may feel perfectly well. Therefore, it is very important to attend your medical appointments regularly, even if you feel fine.

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 combined with another medicine (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 daily.

In patients weighing 35 kg or more, the recommended starting 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).

Adult patients after a recent heart attack: treatment is usually initiated within 12 hours after the heart attack, typically starting with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan may be administered together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure: treatment is usually initiated with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

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

If you take more Valsartán 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

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 your next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartán Normon

If you discontinue treatment with valsartan, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious and may require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

• swelling of 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 adverse effects include:

Common (may affect up to 1 in 10 people):

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting upon standing
• 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)
• sensation of spinning (vertigo)
• marked reduction in kidney function (signs of acute renal failure)
• muscle spasms, irregular heartbeat (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 presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• Blisters on the skin (sign of bullous dermatitis)
• Allergic reactions may occur, with skin rash, itching, and urticaria; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness)
• Purple-red skin spots, fever, itching (signs of blood vessel inflammation, also called vasculitis)
• Bleeding or bruising more 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 levels and reduction in the percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• Increased blood potassium levels (which, in severe cases, may cause muscle spasms and irregular heartbeat)
• Elevation of liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes)
• Increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities)
• Low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse 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.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Normon

Do not store above 30°C. Keep 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 container. The expiry date refers to the last day of the month indicated.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Normon

• The active substance is valsartan.
• One film-coated tablet contains 80 mg of valsartan.
• The other ingredients are microcrystalline cellulose (E-460), colloidal anhydrous silica, sorbitol (E-420), magnesium carbonate (E-504), pregelatinized corn starch, povidone (E-1201), stearic fumarate and sodium, 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 80 mg contains red iron oxide (E-172).

Appearance of the medicinal product and contents of the pack

Pink, cylindrical, film-coated tablets with a score line. The tablet can be divided into equal doses.

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

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid, Spain

Date of the most recent review 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70360/P_70360.html