Valsartan Normon 320 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartán Normon 320 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valsartán Normon is and what it is used for
2. What you need to know before taking Valsartán Normon
3. How to take Valsartán Normon
4. Possible adverse effects
5. How to store Valsartán 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. Valsartán Normon works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

This medicine can be used

• to treat high blood pressure in adults and in children and adolescents from 6 to under 18 years of age. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the 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 levels reduces the risk of developing these conditions.

2. What you need to know before taking 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 severe liver disease,
• if you are more than 3 months pregnant. (It is also advisable to avoid taking valsartan 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

Talk to your doctor or pharmacist before taking Valsartán Normon:

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the renal artery (the artery supplying the kidney),
• if you have recently undergone a kidney transplant (received a new kidney),
• if you have a serious heart condition 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 experience these symptoms while taking Valsartán Normon, stop treatment immediately and never take it again. See 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 medications, 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 valsartan 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 ACE inhibitor 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 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 information under the heading “Do not take Valsartán Normon”.

You must inform your doctor if you think you are (or could be) pregnant. Valsartan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Other medicines and Valsartán Normon

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 (ACEIs) (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.

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

Taking Valsartán Normon with food and drink

You may 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 medicine.

• You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking valsartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative antihypertensive medicine instead of valsartan. 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 at that stage.

• Inform your doctor if you are breastfeeding or plan to breastfeed. Valsartán Normon is not recommended during breastfeeding, and your doctor will choose another medicine for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

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

Valsartán 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Valsartan 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 signs of the condition and frequently feel completely normal. Therefore, it is very important to attend your doctor's appointments regularly, 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). 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 dose is 40 mg of valsartan once daily.

In patients weighing 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 oral valsartan 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 experience severe dizziness or fainting, lie down and contact your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist, or go to hospital immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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 your next dose, skip the missed dose.

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

If you stop taking Valsartan Normon

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 consult a 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 adverse effects may be serious and may require immediate medical attention”),
• sudden loss of consciousness (syncope),
• sensation of spinning (vertigo),
• marked reduction in kidney function (signs of acute renal failure),
• muscle cramps, irregular heartbeat (signs of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of 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 (frequency cannot be estimated from available data)

• blisters on the skin (sign of bullous dermatitis),
• allergic reactions may occur with skin rash, itching and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness),
• purplish red 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 proportion of red blood cells in the blood (which, in severe cases, may lead to anemia),
• increased potassium levels in the blood (which, in severe cases, may cause muscle cramps 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 sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle cramps 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 hypertension 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 effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, 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 this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to 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. Dispose of unused medicines and empty containers at the SIGRE collection point at your pharmacy. If you are in any doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Normon

• The active substance is valsartan. Each tablet contains 320 mg of valsartan.
• The other components are: microcrystalline cellulose (E 460), colloidal anhydrous 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 medicine contains the colouring agents red iron oxide (E 172), brown iron oxide (E 172), and indigo carmine aluminium lake (E 132).

Appearance of the product and contents of the pack

Valsartan Normon 320 mg: are grey-violet, film-coated, oval tablets with a breakline on one side.

The tablets are available in packs containing 7, 14, 28, 56, 98 and 280 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

For further information about this medicine, please contact the Marketing Authorization Holder.

Date of the most recent review of this leaflet: February 2025

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

Spain: Valsartan Normon 320 mg film-coated tablets EFG

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and carton 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