Valsartan Almus 160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartán Almus 160 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Valsartán Almus is and what it is used for
2. What you need to know before taking Valsartán Almus
3. How to take Valsartán Almus
4. Possible adverse effects
5. How to store Valsartán Almus
6. Contents of the pack and further information

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

Valsartan 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.

Valsartan 160 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 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of 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 disorders.
• to treat people after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 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 for treating heart failure) cannot be used, or it may be added to ACE inhibitors when other medications for the treatment of heart failure cannot be used.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This occurs because the heart muscle cannot pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Almus

Do not take Valsartán Almus

• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6).

• if you have severe liver disease.

• if you are more than 3 months pregnant (it is also better to avoid this medicine during the first months of pregnancy – see section “Pregnancy”).

• 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 Almus.

Warnings and precautions

Talk to your doctor:

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the artery to the kidney (renal artery stenosis),
• if you have recently undergone a kidney transplant (received a new kidney),
• if you are being treated for heart attack or heart failure, your doctor may monitor your kidney function,
• 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 Almus, stop taking Valsartán Almus immediately and never take it again. See also section 4, “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Valsartán Almus. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán Almus on your own.
• if you are taking medicines that increase potassium levels in the blood. 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 Almus is not recommended.
• if you have lost a significant amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines that increase urine output),
• if you are taking any of the following medicines used to treat hypertension (high blood pressure):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (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).

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 Almus”.

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

Taking Valsartán Almus with other medicines

Tell 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 Almus 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), angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartán Almus” and “Warnings and precautions”),
• medicines that increase potassium levels in the blood. 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 (such as rifampicin), 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 Almus,
• lithium, a medicine used to treat certain psychiatric disorders.

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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you are pregnant (or suspect you might be). Generally, your doctor will advise you to stop taking valsartan before becoming pregnant or as soon as you know you are pregnant, and will recommend another antihypertensive medicine instead. Valsartán Almus 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 planning to start or are currently breast-feeding, as Valsartán Almus is not recommended for women during this period. Your doctor may choose a treatment that is more suitable if you wish to breast-feed, especially if the baby is a newborn or premature.

Driving and using machines

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

3. How to take Valsartán Almus

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not notice any symptoms of the condition and may feel perfectly normal. This makes it very important to keep your medical appointments even if you feel well.

Adult patients with high blood pressure: The recommended dose is 80 mg daily. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). Valsartán Almus may also be combined with another medicine (for example, a diuretic).

Use in children and adolescents (6 to 18 years of age) 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 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: After a heart attack, treatment is usually started within 12 hours, normally with a low dose of 20 mg, administered twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. 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 medicines for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure: Treatment is usually started 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 Valsartán Almus with or without food. Swallow the tablet with a glass of water.

Take Valsartán Almus approximately at the same time each day.

If you take more Valsartán 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

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 a forgotten dose.

If you stop taking Valsartán Almus

If you stop treatment with Valsartán Almus, 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 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 and itching

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

Other adverse effects include:

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

• 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 patients):

• 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 cramps, 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

Rare (may affect up to 1 in 10,000 patients):

• intestinal angioedema: swelling in the intestine causing 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 easily 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 reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• increased potassium levels in blood (which, in severe cases, may cause muscle cramps and irregular heartbeat)
• elevated 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 blood (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.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Almus

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

Do not store above 30 °C. Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container 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 must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are in doubt, 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 Valsartan Almus

The active substance is Valsartan. Each tablet contains 160 mg of Valsartan.

The other components (excipients) are, in the core: microcrystalline cellulose, crospovidone, and magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E171), Macrogol PEG 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the pack

Valsartan 160 mg film-coated tablets are yellow, oblong, convex, film-coated tablets, scored on one side. The tablet can be divided into two equal doses. It is supplied in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

LABORATORIOS LESVI, S.L.

Avda. de Barcelona, 69 - Sant Joan Despí (Barcelona) - 08970 - Spain

ATLANTIC PHARMA - PRODUÇÕES FARMACÊUTICAS, S.A.

Rua De Tapada Grande 2 - Abrunheira, Sintra - 2710-228 – Portugal

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

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