Valsartan Stadafarma 80 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan Stadafarma 80 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, consult 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 such effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Valsartán Stadafarma 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.

Valsartán Stadafarma 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 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may 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 adult patients 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 inhibitors (ACE inhibitors) (a medication used to treat heart failure) cannot be used, or may be added to ACE inhibitors when other heart failure treatments are not suitable.

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 Stadafarma

Do not take Valsartán Stadafarma:

• if you are allergic (hypersensitive) to valsartan or to any of the other components of Valsartán Stadafarma (listed in section 6).
• if you have a severe liver disease,
• if you are more than 3 months pregnant. (It is best 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 these situations apply to you, inform your doctor and do not take valsartan.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take valsartan:

• if you have a liver disease,

• if you have a severe kidney disease or are undergoing dialysis,

• if you have a narrowing of the artery to the kidney (renal artery stenosis),

• if you have recently had a kidney transplant (received a new kidney),

• if you have a serious heart disease other than heart failure or heart attack,

• if you have ever 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 get these symptoms while taking valsartan, stop taking valsartan immediately and never take it again. See section 4, “Possible side effects”.

• if you are taking medicines that increase the amount of potassium 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 valsartan is not recommended,

• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine output), inform your doctor.

• 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), 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 the treatment of 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 electrolyte levels (e.g., potassium) at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own.

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

You must inform your doctor if you think you are (or might 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).

If any of these situations apply to you, inform your doctor before taking valsartan.

Taking Valsartán Stadafarma 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 valsartan may be altered if taken together with certain medicines. It may be necessary to adjust the dose, 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 to increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren. (See also information under the headings “Do not take Valsartán Stadafarma” 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 (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of valsartan,
• lithium, a medicine used to treat certain psychiatric disorders.

Additionally:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medication 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 the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenona) or beta-blockers (e.g., metoprolol) is not recommended.

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

Taking Valsartán Stadafarma with food and drinks

You may take valsartan regardless of meals.

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before taking any medicine.

• You must inform your doctor if you are pregnant or think you might be pregnant. Generally, your doctor will advise you to stop taking valsartan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartan 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 stage.

• Inform your doctor if you plan to start or are currently breastfeeding, as valsartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

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

Valsartán Stadafarma contains sorbitol.

This medicine contains 9.25 mg of sorbitol per tablet.

Valsartán Stadafarma contains sodium

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

Valsartán Stadafarma contains lactose

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

3. How to take Valsartán Stadafarma

To achieve the best results and reduce the risk of adverse effects, always take valsartan exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not experience any symptoms and may feel perfectly well. This makes it 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).

Children and adolescents (6 to 18 years of age) with high blood pressure:

In patients weighing less than 35 kg, the usual 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).

For children who have difficulty swallowing tablets, administration of valsartan oral solution is recommended.

Adult patients after a recent heart attack:

Treatment usually begins within 12 hours after a heart attack, typically starting with a low dose of 20 mg administered twice daily. 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 started at 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 valsartan with or without food. Swallow valsartan with a glass of water.

Take valsartan at approximately the same time each day.

The tablet score line is intended only to facilitate tablet splitting if you have difficulty swallowing it whole.

If you take more Valsartán Stadafarma than you should

If you experience severe dizziness or fainting, lie down and contact your doctor immediately. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán Stadafarma

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 Stadafarma

If you discontinue treatment with valsartan, 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, valsartan may produce 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 valsartan and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other adverse effects include:

Frequent: 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 impaired renal function).

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, abnormal heart rhythm (signs of hyperkalaemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• 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 diarrhoea

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: fever, joint swelling and 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).
• reduced haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anaemia).
• increased potassium levels in the blood (which, in severe cases, may cause muscle cramps and abnormal heart rhythm).
• 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 patients treated for hypertension than in 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Stadafarma

Keep out of the sight and reach of children.

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

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 you notice that the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán Stadafarma

• The active substance is valsartan. One tablet of Valsartán Stadafarma 80 mg contains 80 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.
• Valsartán Stadafarma 80 mg contains the colouring agent iron oxide red (E 172).

Appearance of the product and contents of the pack

Valsartán Stadafarma 80 mg: are cylindrical, film-coated tablets, pink in colour, with a score line on one side.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Polig. Areta

31620 Huarte (Pamplona)

Spain

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

ZENTIVA K.S.

• Kabelovny 130

10237 Praha 10,

Czech Republic

For further information about this medicinal product, please contact the Marketing Authorisation Holder.

Date of the most recent review of this leaflet: 02/2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/