Valsartan Stadafarma 160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartan Stadafarma 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. Do not give it to others, even if they have the same symptoms as you, as it may 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 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 side 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, leading to increased blood pressure. Valsartan works by blocking the effects of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Stadafarma 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 of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications,
• 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 (ACE) inhibitors (a medication for treating heart failure) cannot be used, or it may be added to ACE inhibitors when other heart failure treatments are not suitable.

Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This condition 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 ingredients of Valsartán Stadafarma (listed in section 6).
• if you have 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 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 have a serious heart condition 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 potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, 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 heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol)

Your doctor may need to monitor your kidney function, blood pressure, and blood 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 during 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 salt substitutes containing potassium, 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 conditions.

Additionally:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medicine for treating heart attack) is not recommended.
• if you are being treated for heart failure, triple combination with ACE inhibitors and other specific medicines for treating heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) 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 with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

• Inform your doctor if you are pregnant or suspect you could 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 another antihypertensive medicine instead. Valsartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that time.

• 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 18.5 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 normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

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).

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

Adult patients after a recent heart attack:

Treatment is usually started within 12 hours after the heart attack, typically with a low starting dose of 20 mg given 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 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 valsartan with or without food. Swallow valsartan with a glass of water.

Take valsartan at approximately the same time each day.

The tablet score is intended solely to facilitate splitting the tablet 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, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 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, valsartan can cause adverse effects, although not everyone gets 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:

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 kidney 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 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)
• purple-red skin 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 haemoglobin levels and reduced percentage of red blood cells in blood (which, in severe cases, may lead to anaemia)
• increased blood potassium levels (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 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, 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 Medicines: 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. Keep in the original packaging 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 in your pharmacy. Ask your pharmacist how to properly 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 Valsartan Stadafarma

• The active substance is valsartan. One tablet of Valsartan Stadafarma 160 mg contains 160 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.
• Valsartan Stadafarma 160 mg contains the colouring agents yellow iron oxide (E 172) and brown iron oxide (E 172).

Nature of the product and contents of the pack

Valsartan Stadafarma 160 mg: are cylindrical, film-coated tablets, ocher-coloured, with a score on one side.

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

Only certain 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 Prague, Czech Republic

Further information on this medicine is available upon request to the Marketing Authorisation Holder.

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

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