Valsaros 10 mg/80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsaros 10mg/80mg film-coated tablets

Valsaros 20mg/80mg film-coated tablets

Valsaros 10mg/160mg film-coated tablets

Valsaros 20mg/160mg film-coated tablets

rosuvastatin/valsartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Valsaros is and what it is used for

Valsaros contains two active substances: rosuvastatin and valsartan.

Valsaros is indicated for the treatment of high blood pressure associated with high levels of cholesterol and/or for the prevention of cardiovascular events.

2. What you need to know before taking Valsaros

Do not take Valsaros:

• If you are allergic to valsartan, rosuvastatin, or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Valsaros, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Valsaros by using appropriate contraceptive methods.
• If you have liver disease.
• If you have severe kidney problems.
• If you experience repeated or unexplained muscle pain or cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplants).
• 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 (or if you have any doubts), contact your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Valsaros.

• If you have kidney problems or are undergoing dialysis.
• If you have liver problems.
• If you experience repeated or unexplained muscle pain or cramps, have a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you develop unexplained muscle pain, especially if you feel unwell or have a fever.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other cholesterol-lowering medicines called fibrates. Please read this leaflet carefully even if you have previously taken other medicines to treat high cholesterol levels.
• If you are taking medicines for HIV infection, such as ritonavir with lopinavir and/or atazanavir; see section "Taking Valsaros with other medicines".
• If you are over 70 years old (as your doctor must choose the most appropriate starting dose of Valsaros for you).
• If you have severe respiratory failure.
• If you are of Asian origin: Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian, for example, as your doctor must choose the most appropriate starting dose of Valsaros for you.
• 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 a heart attack or heart failure; your doctor may monitor your kidney function.
• 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—angioedema—while taking other medicines (including ACE inhibitors). If you develop these symptoms while taking Valsaros, stop 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 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 such cases, Valsaros is not recommended.
• If you are severely dehydrated due to diarrhea, vomiting, or high doses of diuretics.
• If you are taking any of the following medicines for 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 simultaneously with an angiotensin-converting enzyme inhibitor —ACEI— and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists —MRA— (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used for bacterial infections). Combining fusidic acid with Valsaros may lead to serious muscle problems (rhabdomyolysis).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking rosuvastatin or related medicines.
• If you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects breathing muscles) or ocular myasthenia (a condition causing weakness of eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In a small number of people, statins may affect the liver. This is detected through a simple blood test showing elevated liver enzymes—transaminases. For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with Valsaros.

If you have diabetes or are at risk of developing it, your doctor will monitor you closely while you are taking this medicine. You may be at increased risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

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

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop taking rosuvastatin and seek immediate medical attention if you notice any of the symptoms described in section 4.

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

See also the information under the heading "Do not take Valsaros".

If any of the above situations apply to you, inform your doctor before taking Valsaros.

Taking Valsaros with other medicines

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

Tell your doctor if you are taking any of the following medicines:

• Cyclosporine (used, for example, after organ transplants).
• Anticoagulants, e.g., warfarin, acenocoumarol, or phenindione (their anticoagulant effect and risk of bleeding may increase when taken with this medicine), ticagrelor, or clopidogrel.
• Fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (such as ezetimibe).
• Medicines for indigestion (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Oral contraceptives (birth control pills).
• Hormone replacement therapy.
• Other medicines used to treat high blood pressure, especially diuretics.
• Medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• Painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• Certain antibiotics (rifampicin group), a medicine used to prevent organ transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir with lopinavir and/or atazanavir). These medicines may increase the effect of Valsaros.
• Lithium, a medicine used to treat certain psychiatric conditions.
• If you are taking an angiotensin-converting enzyme inhibitor —ACEI— or aliskiren (see also information under the headings "Do not take Valsaros" and "Warnings and precautions").
• If you are being treated simultaneously with an angiotensin-converting enzyme inhibitor —ACEI— and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists —MRA— (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop treatment with this medicine. Your doctor will advise you when it is safe to restart Valsaros. Taking Valsaros together with fusidic acid may rarely cause muscle weakness, muscle pain, or tenderness (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• Capmatinib (used to treat cancer).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high uric acid levels in blood).
• Teriflunomide (used to treat multiple sclerosis).
• Roxadustat (used to treat anemia in patients with chronic kidney disease).
• Tafamidis (used to treat a condition called transthyretin amyloidosis).
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by Valsaros or may alter the effect of Valsaros.

Taking Valsaros with food and drinks

You may take Valsaros with or without food.

Pregnancy and breastfeeding

Do not take Valsaros if you are pregnant or breastfeeding. If you become pregnant while taking Valsaros, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Valsaros by using appropriate contraceptive methods. Ask your doctor or pharmacist for advice before starting treatment with this medicine.

Driving and using machines

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

Valsaros contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to take Valsaros

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Recommended adult dose

The recommended dose is one tablet daily.

You may take this medicine before or after meals and drinks. Take this medicine at the same time every day with water. Do not take this medicine with grapefruit juice.

Use in children and adolescents

Valsaros must not be used in children or adolescents.

Regular cholesterol level checks

It is important that you visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose to the amount of Valsaros suitable for you.

If you take more Valsaros than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you feel severe dizziness and/or fainting, lie down. If you go to the hospital or receive treatment for another condition, inform healthcare professionals that you are taking Valsaros.

If you forget to take Valsaros

Do not worry. Simply take the next scheduled dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Valsaros

Consult your doctor if you wish to stop treatment with Valsaros. Stopping treatment with Valsaros may worsen your condition. Your cholesterol levels may rise again if you stop taking Valsaros. Do not stop taking this medicine unless your doctor tells you to.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Valsaros and seek immediate medical attention if you experience any of the following adverse effects:

• Difficulty breathing, with or without swelling of the face, lips, tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing.
• Severe skin itching (with rash).
• Blisters on the skin, mouth, eyes and/or genitals (Stevens-Johnson syndrome).
• Drug-induced lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Reddish, non-elevated spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If you experience any of the above symptoms, stop taking Valsaros and consult a doctor immediately (see also section 2 "Warnings and precautions").

Also stop taking Valsaros and contact your doctor immediately if you experience unexplained muscle pain and cramps lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have resulted in a potentially fatal muscle injury called rhabdomyolysis.

Frequent adverse effects (may affect up to 1 in 10 people):

• Dizziness.
• Low blood pressure, with or without symptoms such as dizziness or fainting upon standing.
• Reduced kidney function (signs of kidney failure).
• Headache.
• Abdominal pain.
• Constipation.
• Nausea.
• Muscle pain.
• Feeling of weakness.
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Angioedema (see section "Stop taking Valsaros and seek immediate medical attention").
• Sudden loss of consciousness (syncope).
• Sensation of spinning (vertigo).
• Marked reduction in kidney function (signs of acute kidney failure).
• Muscle spasms, irregular heartbeat (signs of hypokalemia).
• Shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure).
• Cough.
• Diarrhea.
• Fatigue.
• Weakness.
• Skin rash, itching, or other skin reactions.
• Increased amount of protein in urine — this usually returns to normal without the need to discontinue Valsaros tablets.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Severe allergic reaction. Symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing, and/or severe skin itching (with rash). If you think you are having an allergic reaction, stop taking Valsaros and seek immediate medical attention.
• Muscle injury in adults. As a precaution, stop taking Valsaros and consult a doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes in blood.
• Reduced platelet count, increasing the risk of bleeding or bruising (thrombocytopenia).

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (liver inflammation).
• Blood traces in urine.
• Nerve damage in arms and legs (such as numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (enlargement of breast tissue in men).
• Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported with similar products.

Adverse effects of unknown frequency (frequency cannot be estimated from available data):

• Allergic reactions with rash, itching, and hives, fever symptoms, joint 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).
• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia).
• Reduced hemoglobin levels and reduced percentage of red blood cells in the blood (which may lead to anemia in severe cases).
• Increased potassium in blood (which, in severe cases, may cause muscle spasms and irregular heartbeat).
• Reduced sodium levels in blood (which may cause fatigue, confusion, muscle twitching, seizures, or coma).
• Increased liver function test values (which may indicate liver damage), including elevated bilirubin levels in blood (which, in severe cases, may cause yellowing of the skin and eyes).
• Increased blood urea nitrogen and increased serum creatinine (which may indicate kidney function abnormalities).
• Dyspnea (shortness of breath).
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injuries.
• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).
• Consult your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

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.

If any of the adverse effects you experience are severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of 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 Medicines: http://www.notificaram.es/. By reporting adverse effects, you help provide more information on the safety of this medicine.

5. Storage of Valsaros

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsaros

The active substances are rosuvastatin and valsartan.

Valsaros 10 mg/80 mg film-coated tablets

Each tablet contains 10 mg of rosuvastatin (as calcium salt) and 80 mg of valsartan.

Valsaros 20 mg/80 mg film-coated tablets

Each tablet contains 20 mg of rosuvastatin (as calcium salt) and 80 mg of valsartan.

Valsaros 10 mg/160 mg film-coated tablets

Each tablet contains 10 mg of rosuvastatin (as calcium salt) and 160 mg of valsartan.

Valsaros 20 mg/160 mg film-coated tablets

Each tablet contains 20 mg of rosuvastatin (as calcium salt) and 160 mg of valsartan.

The other components are:

Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (E470b), mannitol (E421), polyvinylpyrrolidone K25, sodium lauryl sulfate, and yellow iron oxide (E172)

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) —only for Valsaros 10 mg/80 mg, 20 mg/80 mg and 10 mg/160 mg film-coated tablets— and yellow iron oxide (E172) —only for Valsaros 10 mg/160 mg and 20 mg/160 mg film-coated tablets.

See section 2 “Valsaros contains lactose” and sodium.

Nature of the product and pack contents

Valsaros 10 mg/80 mg film-coated tablets

Film-coated tablets, dark pink in colour, round, slightly biconvex with bevelled edges, marked with the code «K4» on one side.

Diameter: 8.7–9.3 mm.

Valsaros 20 mg/80 mg film-coated tablets

Film-coated tablets, dark pink in colour, capsule-shaped, slightly biconvex, marked with the code «K3» on one side.

Dimensions: 14.7–15.3 mm × 6.7–7.3 mm.

Valsaros 10 mg/160 mg film-coated tablets

Film-coated tablets, dark pink in colour, oval, biconvex, marked with the code «K2» on one side.

Dimensions: 16.7–17.3 mm × 7.7–8.3 mm.

Valsaros 20 mg/160 mg film-coated tablets

Film-coated tablets, brownish-yellow in colour, oval, biconvex, marked with the code «K1» on one side.

Dimensions: 16.7–17.3 mm × 7.7–8.3 mm.

Valsaros is available in blisters packed in cartons containing 10, 14, 20, 28, 30, 56, 60, 84, 90 or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

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