VALSAROS 20 MG/160 MG FILM-COATED TABLETS

Introduction

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 the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Valsaros and what is it used for
2. What you need to know before taking Valsaros
3. How to take Valsaros
4. Possible side effects
5. Storage of Valsaros
6. Package contents and additional information

1. What is Valsaros and what is it used for

Valsaros contains two active substances: rosuvastatin and valsartan.

Valsaros is indicated for the treatment of high blood pressure that occurs with high cholesterol levels 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 components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant during treatment with Valsaros, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Valsaros by using adequate contraceptive methods.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C)
• If you are taking a medicine called ciclosporin (used, for example, after organ transplants).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are affected by any of the above situations (or have doubts), consult your doctor again.

Warnings and precautions

Consult 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 have repeated or unexplained muscle pain or cramps, personal or family history of muscle problems, or history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain, especially if you feel unwell or have a fever.
• if you regularly drink large amounts of alcohol.
• if your thyroid gland does not function properly.
• if you are taking other cholesterol-lowering medicines called fibrates. Please read this leaflet carefully, even if you have taken other cholesterol-lowering medicines before.
• if you are taking medicines to treat 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 will choose the most suitable 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 will choose the most suitable starting dose of Valsaros for you.
• if you have narrowing of the kidney artery.
• if you have recently undergone a kidney transplant (have received a new kidney).
• if you are being treated for a heart attack or heart failure; your doctor may check your kidney function.
• if you have severe 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 — angioedema — while being treated with other medicines (including ACE inhibitors). If you experience these symptoms during treatment with Valsaros, stop taking it 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 salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the potassium levels in your blood.
• if you have aldosteronism: a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Valsaros is not recommended.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics.
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor — ACE inhibitor — (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren.
• if you are being treated at the same time with an ACE inhibitor along with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists — MRAs — (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop treatment with this medicine. Your doctor will indicate when it is safe to resume treatment with Valsaros. The combination of Valsaros and fusidic acid can rarely cause muscle weakness, pain, or palpitations (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatin or other related medicines.
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes — transaminases — in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with Valsaros.

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

Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.

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

Consult 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

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

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

• Ciclosporin (used, for example, after organ transplants).
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with this medicine), ticagrelor, or clopidogrel.
• Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe).
• Treatments 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 the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.
• Pain relievers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• Some antibiotics (belonging to the rifampicin group), a medicine used to prevent organ rejection after a transplant (ciclosporin), or an antiretroviral medicine used to treat HIV/SIDA (ritonavir with lopinavir and/or atazanavir). These medicines increase the effect of Valsaros.
• Lithium, a medicine used to treat certain types of psychiatric disorders.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Valsaros" and "Warnings and precautions").
• If you are being treated at the same time with an ACE inhibitor along with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists — MRAs — (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).
• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop treatment with this medicine. Your doctor will indicate when it is safe to resume treatment with Valsaros. The combination of Valsaros and fusidic acid can rarely cause muscle weakness, pain, or palpitations (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• 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 change the effect of Valsaros.

Taking Valsaros with food and drinks

You can take Valsaros with or without food.

Pregnancy and breastfeeding

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

• You must inform your doctor if you think you are (or might become) pregnant.Your doctor will normally advise you to stop taking Valsaros before becoming pregnant or as soon as you become aware of your pregnancy, and will prescribe a different treatment instead of Valsaros.

• Tell your doctor if you are breastfeeding or plan to breastfeed. Treatment with Valsaros is not recommended in breastfeeding women. Your doctor will choose a different treatment if you want to breastfeed.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or performing any other activity that requires concentration, make sure you know how Valsaros affects you. Like many other medicines used to treat high blood pressure, Valsaros can rarely cause dizziness and affect your ability to concentrate. If you feel dizzy, consult your doctor before driving or using machines.

Valsaros contains lactose and sodium

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

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

3. How to take Valsaros

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Usual dose in adults

The recommended dose is one tablet per day.

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

Use in children and adolescents

Valsaros should not be used in children or adolescents.

Regular checks of cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked to ensure that your cholesterol levels have normalized and are maintained at appropriate levels.

Your doctor may decide to increase your dose so that you take the right amount of Valsaros for you.

If you take more Valsaros than you should

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

If you notice a strong dizziness and/or fainting, lie down. If you go to the hospital or receive treatment for another condition, inform the healthcare staff that you are taking Valsaros.

If you forget to take Valsaros

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

If you stop treatment with Valsaros

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

If you have any doubts 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 all people suffer from them.

It is essential that you know what these adverse effects may be. They are usually mild and disappear in a short period.

Stop taking Valsaros and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Severe skin itching (with hives).
• Blisters on the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Red spots on the trunk, not elevated, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS 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 consult your doctor immediately if you experience unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.

Common Adverse Effects(may affect up to 1 in 10 people):

• Dizziness.
• Low blood pressure with or without symptoms such as dizziness or fainting when standing up.
• Decreased renal function (signs of renal 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 your 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 the section "Stop taking Valsaros and seek immediate medical attention").
• Sudden loss of consciousness (syncope).
• Feeling of spinning (vertigo).
• Marked reduction in renal function (signs of acute renal failure).
• Muscle spasms, abnormal heart rhythm (signs of hypokalemia).
• Shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).
• Cough.
• Diarrhea.
• Fatigue.
• Weakness.
• Skin rash, itching, or other skin reactions.
• Increased amount of protein in urine — usually returns to normal without needing to interrupt treatment with 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 hives). If you think you are having an allergic reaction, stop taking Valsarosand seek immediate medical attention.
• Muscle injury in adults. As a precaution, stop taking Valsaros and consult a doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• 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 (inflammation of the liver).
• Traces of blood in urine.
• Nerve damage in legs and arms (such as numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (enlargement of breast tissue in men).
• Intestinal angioedema: swelling in the intestine has been reported, which can cause symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

Adverse Effects of Unknown Frequency(frequency cannot be estimated from available data):

• Allergic reactions with rash, itching, and hives, symptoms of fever, joint swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or flu-like symptoms (signs of serum sickness).
• Purplish-red spots, fever, itching (signs of vasculitis, also known as inflammation of blood vessels).
• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia).
• Decreased hemoglobin level and decreased percentage of red blood cells in the blood (which can cause anemia in severe cases).
• Increased potassium levels in the blood (which can cause muscle spasms and abnormal heart rhythm in severe cases).
• Decreased sodium levels in the blood (which can cause fatigue, confusion, muscle twitching, convulsions, or coma).
• Elevated liver function values (which can indicate liver damage), including increased bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases).
• Increased urea and creatinine levels in the blood (which can indicate kidney function abnormalities).
• 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.
• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which can affect the muscles used for breathing in some cases).
• Myasthenia of the eyes (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in your arms or legs that worsens 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 decreased renal 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 suffer from are severe, or if you notice any adverse effect not described in this leaflet, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsaros

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

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

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Valsaros

The active ingredients 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 ingredients are:

Core of the tablet:microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (E470b), mannitol (E421), povidone 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.

Appearance of the Product and Packaging Contents

Valsaros 10 mg/80 mg film-coated tablets

Dark pink, round, slightly biconvex film-coated tablets with beveled edges and engraved with the mark "K4" on one side.

Diameter: 8.7–9.3 mm.

Valsaros 20 mg/80 mg film-coated tablets

Dark pink, capsule-shaped, slightly biconvex film-coated tablets engraved with the mark "K3" on one side.

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

Valsaros 10 mg/160 mg film-coated tablets

Dark pink, oval, biconvex film-coated tablets engraved with the mark "K2" on one side.

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

Valsaros 20 mg/160 mg film-coated tablets

Brownish-yellow, oval, biconvex film-coated tablets engraved with the mark "K1" on one side.

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

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

Not all 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

You can request more information about this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:August 2025

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