Valarox

Leaflet accompanying the packaging: patient information

Valarox, 10 mg + 80 mg, film-coated tablets

Valarox, 20 mg + 80 mg, film-coated tablets

Valarox, 10 mg + 160 mg, film-coated tablets

Valarox, 20 mg + 160 mg, film-coated tablets

Rosuvastatin + Valsartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Valarox and what is it used for
• 2. Important information before taking Valarox
• 3. How to take Valarox
• 4. Possible side effects
• 5. How to store Valarox
• 6. Package contents and other information

1. What is Valarox and what is it used for

Valarox contains two active substances - rosuvastatin and valsartan.
Valarox is indicated for the treatment of high blood pressure and high cholesterol, and (or) prevention of cardiovascular events.

2. Important information before taking Valarox

When not to take Valarox

• if the patient is allergic to valsartan, rosuvastatin, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding, in case of pregnancy during treatment with Valarox stop treatment immediately and inform your doctor; women of childbearing age taking Valarox should use effective methods of contraception;
• if the patient has liver disease;
• if the patient has severe kidney problems;
• if the patient has recurring or unexplained muscle pain or weakness;
• if the patient is taking a combination of sofosbuvir with velpatasvir and voxilaprevir (used to treat hepatitis C virus infection);
• if the patient is taking cyclosporine (a medicine to prevent organ rejection);
• if the patient has diabetes or has kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above points apply to the patient (or the patient has doubts), consult a doctor again.

Warnings and precautions

Before starting treatment with Valarox, discuss with your doctor or pharmacist:

• if the patient has kidney or liver problems;
• if the patient has recurring or unexplained muscle pain, if muscle pain has occurred in the patient's or their family's history, or if muscle problems have occurred while taking other cholesterol-lowering medicines; in case of unexplained muscle pain, especially if accompanied by malaise or fever, consult a doctor immediately;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has thyroid problems;
• if the patient is taking other cholesterol-lowering medicines, such as fibrates; it is recommended to carefully read the leaflet, even if the patient has taken other cholesterol-lowering medicines in the past;
• if the patient is taking medicines used to treat HIV, such as ritonavir with lopinavir and (or) atazanavir, see section "Valarox and other medicines";
• if the patient is over 70 years old (as the doctor may need to adjust the initial dose for the patient);
• if the patient has severe respiratory failure;
• if the patient is of Asian origin: Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian; the doctor may need to adjust the initial dose of Valarox for the patient;
• if the patient has renal artery stenosis;
• in patients who have recently undergone kidney transplantation (received a new kidney);
• in patients being treated after a heart attack or for heart failure, the doctor may check the patient's kidney function;
• in patients with severe heart disease other than heart failure or heart attack;
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema. Inform your doctor about this. If the patient experiences such symptoms, stop taking Valarox immediately and consult a doctor. The patient should not take Valarox again. See also section 4 "Possible side effects".
• in patients taking medicines that increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to periodically check potassium levels in the blood;
• in patients with aldosteronism. This is a disease in which the adrenal glands produce too much of a hormone called aldosterone. It is not recommended to take Valarox in patients with aldosteronism;
• in patients who have lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes.
• aliskiren.
• if the patient is taking an ACE inhibitor along with another type of medicine known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
• if the patient is taking or has taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection; taking Valarox with fusidic acid may lead to severe muscle problems (rhabdomyolysis).
• if the patient has ever experienced a severe skin rash or peeling of the skin after taking rosuvastatin or other similar medicines.
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes worsen symptoms or cause myasthenia (see section 4).

In a small number of people, statins may affect the liver. This can be determined by a simple blood test that shows increased liver enzyme activity. For this reason, the doctor usually performs a blood test (liver function tests) before and during treatment with Valarox.
Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking this medicine.
People with high sugar and fat levels in the blood, overweight, and high blood pressure may be at risk of developing diabetes.
The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
With the use of rosuvastatin, severe skin reactions have been reported, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, stop taking Valarox and consult a doctor immediately.
See also the information in the subsection "When not to take Valarox".

If any of the above situations apply to the patient, they should inform their doctor before starting treatment with Valarox.

Valarox and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Tell your doctor if you are taking any of the following medicines:

• cyclosporine (a medicine used, e.g., after organ transplantation);
• medicines used to thin the blood, such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken with this medicine), ticagrelor, or clopidogrel;
• fibrates (e.g., gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol levels (e.g., ezetimibe);
• antacids (used to neutralize stomach acid);
• erythromycin (an antibiotic);
• oral contraceptives;
• hormone replacement therapy;
• other blood pressure-lowering medicines, especially diuretics;
• medicines that increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (from the rifamycin group), a medicine used to prevent organ rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir with lopinavir and (or) atazanavir). These medicines may increase the effect of Valarox;
• lithium, a medicine used to treat certain mental illnesses;
• if the patient is taking an ACE inhibitor along with other medicines to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol);
• if it is necessary to take fusidic acid to treat a bacterial infection, stop taking Valarox during this time. The doctor will inform the patient when it is safe to take Valarox again. Taking Valarox with fusidic acid may rarely lead to muscle weakness, sensitivity, or pain (rhabdomyolysis).

(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 virus, taken alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effect of these medicines may be altered by Valarox or they may alter the effect of Valarox.

Valarox with food and drink

Valarox can be taken with or without food.

Pregnancy and breastfeeding

Do not take Valaroxduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Valarox, they should stop takingthe medicine immediately and consult a doctor. Women of childbearing age should use effective methods of contraception while taking Valarox.
Consult a doctor or pharmacist before taking this medicine.

• -It is essential to inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy.The doctor usually recommends stopping Valarox before pregnancy or as soon as pregnancy is confirmed and prescribes another medicine.
• -Inform the doctor about breastfeeding or intention to breastfeed.It is not recommended to take Valarox during breastfeeding. The doctor may choose another medicine if the patient intends to breastfeed

Driving and using machines

Do not drive, operate machinery, or perform other activities that require attention until you know how the medicine affects you.
Like many other medicines used to treat high blood pressure, Valarox may rarely cause dizziness and affect concentration.
If dizziness occurs, consult a doctor.

Valarox contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is "sodium-free".

3. How to take Valarox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose for adults
The recommended dose is one tablet per day.
The medicine can be taken before or after a meal. Take the medicine at the same time every day, with a glass of water. Do not take Valarox with grapefruit juice.

Use in children and adolescents

Valarox should not be used in children and adolescents.

Regular cholesterol level checks

It is essential to visit your doctor for regular cholesterol level checks to ensure that the level has reached and maintained the appropriate values.
The doctor may decide to increase the dose so that the patient takes the appropriate amount of Valarox.

Taking a higher dose of Valarox than recommended

Consult a doctor or the nearest hospital for advice. In case of severe dizziness and (or) fainting, lie down. If the patient goes to the hospital or receives treatment for another illness, inform the medical staff about taking Valarox.

Missing a dose of Valarox

There is no need to worry. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Valarox

Talk to your doctor if you want to stop taking the medicine. Stopping treatment with Valarox may worsen the disease. Stopping treatment with Valarox may cause cholesterol levels to rise again. Do not stop taking the medicine unless your doctor tells you to.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Be aware of the side effects that may occur. These effects are usually mild or moderate and usually go away after a short time.
If the patient experiences any of the following side effects after taking the medicine, stop taking Valarox and consult a doctor immediately:

• 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 itching of the skin (papular rash);
• blistering of the skin, mouth, eyes, and (or) genitals (Stevens-Johnson syndrome);
• lupus-like syndrome (including rash, joint diseases, and effects on blood cells);
• muscle rupture;
• red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, and (or) eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome).

If any of these symptoms occur, stop taking Valarox and consult a doctor immediately (see section 2 "Warnings and precautions").

In addition, stop taking Valarox and consult a doctor immediately,

if the patient experiences any unusual muscle painthat lasts longer than expected. Muscle symptoms are more common in children and adolescents than in adults.
Like other statins, very rare cases of unpleasant muscle symptoms have occurred, which in rare cases can worsen and lead to potentially life-threatening muscle damage called rhabdomyolysis.
Common side effects(may affect up to 1 in 10 people):

• dizziness
• low blood pressure with symptoms such as dizziness and fainting when standing up or without these symptoms
• kidney problems (symptoms of kidney problems)
• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• feeling weak
• diabetes. The risk of developing diabetes is higher if the patient has high sugar and fat levels in the blood, is overweight, and has high blood pressure. During treatment with this medicine, the doctor will monitor the patient.

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

• angioedema (see "Some symptoms that require immediate medical attention")
• sudden loss of consciousness (fainting)
• feeling of spinning (vertigo)
• severe kidney problems (symptoms of severe kidney failure)
• muscle cramps, irregular heartbeat (symptoms of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure)
• cough
• diarrhea
• fatigue
• weakness
• rash, itching, or other skin reactions
• increased protein in the urine - usually returns to normal on its own, without the need to stop taking Valarox

Rare side 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 and breathing, severe itching of the skin (with the formation of papules), if the patient suspects an allergic reaction, stop taking Valarox immediatelyand seek medical attention
• muscle damage in adults - as a precaution, stop taking Valarox and consult a doctor immediatelyif the patient experiences any unusual muscle pain that lasts longer than expected
• severe abdominal pain (pancreatitis)
• increased liver enzyme activity in the blood
• decreased platelet count, which increases the risk of bleeding or bruising (thrombocytopenia)

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

• jaundice (yellowing of the skin and eyes)
• hepatitis
• trace amounts of blood in the urine
• nerve damage in the legs and arms (e.g., numbness)
• joint pain
• memory loss
• gynecomastia (breast enlargement in men)

Frequency not known(frequency cannot be estimated from the available data):

• allergic reactions with rash, itching, and hives; symptoms may include fever, joint swelling, and joint pain, muscle pain, swollen lymph nodes, and (or) flu-like symptoms (symptoms of serum sickness)
• purple-red spots, fever, itching (symptoms of vasculitis)
• fever, sore throat, or mouth ulcers caused by infection (symptoms of neutropenia)
• decreased hemoglobin and red blood cell count in the blood (which in severe cases can lead to anemia)
• increased potassium levels in the blood (which in severe cases can cause muscle cramps and irregular heartbeat)
• decreased sodium levels in the blood (which in severe cases can cause fatigue, confusion, muscle twitching, seizures, or coma)
• increased liver enzyme activity (which may indicate liver damage), including increased bilirubin levels in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate kidney problems)
• shortness of breath
• swelling
• sleep disorders, including insomnia and nightmares
• sexual dysfunction
• depression
• breathing difficulties, including prolonged coughing and (or) shortness of breath or fever
• tendon damage
• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes muscle weakness in the eyes) Consult a doctor if the patient experiences muscle weakness in the arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness or kidney problems are less common in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
If any of these symptoms occur, consult a doctor immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Valarox

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
The batch number is stated on the packaging after the abbreviation "Lot".
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Valarox contains

• The active substances of the medicine are valsartan and rosuvastatin (in the form of rosuvastatin calcium). 10 mg + 80 mg: each film-coated tablet contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 80 mg of valsartan. 20 mg + 80 mg: each film-coated tablet contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 80 mg of valsartan. 10 mg + 160 mg: each film-coated tablet contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 160 mg of valsartan. 20 mg + 160 mg: each film-coated tablet contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 160 mg of valsartan.
• Other ingredients are: tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, mannitol, povidone K25, sodium lauryl sulfate, and yellow iron oxide (E172) tablet coating:10 mg + 80 mg:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) 20 mg + 80 mg:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) 10 mg + 160 mg:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172), yellow iron oxide (E172) 20 mg + 160 mg:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172). See section 2 "Valarox contains lactose and sodium".

What Valarox looks like and package contents

10 mg + 80 mg film-coated tablets (tablets): dark pink, round, slightly convex tablets with a coating and a score on one side, with the marking K4; tablet diameter 8.7-9.3 mm.
20 mg + 80 mg film-coated tablets (tablets): dark pink, capsule-shaped, slightly convex tablets with a coating and a score on one side, with the marking K3; tablet dimensions 14.7-15.3 mm x 6.7-7.3 mm.
10 mg + 160 mg film-coated tablets (tablets): dark pink, oval, slightly convex tablets with a coating and a score on one side, with the marking K2; tablet dimensions 16.7-17.3 mm x 7.7-8.3 mm.
20 mg + 160 mg film-coated tablets (tablets): light brown-yellow, oval, slightly convex tablets with a coating and a score on one side, with the marking K1; tablet dimensions 16.7-17.3 mm x 7.7-8.3 mm.
Packaging:10, 14, 20, 28, 30, 56, 60, 84, 90, and 100 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

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
To obtain more detailed information about the names of this medicine in other European Economic Area countries, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:25.05.2023