Valarox

Leaflet attached to 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

Rosuvastatinum + Valsartanum

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. Contents of the pack 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 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 Valarox stop taking the medicine and inform your doctor; women of childbearing age taking Valarox should use effective methods of contraception;
• if you have liver disease;
• if you have severe kidney problems;
• if you have recurring or unexplained muscle pain or weakness;
• if you are taking a combination of sofosbuvir with velpatasvir and voxilaprevir (used to treat hepatitis C virus infection);
• if you are taking cyclosporin (a medicine that prevents organ rejection);
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine that contains aliskiren.

If any of the above points apply to you (or you are unsure), you should
consult your doctor again.

Warnings and precautions

Before taking Valarox, discuss with your doctor or pharmacist:

• if you have kidney problems or are on dialysis;
• if you have liver problems;
• if you have recurring or unexplained muscle pain, if you have had muscle pain in the past or if you have had muscle problems while taking other cholesterol-lowering medicines; if you experience unexplained muscle pain, especially if you feel unwell or have a fever, tell your doctor immediately;
• if you regularly drink large amounts of alcohol;
• if your thyroid gland does not work properly;
• if you are taking other cholesterol-lowering medicines, such as fibrates; you should carefully read the leaflet, even if you have taken other cholesterol-lowering medicines in the past;
• if you are taking medicines for HIV infection, such as ritonavir with lopinavir and (or) atazanavir, see section "Valarox and other medicines";
• if you are over 70 years old (as your doctor may need to choose a suitable starting dose for you);
• if you have severe respiratory failure;
• if you are of Asian origin: Japanese, Chinese, Filipino, Vietnamese, Korean or Indian; your doctor may need to choose a suitable starting dose of Valarox for you;
• if you have narrowing of the renal artery;
• in patients who have recently undergone kidney transplantation (received a new kidney);
• in patients treated after a heart attack or for heart failure, your doctor may check your kidney function;
• in patients with severe heart disease other than heart failure or heart attack;
• if you have ever had a severe skin rash or peeling of the skin, blisters, and (or) ulcers in the mouth after taking rosuvastatin or other similar medicines.
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (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, your doctor usually performs a blood test (liver function tests) before and during treatment with Valarox.
Patient with diabetes or at risk of developing diabetes will be kept under close medical supervision 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.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood at regular intervals.
There have been reports of severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), during treatment with rosuvastatin. If you experience any of the symptoms described in section 4, stop taking Valarox and contact your doctor immediately.
See also the information in the subsection "When not to take Valarox".

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

Valarox and other medicines

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

• cyclosporin (a medicine used, for example, 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 cholesterol-lowering medicine (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 potassium-containing salt substitutes, 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 (cyclosporin), 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 you are taking an ACE inhibitor with other medicines to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol);
• if you need to take fusidic acid to treat a bacterial infection, stop taking Valarox during this time. Your doctor will tell you when it is safe to start taking Valarox again. Taking Valarox with fusidic acid can rarely lead to muscle weakness, sensitivity, or pain

(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 infection, given 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 Valaroxif you are pregnant or breastfeeding. If you become pregnant while taking Valarox, stop takingthe medicine and contact your doctor. Women of childbearing age should use effective methods of contraception while taking Valarox.
Consult your doctor or pharmacist before taking this medicine.

• -You must inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy.Your doctor will usually advise you to stop taking Valarox before you become pregnant or as soon as you know you are pregnant, and prescribe another medicine.
• -You must inform your doctor if you are breastfeeding or plan to breastfeed.Valarox is not recommended during breastfeeding. Your doctor may choose another medicine if you intend to breastfeed

Driving and using machines

Do not drive, operate machinery, or perform other activities that require concentration 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 your ability to concentrate.
If you experience dizziness, consult your doctor.

Valarox contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "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 important to visit your doctor regularly to check your cholesterol levels and make sure they are at the right levels.
Your doctor may decide to increase the dose so that you take the right amount of Valarox for you.

Taking a higher dose of Valarox than recommended

Contact your doctor or the nearest hospital for advice. If you experience severe dizziness and (or) fainting, lie down. If you go to the hospital or are treated for another illness, tell the medical staff that you are taking Valarox.

Missing a dose of Valarox

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

Stopping treatment with Valarox

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should 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 you experience any of the following side effects after taking the medicine, stop taking Valarox and contact your 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 skin itching (hives);
• blisters on the skin, mouth, eyes, and (or) genitals (Stevens-Johnson syndrome);
• lupus-like syndrome (including rash, joint pain, and effects on blood cells);
• muscle rupture;
• red, flat, target-like, or circular patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

If you experience any of these symptoms, stop taking Valarox and contact your doctor immediately (see section 2 "Warnings and precautions").

In addition, stop taking Valarox and contact your doctor immediately,

if you experience 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 effects have been reported, which in rare cases can 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 (signs of kidney problems)
• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• feeling weak
• diabetes. The risk of developing diabetes is higher if your blood sugar and fat levels are high, you are overweight, and you have high blood pressure. During treatment with this medicine, your doctor will monitor you.

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 (signs of severe kidney failure)
• muscle cramps, irregular heartbeat (signs of hyperkalemia)
• shortness of breath, problems breathing when lying down, swelling of the feet or ankles (signs of heart failure)
• cough
• diarrhea
• fatigue
• weakness
• rash, itching, or other skin reactions
• increased protein in the urine - usually returns to normal 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 skin itching (with hives), if you think you have had an allergic reaction, stop taking Valarox and seek medical attention immediately
• muscle damage in adults - as a precaution, stop taking Valarox and contact your doctor immediately if you experience any unusual muscle painthat lasts longer than expected
• severe abdominal pain (pancreatitis)
• increased liver enzyme activity in the blood
• decreased platelet count, which can increase 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 pain, and swelling, 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 (may indicate liver damage), including increased bilirubin levels in the blood (in severe cases can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (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)
• myasthenic syndrome (a disease that causes muscle weakness in the eyes) You should talk to your doctor if you experience muscle weakness in your 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 were 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 you experience any of these symptoms, tell your doctor immediately.

Reporting side effects

If you experience any side effects, including any 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valarox

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

6. Contents of the pack and other information

What Valarox contains

• The active substances 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 (E 171), macrogol 3350, talc, red iron oxide (E 172) 20 mg + 80 mg:polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E 172) 10 mg +160 mg:polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E 172), yellow iron oxide (E 172) 20 mg+160 mg:polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172). See section 2 "Valarox contains lactose and sodium".

What Valarox looks like and contents of the pack

10 mg + 80 mg film-coated tablets (tablets): dark pink, round, slightly convex tablets with a beveled edge, with "K4" engraved on one side; tablet diameter 8.7– 9.3 mm.
20 mg + 80 mg film-coated tablets (tablets): dark pink, capsule-shaped, slightly convex tablets with a beveled edge, with "K3" engraved on one side; 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 beveled edge, with "K2" engraved on one side; 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 beveled edge, with "K1" engraved on one side; 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 on 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