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

Rosuvastatinum + Valsartanum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 should immediately stop treatment and inform the doctor; women of childbearing age during treatment with 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 that prevents rejection of a transplanted organ);
• 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), should
consult the doctor again.

Warnings and precautions

Before starting treatment with Valarox, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney problems or is on dialysis;
• if the patient has liver problems;
• if the patient has recurring or unexplained muscle pain, if muscle pain has occurred in the past in the patient or their family, or if muscle problems have occurred in the past when taking other cholesterol-lowering medicines; in case of unexplained muscle pain, especially if accompanied by malaise or fever, the doctor should be informed immediately;
• if the patient regularly consumes large amounts of alcohol;
• if the thyroid gland does not work properly;
• if the patient is taking other cholesterol-lowering medicines, such as fibrates; the patient should carefully read the leaflet, even if they have taken other cholesterol-lowering medicines in the past;
• if the patient is taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir, see section "Valarox and other medicines";
• if the patient is over 70 years old (because the doctor must choose an appropriate 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 must choose an appropriate initial dose of Valarox for the patient;
• if the patient has narrowing of the renal artery;
• 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 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 the patient has or has 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), because statins can sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In a small number of people, statins can affect the liver. This can be determined by a simple test that shows increased liver enzyme activity in the blood. For this reason, the doctor usually performs a blood test (liver 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 rash with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, the patient should stop taking Valarox and contact their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as over-the-counter medicines.
The patient should tell their doctor if they are taking any of the following medicines:

• cyclosporine (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 nonsteroidal 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 with other medicines to treat heart failure, 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 rarely lead to muscle weakness, sensitivity, or pain (rhabdomyolysis).
• if the patient has 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 the patient has or has 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), because statins can sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

(Rhabdomyolysis). More information about 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 changed by Valarox or they may change 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 immediately stop takingthis medicine and contact their doctor. Women of childbearing age should use effective methods of contraception while taking Valarox.
The patient should consult their doctor or pharmacist before using this medicine.

• -The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.The doctor will usually recommend stopping Valarox before becoming pregnant or as soon as pregnancy is confirmed and prescribe another medicine.
• -The patient should inform their 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

The patient should not drive vehicles, operate machines, or perform other activities that require attention, until they know how the medicine affects them.
Like many other medicines used to treat high blood pressure, Valarox may rarely cause dizziness and affect concentration.
If dizziness occurs, the patient should consult their doctor.

Valarox contains lactose and sodium

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

3. How to take Valarox

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their 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. The medicine should be taken at the same time every day, with a glass of water. The patient should not take Valarox with grapefruit juice.

Use in children and adolescents

Valarox should not be used in children and adolescents.

Regular cholesterol level check-ups

It is essential to visit the doctor for regular cholesterol level check-ups 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

The patient should contact their doctor or the nearest hospital for advice. In case of severe dizziness and (or) fainting, the patient should lie down. If the patient goes to the hospital or is treated for another illness, they should inform the medical staff that they are taking Valarox.

Missing a dose of Valarox

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

Stopping treatment with Valarox

The patient should talk to their doctor if they 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. The patient should not stop taking the medicine unless their doctor advises them to do so.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• 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 (papular rash);
• blisters on 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, or round patches on the torso, 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 swollen lymph nodes (DRESS or hypersensitivity syndrome).

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

In addition, the patient should stop taking Valarox and immediately consult their doctor,

if they 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 symptoms have been reported, which can rarely worsen and lead to potentially life-threatening muscle damage called rhabdomyolysis.
Common side effects(may occur in up to 1 in 10 patients):

• 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's blood sugar and fat levels are high, they are overweight, and have high blood pressure. During treatment with this medicine, the doctor will monitor the patient.

Uncommon side effects(may occur in up to 1 in 100 patients):

• 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, heart rhythm disturbances (symptoms of hyperkalemia)
• shortness of breath, breathing difficulties when lying down, swelling of the feet or legs (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 occur in up to 1 in 1,000 patients):

• severe allergic reaction - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe skin itching (with the formation of papules), if the patient suspects they have had an allergic reaction, they should stop taking Valarox immediatelyand seek medical attention
• muscle damage in adults - as a precaution, the patient should stop taking Valarox and immediately consult their doctor if they experience any unusual muscle painthat 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 occur in up to 1 in 10,000 patients):

• 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; may occur with symptoms such as fever, joint swelling, and joint pain, muscle pain, swollen lymph nodes, and (or) flu-like symptoms (serum sickness-like reaction)
• 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 heart rhythm disturbances)
• 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 disturbances, 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) The patient should talk to their doctor if they experience muscle weakness in their 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 any of these symptoms occur, the patient should immediately inform their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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:
Al. Jerozolimskie 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, more information can be collected on the safety of the medicine.

5. How to store Valarox

The medicine should be stored out of 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. The patient should ask their 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 (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 package contents

10 mg + 80 mg film-coated tablets (tablets): dark pink, round, slightly convex tablets with a beveled edge, with the inscription K4 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 the inscription K3 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 the inscription K2 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 the inscription K1 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 about the names of this medicine in other EU member states, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:25.05.2023