Rosuvastatin Medical Vallei

Leaflet accompanying the packaging: patient information

Rosuvastatin Medical Valley, 5 mg, film-coated tablets
Rosuvastatin Medical Valley, 10 mg, film-coated tablets
Rosuvastatin Medical Valley, 20 mg, film-coated tablets
Rosuvastatin Medical Valley, 40 mg, film-coated tablets
Rosuvastatinum

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

• Keep this leaflet, so you can read it again if you need to.
• Consult your doctor or pharmacist if you have any further doubts.
• 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 you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Rosuvastatin Medical Valley and what is it used for
• 2. Important information before taking Rosuvastatin Medical Valley
• 3. How to take Rosuvastatin Medical Valley
• 4. Possible side effects
• 5. How to store Rosuvastatin Medical Valley
• 6. Contents of the packaging and other information

1. What is Rosuvastatin Medical Valley and what is it used for

Rosuvastatin Medical Valley belongs to a group of medicines called statins.
Rosuvastatin Medical Valley is recommended for use because:

• The patient has been diagnosed with high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Rosuvastatin Medical Valley is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.

The doctor has prescribed a statin because diet and increased physical activity have proven insufficient to achieve proper cholesterol levels in the blood. Patients taking Rosuvastatin Medical Valley should also follow a low-cholesterol diet and engage in physical exercise.
or

• Rosuvastatin Medical Valley is also recommended if the patient has other factors that increase the risk of heart attack (myocardial infarction), stroke, or similar diseases.

Heart attack, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis is the result of the accumulation of atherosclerotic plaques in blood vessels.

Why is it essential to take Rosuvastatin Medical Valley regularly?

Rosuvastatin Medical Valley is used to achieve proper fat levels in the blood. The most common of these is cholesterol.
There are different types of cholesterol in the blood, so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin Medical Valley can reduce "bad" cholesterol levels and increase "good" cholesterol levels.
• The action of Rosuvastatin Medical Valley involves inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not affect well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, it leads to the accumulation of fatty deposits in the walls of blood vessels and their narrowing.
Sometimes, it can lead to the blockage of a narrowed blood vessel, disruption of blood flow to the heart or brain, and consequently, a heart attack or stroke. Achieving proper cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.
Even if the cholesterol level is normal after taking Rosuvastatin Medical Valley, it is still necessary to continue taking it to prevent the cholesterol level from increasing again, which causes the accumulation of fatty deposits. The use of Rosuvastatin Medical Valley should be discontinued if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Rosuvastatin Medical Valley

When not to take Rosuvastatin Medical Valley:

• If the patient is allergicto rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• If the patient is pregnantor breastfeeding. If a woman taking Rosuvastatin Medical Valley becomes pregnant, she should stop taking the medicine immediately and inform her doctor.Women taking Rosuvastatin Medical Valley should use effective methods to prevent pregnancy,
• If the patient has liver disease,
• If the patient has severe kidney disease,
• If the patient experiences frequent or unexplained muscle pain or weakness,
• If the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat viral hepatitis C infection),
• If the patient is taking cyclosporine(a medicine used, for example, after organ transplantation),
• if the patient has ever had a severe skin rash or peeling, blisters, and (or) ulcers in the mouth after taking Rosuvastatin Medical Valley or other similar medicines.

If any of the above situations apply to the patient (or the patient has doubts),
they should consult their doctor again.
In addition, do not take Rosuvastatin Medical Valley, 40 mg (the highest dose):

• if the patient has moderately severe kidney disease(in case of doubt, consult a doctor),
• if the patient's thyroid gland does not work properly,
• if the patient experiences frequent or unexplained muscle pain or weakness, if the patient or their family members have had muscle diseases or previously experienced muscle disorders while taking cholesterol-lowering medicines,
• if the patient regularly consumes large amounts of alcohol,
• if the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),

if the patient is taking fibrate medicines, i.e., other cholesterol-lowering medicines.

If any of the above situations apply to the patient (or the patient has doubts),
they should consult their doctor again.

Warnings and precautions

Before starting treatment with Rosuvastatin Medical Valley, consult a doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has liver disease,
• if the patient experiences frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases or previously experienced muscle disorders while taking cholesterol-lowering medicines. The patient should immediately consult a doctor if they experience muscle pain or weakness of unknown origin, especially if accompanied by general malaise and fever. The patient should also inform their doctor if they experience persistent muscle weakness,
• 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 can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• if the patient regularly consumes large amounts of alcohol,
• if the patient's thyroid gland does not work properly,
• if the patient is taking cholesterol-lowering medicines from the fibrate group. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before,
• if the patient is taking medicines used to treat HIV, e.g., ritonavir with lopinavir and (or) atazanavir, the patient should refer to the information in the section: "Rosuvastatin Medical Valley and other medicines",
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid(an antibiotic used to treat bacterial infections). Taking fusidic acid with Rosuvastatin Medical Valley can lead to severe muscle damage (rhabdomyolysis); see the section "Rosuvastatin Medical Valley and other medicines",
• if the patient is over 70 years old(as the doctor must choose an appropriate initial dose of Rosuvastatin Medical Valley for the patient),
• if the patient has severe respiratory failure,
• if the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor will determine the appropriate initial dose of Rosuvastatin Medical Valley,
• there have been reports of severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), associated with rosuvastatin use. If the patient experiences any of the symptoms described in section 4, they should stop taking Rosuvastatin Medical Valley and consult their doctor immediately.

If any of the above situations apply to the patient (or the patient has doubts):

Do not take Rosuvastatin Medical Valley in a dose of 40 mg (the highest dose) and before taking Rosuvastatin Medical Valley in any other dose

consult a doctor or pharmacist.
In a small group of patients, statin medicines may affect liver function. To confirm this effect, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends performing a liver enzyme activity test in the blood before starting and during treatment with Rosuvastatin Medical Valley.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

• if the patient is under 6 years old: Rosuvastatin Medical Valley should not be used in children under 6 years old.
• if the patient is under 18 years old: Rosuvastatin Medical Valley, 40 mg, is not suitable for use in children and adolescents under 18 years old.

Rosuvastatin Medical Valley and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor if you are taking:

• cyclosporine (used, for example, after organ transplantation),
• blood thinners, 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,
• medicines from the fibrate group (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used to treat indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see also the section "Warnings and precautions" and section 4),
• oral contraceptives (the pill),
• hormone replacement therapy,
• 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 with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Rosuvastatin Medical Valley may affect the action of these medicines, or these medicines may affect the action of Rosuvastatin Medical Valley.

If the patient needs to take fusidic acid orally for the treatment of a bacterial infection, they should temporarily stop taking Rosuvastatin Medical Valley. The doctor will inform the patient when it is safe to restart Rosuvastatin Medical Valley.

Taking Rosuvastatin Medical Valley with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Pregnancy and breastfeeding

Rosuvastatin Medical Valley should not be takenduring pregnancy or breastfeeding.
If the patient becomes pregnant while taking Rosuvastatin Medical Valley, they should stop taking the medicine immediately and consult their doctor.
While taking Rosuvastatin Medical Valley, the patient should avoid pregnancy and use effective methods to prevent pregnancy.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Most people can drive and operate machinery while taking Rosuvastatin Medical Valley - it will not affect these abilities. However, some patients may experience dizziness while taking Rosuvastatin Medical Valley. If the patient experiences this symptom, they should consult their doctor before driving or operating machinery.

Rosuvastatin Medical Valley contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Rosuvastatin Medical Valley

This medicine should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.

Recommended dose for adults:

Taking Rosuvastatin Medical Valley to lower cholesterol levels:

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg, even if the patient has taken higher doses of other statins before. The size of the initial dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke in the patient,
• the presence of factors that increase the patient's susceptibility to side effects.

Ask your doctor which initial dose of Rosuvastatin Medical Valley is most suitable for you.
The doctor may decide to use a dose of 5 mg as the initial dose if:

• the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderately severe kidney disease,
• the patient is at risk of muscle diseases or pain (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose to suit the patient's needs.
If the patient started treatment with a dose of 5 mg, the doctor may decide to increase it to 10 mg, and then to 20 mg or 40 mg if necessary. If the patient started treatment with a dose of 10 mg, the doctor may decide to increase it to 20 mg, and then to 40 mg if necessary. The treatment period with the established dose between each dose increase is 4 weeks.
The maximum daily dose of Rosuvastatin Medical Valley is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom a dose of 20 mg was insufficient to lower cholesterol levels.

Taking Rosuvastatin Medical Valley to reduce the risk of heart attack or stroke or similar health problems:

The recommended daily dose is 20 mg, but the doctor may decide to reduce it if the patient has the factors described above.

Taking Rosuvastatin Medical Valley in children and adolescents aged 6 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose to suit the patient's needs. The maximum daily dose of Rosuvastatin Medical Valley in children aged 6 to 17 years is 10 mg or 20 mg, depending on the type of disease being treated. The medicine should be taken once daily. Rosuvastatin Medical Valley, 40 mg, should not be takenin children.

Taking the medicine

Swallow the tablet whole with water.
Rosuvastatin Medical Valley should be taken once a day, at any time, with or without food. It is recommended to take the medicine at the same time every day to make it easier to remember.

Control tests for cholesterol levels

To ensure that cholesterol levels have decreased and are normal, regular check-ups and blood tests should be performed.
The doctor may decide to increase the dose of Rosuvastatin Medical Valley to suit the patient's needs.

Taking a higher dose of Rosuvastatin Medical Valley than recommended

In case of taking a higher dose of Rosuvastatin Medical Valley than recommended, consult a doctor or go to the nearest hospital.
If the patient is in the hospital or being treated for another disease, they should inform their doctor or other medical staff about taking Rosuvastatin Medical Valley.

Missing a dose of Rosuvastatin Medical Valley

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

Stopping treatment with Rosuvastatin Medical Valley

Tell your doctor if you want to stop taking Rosuvastatin Medical Valley. Cholesterol levels may increase again if treatment with Rosuvastatin Medical Valley is stopped.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin Medical Valley can cause side effects, although not everybody gets them.
It is essential to know what side effects can occur. They are usually mild and disappear shortly after starting treatment.

Stop taking Rosuvastatin Medical Valley and seek medical attention immediately if you experience the following allergic reactions:

Medical attention, if the following reactions occur:

• Difficulty breathing with swelling of the face, lips, tongue, and (or) throat, or without
• Swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing
• Severe itching of the skin (with lumps)
• 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 eyes. The occurrence of this type of severe skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

In addition, stop taking Rosuvastatin Medical Valley and consult your doctor immediately:

• If the patient experiences any unusual muscle pain or weaknessthat lasts longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. Like other statins, rosuvastatin has rarely caused unpleasant muscle symptoms, which can occasionally worsen and lead to potentially life-threatening muscle damage (rhabdomyolysis).
• If the patient experiences symptoms of a lupus-like syndrome(such as rash, joint diseases, and effects on blood cells)

If the patient experiences muscle rupture.

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients):

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Weakness
• Dizziness
• Increased protein in the urine. This usually disappears on its own and does not require discontinuation of Rosuvastatin Medical Valley (only applies to a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The treating doctor will monitor patients at risk while they are taking this medicine.

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 patients):

• Rash, itching, or other skin reactions.
• Increased protein in the urine. This usually disappears on its own and does not require discontinuation of Rosuvastatin Medical Valley (applies to doses of 5 mg, 10 mg, and 20 mg).

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1,000 patients):

• Severe allergic reactions - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, and severe itching of the skin (with lumps). If the patient suspects an allergic reaction, they should stop taking Rosuvastatin Medical Valley and seek medical attention immediately.
• Muscle damage in adults - the patient should exercise caution, i.e., stop taking Rosuvastatin Medical Valley and consult their doctor immediately if they experience muscle pain or weakness.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme levels in the blood.
• Increased tendency to bleed or bruising due to a low platelet count.
• Symptoms of a lupus-like syndrome (such as rash, joint diseases, and effects on blood cells).

Very rare side effects (occurring in less than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes),
• Hepatitis,
• Blood in the urine,
• Nerve damage in the arms and legs (felt as numbness),
• Joint pain,
• Memory loss,
• Breast enlargement in men (gynecomastia).

Unknown frequency (cannot be estimated from the available data):

• Diarrhea (loose stools),
• Cough,
• Shortness of breath,
• Swelling,
• Sleep disorders, including insomnia and nightmares,
• Sexual dysfunction,
• Depression,
• Breathing problems, including persistent cough 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).

Tell your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 or its representative.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Rosuvastatin Medical Valley

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging/blisters after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
• No special precautions for storage temperature are required. Store in the original packaging to protect from light.
• Do not dispose of medicines in the sewage system or household waste. Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Rosuvastatin Medical Valley contains

The active substance of the medicine is rosuvastatin.
Each film-coated tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (in the form of rosuvastatin calcium).
The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, crospovidone, lactose monohydrate, magnesium stearate.
The tablet coating contains:
Polyethylene glycol (PEG)
Titanium dioxide (E 171)
Talc
Glycerol
Partially hydrolyzed polyvinyl alcohol
Iron oxide yellow (E 172) (only 5 mg tablet)
Iron oxide red (E 172) (10 mg, 20 mg, and 40 mg tablets)

What Rosuvastatin Medical Valley looks like and what the packaging contains

Rosuvastatin Medical Valley, 5 mg, film-coated tablets: Yellow, round, biconvex film-coated tablets, with "ROS" embossed above "5" on one side, 7 mm in diameter.
Rosuvastatin Medical Valley, 10 mg, film-coated tablets: Pink, round, biconvex film-coated tablets, with "ROS" embossed above "10" on one side, 7 mm in diameter.
Rosuvastatin Medical Valley, 20 mg, film-coated tablets: Pink, round, biconvex film-coated tablets, with "ROS" embossed above "20" on one side, 9 mm in diameter.
Rosuvastatin Medical Valley, 40 mg, film-coated tablets: Pink, oval, biconvex film-coated tablets, with "ROS" embossed on one side and "40" on the other, 6.8 x 11.4 mm in size.
Tablets are packaged in OPA-Aluminum-PVC/Aluminum blisters.
The medicine is available in cardboard boxes containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer

Laboratorios Liconsa, S.A.
Poligono Industrial Miralcampo. Avda. Miralcampo, 7
19200 Azuqueca De Henares - Guadalajara
Spain

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

Date of last revision of the leaflet:10/2024