Rosuvastatin Medical Vallei

Leaflet attached to 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

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 necessary.
• You should consult a 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, you should 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 found to have 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 a change in diet and increased physical activity
have proven insufficient to achieve the correct cholesterol level
in the blood. The patient taking Rosuvastatin Medical Valley should also follow
a diet with a reduced amount of cholesterol and engage in physical activity.
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.

Myocardial infarction, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in blood vessels.

Why is it important to take Rosuvastatin Medical Valley regularly?

Rosuvastatin Medical Valley is used to achieve correct values of fat substance 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 may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Rosuvastatin Medical Valley involves inhibiting the production of "bad" cholesterol in the body. It also helps to remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not change their well-being, as they do not
cause any symptoms. However, if the patient does not receive treatment, it leads to the deposition of fatty substances in the walls of blood vessels and their narrowing.
Sometimes it may lead to the blockage of a narrowed blood vessel, disruption of blood flow
to the heart or brain, and consequently to a heart attack or stroke. Achieving correct cholesterol levels
in the blood reduces the risk of a heart attack, stroke, or similar diseases.
Even if the cholesterol level is correct after taking Rosuvastatin Medical Valley, you should still take it to prevent the cholesterol level from increasing again
and causing the deposition of fatty substances. You should stop taking the medicine if your doctor advises you to do so or if you become pregnant.

2. Important information before taking Rosuvastatin Medical Valley

When not to take Rosuvastatin Medical Valley:

• If you are allergicto rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• If you are 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 of contraception,
• If you have liver disease,
• If you have severe kidney disease,
• If you have frequent or unexplained muscle weakness or pain,
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat viral hepatitis C infection),
• If you are taking cyclosporine(a medicine used, for example, after organ transplantation),
• if you have ever had a severe skin rash or skin 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 you (or you have doubts)
you should consult your doctor again.
In addition, do not take Rosuvastatin Medical Valley, 40 mg (the highest dose):

• If you have moderately severe kidney disease(if in doubt, ask your doctor),
• If your thyroid gland does not work properly,
• If you have frequent or unexplained muscle weakness or pain, if you or your family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines,
• If you regularly consume large amounts of alcohol,
• If you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),

If any of the above situations apply to you (or you have doubts):

• you should consult your doctor.

Warnings and precautions

Before starting treatment with Rosuvastatin Medical Valley, you should consult your doctor or
pharmacist:

• If you have kidney disease,
• If you have liver disease,
• If you have frequent or unexplained muscle weakness or pain, or if you or your family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines. You should contact your doctor immediately if you experience muscle weakness or pain of unknown origin, especially if it is accompanied by general malaise and fever. You should also inform your doctor if you experience persistent muscle weakness,
• If you have myasthenia(a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness, including eye muscles), as statins may sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• If you regularly consume large amounts of alcohol,
• If your thyroid gland does not work properly,
• If you are taking cholesterol-lowering medicines from the fibrate group. You should read the leaflet carefully, even if you have taken other cholesterol-lowering medicines before,
• If you are taking medicines used to treat HIV, such as ritonavir with lopinavir and (or) atazanavir, you should read the information in the section: "Rosuvastatin Medical Valley and other medicines",
• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid(an antibiotic used to treat bacterial infections). Taking fusidic acid at the same time as Rosuvastatin Medical Valley may lead to severe muscle damage (rhabdomyolysis); see the section "Rosuvastatin Medical Valley and other medicines",
• If you are over 70 years old(because your doctor will need to choose the right starting dose of Rosuvastatin Medical Valley for you),
• If you have severe respiratory failure,
• If you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor will determine the appropriate starting dose of Rosuvastatin Medical Valley,
• there have been reports of severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), associated with rosuvastatin use. If you experience any of the symptoms described in section 4, you should stop taking Rosuvastatin Medical Valley and consult your doctor immediately.

If any of the above situations apply to you (or you have doubts):

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

you should consult your doctor or pharmacist.
A small number of patients taking statins may experience liver problems. 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 you are under 6 years old: Rosuvastatin Medical Valley should not be used in children under 6 years old.
• If you are under 18 years old: Rosuvastatin Medical Valley at a dose of 40 mg is not suitable for use in children and adolescents under 18 years old.

Rosuvastatin Medical Valley and other medicines

You should 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.
You should 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 you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Rosuvastatin Medical Valley. Your doctor will tell you when you can safely start taking Rosuvastatin Medical Valley again.

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.
If you experience any of these symptoms, you should stop taking Rosuvastatin Medical Valley and consult your doctor immediately.

Pregnancy and breastfeeding

Rosuvastatin Medical Valley should not be takenduring pregnancy or breastfeeding.
If you become pregnant while taking Rosuvastatin Medical Valley, you should stop taking the medicine immediately and consult your doctor.
While taking Rosuvastatin Medical Valley, you should avoid becoming pregnant and use effective methods of contraception.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Rosuvastatin Medical Valley - it will not affect these abilities. However, some patients may experience dizziness while taking Rosuvastatin Medical Valley. If this symptom occurs, you should consult your doctor before driving a car or operating machinery.

Rosuvastatin Medical Valley contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Rosuvastatin Medical Valley

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

The recommended dose for adults is as follows:

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 you have 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,
• the presence of factors that increase the risk of side effects.

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

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

Increasing the dose and maximum daily dose

Your doctor may decide to increase the dose to suit your needs.
If you started treatment with a dose of 5 mg, your doctor may decide to increase it to 10 mg,
and then to 20 mg or 40 mg if necessary. If you started treatment with a dose of
10 mg, your 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 your doctor may decide to reduce it if you have the factors described above.

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

The dose range for use in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase the dose to suit your 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 disease being treated. The medicine should be taken once daily. Rosuvastatin Medical Valley at a dose of 40 mg should not be usedin children.

Taking the medicine

The tablet should be swallowed 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 to make it easier to remember.

Control tests for cholesterol levels

To ensure that cholesterol levels have decreased and are correct, you should regularly undergo check-ups and blood tests.
Your doctor may decide to increase the dose of Rosuvastatin Medical Valley to suit your needs.

Taking a higher dose of Rosuvastatin Medical Valley than recommended

If you have taken a higher dose of Rosuvastatin Medical Valley than recommended, you should consult your doctor or go to the nearest hospital.
If you are in the hospital or being treated for another illness, you should inform your doctor or other medical staff that you are taking Rosuvastatin Medical Valley.

Missing a dose of Rosuvastatin Medical Valley

You should 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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important for you to know what side effects may occur. They are usually mild and disappear shortly after starting treatment.

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

Medical help, 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 may cause difficulty swallowing
• Severe itching of the skin (with hives)
• Red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, 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 body temperature, and enlarged lymph nodes (DRESS syndrome

or hypersensitivity syndrome).

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

• If you experience any unusual muscle weakness or painthat 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 in rare cases have developed into a potentially life-threatening muscle damage called rhabdomyolysis
• If you experience symptoms of lupus-like syndrome(such as rash, joint diseases, and effects on blood cells)

If you experience 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 symptom usually disappears on its own and does not require stopping Rosuvastatin Medical Valley (only applies to a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you closely while you 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 symptom usually disappears on its own and does not require stopping Rosuvastatin Medical Valley (only 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, severe itching of the skin (with hives). If you suspect an allergic reaction, you should stop taking Rosuvastatin Medical Valley and seek medical attention immediately.
• Muscle damage in adults - you should exercise caution, i.e., stop taking Rosuvastatin Medical Valley and consult your doctor immediately if you experience muscle pain or other symptomsthat last longer than expected.
• 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 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 to 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),
• Myasthenia gravis (a disease that causes muscle weakness, including eye muscles).

You should talk to 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal 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 to gather more information on the safety of this medicine.

5. How to store Rosuvastatin Medical Valley

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton/blister after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
• There are no special precautions for storing the medicinal product in terms of temperature. Store in the original packaging to protect from light.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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
Yellow iron oxide (E 172) (only 5 mg tablet)
Red iron oxide (E 172) (10 mg, 20 mg, and 40 mg tablets)

What Rosuvastatin Medical Valley looks like and what the pack contains

Rosuvastatin Medical Valley, 5 mg, film-coated tablets: Yellow, round, biconvex film-coated tablets, with the inscription "ROS" above "5" on one side, with a diameter of 7 mm.
Rosuvastatin Medical Valley, 10 mg, film-coated tablets: Pink, round, biconvex film-coated tablets, with the inscription "ROS" above "10" on one side, with a diameter of 7 mm.
Rosuvastatin Medical Valley, 20 mg, film-coated tablets: Pink, round, biconvex film-coated tablets, with the inscription "ROS" above "20" on one side, with a diameter of 9 mm.
Rosuvastatin Medical Valley, 40 mg, film-coated tablets: Pink, oval, biconvex film-coated tablets, with the inscription "ROS" on one side and "40" on the other, with dimensions of 6.8 x 11.4 mm.
The tablets are packaged in blisters made of OPA-Aluminum-PVC/Aluminum foil.
The medicine is available in cartons 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