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 to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness 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 changing the diet and increasing the amount of physical exercise
has proven to be 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 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.

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 the blood vessels.

Why is it important to take Rosuvastatin Medical Valley regularly?

Rosuvastatin Medical Valley is used to achieve the 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 the level of "bad" cholesterol and an increase in the level of "good" cholesterol.
• The action of Rosuvastatin Medical Valley consists in 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 the 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 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 of contraception,
• If the patient has liver disease,
• If the patient has severe kidney disease,
• If the patient has 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 contact their doctor again.
Additionally, do not take Rosuvastatin Medical Valley, 40 mg (the highest dose):

• If the patient has moderately severe kidney disease(in case of doubt, ask your doctor),
• If the patient's thyroid gland does not work properly,
• If the patient has frequent or unexplained muscle pain or weakness, if the patient or their family members have had muscle diseases or previously had 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, and Indian),

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

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

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken,
as well as the 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,
• fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and section "Warnings and precautions"),
• 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 virus, 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.

Rosuvastatin Medical Valley may change the effect of these medicines or these medicines may change the effect of Rosuvastatin Medical Valley.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Rosuvastatin Medical Valley. The doctor will inform the patient when they 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 about 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 of contraception.
Before taking any medicine, the patient should consult their 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 such a symptom occurs, the patient should consult their doctor before driving a car or operating machines.

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 doubts, the patient should consult their doctor or pharmacist.

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 the patient has previously taken higher doses of other statins. The size of the initial dose depends on:

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

The patient should ask their doctor which initial dose of Rosuvastatin Medical Valley is most suitable for them.
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 developing muscle diseases (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose so that it is suitable for 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 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 use in children and adolescents aged 6 to 17 years is from 5 to 20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose so that it is suitable for the patient. 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 at a dose of 40 mg should not be usedin children.

Taking the medicine

The tablet should be swallowed whole, with a glass of 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, regular check-ups and blood tests should be performed.
The doctor may decide to increase the dose of Rosuvastatin Medical Valley so that it is suitable for the patient.

Taking a higher dose of Rosuvastatin Medical Valley than recommended

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

Missing a dose of Rosuvastatin Medical Valley

The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping Rosuvastatin Medical Valley

The patient should tell their doctor if they want to stop taking Rosuvastatin Medical Valley. Cholesterol levels may increase again if the patient stops taking Rosuvastatin Medical Valley.
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.
It is important for the patient to know what side effects may occur. Usually, they are mild and disappear shortly after starting treatment.

The patient should stop taking Rosuvastatin Medical Valley and seek medical help immediately if they 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 can 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, 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The patient should stop taking Rosuvastatin Medical Valley and consult their 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, very rare cases of unpleasant muscle symptoms have occurred, which can rarely worsen and lead to potentially life-threatening muscle damage called 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 symptom usually disappears on its own and there is no need to stop taking Rosuvastatin Medical Valley (applies only to a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if the patient has high levels of sugar and fat in the blood, 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 symptom usually disappears on its own and there is no need to stop taking Rosuvastatin Medical Valley (applies only 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 the patient suspects an allergic reaction, they should stop taking Rosuvastatin Medical Valley and seek medical help 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 other muscle symptomsthat last longer than expected.
• Severe abdominal pain (pancreatitis).
• Increased liver enzyme levels in the blood.
• Increased tendency to bleed or bruise 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 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),
• Myasthenic ophthalmia (a disease that causes muscle weakness in the eyes).

The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including those not listed in the 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 or its representative.
Reporting side effects can help gather more information on the safety of the 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. The patient should ask their 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
Polyvinyl alcohol, partially hydrolyzed
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 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 OPA-Aluminum-PVC/Aluminum blisters.
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