Rosuvastatin medical valley

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Rosuvastatin Medical Valley is and what it is 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 pack and other information

1. What Rosuvastatin Medical Valley is and what it is 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 indicates an increased risk of heart attack (myocardial infarction) or stroke. Rosuvastatin Medical Valley is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol.

Your doctor has prescribed a statin because changes in diet and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood. Patients taking Rosuvastatin Medical Valley should also follow a cholesterol-lowering diet and engage in regular physical exercise.
or

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

Heart attacks, strokes, and other related problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why is it important to take Rosuvastatin Medical Valley regularly?
Rosuvastatin Medical Valley is used to achieve normal levels of blood lipids. The most common lipid is cholesterol.
There are different types of cholesterol in the blood, known as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin Medical Valley can reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
• Rosuvastatin Medical Valley works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the bloodstream.

In most people, high cholesterol does not cause noticeable symptoms or changes in how they feel. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, which can result in a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels become normal after using Rosuvastatin Medical Valley, you must continue taking the medicine. This prevents cholesterol levels from rising again, which could lead to further accumulation of fatty deposits. You should stop taking the medicine only 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 allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant or breastfeeding. If a woman taking Rosuvastatin Medical Valley becomes pregnant, she must stop taking it 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 experiences frequent or unexplained muscle pain or discomfort,
• if the patient is taking the 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 previously experienced severe skin rash, skin peeling, blisters and (or) oral ulcers after taking Rosuvastatin Medical Valley or other similar medicines.

If any of the situations listed above apply to the patient (or if the patient has any doubts),
the patient should contact their doctor again.
Additionally, do not use Rosuvastatin Medical Valley 40 mg (the highest dose):

• if the patient has moderate kidney disease (in case of doubt, consult a doctor),

• if the patient’s thyroid gland is not functioning properly,

• if the patient experiences frequent or unexplained muscle pain or discomfort, if the patient or family members have a history of muscle disorders, or if muscle-related side effects occurred previously during treatment with lipid-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 fibrates (other medicines used to lower cholesterol levels).

If any of the situations listed above apply to the patient (or if the patient has any doubts),
the patient should contact 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 discomfort, or if the patient or family members have a history of muscle disorders, or if the patient previously experienced muscle-related side effects while taking lipid-lowering medicines. The patient should contact their doctor immediately if unexplained muscle pain or discomfort occurs, especially if accompanied by general malaise and fever. The patient should also inform their doctor if persistent muscle weakness occurs,
• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or trigger the onset of myasthenia (see section 4),
• if the patient regularly consumes large amounts of alcohol,
• if the patient’s thyroid gland is not functioning properly,
• if the patient is taking fibrates, other cholesterol-lowering medicines. The patient should read the leaflet carefully, even if they have previously taken other cholesterol-lowering medicines,
• if the patient is taking medicines used to treat HIV infection, e.g.: ritonavir with lopinavir and (or) atazanavir; please 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 (a medicine used for bacterial infections). Taking fusidic acid together with Rosuvastatin Medical Valley may lead to severe muscle damage (rhabdomyolysis); see section "Rosuvastatin Medical Valley and other medicines",
• if the patient is over 70 years of age (because the doctor must determine the appropriate starting 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). The doctor will determine the appropriate starting dose of Rosuvastatin Medical Valley for these patients,
• severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, the patient must stop taking Rosuvastatin Medical Valley and contact their doctor immediately.

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

• Do not take Rosuvastatin Medical Valley 40 mg (the highest dose), and before taking Rosuvastatin Medical Valley at any other dose, contact a doctor or pharmacist.

In a small number of patients, statins may affect liver function. To
assess this effect, blood tests measuring liver enzyme activity are performed.
Typically, the doctor will recommend checking liver enzyme activity in the blood
before starting and during treatment with Rosuvastatin Medical Valley.
Patients with diabetes or those at risk of developing diabetes will be under
close medical supervision while taking this medicine. Patients with high blood
sugar and lipid levels, overweight, and high blood pressure may be at increased risk
of developing diabetes.
Children and adolescents

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

Rosuvastatin Medical Valley and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used,
or planned for use.
Tell your doctor if you are taking:

• cyclosporine (used, for example, after organ transplantation),
• anticoagulant medicines, e.g., warfarin, acenocoumarol, or phenindione (their blood-thinning effect and risk of bleeding may be increased when taken together with this medicine), ticagrelor, or clopidogrel,
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine that lowers blood cholesterol (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, taken 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 alter the effect of these medicines, or these medicines may alter
the effect of Rosuvastatin Medical Valley.
If the patient needs to take oral fusidic acid for a bacterial infection,
Rosuvastatin Medical Valley should be temporarily discontinued. The doctor will inform the patient
when it is safe to restart Rosuvastatin Medical Valley. Taking Rosuvastatin Medical Valley with fusidic acid
may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More
information about rhabdomyolysis is provided in section 4.
Pregnancy and breastfeeding
Rosuvastatin Medical Valley must not be used during pregnancy or while breastfeeding.
If a woman becomes pregnant while taking Rosuvastatin Medical Valley, she must
stop taking it immediately and contact her doctor.
While taking Rosuvastatin Medical Valley, pregnancy should be avoided and effective
contraceptive methods should be used.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Rosuvastatin Medical Valley – it will not impair these abilities. However, some patients may experience dizziness during treatment with Rosuvastatin Medical Valley. If this symptom occurs, the patient should contact their doctor before driving or operating machinery.
Rosuvastatin Medical Valley contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should
contact their doctor before taking this medicine.
3. How to take Rosuvastatin Medical Valley
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
a doctor or pharmacist.
Recommended dose for adults is as follows:
Use of Rosuvastatin Medical Valley to lower cholesterol levels:
Starting dose
Treatment should be initiated with a dose of 5 mg or 10 mg, even if the patient previously took
higher doses of other statins. The choice of starting dose depends on:

• cholesterol level,
• the patient’s risk level for heart attack or stroke,
• the presence of factors increasing susceptibility to adverse effects.

Ask the doctor which starting dose of Rosuvastatin Medical Valley is most appropriate for the patient.
The doctor may decide to use a 5 mg starting dose if:

• the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India),
• the patient is over 70 years of age,
• the patient has moderate to severe kidney disease,
• the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation and maximum daily dose
The doctor may decide to increase the dose as appropriate for the patient’s needs.
If the patient started treatment with 5 mg, the doctor may increase it to 10 mg,
then to 20 mg or 40 mg, if necessary. If the patient started with 10 mg, the doctor may increase it to 20 mg, then to 40 mg, if necessary. The treatment period at a given dose between each increase should be 4 weeks.
The maximum daily dose of Rosuvastatin Medical Valley is 40 mg. This dose is used in patients with high cholesterol levels and high risk of heart attack or stroke, when a 20 mg dose was insufficient to reduce cholesterol levels.
Use of 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 any of the factors described above.
Use 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 starting dose is 5 mg once daily, and the doctor may gradually increase the dose as appropriate 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 condition being treated. The medicine should be taken once daily. Rosuvastatin Medical Valley 40 mg should not be used in children.
How to take the medicine
The tablet should be swallowed whole with water.
Rosuvastatin Medical Valley should be taken once daily, at any time, with or without food. It is recommended to take the medicine at the same time each day to aid memory.
Regular cholesterol monitoring
To ensure cholesterol levels have decreased and remain within normal range, regular check-ups and blood tests are necessary.
The doctor may decide to increase the dose of Rosuvastatin Medical Valley as appropriate for the patient.
Taking more than the recommended dose of Rosuvastatin Medical Valley
If more than the recommended dose of Rosuvastatin Medical Valley is taken, contact a doctor or go to the nearest hospital immediately.
If the patient is in hospital or being treated for another condition, they should inform the doctor or medical staff about taking Rosuvastatin Medical Valley.
Missed dose of Rosuvastatin Medical Valley
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping treatment with Rosuvastatin Medical Valley
Inform the doctor if the patient wishes to stop taking Rosuvastatin Medical Valley. Cholesterol levels may rise again if treatment with Rosuvastatin Medical Valley is stopped.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
The patient must immediately stop taking Rosuvastatin Medical Valley and seek medical help
if any of the following allergic reactions occur:

• 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 (with hives)
• Red, flat, disc-shaped or round skin rashes on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genital organs, and eyes. Such severe skin rashes may 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).

Additionally, the patient must discontinue taking Rosuvastatin Medical Valley and immediately
contact a doctor:

• If the patient experiences any unusual discomfort or muscle pain lasting longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a very small number of people have experienced unpleasant muscle symptoms, which rarely worsened and progressed to potentially life-threatening muscle damage called rhabdomyolysis.
• If the patient develops symptoms of a lupus-like syndrome (such as rash, joint disorders, and effects on blood cells)
• If the patient experiences muscle rupture.

Adverse reactions occurring frequently (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 urine. This symptom usually resolves spontaneously and does not require discontinuation of Rosuvastatin Medical Valley (applies only to the 40 mg dose).
• Diabetes. The likelihood of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight, and high blood pressure. The treating physician will monitor patients at risk during treatment with this medicine.

Adverse reactions occurring uncommonly (in more than 1 in 1,000 but less than 1 in 100 patients):

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

Adverse reactions occurring rarely (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 skin itching (with hives). If the patient suspects an allergic reaction, they must immediately stop taking Rosuvastatin Medical Valley and seek medical help.
• Muscle damage in adults – the patient should exercise caution, i.e. discontinue taking Rosuvastatin Medical Valley and contact a doctor immediately if muscle pain or other muscle-related symptoms persist longer than expected.
• Severe abdominal pain (pancreatitis).
• Increased levels of liver enzymes in blood.
• Increased tendency for bleeding or bruising due to low platelet count.
• Lupus-like syndrome symptoms (such as rash, joint disorders, and effects on blood cells).

Adverse reactions occurring very rarely (in less than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes),
• Hepatitis (liver inflammation),
• Presence of blood in urine,
• Damage to nerves in the upper and lower limbs (felt as numbness),
• Joint pain,
• Memory loss,
• Breast enlargement in men (gynecomastia).

Unknown frequency (cannot be estimated from available data):

• Diarrhea (loose stools),
• Cough,
• Shallow breathing,
• Swelling,
• Sleep disturbances, including insomnia and nightmares,
• Sexual dysfunction,
• Depression,
• Breathing problems, including persistent cough and (or) shallow breathing or fever,
• Tendon damage,
• Persistent muscle weakness,
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing),
• Ocular myasthenia (a disease causing weakness of eye muscles).

The patient should talk to a doctor if they experience weakness in the arms or legs that worsens
with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Reporting adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 4921 301, fax: +48 22 4921 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps gather more information on the safety of the medicine.

5. How to store Rosuvastatin Medical Valley

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton/blister labeled “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
• No special precautions regarding storage temperature are required. Store in the original packaging to protect from light.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

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

What Rosuvastatin Medical Valley looks like and contents of the pack
Rosuvastatin Medical Valley 5 mg, coated tablets: Yellow, round, biconvex coated tablets, with the imprint "ROS" above "5" on one side, 7 mm in diameter.
Rosuvastatin Medical Valley 10 mg, coated tablets: Pink, round, biconvex coated tablets, with the imprint "ROS" above "10" on one side, 7 mm in diameter.
Rosuvastatin Medical Valley 20 mg, coated tablets: Pink, round, biconvex coated tablets, with the imprint "ROS" above "20" on one side, 9 mm in diameter.
Rosuvastatin Medical Valley 40 mg, coated tablets: Pink, oval, biconvex coated tablets, with the imprint "ROS" on one side and "40" on the other side, 6.8 x 11.4 mm in size.

The tablets are packed in blisters made of OPA-Aluminium-PVC/Aluminium foil.
The medicine is available in cardboard boxes containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, or 100 coated tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names: