PATIENT INFORMATION LEAFLET

Provisacor20 mg film-coated tablets

rosuvastatin

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any questions, ask yourdoctor or pharmacist.

-This medicine has been prescribed for youonlyand should not be given to others even if they havethe same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.What Provisacor is and what it is used for

2.What you need to know before you start taking Provisacor

3.How to take Provisacor

4.Possible side effects

1. Storage of Provisacor
2. Contents of the pack and additional information

Provisacor belongs to a group of medications called statins.

They have prescribed Provisacor because:

• You have high levels of cholesterol.This means you are at risk of having a heart attack or a cerebral infarction.Provisacor is used in adults, adolescents, and children 6 years of age or older to treat high cholesterol.

• They have indicated that you should take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels.You must maintain a diet that helps to reduce cholesterol and continue to perform physical exercise while on treatment with Provisacor.

Or

• You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may be caused by a disease called atherosclerosis.Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why it is important to continue taking Provisacor

Provisacor is used to correct the levels of fatty substances in the blood called lipids, with cholesterol being the most well-known.

There are different types of cholesterol in the blood, bad cholesterol (LDL-C) and good cholesterol (HDL-C).

• Provisacor decreases the amount of bad cholesterol and increases good cholesterol.
• It acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high levels of cholesterol do not affect how they feel since they do not produce any symptoms.However, if not treated, fatty deposits can form in the walls of blood vessels causing them to narrow.

Sometimes, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction.By reducing your cholesterol levels, you can reduce the risk of having a heart attack, cerebral infarction, or other health-related problems.

You needto continue taking Provisacor, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and causing the formation of fatty deposits.However, you should interrupt treatment if your doctor indicates so or if you become pregnant.

Do not take Provisacor

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of Provisacor (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking Provisacorstop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Provisacor using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications(used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

If you find yourself in any of the above situations (or are unsure), please consult your doctor again.

Also, do not take the highest dose (40 mg)

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glanddoes not function correctly.
• If you have repeated or unjustified muscle pain and cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other medications to lower cholesterol levels.

• If you regularly consume large amounts of alcohol.

• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you are taking other medications called fibratesto lower cholesterol.

If you find yourself in any of the above situations (or are unsure),please consult your doctor again.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Provisacor.

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unjustified muscle pain and cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other medications to lower cholesterol levels. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also, inform your doctor or pharmacist if you experience constant muscle weakness.
• If you have or have had myasthenia(a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section4).
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking Provisacor or other related medications.
• If you regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken medications to lower cholesterol before.
• If you are taking medications to treat HIV (AIDS virus),such as ritonavir with lopinavir and/or atazanavir, see“Other medications and Provisacor”.
• If you are taking or have taken in the last 7days a medication called fusidic acid,(a medication for bacterial infection),oral or by injection. The combination of fusidic acid and Provisacor can cause severe muscle problems (rhabdomyolysis), please see“Other medications andProvisacor”.
• If you are over 70 years old,as your doctor must establish the starting dose of Provisacor suitable for you.
• If you have severe respiratory failure.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor must establish the starting dose of Provisacor suitable for you.

If you find yourself in any of these situations mentioned above (or are unsure):

• Do not take the highest dose of 40 mg and consult your doctor or pharmacist before starting to take any dose of Provisacor.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Provisacor treatment. Stop using Provisacor and seek medical attention immediately if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with Provisacor.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar levels, are overweight, and have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Provisacor should not be administered to children under 6 years of age.

Other medications and Provisacor

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Inform your doctor if you are using any of the following medications:

• ciclosporina (used after an organ transplant),
• warfarina, clopidogrel or ticagrelor (or any other anticoagulant medication, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba),
• medications for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - please see below and in Warnings and precautions),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamida (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood),
• teriflunomida (used to treat multiple sclerosis),
• any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir,sofosbuvir, voxilaprevir,ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis).

The effects of these medications may be modified by Provisacor or may change the effect of Provisacor.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking Provisacor temporarily. Your doctor will indicate when it is safe to start taking Provisacor again. Taking Provisacor with fusidic acid can rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section4.

Pregnancy and breastfeeding

Do not take Provisacorif you are pregnant or breastfeeding. If you become pregnant while taking Provisacorstop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Provisacor using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Most patients can drive vehicles and use machines during treatment with Provisacor as it will not affect their ability. However, some people may feel dizzy during treatment with Provisacor. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Provisacor contains lactose.

If your doctor has told you that you have an intolerance to certain sugars (lactose or milk sugar), consult with him before taking Provisacor.

The complete list of components can be found inContainer contents and additional information.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Provisacor for high cholesterol levels:

Starting dose

Your treatment with Provisacor should start withthe dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin previously. The choice of starting dose will depend on:

• Your cholesterol levels.
• The degree of risk you have of suffering a heart attack or cerebral infarction.
• If you have factors that make you more vulnerable to possible adverse effects.

Check with your doctor or pharmacist which is the best starting dose of Provisacor for you.

Your doctor may decide to start treatment with the lower dose (5 mg):

• If you are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you have a risk of suffering muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the right dose of Provisacor for you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then to 20 mg and later to 40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to double the dose to 20 mg and then to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of Provisacor is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking Provisacor to reduce the risk of suffering a heart attack, a cerebral infarction or related health problems:

The recommended dose is 20 mg per day. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once a day. The usual starting dose for treatment is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of Provisacor for you. The recommended maximum daily dose of Provisacor is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take your dose once a day.

Swallowing the tablets

Swallow each tablet whole with water.

Take Provisacor once a day.You can take it at any time of the day with or without food.

Try to take the tablets at the same time every day. This will help you remember to take them.

Regular cholesterol level checks

It is essential that you visit your doctor regularly for cholesterol level checks, in order to check that your cholesterol levels have normalized and are maintained at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right dose of Provisacor for you.

If you take more Provisacor than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you enter a hospital or receive treatment for another illness, inform the healthcare staff that you are taking Provisacor.

If you forget to take Provisacor

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Provisacor

Consult your doctor if you want to interrupt treatment with Provisacor. Your cholesterol levels may increase again if you stop taking Provisacor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicine may cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking Provisacor and seek medical attention immediatelyif you experience any of the following allergic reactions:

• 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.
• Intense itching of the skin (with rashes).
• Reddish patches on the trunk, not elevated, in the shape of a target or circles, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Provisacor and consult your doctor immediately:

• If you experience unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury calledrhabdomyolysis.

• If you experience muscle rupture.

• If you experience a syndrome with symptoms similar to lupus(including urticaria, joint disorders, and effects on blood cells).

Common side effects (may affect up to 1 in 10 people)

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with Provisacor tablets (a common side effect only with the daily dose of 40 mg of Provisacor).
• Diabetes.This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people)

• Urticaria, itching, and other skin reactions.
• An increase in the amount of protein in urine – this usually returns to normal on its own without the need to stop treatment with Provisacor tablets (a rare side effect with daily doses of 5 mg, 10 mg, and 20 mg of Provisacor).

Very rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, intense itching of the skin (with rashes). If you think you are having an allergic reaction, stop taking Provisacorand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking Provisacor and consult your doctor immediately if you have unexplained muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells).

Very rare side effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and increased breast size in men (gynecomastia).

Side effects of unknown frequency (cannot be estimated from available data) that may include

• Diarrhea (loose stools), cough, shortness of breath, edema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, respiratory problems, including persistent cough and/or shortness of breath or fever, tendon injuries, and constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Blisters: Do not store above 86°F (30°C). Store in the original packagingto protect it from moisture.
• Containers:Do not store above 86°F (30°C).Keep the container perfectly closed to protect it from moisture.
• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Provisacor

The active ingredient of Provisacor is rosuvastatina. The film-coated tablets of Provisacor contain rosuvastatina calcium equivalent to 20mg of rosuvastatina. The other components of the tablets are: lactose monohydrate, microcrystalline cellulose (E460), calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, and titanium dioxide (E171). Provisacor 20 mg film-coated tablets also contain iron oxide red (E172).

Appearance of the product and contents of the packaging

Provisacor is presented in blister packs of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets and in plastic bottles of 30 and 100 tablets. (Not all packaging sizes may be marketed in all countries).

Provisacor 20 mg film-coated tablets are pink, round tablets with the imprint ‘ZD4522’ and ‘20’ on one side and smooth on the other.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Responsible manufacturer:

AstraZeneca AB, S-152 57, Södertälje, Sweden

Telephone: +46 8 553 260 000

Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany

Telephone: +49 (0) 241 569 0

Farmaceutici Formenti S.p.A., Via Di Vittorio 2, 21040 Origgio (VA), Italy

Telephone: +39 02 969581

Local representative:

Laboratorios Almirall, S.L.

Ronda General Mitre, 151

08022 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Provisacor 20 mg (NL, IT, PT, ES).

Last review date of this leaflet: August 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/