PROVISACOR 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Provisacor5 mg film-coated tablets

rosuvastatin

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

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

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Provisacor and what is it used for
2. What you need to know before you take Provisacor
3. How to take Provisacor
4. Possible side effects
   1. Storage of Provisacor
   2. Contents of the pack and further information

1. What is Provisacor and what is it used for

Provisacor belongs to a group of medicines called statins.

You have been prescribed Provisacor because:

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

• You have been told to take a statin because changes to your diet and increased exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps lower cholesterol and continue to exercise while being treated with Provisacor.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important to keep taking Provisacor

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

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

• Provisacor reduces the amount of "bad" cholesterol and increases the "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improving the body's ability to remove it from the blood.

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

Sometimes, these narrowed blood vessels can become blocked, preventing blood from reaching the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You need to keep taking Provisacor, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from rising again and causing the buildup of fatty deposits.However, you should stop treatment if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Provisacor

Do not take Provisacor

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

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

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

• If you have moderate kidney problems(if in doubt, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pains or cramps,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines.

• If you regularly drink large amounts of alcohol.

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

If you are 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 unexplained muscle pains or cramps,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia(a disease that causes general muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the condition or trigger myasthenia (see section 4).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Provisacor or other related medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working correctly.
• If you are taking other medicines called fibratesto lower cholesterol.
• If you are taking medicines to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see "Other medicines and Provisacor".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(an antibiotic), orally or by injection. The combination of fusidic acid and Provisacor can rarely cause serious muscle problems (rhabdomyolysis), see more information on rhabdomyolysis in section 4.
• If you are over 70 years old,as your doctor will need to choose the right starting dose of Provisacor 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 will need to choose the right starting dose of Provisacor for you.

If you are in any of these situations (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. 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 checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests (liver function tests) before and after treatment with Provisacor.

While you are taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to 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 given to children under 6 years of age.

Other medicines and Provisacor

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• ciclosporin (used after an organ transplant),
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also "Warnings and precautions" and section 4),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (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),
• teriflunomide (used to treat multiple sclerosis),
• leflunomide (used to treat rheumatoid arthritis),
• any of the following medicines 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),
• momelotinib (used to treat myelofibrosis in adults with anemia).

The effects of these medicines can be altered by Provisacor or can change the effect of Provisacor.

If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine.Your doctor will tell you when it is safe to restart Provisacor. Taking Provisacor with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and use machines while being treated 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 some sugars (lactose or milk sugar), consult them before taking Provisacor.

The complete list of ingredients is found in Contents of the pack and further information.

3. How to take Provisacor

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking Provisacor for high cholesterol:

Starting dose

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

• Your cholesterol levels.
• The level of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to possible side effects.

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

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

• If you are of Asian 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 are at risk of muscle pains or 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 an interval of four weeks between each dose adjustment.

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

If you are taking Provisacor to reduce the risk of having a heart attack, stroke, or related health problems:

The recommended dose is 20 mg once daily. 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 daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase the dose to the dose of Provisacor that is right for you. The maximum recommended 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 daily.

Taking the tablets

Swallow each tablet whole with water.

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

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

Regular checks of cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at the right 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 the nearest hospital for advice.

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

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking Provisacor.

If you forget to take Provisacor

Do not worry, just take the next scheduled dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Provisacor

Consult your doctor if you want to stop taking Provisacor. Your cholesterol levels may rise again if you stop taking Provisacor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop taking Provisacor and seek immediate medical attentionif 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red spots on the torso, not raised, in a target or circular shape, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Provisacor and consult your doctor immediately:

• If you experience unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.

• If you experience muscle rupture.

• If you present with a syndrome that has symptoms similar to lupus(including hives, joint disorders, and effects on blood cells).

Common Adverse 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 the urine – this usually reverses on its own without the need to interrupt treatment with Provisacor tablets (common adverse effect only with the daily dose of 40 mg of Provisacor).
• Diabetes. This is more likely if you have high sugar and lipid levels in the blood, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with Provisacor tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of Provisacor).

Rare Adverse 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 hives). If you think you are having an allergic reaction, stop taking Provisacorand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Provisacor and consult your doctor immediately if you have unjustified 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 usual due to a low platelet count in the blood.
• Syndrome that has symptoms similar to lupus (including hives, joint disorders, and effects on blood cells).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

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

Adverse 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.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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 or drooping eyelids, difficulty swallowing or difficulty breathing.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Provisacor

• Blisters: Do not store above 30°C. Store in the original package to protect from moisture.
• Bottles: Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.
• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date shown on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Provisacor

The active ingredient of Provisacor is rosuvastatin. The film-coated Provisacor tablets contain rosuvastatin calcium equivalent to 5 mg of rosuvastatin. The other ingredients of the tablets are: lactose monohydrate, microcrystalline cellulose (E460), calcium phosphate, crospovidone, magnesium stearate, hypromellose, glycerol triacetate, titanium dioxide (E171). Provisacor 5 mg film-coated tablets also contain yellow iron oxide (E172).

Appearance of the Product and Package Contents

Provisacor is available 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 pack sizes may be marketed in all countries).

Provisacor 5 mg film-coated tablets are yellow, round, and bear the engraving ‘ZD4522’ and ‘5’ on one side and are smooth on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Manufacturer:

AstraZeneca AB, S-152 57, Södertälje, Sweden

Phone: +46 8 553 260 000

Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany

Phone: +49 (0) 241 569 0

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

Phone: +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 under the following names:

Provisacor 5 mg (NL, IT, PT, ES).

Date of the Last Revision of this Leaflet: April 2025

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