Provisacor 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Provisacor 5 mg film-coated tablets

rosuvastatin

Read the entire 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 your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents:

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

1. What Provisacor is and what it is used for

Provisacor belongs to a group of medicines called statins.

You have been prescribed Provisacor because:

• You have high cholesterol levels. 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.

• Your doctor has advised you to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue regular physical exercise while taking Provisacor.

Or

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

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

Why it is important that you continue taking Provisacor

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

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

• Provisacor reduces the amount of "bad" cholesterol and increases "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 you feel, as they cause no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to continue taking Provisacor, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and stops the formation 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 taking Provisacor

Do not take Provisacor

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Provisacor (listed in section 6).
• If you are pregnant or 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 experience repeated or unexplained muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

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

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

• If you have moderate kidney problems (if in doubt, consult your doctor).

• If your thyroid gland is not functioning properly.

• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines.

• If you regularly consume large amounts of alcohol.

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).

• If you are taking other medicines called fibrates to lower cholesterol.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Provisacor.

• If you have kidney problems.
• If you have liver problems.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also feel generally unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Provisacor or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see “Other medicines and Provisacor”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and Provisacor may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Provisacor”.
• If you are over 70 years old, as your doctor must determine the appropriate starting dose of Provisacor for you.
• If you have severe respiratory insufficiency.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of Provisacor for you.

If you are in any of the situations mentioned above (or are unsure):

• Do not take the higher dose of 40 mg and consult your doctor or pharmacist before starting 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 immediate medical attention if you notice any of the symptoms described in section 4.

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

While taking this medicine, your doctor will monitor you closely 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 administered 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 need to take any other medicines.

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

• cyclosporine (used after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant medicine, 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 – please see below and Warnings and precautions),
• 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 blood levels of uric acid),
• 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 or vadadustat (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 may be altered by Provisacor or they may alter the effect of Provisacor.

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

Pregnancy and breastfeeding

Do not take Provisacor if you are pregnant or 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive vehicles and operate machinery while taking 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 machinery.

Provisacor contains lactose.

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

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

3. How to take Provisacor

Follow exactly the instructions for administration of this medicine as given 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 begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin. The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level for having a heart attack or stroke.
• Whether you have factors that make you more susceptible to potential 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 smallest dose (5 mg):

• If you are of Asian origin (e.g., 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 pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the appropriate dose of Provisacor for your condition. 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 heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking Provisacor to reduce the risk of heart attack, stroke, 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 for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg per day, and your doctor may gradually increase the dose until reaching the appropriate Provisacor dose for you. The maximum recommended daily dose of Provisacor is 10 or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily.

How to take the tablets

Swallow each tablet whole with water.

Take Provisacor once daily. You may 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 cholesterol level checks

It is important that you visit your doctor regularly for cholesterol checks to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the appropriate 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Provisacor

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Provisacor

Consult your doctor if you wish to discontinue treatment with Provisacor. Your cholesterol levels may rise again if you stop taking Provisacor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Provisacor and seek immediate medical attention if 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 hives).
• Red, flat, non-elevated spots on the trunk, often circular or target-shaped, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread 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 cramps that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have resulted in a potentially fatal muscle injury called rhabdomyolysis.

• If you experience muscle rupture.

• If you develop a syndrome with symptoms resembling lupus (including hives, joint disorders, and effects on blood cells).

Frequent adverse effects (may affect up to 1 in 10 people)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• Increased levels of protein in urine – this usually returns to normal on its own without the need to stop treatment with Provisacor tablets (this adverse effect is uncommon with the 5 mg, 10 mg, and 20 mg daily doses 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 Provisacor and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Provisacor and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to low platelet levels in the blood.
• Syndrome with symptoms resembling 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 arms and legs (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse effects with unknown frequency (cannot be estimated from available data) 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 persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

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

5. Storage of Provisacor

• Blister packs: Do not store above 30°C. Keep in the original packaging 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 the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging/blister label/label after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Provisacor

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

Appearance of the product and contents of the pack

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany

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 medicinal product is authorised in the European Economic Area member states under the following names:
Provisacor 5 mg (NL, IT, PT, ES).

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/