Package leaflet: Information for the user

Provisacor 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

rosuvastatin
Please 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.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Provisacor is and what it is used for
What you need to know before you take Provisacor
How to take Provisacor
Possible side effects
How to store Provisacor
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:

Your cholesterol level is high. This means you are at risk of heart attack or stroke. Provisacor is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
You have been prescribed a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking Provisacor, you must continue with a cholesterol-lowering diet and maintain regular physical exercise.

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

Heart attack, stroke, and related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.
Why it is important to continue taking Provisacor
Provisacor is used to correct levels of fatty substances in the blood known as lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and so-called "good" cholesterol (HDL-C).

Provisacor can reduce "bad" cholesterol and increase "good" cholesterol.
It works by helping to block the body's production of "bad" cholesterol and also improves the body’s ability to remove "bad" cholesterol from the blood.

For many people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if high cholesterol is not treated, fatty deposits can build up in the walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, stopping blood flow to the heart or brain, thereby causing a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You must continue taking Provisacor, even if your cholesterol levels have returned to normal, to prevent these levels from rising again, which could lead to the formation of fatty deposits. However, you should stop taking Provisacor on medical advice or if you become pregnant.

2. What you should know before taking Provisacor

Do not take Provisacor:

if you have previously had an allergic reaction to Provisacor or to any of the ingredients of this medicine;
if you are pregnant or breastfeeding. If you become pregnant while taking Provisacor, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Provisacor by using appropriate contraceptive measures;
if you have liver disease;
if you have severe kidney problems;
if you have repeated or unexplained muscle cramps or pain;
if you are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation). If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.

In addition, do not take Provisacor 40 mg (the highest dose):

if you have moderate kidney problems (if in doubt, consult your doctor);
if your thyroid gland is not functioning properly;
if you have repeated or unexplained muscle cramps or pain, 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 (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
if you are taking other cholesterol-lowering medicines called fibrates.

If you fall into any of the above categories (or have any doubts), you must consult your doctor and
inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking Provisacor if:

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

If you fall into any of the above categories (or are unsure):

do not take Provisacor 40 mg (the highest dose) and consult your doctor or pharmacist before starting Provisacor at any dosage. Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Provisacor. Discontinue use of 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 have a negative effect on the liver, which can be detected by a simple blood test showing elevated liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with Provisacor. During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Children and adolescents

If the patient is under 6 years of age: Provisacor must not be administered to children under 6 years of age.
If the patient is under 18 years of age: Provisacor 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Provisacor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

cyclosporine (used, for example, after organ transplantation),
warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood),
fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
antacids (used to neutralize stomach acid),
erythromycin (an antibiotic),
fusidic acid (an antibiotic – please read the section “Warnings and precautions”),
an oral contraceptive (the pill),
regorafenib (used to treat tumors),
darolutamide (used to treat tumors),
capmatinib (used to treat tumors),
hormone replacement therapy,
fostamatinib (used to treat low platelet count),
febuxostat (used to treat and prevent high levels of uric acid 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 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 anemic adults)

The effects of these medicines may be altered by Provisacor, or the effect of Provisacor may be altered by these medicines.
If you need to take fusidic acid orally to treat a bacterial infection,
you will need to temporarily stop taking this medicine. Your doctor
will advise you when it is safe to resume taking Provisacor. Taking
Provisacor with fusidic acid may rarely cause muscle weakness, tenderness, or
muscle pain (rhabdomyolysis). For more information about rhabdomyolysis,
see section 4.
Pregnancy and breastfeeding
Do not take Provisacor if you are pregnant or breastfeeding. If you become pregnant while taking
Provisacor, you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with Provisacor by using appropriate contraceptive measures.
Consult your doctor or pharmacist before taking any medicine.
Driving and use of machines
Most people can drive and operate machinery while taking Provisacor – it does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with Provisacor. If you experience dizziness, consult your doctor before driving or operating machinery.
Provisacor contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them before taking Provisacor.
For the complete list of other ingredients, see section “Contents of the pack and other information”.

3. How to take Provisacor

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Usual dosage in adults
If you are taking Provisacor for high cholesterol:
Starting dose
Treatment with Provisacor should begin at a dose of 5 mg or 10 mg, even if you have previously taken higher doses of other statins. The choice of starting dose depends on:

your cholesterol level;
your risk of having a heart attack or stroke;
whether you have any factors that may make you more susceptible to possible side effects. Check with your doctor or pharmacist to determine the most appropriate starting dose of Provisacor for you. Your doctor may decide to prescribe the lowest dose (5 mg) if you:
are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
are over 70 years old;
have moderate kidney problems;
are at risk of muscle pain or muscle damage (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose to determine the most suitable dose for you. If starting at 5 mg, your doctor may, if necessary, double the dose to 10 mg, then to 20 mg, and subsequently to 40 mg. If starting at 10 mg, your doctor may, if necessary, double the dose to 20 mg and then to 40 mg. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Provisacor is 40 mg. This dose is reserved only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels have not sufficiently decreased with the 20 mg dose.
If you are taking Provisacor to reduce the risk of heart attack,
stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the risk factors listed above.
Use in children aged 6 to 17 years
The dosage 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 daily. Your doctor may gradually increase the dose to reach the most appropriate Provisacor dose for the patient. The maximum daily dose of Provisacor is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. The dose should be taken once daily. Provisacor 40 mg tablets must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water.
Provisacor should be taken once daily. Provisacor can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.
Regular cholesterol checks
It is important to return to your doctor for regular cholesterol checks to ensure your cholesterol has reached and remains at the appropriate levels. Your doctor may decide to increase your dose to determine the most suitable amount of Provisacor for you.
If you take more Provisacor than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform the hospital doctor that you are taking Provisacor.
If you forget to take Provisacor
Do not panic. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Provisacor
Inform your doctor if you intend to stop taking Provisacor. If you stop taking Provisacor, your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important to be aware of which of these side effects may occur. Usually they are mild and disappear within a short time.

Stop taking Provisacor and seek immediate medical help 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 that may cause difficulty swallowing;
Severe itching of the skin (with raised hives);
Flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Provisacor and contact your doctor immediately:

If you experience unusual muscle pains or cramps lasting 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 muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.
If you experience muscle tearing.
If you develop lupus-like syndrome (characterized by skin rash, joint disorders and effects on blood cells).

Common possible side effects (may occur in 1 out of 10 to 1 out of 100 patients):

Headache, stomach pain, constipation, feeling unwell, muscle pain, feeling of weakness, dizziness.
Increased amount of protein in the urine – values usually return to normal on their own without needing to stop Provisacor (only for Provisacor 40 mg).
Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon possible side effects (may occur in 1 out of 100 to 1 out of 1,000 patients):

Skin rash, itching and other skin reactions.
Increased amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with Provisacor (only for Provisacor 5 mg, 10 mg and 20 mg).

Rare possible side effects (may occur in 1 out of 1,000 to 1 out of 10,000 patients):

Severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised hives). If you suspect an allergic reaction, stop taking Provisacor and seek immediate medical help.
Muscle damage in adults – as a precaution, stop taking Provisacor and contact your doctor immediately if you have unusual muscle pains or cramps that last longer than expected.
Severe stomach pain (inflamed pancreas).
Increased liver enzymes in the blood.
Bleeding or bruising more easily than normal due to low platelet levels in the blood.
Lupus-like syndrome (characterized by skin rash, joint disorders and effects on blood cells).

Very rare possible side effects (may occur in fewer than 1 out of 10,000 patients):

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

Side effects of unknown frequency may include:

Diarrhoea (passing loose stools), cough, shortness of breath, oedema (swelling), sleep disorders including insomnia and nightmares, sexual problems, depression, breathing problems including persistent cough and/or shortness of breath or fever, tendon injury and persistent muscle weakness;
Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases muscles used for breathing). Ocular myasthenia (a disease causing weakness of the eye muscles). Contact your doctor if you experience weakness in arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or laboured breathing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Provisacor

Blister: store below 30°C. Keep in the original packaging to protect the medicine from moisture.
Containers: store below 30°C. Keep the bottle tightly closed to protect the medicine 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 carton/blister pack/labelling, following "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Provisacor contains
The active substance in Provisacor is rosuvastatin. Provisacor film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other components are: monohydrate lactose, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171). Provisacor 10 mg, 20 mg and 40 mg film-coated tablets also contain red iron oxide (E172).
Provisacor 5 mg film-coated tablets also contain yellow iron oxide (E172).
Description of the appearance of Provisacor and package contents
Provisacor is supplied in blister packs containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 and 100 tablets, and plastic containers containing 30 and 100 tablets.
(Not all pack sizes may be marketed in all countries.)
Provisacor is available in four tablet strengths:
Provisacor 5 mg film-coated tablets, yellow, round, marked with “ZD4522” and “5” on one side and smooth on the other side.
Provisacor 10 mg film-coated tablets, pink, round, marked with “ZD4522” and “10” on one side and smooth on the other side.
Provisacor 20 mg film-coated tablets, pink, round, marked with “ZD4522” and “20” on one side and smooth on the other side.
Provisacor 40 mg film-coated tablets, pink, oval, marked with “ZD4522” on one side and “40” on the other side.
Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano, Italy
Manufacturers
AstraZeneca AB, S-152 57, Södertälje, Sweden
Tel.: +46 8 55326000
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany
Tel.: +49 (0) 241 569 0
Farmaceutici Formenti S.p.A.
Via Di Vittorio, 2
21040 Origgio (VA), Italy
This medicinal product is authorized in the European Economic Area countries under the
following names:
Provisacor 5 mg, 10 mg, 20 mg and 40 mg (Italy, Netherlands, Portugal) and 5 mg, 10 mg and 20 mg (Spain).