Rosuvastatin ABC Farmaceutici: detailed information

Package leaflet: Information for the user

ROSUVASTATIN ABC FARMACEUTICI 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

rosuvastatin
Equivalent medicinal product
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What ROSUVASTATIN ABC FARMACEUTICI is and what it is used for
What you need to know before taking ROSUVASTATIN ABC FARMACEUTICI
How to take ROSUVASTATIN ABC FARMACEUTICI
Possible side effects
How to store ROSUVASTATIN ABC FARMACEUTICI
Contents of the pack and other information

What ROSUVASTATIN ABC FARMACEUTICI is and what it is used for
ROSUVASTATIN ABC FARMACEUTICI belongs to a group of medicines called statins.
You have been prescribed ROSUVASTATIN ABC FARMACEUTICI because:

Your cholesterol level is high. This means you are at risk of heart attack or stroke. ROSUVASTATIN ABC FARMACEUTICI is used in adults, adolescents and children aged 6 years and older to treat high cholesterol.
You have been prescribed a statin because dietary changes and increased physical activity have not been sufficient to correct your cholesterol levels. While taking ROSUVASTATIN ABC FARMACEUTICI, you must continue your cholesterol-lowering diet and physical activity.

You have other risk factors that increase the likelihood of heart attack, stroke or related health problems. Heart attack, stroke and related health problems may 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 ROSUVASTATIN ABC FARMACEUTICI
ROSUVASTATIN ABC FARMACEUTICI is used to correct levels of fatty substances in the
blood called 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).

ROSUVASTATIN ABC FARMACEUTICI can reduce “bad” cholesterol and increase “good” cholesterol.
It works by helping to block the body's production of “bad” cholesterol. It 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 narrowing.
Sometimes, these narrowed blood vessels can become blocked, stopping blood flow to the heart or brain, resulting in 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 ROSUVASTATIN ABC FARMACEUTICI, even if your cholesterol levels have returned to normal, to prevent them from rising again, which could lead to fatty deposits forming.
However, you must stop taking ROSUVASTATIN ABC FARMACEUTICI on medical advice or if you become pregnant.
What you need to know before taking ROSUVASTATIN ABC FARMACEUTICI
Do not take ROSUVASTATIN ABC FARMACEUTICI

if you have previously had an allergic reaction to ROSUVASTATIN ABC FARMACEUTICI or to any of the ingredients of this medicine;
if you are pregnant or breastfeeding. If you become pregnant while taking ROSUVASTATIN ABC FARMACEUTICI, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking ROSUVASTATIN ABC FARMACEUTICI by using appropriate contraceptive measures;
if you have liver disease;
if you have severe kidney problems;
if you have repeated or unexplained muscle aches or pains;
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 transplant).

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 ROSUVASTATIN ABC FARMACEUTICI 40 mg (the highest dose):

if you have moderate kidney problems (ask your doctor if you are unsure);
if your thyroid gland is not functioning properly;
if you have repeated or unexplained muscle aches or pains, 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 and 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 ROSUVASTATIN ABC FARMACEUTICI.

if you have kidney problems;
if you have liver problems;
if you have had repeated or unexplained muscle aches or pains, 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 aches or pains, especially if accompanied by malaise or 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, 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 cause its onset (see section 4);
if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking ROSUVASTATIN ABC FARMACEUTICI 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 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, for example ritonavir with lopinavir and/or atazanavir, read section “Other medicines and ROSUVASTATIN ABC FARMACEUTICI”;
if you are taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine for treating bacterial infections). The combination of fusidic acid and ROSUVASTATIN ABC FARMACEUTICI can lead to serious muscle problems (rhabdomyolysis); please read the section “Other medicines and ROSUVASTATIN ABC FARMACEUTICI”;
if you are over 70 years old (your doctor needs to choose the appropriate starting dose of ROSUVASTATIN ABC FARMACEUTICI for you);
if you have severe respiratory failure;
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the appropriate starting dose of ROSUVASTATIN ABC FARMACEUTICI for you.

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

do not take ROSUVASTATIN ABC FARMACEUTICI 40 mg (the highest dose) and check with your doctor or pharmacist before starting ROSUVASTATIN ABC FARMACEUTICI at any dosage.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with ROSUVASTATIN ABC FARMACEUTICI. Discontinue use of ROSUVASTATIN ABC FARMACEUTICI and seek immediate medical help 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 measuring increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with ROSUVASTATIN ABC FARMACEUTICI.
During treatment with this medicine, your doctor will carefully 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: ROSUVASTATIN ABC FARMACEUTICI must not be given to children under 6 years of age.
If the patient is under 18 years of age: ROSUVASTATIN ABC FARMACEUTICI 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

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

cyclosporine (used, for example, after organ transplant),
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),
remedies for indigestion (used to neutralize stomach acids),
erythromycin (an antibiotic), fusidic acid (an antibiotic - please read section “Warnings and precautions”),
an oral contraceptive (the pill),
regorafenib (used to treat tumours),
darolutamide (used to treat tumours),
capmatinib (used to treat tumours),
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 (used to treat anaemia in patients with chronic kidney disease)
tafamidis (used to treat a disease called transthyretin amyloidosis)
momelotinib (used to treat myelofibrosis in adults with anaemia)

The effects of these medicines may be altered by ROSUVASTATIN ABC FARMACEUTICI, or the effect of ROSUVASTATIN ABC FARMACEUTICI may be altered by these medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking ROSUVASTATIN ABC FARMACEUTICI.
Taking ROSUVASTATIN ABC FARMACEUTICI with fusidic acid may rarely cause weakness, tenderness or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Pregnancy and breastfeeding
Do not take ROSUVASTATIN ABC FARMACEUTICI if you are pregnant or breastfeeding.
If you become pregnant while taking ROSUVASTATIN ABC FARMACEUTICI, you must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with ROSUVASTATIN ABC FARMACEUTICI by using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking ROSUVASTATIN ABC FARMACEUTICI – it does not affect their ability to drive or use machinery. However, some people may experience dizziness during treatment with ROSUVASTATIN ABC FARMACEUTICI. If you experience dizziness, consult your doctor before driving or using machinery.
ROSUVASTATIN ABC FARMACEUTICI contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them before taking ROSUVASTATIN ABC FARMACEUTICI.
For a complete list of other ingredients, see section “Contents of the pack and other information”.
How to take ROSUVASTATIN ABC FARMACEUTICI
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Usual dosage in adults
If you are taking ROSUVASTATIN ABC FARMACEUTICI for high cholesterol:
Starting dose
Treatment with ROSUVASTATIN ABC FARMACEUTICI should start with 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;
the possible presence of factors that may make you more sensitive to potential side effects. Check with your doctor or pharmacist which starting dose of ROSUVASTATIN ABC FARMACEUTICI is most suitable for you. Your doctor may decide to give you the lowest dose (5 mg) if you:
are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
are over 70 years old;
have moderate kidney problems;
are at risk of muscle aches and pains (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase the dose. This is to determine the most appropriate dose for you.
If you start with a 5 mg dose, your doctor, if necessary, may decide to double the dose to 10 mg, then to 20 mg and then to 40 mg. If you start with 10 mg, your doctor may decide, if necessary, to double this dose to 20 mg and then to 40 mg. There must be an interval of 4 weeks between dose adjustments.
The maximum daily dose of ROSUVASTATIN ABC FARMACEUTICI is 40 mg. It is administered only to patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not decreased sufficiently with the 20 mg dose.
If you are taking ROSUVASTATIN ABC FARMACEUTICI 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 in children and adolescents aged 6 to 17 years is from 5 mg to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until the most appropriate dose of ROSUVASTATIN ABC FARMACEUTICI for the patient is reached. The maximum daily dose of ROSUVASTATIN ABC FARMACEUTICI 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. ROSUVASTATIN ABC FARMACEUTICI 40 mg tablets must not be used in children.
Administration of the tablets
Swallow each tablet whole with a glass of water.
ROSUVASTATIN ABC FARMACEUTICI must be taken once daily.
ROSUVASTATIN ABC FARMACEUTICI 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.
The 10 mg, 20 mg and 40 mg tablets have a score line which allows them to be divided into two equal parts.
Regular cholesterol checks
It is important to return to your doctor for regular cholesterol level checks to ensure your cholesterol has reached and maintains the correct levels. Your doctor may decide to increase the dose until the most appropriate amount of ROSUVASTATIN ABC FARMACEUTICI for you is reached.
If you take more ROSUVASTATIN ABC FARMACEUTICI 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 ROSUVASTATIN ABC FARMACEUTICI.
If you forget to take ROSUVASTATIN ABC FARMACEUTICI
Do not panic; take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking ROSUVASTATIN ABC FARMACEUTICI
Inform your doctor if you intend to stop taking ROSUVASTATIN ABC FARMACEUTICI. If you stop taking ROSUVASTATIN ABC FARMACEUTICI, your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
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.
They are usually mild and disappear quickly.
Stop taking ROSUVASTATIN ABC FARMACEUTICI 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 causing difficulty swallowing;
Severe skin itching (with raised hives);
Flat, reddish, target-shaped or circular spots 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).

In addition, stop taking ROSUVASTATIN ABC FARMACEUTICI and contact your doctor immediately:

If you have unusual muscle aches or pains 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 muscle-related side effects, and rarely these have progressed to a disease causing muscle damage, potentially fatal, known as rhabdomyolysis.
If you experience muscle tearing.
If you develop lupus-like syndrome (which includes rash, joint disorders and effects on blood cells).

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

Headache, stomach pain, constipation, feeling unwell, muscle pain, feeling weak, dizziness.
Increased amount of protein in urine – values usually return to normal on their own without needing to stop taking ROSUVASTATIN ABC FARMACEUTICI (only for ROSUVASTATIN ABC FARMACEUTICI 40 mg).
Diabetes. More likely if you have high levels of sugar and fat in your blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

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

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

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

Severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised hives). If you suspect an allergic reaction, stop taking ROSUVASTATIN ABC FARMACEUTICI and seek immediate medical help.
Muscle damage in adults – as a precaution, stop taking ROSUVASTATIN ABC FARMACEUTICI and contact your doctor immediately if you have unusual muscle aches or pains that persist 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 (which includes rash, joint disorders and effects on blood cells).

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

Jaundice (yellowing of the skin and eyes), hepatitis (inflammation of the liver), blood in 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 (loss of liquid 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, the muscles used for breathing). Ocular myasthenia (a disease causing weakness of the eye muscles). Contact 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 laboured breathing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
How to store ROSUVASTATIN ABC FARMACEUTICI
Keep in the original packaging to protect the medicine from light.
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, after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What ROSUVASTATIN ABC FARMACEUTICI contains
The active substance in ROSUVASTATIN ABC FARMACEUTICI is rosuvastatin.
ROSUVASTATIN ABC FARMACEUTICI film-coated tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin. ROSUVASTATIN ABC FARMACEUTICI 10 mg, 20 mg and 40 mg film-coated tablets also contain red iron oxide (E172). ROSUVASTATIN ABC FARMACEUTICI 5 mg film-coated tablets also contain yellow iron oxide (E172).
Description of the appearance of ROSUVASTATIN ABC FARMACEUTICI and contents of the pack
The tablets are available in Al/Al blisters in packs of 28 tablets.
Not all pack sizes may be marketed.
ROSUVASTATIN ABC FARMACEUTICI is supplied in four tablet strengths:
ROSUVASTATIN ABC FARMACEUTICI 5 mg film-coated tablets, yellow, round, biconvex, with “135” engraved on one side and “5” on the other.
ROSUVASTATIN ABC FARMACEUTICI 10 mg film-coated tablets, light pink, round, biconvex, with a score line on both sides separating “11” and “36” on one side and “10” on the other.
ROSUVASTATIN ABC FARMACEUTICI 20 mg film-coated tablets, light pink, biconvex, with a score line on both sides separating “11” and “37” on one side and “20” on the other.
ROSUVASTATIN ABC FARMACEUTICI 40 mg film-coated tablets, light pink, oval, biconvex with rounded edges, with a score line on both sides.
Marketing Authorization Holder
ABC Farmaceutici S.p.A - Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
ABC Farmaceutici S.p.A. - Via Cantone Moretti, 29 - Loc. San Bernardo –10015 Ivrea (TO)