ROSUVASTATINA 5 mg Фильм-Coated Таблетки

Содержание инструкции

1. ROSUVASTATINA ABC FARMACEUTICI 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
2. ROSUVASTATINA ABC FARMACEUTICI. If you feel dizzy, consult your doctor before
3. ROSUVASTATINA ABC FARMACEUTICI must be taken once a day.
4. ROSUVASTATINA ABC FARMACEUTICI 40 mg film-coated tablets, are pink

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

rosuvastatina

Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What is ROSUVASTATINA ABC FARMACEUTICI and what it is used for
• 2. What you need to know before you take ROSUVASTATINA ABC FARMACEUTICI
• 3. How to take ROSUVASTATINA ABC FARMACEUTICI
• 4. Possible side effects
• 5. How to store ROSUVASTATINA ABC FARMACEUTICI
• 6. Contents of the pack and other information

What is ROSUVASTATINA ABC FARMACEUTICI and what it is used for
ROSUVASTATINA ABC FARMACEUTICI belongs to a group of medicines called statins.

You have been prescribed ROSUVASTATINA ABC FARMACEUTICI because:

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. ROSUVASTATINA ABC FARMACEUTICI is used in adults, adolescents and children aged 6 years and over to treat high cholesterol.
• You have been prescribed a statin because changes to your diet and increased exercise have not been enough to correct your cholesterol levels. While taking ROSUVASTATINA ABC FARMACEUTICI you should continue a cholesterol-lowering diet and exercise.

or

• You have other factors that increase your risk of heart attack, stroke or health problems related to them. Heart attack, stroke and related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to the formation of fatty deposits inside the arteries.

Why it is important to continue taking ROSUVASTATINA ABC FARMACEUTICI
ROSUVASTATINA ABC FARMACEUTICI is used to correct the levels of fatty substances in the
blood called lipids, the most common of which is cholesterol.
There are several types of cholesterol in the blood: so-called “bad” cholesterol (LDL-C) and
so-called “good” cholesterol (HDL-C).

• ROSUVASTATINA ABC FARMACEUTICI can reduce “bad” cholesterol and increase “good” cholesterol.

• It works by helping to block the production of “bad” cholesterol by the body. 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 has no
symptoms. However, if high cholesterol is not treated, fatty deposits can accumulate in the
walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, blocking blood flow to the heart or
brain, resulting in 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 to take ROSUVASTATINA ABC FARMACEUTICI, even if your cholesterol
levels have returned to normal, to prevent them from rising again, causing the
formation of fatty deposits.
However, you must stop taking ROSUVASTATINA ABC FARMACEUTICI on medical advice or if you become pregnant.

What you need to know before you take ROSUVASTATINA ABC FARMACEUTICI
Do not take ROSUVASTATINA ABC FARMACEUTICI

• if you have previously had an allergic reaction to ROSUVASTATINA ABC FARMACEUTICIor to any of the ingredients of this medicine;
• if you are pregnant or breastfeeding. If you become pregnant while taking ROSUVASTATINA ABC FARMACEUTICI, stop taking it immediately andtell your doctor. Women must avoid becoming pregnant while taking ROSUVASTATINA ABC FARMACEUTICI, using appropriate contraceptive measures;
• if you have a 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 containingsofosbuvir/velpatasvir/voxilaprevir(used to treat a viral infection of the liver called hepatitis C);
• if you are taking a medicine called ciclosporin(used, for example, after organ transplantation)

If you are in any of these situations (or are unsure), you should talk to your doctor.

Also, do not take ROSUVASTATINA 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 working properly;
• if you have repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol;
• if you regularly drink large amounts of alcohol;
• if you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
• if you are taking other medicinesto lower cholesterol called fibrates.

If you are in any of these situations (or are unsure), you should talk to your doctor before taking ROSUVASTATINA ABC FARMACEUTICI.
Warnings and precautions
Talk to your doctor or pharmacist before taking ROSUVASTATINA 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 had muscle problems while taking other medicines to lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches, pains or weakness, especially if accompanied by fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness;
• if you have or have had myasthenia gravis(a condition characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia gravis or cause it to appear (see section 4).
• if you have ever developed a severe skin rash or blistering, blisters and/orulcers in the mouth after taking ROSUVASTATINA ABC FARMACEUTICI or otherrelated medicines;
• if you regularly drink large amounts of alcohol;
• if your thyroid gland is not working properly;
• if you are taking other medicines to lower cholesterol called fibrates. Read carefully

above;

• if you are taking medicines used to treat HIV infections, for example ritonavir with lopinavir and/or atazanavir, read the section “Other medicines and ROSUVASTATINA ABCFARMACEUTICI”;
• if you are taking or have taken in the last 7 days, orally or by injection, amedicine called fusidic acid(a medicine to treat bacterial infections). The combination of fusidic acid and ROSUVASTATINA ABC FARMACEUTICI can lead to serious muscle problems (rhabdomyolysis), please read the section “Other medicines andROSUVASTATINA ABC FARMACEUTICI”;
• if you are over 70 years of age(your doctor needs to choose the initial dose of ROSUVASTATINA ABC FARMACEUTICI that is right for you);
• if you have severe breathing difficulties;
• if you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the initial dose of ROSUVASTATINA ABC FARMACEUTICI that is right for you.

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

• do not take ROSUVASTATINA ABC FARMACEUTICI 40 mg (the highest dose) and checkwith your doctor or pharmacist before starting to take ROSUVASTATINA ABCFARMACEUTICI at any dose.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with ROSUVASTATINA ABC FARMACEUTICI. Stop using ROSUVASTATINA ABC FARMACEUTICI and seek immediate medical attention if you develop symptoms described in section 4.
In a small number of people, statins can have a negative effect on the liver, which can
be identified with a simple test that detects increased levels of liver enzymes in the blood. For
this reason, your doctor may ask you to have this test (liver function test) before and
during treatment with ROSUVASTATINA ABC FARMACEUTICI.
During treatment with this medicine, your doctor will carefully check that you do not have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high
levels of sugars and fats in your blood, if you are overweight and have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: ROSUVASTATINA ABC FARMACEUTICI should not be given to children under 6 years of age.
• If the patient is under 18 years of age:ROSUVASTATINA ABC FARMACEUTICI 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

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

• ciclosporin (used, for example, after organ transplantation),
• warfarin, clopidogrel or ticagrelor (or any other medicine used to thin your 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 cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet counts),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• 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 condition called transthyretin amyloidosis)

The effects of these medicines can be altered by ROSUVASTATINA ABC
FARMACEUTICI, or the effect of ROSUVASTATINA ABC FARMACEUTICI can 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 tell you
when you can start taking ROSUVASTATINA ABC FARMACEUTICI safely again.
Taking ROSUVASTATINA ABC FARMACEUTICI with fusidic acid can rarely
lead to muscle weakness, sensitivity to pain or muscle pain (rhabdomyolysis). For more
information about rhabdomyolysis see section 4.
Pregnancy and breastfeeding
Do not takeROSUVASTATINA ABC FARMACEUTICIif you are pregnant or breastfeeding.
If you become pregnant while taking ROSUVASTATINA ABC FARMACEUTICI, you must stop
taking it immediatelyand tell your doctor.
Women must avoid becoming pregnant while taking ROSUVASTATINA ABC
FARMACEUTICI, using appropriate contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive and use machines while taking
ROSUVASTATINA ABC FARMACEUTICI – it has no effect on their ability to drive cars
and use machines. However, some people may experience dizziness while taking

ROSUVASTATINA ABC FARMACEUTICI. If you feel dizzy, consult your doctor before

driving or operating machinery.
ROSUVASTATINA ABC FARMACEUTICI contains lactose
If your doctor has diagnosed you with an intolerance to some sugars (lactose or milk sugar), contact them before taking ROSUVASTATINA ABC FARMACEUTICI.
For the complete list of other components, see the section “ Contents of the pack and other
information”.

How to take ROSUVASTATINA ABC FARMACEUTICI
Take this medicine following the instructions of your doctor exactly. If you have doubts, consult
your doctor or pharmacist.

Usual dosage in adults
If you are taking ROSUVASTATINA ABC FARMACEUTICI for high cholesterol:

Initial dose
Treatment with ROSUVASTATINA ABC FARMACEUTICI should begin with a dose of 5 mg
or 10 mg, even if you have previously taken higher dosages with other statins. The choice of the initial dose depends on:

• your cholesterol level;
• the level of risk of having a heart attack or stroke;
• the possible presence of factors that may make you more sensitive to possible side effects. Check with your doctor or pharmacist what is the most suitable initial dose of ROSUVASTATINA ABC FARMACEUTICI for you. The 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
The doctor may decide to increase the dose. All of this in order to determine the most suitable dose for you.
If you start with a 5 mg dose, the 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, the 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 one
dose adjustment and another.
The maximum daily dose of ROSUVASTATINA ABC FARMACEUTICI is 40 mg. It is
administered only to patients with high cholesterol levels and at high risk of heart attack or
stroke, whose cholesterol levels have not lowered sufficiently with the 20 mg dose.

If you are taking ROSUVASTATINA ABC FARMACEUTICI to reduce the risk of
heart attack, stroke or health problems related to them:
The recommended dose is 20 mg per day. However, the doctor may decide to use a lower dosage if you have one of the risk factors mentioned 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 a day. The usual initial dose is 5 mg per day, and your doctor may gradually increase
the dose to reach the most appropriate dosage of ROSUVASTATINA ABC FARMACEUTICI
for the patient. The maximum daily dose of ROSUVASTATINA ABC

FARMACEUTICI is 10 mg or 20 mg for children aged 6 to 17 years depending on how
the underlying condition is being treated. The dose must be taken once a day. The tablets
of ROSUVASTATINA ABC FARMACEUTICI 40 mg must notbe used in children.

Administration of the tablets
Swallow each tablet whole with a glass of water.

ROSUVASTATINA ABC FARMACEUTICI must be taken once a day.

ROSUVASTATINA ABC FARMACEUTICI can be taken at any time of the day

with or without food.
Try to take the tablets at approximately the same time each day; this may help you to remember to take them.
The 10 mg, 20 mg and 40 mg tablets have a score line that is used to divide the tablets into two equal halves.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to be sure that your cholesterol has reached and maintains the correct levels. The doctor may decide to increase the dose up to the amount of ROSUVASTATINA ABC FARMACEUTICI that is most suitable for you.

If you take more ROSUVASTATINA 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, tell the hospital doctor that you are taking ROSUVASTATINA ABC FARMACEUTICI.

If you forget to take ROSUVASTATINA ABC FARMACEUTICI
Do not worry, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking ROSUVASTATINA ABC FARMACEUTICI
Tell your doctor if you intend to stop taking ROSUVASTATINA ABC FARMACEUTICI. If you stop taking ROSUVASTATINA ABC FARMACEUTICI, your cholesterol levels may rise again.
If you have any doubts about the use of this medicine, ask 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 in a short time.

Stop taking ROSUVASTATINA ABC FARMACEUTICI and seek immediate medical helpif 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 can cause difficulty swallowing;
• Severe itching of the skin (with raised blisters);
• Reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 ROSUVASTATINA ABC FARMACEUTICI and immediately contact your doctor:

• If you have unusual muscle aches or painsthat last longer than you would expect. 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 side effects, and rarely these have evolved into a disease that leads to muscle damage, potentially fatal, known as rhabdomyolysis.
• If you experience muscle rupture.
• If you have lupus-like syndrome(which includes rash, joint disorders and effects on blood cells).

Common possible side effects(these can occur in 1 in 10 and 1 in 100 patients):

• Headache, stomach pain, constipation, feeling unwell, muscle pain, feeling weak, dizziness.
• An increase in the amount of protein in the urine - usually the values return to normal on their own without having to stop taking ROSUVASTATINA ABC FARMACEUTICI (only for ROSUVASTATINA ABC FARMACEUTICI 40 mg).
• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon possible side effects(these can occur in 1 in 100 and 1 in 1,000 patients):

• Skin rash, itching and other skin reactions.
• An increase in the amount of protein in the urine - these usually return to normal on their own without the need to stop treatment with ROSUVASTATINA ABC FARMACEUTICI (only for ROSUVASTATINA ABC FARMACEUTICI 5mg, 10 mg and 20 mg).

Rare possible side effects(these can occur in 1 in 1,000 and 1 in 10,000 patients):

• Severe allergic reactions - the signals include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised blisters). If you suspect you have an allergic reaction, stop takingROSUVASTATINA ABC FARMACEUTICIand seek immediate medical help.
• Muscle damage in adults - as a precaution, stop takingROSUVASTATINA ABC FARMACEUTICI and contact your doctor immediately if you haveunusual muscle aches or painsthat persist longer than you would expect.
• Severe stomach pain (inflamed pancreas).
• Increased liver enzymes in the blood.
• Bleeding or bruising more easily than usual due to a low level of platelets in the blood.
• Lupus-like syndrome (which includes rash, joint disorders and effects on blood cells).

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

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

Side effects of unknown frequency can include:

• Diarrhea (loose stools), cough, shortness of breath, edema (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 constant muscle weakness;
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing). Ocular myasthenia (a disease that causes 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 shortness of breath.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 ROSUVASTATINA ABC FARMACEUTICI
Keep in the original package 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 box/blister, after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the water 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 contains ROSUVASTATINA ABC FARMACEUTICI
Theactive ingredientof ROSUVASTATINA ABC FARMACEUTICI is rosuvastatin.
ROSUVASTATINA 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. ROSUVASTATINA ABC FARMACEUTICI 10 mg, 20 mg and 40 mg film-coated tablets also contain red iron oxide (E172). ROSUVASTATINA ABC FARMACEUTICI 5 mg film-coated tablets also contain yellow iron oxide (E172).

Description of the appearance of ROSUVASTATINA ABC FARMACEUTICI and contents of the pack
The tablets are available in Al/Al blisters in packs of 28 tablets.
Not all packs may be marketed.
ROSUVASTATINA ABC FARMACEUTICI is supplied in tablets of four dosages:
ROSUVASTATINA ABC FARMACEUTICI 5 mg film-coated tablets, yellow in color, round, biconvex and imprinted with " 135" on one side and " 5" on the other
ROSUVASTATINA ABC FARMACEUTICI 10 mg film-coated tablets, light pink in color, round, biconvex and imprinted on both sides with a fracture line separating “ 11” and “ 36” on one side and “ 10” on the other.
ROSUVASTATINA ABC FARMACEUTICI 20 mg film-coated tablets, light pink in color, biconvex and imprinted on both sides with a fracture line separating “ 11” and “ 37” on one side and “ 20” on the other.

ROSUVASTATINA ABC FARMACEUTICI 40 mg film-coated tablets, are pink

light, oval, biconvex with rounded edge and with fracture line on both sides.

Marketing Authorisation Holder
ABC Farmaceutici S.p.A - Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturer
ABC Farmaceutici S.p.A. - Via Cantone Moretti, 29 - Loc. San Bernardo –10015 Ivrea (TO)