ROSUVASTATINA 5 mg Фильм-Coated Таблетки

Содержание инструкции

1. ROSUVASTATINA SPECIAL PRODUCT’S LINE 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is ROSUVASTATINA SPECIAL PRODUCT’S LINE and what is it used for?
   2. What you need to know before taking ROSUVASTATINA SPECIAL PRODUCT’S LINE
   3. How to take ROSUVASTATINA SPECIAL PRODUCT’S LINE
   4. Possible side effects
   5. How to store ROSUVASTATINA SPECIAL PRODUCT’S LINE
   6. Package Contents and Other Information

ROSUVASTATINA SPECIAL PRODUCT’S LINE 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 taking this medicine as 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 ROSUVASTATINA SPECIAL PRODUCT’S LINE is and what it is used for
• 2.What you need to know before you take ROSUVASTATINA SPECIAL PRODUCT’S LINE
• 3.How to take ROSUVASTATINA SPECIAL PRODUCT’S LINE
• 4.Possible side effects
• 5.How to store ROSUVASTATINA SPECIAL PRODUCT’S LINE
• 6.Contents of the pack and other information

1. What is ROSUVASTATINA SPECIAL PRODUCT’S LINE and what is it used for?

ROSUVASTATINA SPECIAL PRODUCT’S LINE belongs to a group of medicines called statins.
You have been prescribed this medicine because:

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

Or

• You have other factors that increase your risk of developing a heart attack, stroke or heart-related disorders.

Heart attack, stroke and other disorders can be caused by a disease called atherosclerosis.
Atherosclerosis is due to the formation of fatty deposits in the arteries.
Why it is important to continue taking ROSUVASTATINA SPECIAL PRODUCT’S LINE:

• ROSUVASTATINA SPECIAL PRODUCT’S LINE is used to modify the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
• There are different types of cholesterol present in the blood - “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).

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• ROSUVASTATINA SPECIAL PRODUCT’S LINE 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 it from the blood.
• For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels causing them to narrow.
• Sometimes, this narrowing of the blood vessels can cause a blockage of blood flow to the heart or brain resulting in a heart attack or stroke. By lowering cholesterol levels, you can reduce your risk of a heart attack, stroke or other related health problems.
• You need to continue taking ROSUVASTATINA SPECIAL PRODUCT’S LINE, even if your cholesterol levels are normal, to prevent these levels from rising againcausing the formation of fatty deposits. However, taking it must be stopped if your doctor decides or in case of pregnancy.

2. What you need to know before taking ROSUVASTATINA SPECIAL PRODUCT’S LINE

Do not take ROSUVASTATINA SPECIAL PRODUCT’S LINE

• If you are allergic to rosuvastatin, or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant during treatment with rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with rosuvastatin by using suitable contraception.
• If you have a liver disease.
• If you have severe kidney problems.
• If you have unexplained muscle weakness and pain that is recurrent or persistent.
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If any of these apply to you (or if you are unsure), please consult your doctor.
• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking ROSUVASTATINA SPECIAL PRODUCT’S LINE.

Also, do not take ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg (the highest dose):

• If you have moderate kidney problems (if you are unsure, ask your doctor).
• If you have a thyroid gland that is not functioning properly.
• If you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems, or if you have previously experienced muscle problems while taking other medicines that lower cholesterol.
• If you regularly consume significant amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.
• If any of these apply to you (or if you are unsure), please consult your doctor.

Warnings and precautions
Ask your doctor or pharmacist for advice before taking ROSUVASTATINA SPECIAL PRODUCT’S LINE

• If you have kidney problems.
• If you have liver problems.
• If you have a personal or family history of muscle problems, or if you have previously experienced muscle problems while taking other medicines that lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if accompanied by fever or malaise. Also, tell your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly consume significant amounts of alcohol. Pag. 2 a 9
• If you have a thyroid gland that is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Please read

high cholesterol.

• If you are taking medicines used to fight HIV infection, for example lopinavir/ritonavir and/or atazanavir see section “Other medicines and ROSUVASTATINA SPECIAL PRODUCT’S LINE”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic for bacterial infections) orally or by injection. The combination of fusidic acid and ROSUVASTATINA SPECIAL PRODUCT’S LINE can lead to serious muscle problems (rhabdomyolysis), see section “Other medicines and ROSUVASTATINA SPECIAL PRODUCT’S LINE”
• If you are over 70 years of age(your doctor must choose the correct starting dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE suitable for you).
• If you have severe breathing difficulties.
• If you are of Asian origin - Japanese, Chinese, Filipino, Vietnamese, Korean or Indian. Your doctor must choose the correct starting dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE suitable for you.
• 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 that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

Tell your doctor or pharmacist if you develop a persistent cough, shortness of breath or difficulty breathing.
This medicine can cause scarring of the lungs and you may need to be monitored by your
doctor (interstitial lung disease).
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with ROSUVASTATINA SPECIAL PRODUCT’S LINE. Stop using ROSUVASTATINA SPECIAL PRODUCT’S LINE and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and Adolescents

• If the patient’s age is less than 6 years: ROSUVASTATINA SPECIAL PRODUCT’S LINE should not be given to children under 6 years of age.
• If the patient’s age is less than 18 years: the 40 mg ROSUVASTATINA SPECIAL PRODUCT’S LINE tablet is not suitable for use in children and adolescents under 18 years of age.

If any of these apply to you (or if you are unsure):

Do not take ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg (the highest dose) and consult your doctor or
pharmacist before actually starting to take any dose of ROSUVASTATINA SPECIAL
PRODUCT’S LINE.
Statins can alter liver function in a small number of people. This is detected with a simple test, which allows monitoring of increased levels of liver enzymes in the blood. For this reason, your doctor will usually request this blood test (liver function test) before and during treatment with ROSUVASTATINA SPECIAL PRODUCT’S LINE.
During treatment with this medicine, your doctor will carefully monitor 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.

Other medicines and ROSUVASTATINA SPECIAL PRODUCT’S LINE
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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those listed below:

• cyclosporine (used, for example, after organ transplantation),
• warfarin, ticagrelor or clopidogrel (or any other medicine to prevent blood clots),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• remedies for indigestion (used to neutralize stomach acid) erythromycin (an antibiotic),
• oral contraceptives (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),
• anti-viral medicines such as ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. (used for the treatment of HIV or hepatitis C infection - see section “Warnings and precautions”).

The effects of these medicines can alter the effect of ROSUVASTATINA SPECIAL PRODUCT’S LINE
or the effect of these medicines can be changed by ROSUVASTATINA SPECIAL PRODUCT’S LINE.
If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart taking ROSUVASTATINA SPECIAL PRODUCT’S LINE. Taking ROSUVASTATINA
SPECIAL PRODUCT’S LINE with fusidic acid can rarely cause weakness, fatigue or muscle pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Pregnancy and breastfeeding
Do not take ROSUVASTATINA SPECIAL PRODUCT’S LINE if you are pregnant or breastfeeding. If you become
pregnant during treatment with ROSUVASTATINA SPECIAL PRODUCT’S LINE stop taking it immediately
and inform your doctor. Women must avoid pregnancy during treatment with
ROSUVASTATINA SPECIAL PRODUCT’S LINE by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Most people can drive vehicles and operate machinery during treatment with
ROSUVASTATINA SPECIAL PRODUCT’S LINE, the treatment does not alter their ability to drive or operate
machinery. However, some people may experience dizziness during treatment with
ROSUVASTATINA SPECIAL PRODUCT’S LINE. If you experience dizziness, consult your doctor before driving vehicles or
using machinery.

ROSUVASTATINA SPECIAL PRODUCT’S LINE contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take ROSUVASTATINA SPECIAL PRODUCT’S LINE

Take this medicine always exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

Usual doses in adults
If you are taking ROSUVASTATINA SPECIAL PRODUCT’S LINEfor high cholesterol:
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Initial dose
Treatment with ROSUVASTATINA SPECIAL PRODUCT’S LINEshould start with a dose of 5 mg or 10
mg, even if you were previously taking a different statin with a higher dosage. The choice of the initial dose depends on:

• Your cholesterol level.
• Your risk level of heart attack or stroke.
• If you are more exposed to the risk of developing possible side effects.

Please consult your doctor or pharmacist to find out which initial doses of ROSUVASTATINA SPECIAL
PRODUCT’S LINE are most suitable 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).
• You are over 70 years of age.
• You have moderate kidney problems.
• You are at risk of muscle pain (myopathy).

Dose increase and maximum daily dose
The doctor may decide to increase the dose. This will allow you to take the right amount of
ROSUVASTATINA SPECIAL PRODUCT’S LINE for you. If you started with a 5 mg dose, your doctor may
decide to double it to 10 mg, then to 20 mg and then to 40 mg, if necessary. If you started with a 10 mg dose,
your doctor may decide to double it to 20 mg and then to 40 mg, if necessary. There will be an interval of
4 weeks between each dose adjustment.
The maximum daily dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE is 40 mg. It is only recommended
for patients who have high cholesterol levels and are at high risk of heart attacks or strokes, whose
cholesterol levels are not lowered sufficiently with a 20 mg dose.

If you are taking ROSUVASTATINA SPECIAL PRODUCT’S LINE 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 prescribe lower doses if one of the
conditions listed above applies to you.

Usual doses in children and adolescents aged 6-17 years
The usual initial dose is 5 mg. The doctor may increase the dose until the amount of
ROSUVASTATINA SPECIAL PRODUCT’S LINE you need is reached. The maximum daily dose of
ROSUVASTATINA SPECIAL PRODUCT’S LINE is 10 mg for children aged 6 to 9 years and 20
mg for children aged 10 to 17 years. Take the dose once a day. ROSUVASTATINA
SPECIAL PRODUCT’S LINE 40 mg tablets should not be used in children.

Taking the tablets
Swallow each tablet whole with a glass of water.
ROSUVASTATINA SPECIAL PRODUCT’S LINE must be taken once a day. ROSUVASTATINA
SPECIAL PRODUCT’S LINE 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 not to forget to take them.
Regular checks of cholesterol levels It is important to return to the doctor to check your cholesterol levels regularly
and make sure they have been reached and maintained within normal values.
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The dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE may be increased by the doctor until
the amount you need is reached.

If you take more ROSUVASTATINA SPECIAL PRODUCT’S LINE than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or are being treated for another condition, tell the medical staff that you
are taking ROSUVASTATINA SPECIAL PRODUCT’S LINE.

If you forget to take ROSUVASTATINA SPECIAL PRODUCT’S LINE
Do not worry; take the next dose at the right time. Do not take a double dose to make up for the
missed dose.

If you stop taking ROSUVASTATINA SPECIAL PRODUCT’S LINE
Talk to your doctor if you want to stop taking ROSUVASTATINA SPECIAL PRODUCT’S LINE. Cholesterol levels
may increase again if you stop taking ROSUVASTATINA SPECIAL PRODUCT’S
LINE.
If you have any doubts about the use of this medicine, ask 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 that you are aware of these side effects. These are generally mild and
disappear after a short period of time. Stop takingROSUVASTATINA SPECIAL PRODUCT’S
LINE and see your doctor immediately 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 can cause difficulty swallowing.
• Severe itching of the skin (with raised bumps).

Also, stop taking ROSUVASTATINA SPECIAL PRODUCT’S LINE and talk to your doctor
immediately:

• if you have unexplained muscle weakness and pain, which lasts longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a few people have experienced unpleasant muscle effects that rarely became a muscle damage potentially life-threatening known as rhabdomyolysis.
• If you experience muscle rupture.
• If you have a lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).
• If you develop red, flat, target-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• If you have a widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug reaction with eosinophilia and systemic symptoms).

Other possible side effects
Common(may affect up to 1 in 10 and 1 in 100 people):

• Headache;
• Stomach pain;
• Constipation;
• Feeling unwell;

Pag. 6 a 9

• Muscle pain
• Feeling of weakness;
• Dizziness;
• Increased amount of protein in the urine which usually returns to normal without having to stop taking ROSUVASTATINA SPECIAL PRODUCT’S LINE tablets (only ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg).
• Diabetes. This is more likely if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon possible side effects(these may affect up to 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 SPECIAL PRODUCT’S LINE (only with ROSUVASTATINA SPECIAL PRODUCT’S LINE 5 mg, 10 mg and 20 mg).

Rare possible side effects( may affect up to 1 in 1,000 and 1 in 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 hives). If you suspect you have an allergic reaction, stop taking withROSUVASTATINA SPECIAL PRODUCT’S LINEand seek medical help immediately;
• Muscle damage in adults - as a precaution, stop taking with ROSUVASTATINA SPECIAL PRODUCT’S LINE and see your doctor immediately if you have unusualmuscle aches or painsthat last longer than you would expect;
• Severe stomach pain (inflamed pancreas);
• Bruising or bleeding more often or more easily than usual, may be signs of a low number of platelets in the blood (thrombocytopenia);
• Increased liver enzymes in the blood;
• If you experience muscle rupture.
• If you have a lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).

Very rare possible side effects(may affect up to 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes);
• Hepatitis (inflammation of the liver);
• Blood in the urine;
• Nerve damage in the arms and legs (numbness);
• Joint pain;
• Memory loss;
• Gynecomastia (enlargement of the breasts in men).

Side effects with frequencynot known (frequency cannot be estimated based on available
data):

• Diarrhea (loose stools);
• Cough;
• Shortness of breath;
• Edema (swelling);
• Sleep disorders, including difficulty sleeping and nightmares;
• Sexual difficulties;
• Depression; Pag. 7 a 9
• Tendon disorders, sometimes complicated by rupture or tears;
• Persistent 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).

See 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 get any side effects, even 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.

5. How to store ROSUVASTATINA SPECIAL PRODUCT’S LINE

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the box/blister/label after Exp. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Do not dispose of any medicine in waste water 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 ROSUVASTATINA SPECIAL PRODUCT’S LINE contains
The active ingredient is rosuvastatin.
Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin (as rosuvastatin calcium salt).
The other ingredients are:
Tablet core:
Dihydrocalcium phosphate hydrate; Microcrystalline cellulose; Lactose monohydrate; Crospovidone; Magnesium
stearate.
Film coating:

5 mg tablets
Opadry II 32K520157 Yellow: HPMC Hypromellose (E464); Lactose monohydrate; Titanium dioxide (E171);
Triacetin; Yellow iron oxide (E172); Red iron oxide (E172).

10, 20, 40 mg tablets
Opadry II 32K540093 Pink: HPMC Hypromellose (E464); Lactose monohydrate; Titanium dioxide (E171);
Triacetin; Yellow iron oxide (E172); Red iron oxide (E172).

Description of the appearance of ROSUVASTATINA SPECIAL PRODUCT’S LINE and package contents
ROSUVASTATINA SPECIAL PRODUCT’S LINE 5 mg:A film-coated tablet, yellow
in color, round, biconvex with "5" inscribed on one side and "B" on the opposite side.

ROSUVASTATINA SPECIAL PRODUCT’S LINE 10 mg:A film-coated tablet, pink
in color, round, biconvex, with "10" inscribed on one side and "B" on the opposite side.

ROSUVASTATINA SPECIAL PRODUCT’S LINE 20 mg:A film-coated tablet, pink
in color, round, biconvex, with "20" inscribed on one side and "B" on the opposite side.

ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg:A film-coated tablet, pink in color, oval,
biconvex, with "40" inscribed on one side and "B" on the opposite side.
ROSUVASTATINA SPECIAL PRODUCT’S LINE is available in packs of 28 tablets.
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Marketing Authorisation Holder:
Special Product’s Line S.p.A.
Via Alberico II, 35
00193 Rome - Italy

Manufacturer responsible for batch release:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo,1
03012 Anagni (FR) - Italy
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