Rosuvastatin Special Product's Line

Italy
Brand name Rosuvastatin Special Product's Line
Form tablets, film-coated
Active substance / Dosage
ROSUVASTATIN
Prescription type Prescription only
ATC code
C10AA07
Registration number 045265
Manufacturer SPECIAL PRODUCT'S LINE S.P.A.
Rosuvastatin Special Product's Line tablets, film-coated

Table of Contents

Patient Information Leaflet

ROSUVASTATINA SPECIAL PRODUCT’S LINE 5 mg film-coated tablets

ROSUVASTATINA SPECIAL PRODUCT’S LINE 10 mg film-coated tablets
ROSUVASTATINA SPECIAL PRODUCT’S LINE 20 mg film-coated tablets
ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg film-coated tablets
Rosuvastatin
Generic medicine
Please read all of 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 may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to 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 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. Contents of the pack and other information

1. What ROSUVASTATINA SPECIAL PRODUCT’S LINE is and what it is 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 heart attack or stroke. ROSUVASTATINA SPECIAL PRODUCT’S LINE is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
  • You have been prescribed a statin because changes in diet and increased physical activity have not been sufficient to correct your cholesterol levels. While taking ROSUVASTATINA SPECIAL PRODUCT’S LINE, you must continue a cholesterol-lowering diet and maintain regular physical exercise.

Or

  • You have other factors that increase your risk of heart attack, stroke, or related heart conditions.

Heart attack, stroke, and other disorders may be caused by a disease called atherosclerosis.
Atherosclerosis is due to the buildup 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 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 – "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).
  • ROSUVASTATINA SPECIAL PRODUCT’S LINE 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 it from the blood.
  • For most people, high cholesterol does not cause any symptoms. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels, causing them to narrow.
  • Sometimes, this narrowing of blood vessels can block the flow of blood to the heart or brain, resulting in heart attack or stroke. By lowering cholesterol levels, it is possible to reduce the risk of heart attack, stroke, or other related health problems.
  • You must continue taking ROSUVASTATINA SPECIAL PRODUCT’S LINE, even if your cholesterol levels are normal, to prevent them from rising again and causing fatty deposits to form. However, treatment must be stopped if your doctor decides so or if you become pregnant.

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 while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin by using an appropriate contraceptive method.
  • If you have liver disease.
  • If you have severe kidney problems.
  • If you have unexplained, repeated muscle pain or weakness.
  • If you are taking a medicine called cyclosporine (used, for example, after organ transplant).
  • If any of these apply to you (or if you have any doubts), please consult your doctor.
  • If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking ROSUVASTATINA SPECIAL PRODUCT’S LINE.

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

  • If you have moderately severe kidney problems (if in doubt, consult your doctor).
  • If your thyroid gland is not functioning properly.
  • If you have experienced repeated or unexplained muscle pain, or if you have a personal or family history of muscle disorders, or if you 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 medicines called fibrates to lower cholesterol.
  • If any of these apply to you (or if you have any doubts), 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 disorders, or if you previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain, tenderness or weakness, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
  • 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. Please read this leaflet carefully, even if you have previously taken other medicines for high cholesterol levels.
  • If you are taking medicines used to treat HIV infection, such as 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 an oral or injectable medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and ROSUVASTATINA SPECIAL PRODUCT’S LINE may lead to serious muscle problems (rhabdomyolysis) – see section “Other medicines and ROSUVASTATINA SPECIAL PRODUCT’S LINE”.
  • If you are over 70 years old (your doctor must choose the correct starting dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE suitable for you).
  • If you have severe respiratory insufficiency.
  • 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 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), since statins may sometimes worsen myasthenia or cause its onset (see section 4).

Inform your doctor or pharmacist if you develop a persistent cough, shortness of breath or difficulty breathing.
This medicine may cause lung scarring 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. Discontinue use of 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 is under 6 years of age: ROSUVASTATINA SPECIAL PRODUCT’S LINE must not be administered to children under 6 years of age.
  • If the patient is under 18 years of age: the 40 mg tablet of ROSUVASTATINA SPECIAL PRODUCT’S LINE is not suitable for use in children and adolescents under 18 years of age.

If any of these apply to you (or if you have any doubts):
Do not take ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg (the highest dose) and consult your doctor or
pharmacist before starting to take any dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE.
Statins may affect liver function in a small number of people. This is detected by a simple blood test that monitors increases in liver enzyme levels. 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 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 fats in the blood, if you are overweight, or if you have high blood pressure.

Other medicines and ROSUVASTATINA SPECIAL PRODUCT’S LINE
Inform 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 transplant),
  • 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),
  • antacids (used to neutralize stomach acid), erythromycin (an antibiotic),
  • oral contraceptives (the pill),
  • hormone replacement therapy,
  • regorafenib (used to treat cancer),
  • antiviral medicines such as ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. (used to treat HIV or hepatitis C infection – see section “Warnings and precautions”).

These medicines may alter the effect of ROSUVASTATINA SPECIAL PRODUCT’S LINE or the effect of these medicines may be altered by ROSUVASTATINA SPECIAL PRODUCT’S LINE.
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart ROSUVASTATINA SPECIAL PRODUCT’S LINE. Taking ROSUVASTATINA SPECIAL PRODUCT’S LINE with fusidic acid may rarely cause muscle weakness, fatigue or muscle pain (rhabdomyolysis). See further information on 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 while taking 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 an appropriate contraceptive method.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive and use machines while being treated with ROSUVASTATINA SPECIAL PRODUCT’S LINE, as the treatment does not affect their ability to drive or operate machinery. However, some people may experience dizziness while taking ROSUVASTATINA SPECIAL PRODUCT’S LINE. If you feel dizzy, consult your doctor before driving or operating machinery.

ROSUVASTATINA SPECIAL PRODUCT’S LINE contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
For the full list of ingredients, please see section 6 of this leaflet.

3. How to take ROSUVASTATINA SPECIAL PRODUCT’S LINE

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual doses in adults
If you are taking ROSUVASTATINA SPECIAL PRODUCT’S LINE for high cholesterol:
Starting dose
Treatment with ROSUVASTATINA SPECIAL PRODUCT’S LINE should begin with a dose of 5 mg or 10
mg, even if you were previously taking a different statin at a higher dose. The choice of starting dose depends on:

  • Your cholesterol level.
  • Your risk level for heart attack or stroke.
  • Whether you are at increased risk of developing possible side effects.

Please consult your doctor or pharmacist to determine which starting dose of ROSUVASTATINA SPECIAL
PRODUCT’S LINE is most suitable 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).
  • You are over 70 years old.
  • You have moderate kidney problems.
  • You are at risk of muscle pain (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose. This will allow you to take an amount of
ROSUVASTATINA SPECIAL PRODUCT’S LINE appropriate for your needs. 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. This dose is recommended only
for patients with high cholesterol levels and at high risk of heart attacks or strokes, whose cholesterol levels are not sufficiently lowered with a 20 mg dose.
If you are taking ROSUVASTATINA SPECIAL PRODUCT’S LINE to reduce the risk of heart attack,
stroke, or related health problems
The recommended dose is 20 mg daily. However, your doctor may prescribe lower doses if any of the
conditions listed above apply to you.
Usual doses in children and adolescents aged 6–17 years
The usual starting dose is 5 mg. Your doctor may increase the dose to achieve the amount of
ROSUVASTATINA SPECIAL PRODUCT’S LINE needed. 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 daily. ROSUVASTATINA
SPECIAL PRODUCT’S LINE 40 mg tablet must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water.
ROSUVASTATINA SPECIAL PRODUCT’S LINE should be taken once daily. ROSUVASTATINA
SPECIAL PRODUCT’S LINE 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 regularly to monitor your
cholesterol levels and ensure they have been reached and are maintained within normal ranges.
Your doctor may increase your dose of ROSUVASTATINA SPECIAL PRODUCT’S LINE until the appropriate amount for you is achieved.
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, inform 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 usual time. Do not take a double dose to make up for a missed dose.
If you stop taking ROSUVASTATINA SPECIAL PRODUCT’S LINE
Talk to your doctor if you wish to stop taking ROSUVASTATINA SPECIAL PRODUCT’S LINE. Your
cholesterol levels may rise again if you stop taking ROSUVASTATINA SPECIAL PRODUCT’S
LINE.
If you have any questions about the use of 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 that you are aware of these side effects. These are generally mild and disappear after a short period of time. Stop taking ROSUVASTATIN SPECIAL PRODUCT’S LINE 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.
  • Severe skin itching (with raised lumps).

Also, stop taking ROSUVASTATIN SPECIAL PRODUCT’S LINE and speak to your doctor immediately:

  • If you have unusual muscle weakness or pain that persists longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a small number of people have experienced unpleasant muscle effects, rarely progressing to potentially life-threatening muscle damage known as rhabdomyolysis.
  • If you experience muscle tearing.
  • If you develop lupus-like syndrome (including skin rash, joint problems, and effects on blood cells).
  • If you develop flat, red, 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).
  • If you develop widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

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

Possible uncommon side effects (may occur in 1 in 100 to 1 in 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 the need to stop treatment with ROSUVASTATIN SPECIAL PRODUCT’S LINE (only for ROSUVASTATIN SPECIAL PRODUCT’S LINE 5 mg, 10 mg, and 20 mg).

Possible rare 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 or breathing, severe skin itching (with raised hives). If you suspect you are having an allergic reaction, stop taking ROSUVASTATIN SPECIAL PRODUCT’S LINE and seek immediate medical help;
  • Muscle damage in adults – as a precaution, stop taking ROSUVASTATIN SPECIAL PRODUCT’S LINE and contact your doctor immediately if you have unusual muscle cramps or pain that lasts longer than expected;
  • Severe stomach pain (inflamed pancreas);
  • Bruising or bleeding more often or easily than usual, which may be signs of a low platelet count in the blood (thrombocytopenia);
  • Increased liver enzymes in the blood;
  • If you experience muscle tearing;
  • If you develop lupus-like syndrome (including skin rash, joint problems, and effects on blood cells).

Possible very rare side effects (may affect up to 1 in 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;
  • Gynecomastia (breast enlargement in men).

Side effects with unknown frequency (frequency cannot be estimated from available data):

  • Diarrhea (loose stools);
  • Cough;
  • Shortness of breath;
  • Edema (swelling);
  • Sleep disorders, including difficulty sleeping and nightmares;
  • Sexual problems;
  • Depression;
  • Tendon disorders, sometimes complicated by ruptures or tears;
  • 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 shortness of breath.

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ROSUVASTATIN SPECIAL PRODUCT’S LINE

  • 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/label after Exp. The expiry date refers to the last day of that month.
  • Do not store above 30°C.
  • 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 ROSUVASTATINA SPECIAL PRODUCT’S LINE contains
The active substance is rosuvastatin.
Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium).
The other components are:
Tablet core:
Calcium hydrogen phosphate dihydrate; microcrystalline cellulose; lactose monohydrate; crospovidone; magnesium stearate.
Film coating:
Tablets of 5 mg
Opadry II 32K520157 Yellow: hypromellose HPMC (E464); lactose monohydrate; titanium dioxide (E171); triacetin; yellow iron oxide (E172); red iron oxide (E172).
Tablets of 10, 20, 40 mg
Opadry II 32K540093 Pink: hypromellose HPMC (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 yellow, round, biconvex, film-coated tablet, engraved with "5" on one side and "B" on the other side.
ROSUVASTATINA SPECIAL PRODUCT’S LINE 10 mg: A pink, round, biconvex, film-coated tablet, engraved with "10" on one side and "B" on the other side.
ROSUVASTATINA SPECIAL PRODUCT’S LINE 20 mg: A pink, round, biconvex, film-coated tablet, engraved with "20" on one side and "B" on the other side.
ROSUVASTATINA SPECIAL PRODUCT’S LINE 40 mg: A pink, oval, biconvex, film-coated tablet, engraved with "40" on one side and "B" on the other side.
ROSUVASTATINA SPECIAL PRODUCT’S LINE is available in packs of 28 tablets.

Marketing Authorization Holder:
Special Product’s Line S.p.A.
Via Alberico II, 35
00193 Rome - Italy

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