Rosuberol

Package leaflet: Information for the user

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

rosuvastatin
Generic medicine
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, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ROSUBEROL is and what it is used for

ROSUBEROL belongs to a group of medicines called "statins".
You have been prescribed ROSUBEROL because:

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

Or

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

Why it is important to continue taking ROSUBEROL
ROSUBEROL 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).

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

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

2. What you should know before taking ROSUBEROL

Do not take ROSUBEROL

• if you have previously had an allergic reaction 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 ROSUBEROL, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with ROSUBEROL 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 the combination medicine sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If any of the above apply to you (or if you have any doubts), you must consult your doctor and inform them.
Additionally, do not take ROSUBEROL 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, or Indian);
• if you are taking other cholesterol-lowering medicines called fibrates.

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

• you have kidney problems;
• you have liver problems;
• 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;
• you regularly consume large amounts of alcohol;
• your thyroid gland is not functioning properly;
• you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; refer to section “Other medicines and ROSUBEROL”;
• you are taking antibiotics containing fusidic acid; refer to section “Other medicines and ROSUBEROL”;
• you are over 70 years of age (your doctor needs to choose the appropriate starting dose for you);
• you have severe respiratory failure;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting dose of ROSUBEROL for you;
• you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and ROSUBEROL can lead to serious muscle problems (rhabdomyolysis); please refer to section “Other medicines and ROSUBEROL”;
• 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);
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking ROSUBEROL or other related medicines.

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

• do not take ROSUBEROL 40 mg (the highest dose) and consult your doctor or pharmacist before starting ROSUBEROL at any dosage.
• Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with ROSUBEROL. Stop using ROSUBEROL and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may have a negative effect on the liver, which can be detected through a simple blood test measuring liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with ROSUBEROL.
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 fats in your blood, are overweight, and have high blood pressure.
Children and adolescents

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

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

• cyclosporine (used, for example, after organ transplantation);
• warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood);
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• remedies for indigestion (used to neutralize stomach acids);
• erythromycin (an antibiotic); fusidic acid (an antibiotic—please read section “Warnings and precautions”);
• 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 it is safe to restart ROSUBEROL. Taking ROSUBEROL with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information about rhabdomyolysis;
• an oral contraceptive (the pill);
• regorafenib (used to treat tumors);
• darolutamide (used to treat tumors);
• capmatinib (used to treat tumors);
• hormone replacement therapy;
• fostamatinib (used to treat low platelet count);
• febuxostat (used to treat and prevent high levels of uric acid in the blood);
• teriflunomide (used to treat multiple sclerosis);
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir,
• glecaprevir, pibrentasvir;
• roxadustat (used to treat anemia in patients with chronic kidney disease);
• tafamidis (used to treat a disease called transthyretin amyloidosis).

The effects of these medicines may be altered by ROSUBEROL, or the effect of ROSUBEROL may be altered by these medicines.
Pregnancy and breastfeeding
Do not take ROSUBEROL if you are pregnant or breastfeeding. If you become pregnant while taking ROSUBEROL, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with ROSUBEROL 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 ROSUBEROL—this medicine does not affect their ability to drive or use machinery. However, some people may experience dizziness during treatment with ROSUBEROL. If you experience dizziness, consult your doctor before driving or operating machinery.
ROSUBEROL 5 mg, 10 mg, 20 mg, and 40 mg contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
ROSUBEROL 40 mg contains sunset yellow (E110) and cochineal red (E124), which may cause allergic reactions.

3. How to take ROSUBEROL

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Use in adults
If you are taking ROSUBEROL for high cholesterol:
Starting dose
Treatment with ROSUBEROL should begin 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;
• whether you have any factors that may make you more sensitive to possible side effects. Check with your doctor or pharmacist which starting dose of ROSUBEROL is most suitable for you. Your doctor may decide to prescribe the lower dose (5 mg) if you:
• are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• are over 70 years old;
• have moderate kidney problems;
• are at risk of muscle pain or cramps (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose, in order 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 finally 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 should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of ROSUBEROL is 40 mg. This dose is administered only to patients with high
cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels have not sufficiently decreased with the 20 mg dose.
If you are taking ROSUBEROL 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 usual starting dose is 5 mg. Your doctor may increase the dose to reach the most appropriate
ROSUBEROL dosage for you. The maximum daily dose of ROSUBEROL is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. The dose should be taken once daily. ROSUBEROL 40 mg tablets must not be used in children.
How to take the tablets
Swallow each tablet whole with a glass of water. ROSUBEROL should be taken once daily. ROSUBEROL 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.
Periodic cholesterol checks
It is important to return to your doctor for regular cholesterol level checks, to ensure that your cholesterol has reached and maintains the appropriate levels. Your doctor may decide to increase your dose until the most suitable amount of ROSUBEROL is reached.
If you take more ROSUBEROL 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 ROSUBEROL.
If you forget to take ROSUBEROL
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking ROSUBEROL
Inform your doctor if you intend to stop taking ROSUBEROL. If you stop taking ROSUBEROL, your cholesterol levels may rise again.
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 experiences them. It is important to be aware of which of these side effects may occur. They are usually mild and disappear within a short time.
Stop taking ROSUBEROL 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 which may cause difficulty swallowing;
• severe itching of the skin (with raised hives);
• lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
• muscle tearing.
• Flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking ROSUBEROL and contact your doctor immediately if you experience unusual
muscle aches or pains lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.
Possible side effects:
Common (may occur in 1 to 100 and 1 to 1000 patients)

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

Uncommon (may occur in 1 to 100 and 1 to 1000 patients)

• rash; itching and other skin reactions;
• increased levels of protein in the urine – these usually return to normal on their own without needing to stop treatment with ROSUBEROL (only for ROSUBEROL 5 mg, 10 mg and 20 mg).

Rare (may occur in 1 to 1000 and 1 to 10,000 patients)

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

Very rare (may occur in fewer 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;
• breast enlargement in men (gynaecomastia).

Not known (cannot be estimated from available data)

• diarrhoea (passing liquid stools);
• Stevens-Johnson syndrome (characterised by blisters on the skin, mouth, eyes and genitals);
• 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;
• persistent muscle weakness;
• myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing);
• ocular myasthenia (a condition causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision, drooping eyelids, difficulty swallowing or laboured breathing.
Reporting of side effects
If you experience any side effects, 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 ROSUBEROL

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the pack and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ROSUBEROL contains

• The active substance is rosuvastatin. ROSUBEROL film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
• The other components are:
  Film-coated tablets 5 mg
  Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
  Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, quinoline yellow (E104).
  Film-coated tablets 10 mg
  Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
  Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, allura red (E129).
  Film-coated tablets 20 mg
  Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
  Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, carmine (E120).
  Film-coated tablets 40 mg
  Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
  Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, sunset yellow (E110), cochineal red (E124).

Description of the appearance of ROSUBEROL and package contents
ROSUBEROL 5 mg tablets are yellowish, film-coated, round tablets, marked with "5" on one side.
ROSUBEROL 10 mg tablets are light pink, film-coated, round tablets, marked with "10" on one side.
ROSUBEROL 20 mg tablets are dark pink, film-coated, round tablets, marked with "20" on one side.
ROSUBEROL 40 mg tablets are red, film-coated, round tablets, marked with "40" on one side.
The tablets are available in PA/Aluminum/PVC-ALU blisters, pack size: 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
PHARMEXTRACTA S.P.A. – Via G. Natta 28, 29010 Pontenure (PC), Italy

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland