ROSUBEROL 5 mg Film-Coated Tablets

Зміст інструкції

1. ROSUBEROL 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is ROSUBEROL and what is it 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. Package Contents and Other Information

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

rosuvastatin
Generic medicine

Read this leaflet carefully before you start 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 ROSUBEROL is and what it is used for
• 2. What you need to know before you take 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 is ROSUBEROL and what is it used for

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

• Your cholesterol level is high. This means that you are at risk of heart attack or stroke. ROSUBEROL is used in adults, adolescents and children aged 6 years and over for the treatment of high cholesterol levels. 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 ROSUBEROL you should continue a diet to reduce your cholesterol levels and continue exercising.

Or

• You have other factors that increase the risk of developing a heart attack, stroke or related health problems. 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 ROSUBEROL
ROSUBEROL 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: the so-called “bad” cholesterol (LDL-C) and the
so-called “good” cholesterol (HDL-C).

• ROSUBEROL can reduce “bad” cholesterol and increase “good” cholesterol.
• It works by blocking 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, because it gives no symptoms.
However, if high cholesterol is not treated, fatty deposits can accumulate in the walls of the
blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, blocking the flow of blood to the heart or brain
and consequently 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 to take ROSUBEROL, even if your cholesterol levels have returned to normal, to
prevent these levels from rising again, causing the formation of fatty deposits.
However, you must stop taking ROSUBEROL on medical advice or if you are pregnant.

2. What you need to know before taking ROSUBEROL

Do not take ROSUBEROL

• if you have previously had an allergic reaction to rosuvastatin or 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 the intake of ROSUBEROL, 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 consisting of 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 you fall into one of the above cases (or have any doubts), you should return to your doctor and inform them.
Also, do not take ROSUBEROL 40 mg (the highest dose):

• if you have moderate kidney problems (ask your doctor for any doubts);
• if your thyroid 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 had muscle problems while taking other medicines to lower cholesterol;
• 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 medicines to lower cholesterol called fibrates.

If you fall into one of the above cases (or have any doubts), you should return to your doctor and inform them.

Warnings and precautions
Consult your doctor or pharmacist before taking ROSUBEROL.

• 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. Immediately inform your doctor if you have 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 regularly consume large amounts of alcohol;
• if your thyroid is not functioning properly;
• if you are taking other medicines to lower cholesterol called fibrates. Read this carefully
• if you are taking medicines used to treat HIV infections, for example ritonavir with lopinavir/ and/or atazanavir, read the section “Other medicines and ROSUBEROL”;
• if you are taking antibiotics containing fusidic acid, read the section “Other medicines and ROSUBEROL”;
• if you are over 70 years of age (the doctor needs to choose the appropriate initial dose for you);
• if you have severe respiratory failure;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). The doctor needs to choose the initial dose of ROSUBEROL suitable for you;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and ROSUBEROL can lead to serious muscle problems (rhabdomyolysis); please read the section “other medicines and ROSUBEROL”
• 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 occur (see section 4).
• if you have ever developed a severe skin rash or peeling skin, blisters and/or mouth ulcers after taking ROSUBEROL or other related medicines;

If you fall into one of the above cases (or are not sure):

• do not take ROSUBEROL 40 mg (the highest dose) and check with your doctor or pharmacist before starting to take ROSUBEROL at any dosage.
• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with 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 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, the
doctor will ask to perform this test (liver function test), before and during treatment with
ROSUBEROL.
During treatment with this medicine, the 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 the blood, if you are overweight and have high blood pressure.

Children and adolescents

• if the patient is under 6 years of age: ROSUBEROL should not be given 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
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:

• 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 acids in the stomach);
• erythromycin (an antibiotic); fusidic acid (an antibiotic - please read the section “Warnings and precautions”).
• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when to safely restart ROSUBEROL. Taking ROSUBEROL with fusidic acid can rarely cause weakness, soreness or muscle pain (rhabdomyolysis). See section 4 for more information regarding 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),
• one 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, you should stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with ROSUBEROL using appropriate
contraceptive measures.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive vehicles and use machines while taking
ROSUBEROL – it has no effect on their ability to drive vehicles and use machines. However, some
people may experience dizziness while taking ROSUBEROL. If you experience dizziness, consult
your doctor before driving vehicles or using machines.

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 him before taking this
medicine.

ROSUBEROL 40 mg contains yellow sunset (E110) and cochineal red (E124)which may cause
allergic reactions.

3. How to take ROSUBEROL

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Use in adults
If you are taking ROSUBEROL for high cholesterol:

Initial dose
Treatment with ROSUBEROL must begin with a dose of 5 mg or 10 mg, even if you previously took 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 ROSUBEROL 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 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 ROSUBEROL is 40 mg. It is administered only to patients with high levels
of cholesterol 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 ROSUBEROL 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 listed above.

Use in children aged between 6 and 17 years
The usual initial dose is 5 mg. The doctor may increase the dose up to the most appropriate dosage of
ROSUBEROL for you. The maximum daily dose of ROSUBEROL is 10 mg for children
aged between 6 and 9 years and 20 mg for children aged between 10 and 17 years. The dose must be
taken once a day. ROSUBEROL 40 mg tablets should not be used in children.

Taking the tablets
Swallow each tablet whole with a glass of water. ROSUBEROL must be taken once a
day. ROSUBEROL 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.

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 having you take the amount of ROSUBEROL most suitable for you.

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, tell the hospital doctor that you are
taking ROSUBEROL.

If you forget to take ROSUBEROL
Do not worry, 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 ROSUBEROL
Tell your doctor if you intend to stop taking ROSUBEROL. If you stop taking ROSUBEROL your cholesterol levels may rise again.
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 everybody gets them.
It is important to be aware of which of these side effects may occur. Usually they are mild and disappear in a short time.

Stop taking ROSUBEROL and seek immediate medical helpif you experience any of the following allergic reactions:

• difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of face, lips, tongue and/or throat that can cause difficulty in swallowing;
• severe itching of the skin (with raised bumps);
• lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
• muscle tearing.
• Reddish, non-raised, target- or circular-shaped spots 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking ROSUBEROL and see your doctor immediately if you have unusual muscle aches or pains,which 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 progressed to a condition leading to muscle damage, potentially fatal, known as rhabdomyolysis.
Possible side effects:

Common (may affect up to 1 in 10 people)

• headache;
• stomach pain;
• constipation;
• feeling unwell;
• muscle pain;
• feeling weak;
• dizziness;
• an increase in the amount of protein in your urine - values usually return to normal on their own without having to stop taking ROSUBEROL (only for ROSUBEROL 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 (may affect up to 1 in 100 people)

• 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 ROSUBEROL (only for ROSUBEROL 5- 10 mg and 20 mg).

Rare (may affect up to 1 in 1,000 people)

• 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 bumps). 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 see your doctor immediately if you have unusual muscle aches or pains that 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 low platelet levels in the blood.
• Lupus-like syndrome (which includes skin rash, joint disorders and effects on blood cells).

Very rare (may affect up to 1 in 10,000 people)

• 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 (gynecomastia).

Not known (frequency cannot be estimated from the available data)

• diarrhoea (loose stools);
• Stevens-Johnson syndrome (which manifests through blisters on 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 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 of side effects
If you get any side effects, even those not listed in this leaflet, please 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 ROSUBEROL

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is rosuvastatin. ROSUBEROL film-coated tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• Other ingredients are: Film-coated tablets 5 mgCore: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate. Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin and quinoline yellow (E104). Film-coated tablets 10 mgCore: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate. Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, allura red (E129) Film-coated tablets 20 mg

Core: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate.
Film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, carmine (E120)

Film-coated tablets 40 mg
Core: microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate.
Film coating: lactose monohydrate, 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 and have a round shape with
" 5" imprinted on one side.
ROSUBEROL 10 mg tablets are light pink, film-coated and have a round shape with
" 10" imprinted on one side.
ROSUBEROL 20 mg tablets are dark pink, film-coated and have a round shape with
" 20" imprinted on one side.
ROSUBEROL 40 mg tablets are red, film-coated and have a round shape with imprinted
" 40" on one side.
The tablets are available in PA/Aluminum/PVC-ALU blisters in packs of 28 tablets.
Not all pack sizes may be marketed.

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

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