Rosuvastatin msn: detailed information

Package leaflet: Information for the patient

Rosuvastatin MSN, 5 mg, film-coated tablets
Rosuvastatin MSN, 10 mg, film-coated tablets
Rosuvastatin MSN, 20 mg, film-coated tablets
Rosuvastatin MSN, 40 mg, film-coated tablets
Rosuvastatinum
Please 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Rosuvastatin MSN is and what it is used for
What you need to know before taking Rosuvastatin MSN
How to take Rosuvastatin MSN
Possible side effects
How to store Rosuvastatin MSN
Contents of the pack and other information

1. What Rosuvastatin MSN is and what it is used for

Rosuvastatin MSN belongs to a group of medicines called statins.
Rosuvastatin MSN is recommended for use because:

You have high cholesterol levels. This means you are at risk of heart attack (myocardial infarction) or stroke. Rosuvastatin MSN is used in adults, adolescents, and children aged over 6 years to treat high cholesterol levels.
A statin has been recommended because dietary changes and increased physical activity have not been sufficient to achieve normal cholesterol levels. While taking Rosuvastatin MSN, you should continue a cholesterol-lowering diet and engage in regular physical exercise.

You have other risk factors increasing the likelihood of heart attack, stroke, or other similar conditions.

Heart attack, stroke, or other health problems may be caused by a disease called
atherosclerosis. Atherosclerosis results from the buildup of atherosclerotic plaques in the blood
vessels.
Why is it important to take Rosuvastatin MSN
Rosuvastatin MSN is used to achieve normal blood levels of fatty substances called lipids, most commonly cholesterol.
There are different types of cholesterol in the blood, known as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Rosuvastatin MSN can reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
Rosuvastatin MSN works by inhibiting the production of "bad" cholesterol in the body and by helping to remove it from the blood.

In most people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
Sometimes, narrowed blood vessels may become completely blocked, interrupting blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar cholesterol-related conditions can be reduced.
You should continue taking Rosuvastatin MSN even after achieving normal cholesterol levels, because the medicine prevents cholesterol levels from rising again, which could lead to further fatty deposits.
However, you should stop taking the medicine if your doctor advises you to do so, or if you become pregnant.

2. Important information before using Rosuvastatin MSN

When not to use Rosuvastatin MSN:

if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
if the patient is pregnant or breastfeeding. If pregnancy occurs while taking Rosuvastatin MSN, treatment must be stopped immediately and the patient should contact her doctor. Women of childbearing potential taking Rosuvastatin MSN should use effective contraceptive methods.
if the patient has liver disease.
if the patient has severe kidney disease.
if the patient experiences recurrent or unexplained muscle pain.
if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral hepatitis C infection).
if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation).

If any of the above situations apply to the patient (or in case of doubt), the patient should contact their doctor again.
Additionally, do not take Rosuvastatin MSN at the 40 mg dose (the highest dose):

if the patient has moderately severe kidney disease (in case of doubt, contact the doctor),
if the patient has thyroid dysfunction,
if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in relatives, or if muscle problems occurred while previously taking other cholesterol-lowering medicines,
if the patient regularly consumes large amounts of alcohol,
if the patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
if the patient is taking other medicines called fibrates that lower cholesterol levels.

If any of the above situations apply to the patient (or in case of doubt), the patient should contact their doctor again.
Warnings and precautions
Before starting treatment with Rosuvastatin MSN, discuss the following with your doctor or pharmacist:

if the patient has kidney problems.
if the patient has liver problems.
if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in relatives, or if muscle problems occurred while previously taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by malaise or fever, contact the doctor immediately. Also inform the doctor or pharmacist about persistent muscle weakness.
if the patient has ever had a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatin MSN or similar medicines.
if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or lead to the development of myasthenia (see section 4).
if the patient regularly consumes large amounts of alcohol.
if the patient has thyroid dysfunction.
if the patient is taking other medicines called fibrates that lower cholesterol levels. Please read the package leaflet carefully, especially if other cholesterol-lowering medicines have been taken in the past.
if the patient is taking medicines used in HIV infection, e.g. ritonavir with lopinavir and/or atazanavir (see section "Rosuvastatin MSN and other medicines").
if the patient is taking or has taken orally or by injection, within the last 7 days, a medicine called fusidic acid (used for bacterial infections). Taking fusidic acid with Rosuvastatin MSN may lead to serious muscle problems (rhabdomyolysis); see also "Rosuvastatin MSN and other medicines".
patients over 70 years of age (because the doctor will determine the appropriate starting dose of Rosuvastatin MSN for the patient).
patients with severe respiratory insufficiency.
patients of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate starting dose of Rosuvastatin MSN for the patient.

If any of the above situations apply to the patient (or in case of doubt):

Do not take Rosuvastatin MSN at the 40 mg dose (the highest dose) and contact your doctor or pharmacist before taking any dose of Rosuvastatin MSN.

Severe skin reactions have been reported during treatment with Rosuvastatin MSN, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, stop taking Rosuvastatin MSN and contact your doctor immediately.
In a small number of patients, statins may affect liver function. This effect can be detected by a simple blood test measuring liver enzyme activity. Therefore, your doctor will usually recommend blood tests (liver enzyme activity) before starting and during treatment with Rosuvastatin MSN.
While taking this medicine, your doctor will closely monitor patients with diabetes and patients at risk of developing diabetes. Patients at risk of developing diabetes are those with high blood sugar and fat levels, overweight patients, and patients with high blood pressure.
Children and adolescents

Patients under 6 years of age: Rosuvastatin MSN should not be used in children under 6 years of age.
Patients under 18 years of age: Rosuvastatin MSN 40 mg is not suitable for use in children and adolescents under 18 years of age.

Rosuvastatin MSN and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Inform your treating doctor if the patient is taking any of the following medicines:

cyclosporine (used, for example, after organ transplantation),
warfarin, ticagrelor, or clopidogrel (or any other medicine used to thin the blood),
fibrates (such as gemfibrozil, fenofibrate) or other cholesterol-lowering medicines (e.g. ezetimibe),
medicines used for indigestion (used to neutralize stomach acid),
erythromycin (an antibiotic), fusidic acid (an antibiotic - see also "Warnings and precautions" and below),
oral contraceptive (the pill),
regorafenib (used in cancer treatment),
darolutamide (used in cancer treatment),
capmatinib (used in cancer treatment),
hormone replacement therapy,
fostamatinib (used in the treatment of low platelet count),
febuxostat (used in the treatment and prevention of high blood uric acid levels),
teriflunomide (used in the treatment of multiple sclerosis),
any of the following medicines used to treat viral infections, including HIV or hepatitis C virus infection, used alone or in combination (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
roxadustat (used in the treatment of anaemia in patients with chronic kidney disease),
tafamidis (used in the treatment of a disease called transthyretin amyloidosis).

Rosuvastatin MSN may alter the effect of these medicines, or these medicines may alter the effect of Rosuvastatin MSN.
If oral fusidic acid is required to treat a bacterial infection, temporary discontinuation of Rosuvastatin MSN is recommended. Your doctor will inform you when it is safe to restart Rosuvastatin MSN. Taking Rosuvastatin MSN with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
Pregnancy and breastfeeding
Do not take Rosuvastatin MSN during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Rosuvastatin MSN, she should stop taking the medicine immediately and contact her doctor. Women of childbearing potential should use effective contraceptive methods while taking Rosuvastatin MSN.
Consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
For most patients, Rosuvastatin MSN does not affect the ability to drive or operate machinery. However, some patients may experience dizziness while taking Rosuvastatin MSN. If dizziness occurs, contact your doctor before driving or operating machinery.
Rosuvastatin MSN contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should contact their doctor before taking this medicine.
A full list of ingredients is provided in section: "Contents of the pack and other information".

3. How to use Rosuvastatin MSN

This medicine should always be taken exactly as directed by your doctor. In case of doubt, consult your doctor or pharmacist.

Usual doses for adult patients

Use of Rosuvastatin MSN to reduce high cholesterol levels:

Starting dose
Treatment with Rosuvastatin MSN should be initiated at a dose of 5 mg or 10 mg, even if the patient has previously taken other statins at higher doses. The starting dose depends on:

cholesterol levels,
the level of risk for heart attack or stroke,
the presence of any factor that may increase the risk of adverse effects.

Contact your doctor or pharmacist to determine the appropriate starting dose.

Your doctor may prescribe the lowest dose (5 mg) if:

the patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
the patient is over 70 years of age,
the patient has moderately impaired kidney function,
there is a risk of muscle pain or muscle problems (myopathy).

Increasing the dose and maximum daily dose
To achieve the desired cholesterol level, your doctor may decide to gradually increase the dose until the appropriate dose of Rosuvastatin MSN is reached for the individual patient. If treatment is started at 5 mg, your doctor may decide to increase it to 10 mg, then to 20 mg, and subsequently to 40 mg, if necessary.
If treatment is started at 10 mg, your doctor may decide to increase the dose to 20 mg, and if needed, further to 40 mg. There should be a four-week interval between each dose adjustment.

The maximum daily dose of Rosuvastatin MSN is 40 mg. This applies only to patients with high cholesterol levels and a high risk of heart attack or stroke, in whom cholesterol levels are not sufficiently reduced with a 20 mg dose.

Use of Rosuvastatin MSN to reduce the risk of heart attack, stroke, or other related health problems:

The recommended starting dose is 20 mg once daily. However, your doctor may decide to reduce the dose if any of the factors mentioned above are present.

Use in children and adolescents aged 6 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg once daily. Your doctor may gradually increase the dose until the appropriate dose for the individual patient is reached. The maximum daily dose of Rosuvastatin MSN is 10 mg or 20 mg in children and adolescents aged 6 to 17 years, depending on the patient's medical condition. The dose should be taken once daily. Rosuvastatin MSN 40 mg must not be used in children.

How to take the tablets

Swallow the tablet whole with water.

Rosuvastatin MSN should be taken once daily. Rosuvastatin MSN can be taken at any time of day, with or without food.

To help remember to take the medicine, it is advisable to take it at the same time each day.

Regular medical check-ups to monitor cholesterol levels

Regular follow-up visits to monitor cholesterol levels are important.

Your doctor may increase the dose of Rosuvastatin MSN to the dose appropriate for you.

Taking more than the recommended dose of Rosuvastatin MSN

Contact your doctor or the nearest hospital immediately.

If you are admitted to hospital or are being treated for other conditions, inform the medical staff that you are taking Rosuvastatin MSN.

Missed dose of Rosuvastatin MSN

If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

Stopping Rosuvastatin MSN

Before stopping Rosuvastatin MSN, consult your doctor.

Stopping treatment with Rosuvastatin MSN may cause cholesterol levels to rise again.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur.
Adverse reactions are generally mild and short-lived.
If any of the following adverse reactions occur, stop taking
Rosuvastatin MSN and contact your doctor immediately:

Breathing difficulties, 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 lumps),
Flat, round or disc-shaped red patches on the trunk, often with blisters in the centre, peeling of the skin, mouth ulcers, throat, nose, genital organs and inside the eyes. Such 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).

You should also stop taking Rosuvastatin MSN and contact your doctor immediately:

If you experience unusual muscle pain or muscle problems that last longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adults. As with other statins, muscle-related adverse reactions occur in a small number of patients and rarely may develop into potentially life-threatening muscle damage called rhabdomyolysis.
If the patient has experienced muscle rupture.
If the patient develops a lupus-like syndrome (including rash, joint function disorders and effects on blood cells).

Common adverse reactions (may affect from 1 in 10 to 1 in 100 patients):

Headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness.
Increased protein in the urine – usually resolves spontaneously without the need to discontinue Rosuvastatin MSN (only at the 40 mg dose).
Diabetes. The likelihood of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight and has high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon adverse reactions (may affect from 1 in 100 to 1 in 1,000 patients):

Rash, itching or other skin reactions.
Increased protein in the urine – usually resolves spontaneously without the need to discontinue Rosuvastatin MSN (only at doses of 5 mg, 10 mg and 20 mg).

Rare adverse reactions (may affect from 1 in 1,000 to 1 in 10,000 patients):

Severe allergic reaction, including swelling of the face, lips, tongue and (or) throat, which may cause difficulty swallowing and breathing, severe itching of the skin (with lumps). If an allergic reaction occurs, stop taking Rosuvastatin MSN and contact your doctor immediately.
Muscle damage in adults. If unusual muscle pain or muscle problems lasting longer than expected occur, stop taking Rosuvastatin MSN and contact your doctor immediately.
Severe abdominal pain (pancreatitis).
Increased liver enzyme activity in the blood.
Increased tendency to bleed or bruise due to low platelet count.
Lupus-like disease syndrome (including rash, joint function disorders and effects on blood cells).

Very rare adverse reactions (may affect less than 1 in 10,000 patients):

Jaundice (yellowing of the skin and eyes), hepatitis, trace amounts of blood in the urine, damage to nerves in the upper and lower limbs (numbness), joint pain, memory loss, gynaecomastia (enlargement of breasts in men).

Adverse reactions with unknown frequency may include:

Diarrhoea (loose stools), cough, shortness of breath (dyspnoea), swelling (oedema), sleep disturbances including insomnia and nightmares, sexual dysfunction, breathing problems including persistent cough and/or shortness of breath or fever, tendon damage, persistent muscle weakness.
Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
Ocular myasthenia (a disease causing weakness of the eye muscles). Talk to your doctor if the patient experiences weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Rosuvastatin MSN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister
after: EXP. The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Rosuvastatin MSN contains
The active substance is rosuvastatin. One coated tablet contains 5 mg, 10 mg, 20 mg or
40 mg of rosuvastatin ( Rosuvastatinum ) (as rosuvastatin calcium).
The other ingredients are: microcrystalline cellulose (E 460), crospovidone type B, pregelatinized
corn starch, meglumine, mannitol, magnesium stearate.
Tablet coating Opadry II 32K580000 White: hypromellose 15 mPas, lactose monohydrate, titanium
dioxide (E 171), triacetin.

What Rosuvastatin MSN looks like and contents of the pack

Rosuvastatin MSN 5 mg are white or almost white, biconvex, round coated tablets, approximately 7 mm in diameter and 4 mm in thickness, with the imprint “R5” on one side and smooth on the other side.
Rosuvastatin MSN 10 mg are white or almost white, biconvex, round coated tablets, approximately 7 mm in diameter and 4 mm in thickness, with the imprint “R10” on one side and smooth on the other side.
Rosuvastatin MSN 20 mg are white or almost white, biconvex, round coated tablets, approximately 9 mm in diameter and 5 mm in thickness, with the imprint “R20” on one side and smooth on the other side.
Rosuvastatin MSN 40 mg are white or almost white, biconvex, oval coated tablets, approximately 12 mm in length, 7 mm in width and 5 mm in thickness, with the imprint “R” on one side and “40” on the other side.

The tablets are packed in aluminium/aluminium foil blisters placed in a cardboard box,
or in HDPE bottles with a desiccant (1 g), fitted with a PP child-resistant closure with seal, and placed in a cardboard box.
Pack sizes:
Blister packs: 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 or 100 tablets.
HDPE bottles: 30 tablets (for 40 mg strength) or 90 tablets (for 5 mg, 10 mg, 20 mg strengths).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Vivanta Generics s.r.o.
Třtinová 260/1, Čakovice
196 00 Prague 9
Czech Republic
tel.: (+48) 699 711 147

Importer:
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Rosuvastatin MSN 5 mg/10 mg/20 mg/40 mg filmomhulde tabletten
Czech Republic: Corvapro Neo
Slovakia: Provacor
Poland: Rosuvastatin MSN
Romania: Rosuvastatină MSN 5 mg comprimate filmate
Rosuvastatină MSN 10 mg comprimate filmate
Rosuvastatină MSN 20 mg comprimate filmate
Rosuvastatină MSN 40 mg comprimate filmate
Hungary: Rosuvastatin MSN 5 mg/10 mg/20 mg/40 mg