Rosuvastatin Adamed Pharma: detailed information

Package leaflet: Information for the user

Rosuvastatina Adamed Pharma 15 mg film-coated tablets, 30 mg film-coated tablets

Rosuvastatin
Please read all of this leaflet carefully before you start 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rosuvastatina Adamed Pharma is and what it is used for

Rosuvastatina Adamed Pharma belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Adamed Pharma because:

Your cholesterol level is high. This means you are at risk of heart attack or stroke. Rosuvastatina Adamed Pharma is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
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 Rosuvastatina Adamed Pharma, you must continue your cholesterol-lowering diet and maintain regular physical activity.

You have other factors that increase your risk 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 keep taking Rosuvastatina Adamed Pharma
Rosuvastatina Adamed Pharma 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).

Rosuvastatina Adamed Pharma 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 "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 not treated, 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 and 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 should continue taking Rosuvastatina Adamed Pharma, 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 Rosuvastatina Adamed Pharma on medical advice or if you become pregnant.

2. What you should know before taking Rosuvastatina Adamed Pharma

Do not take Rosuvastatina Adamed Pharma:

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 Rosuvastatina Adamed Pharma, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatina Adamed Pharma by using appropriate contraceptive measures.
If you have liver disease.
If you have severe kidney problems.
If you have repeated or unexplained muscle spasms or muscle pain.
If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral liver infection called hepatitis C).
If you are taking a medicine called cyclosporine (used, for example, after organ transplantation). If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.

In addition, do not take Rosuvastatina Adamed Pharma 30 mg or rosuvastatin 40 mg (the higher doses):

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 spasms or pain, a personal or family history of muscle disorders, 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 you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina Adamed Pharma if:

You have kidney problems.
You have liver problems.
You have experienced repeated or unexplained muscle spasms or pain, a personal or family history of muscle disorders, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle spasms or pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
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), as statins may sometimes worsen myasthenia gravis or trigger its onset (see section 4).
You have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatina Adamed Pharma or similar medicines.
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 infection, e.g., ritonavir with lopinavir and/or atazanavir; read section “Other medicines and Rosuvastatina Adamed Pharma”.
You are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infection). The combination of fusidic acid and Rosuvastatina Adamed Pharma may lead to serious muscle problems (rhabdomyolysis).
You are over 70 years old (your doctor needs to choose the appropriate starting dose for you).
You have severe respiratory insufficiency.
You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting dose for you.

If you fall into any of the above categories (or are unsure):
Do not take Rosuvastatina Adamed Pharma 30 mg or rosuvastatin 40 mg (the higher doses) and
consult your doctor or pharmacist before starting any dose of Rosuvastatina Adamed Pharma.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin treatment.
Discontinue use of Rosuvastatina Adamed Pharma 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. This can be detected through a simple blood test that measures increased levels of liver enzymes. For this reason, your doctor will ask you to have this test (liver function test) before and during treatment with Rosuvastatina Adamed Pharma.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure.

Children and adolescents
If the patient is under 6 years of age: Rosuvastatina Adamed Pharma must not be administered to children under 6 years of age.
If the patient is under 18 years of age: Rosuvastatina Adamed Pharma 30 mg tablets or rosuvastatin 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosuvastatina Adamed Pharma
Inform 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), blood anticoagulants such as warfarin, acenocoumarol, fluindione (their blood-thinning effect and risk of bleeding may increase if taken together with this medicine), ticagrelor or clopidogrel, 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), fusidic acid (an antibiotic – please read below and section “Warnings and precautions”),
An oral contraceptive (the pill),
Regorafenib (used to treat cancer),
Darolutamide (used to treat cancer),
Capmatinib (used to treat cancer), 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), regorafenib (used to treat cancer), any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, 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 Rosuvastatina Adamed Pharma, or the effect of Rosuvastatina Adamed Pharma may be altered by these medicines.
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 Adamed Pharma. Taking Rosuvastatina Adamed Pharma with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding
Do not take Rosuvastatina Adamed Pharma if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina Adamed Pharma, you must stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatina Adamed Pharma 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 Rosuvastatina Adamed Pharma – it does not affect their ability to drive or use tools or machines.
However, some people may experience dizziness during treatment with Rosuvastatina Adamed Pharma. If you experience dizziness, consult your doctor before driving or using machinery.

Rosuvastatina Adamed Pharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
For the full list of ingredients, see section “Contents of the pack and other information”.

Rosuvastatina Adamed Pharma contains quinoline yellow aluminium lake (E104)
It may cause allergic reactions.

3. How to take Rosuvastatina Adamed Pharma

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Usual dosage in adults
If you are taking Rosuvastatina Adamed Pharma for high cholesterol:
Starting dose
Treatment with Rosuvastatina Adamed Pharma 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 level 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 Rosuvastatina Adamed Pharma is most suitable for you.

Your doctor may decide to prescribe you the lowest 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 aches (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose in order to determine the most appropriate dose of Rosuvastatina Adamed Pharma for you. If you start with a 5 mg dose, your doctor may gradually increase the dose as needed, up to a maximum daily dose of 40 mg. There should be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rosuvastatina Adamed Pharma is 40 mg. This dose is given only to patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels have not decreased sufficiently with a lower dose.
If you are taking Rosuvastatina Adamed Pharma 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 achieve the most appropriate dose of Rosuvastatina Adamed Pharma for you. The maximum daily dose of Rosuvastatina Adamed Pharma 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. Rosuvastatina Adamed Pharma tablets 30 mg or rosuvastatin 40 mg must not be used in children.
Administration of tablets
Swallow each tablet whole with a glass of water.
Take Rosuvastatina Adamed Pharma once daily. It 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.
Periodic cholesterol checks
It is important to return to your doctor periodically to check your cholesterol levels, to ensure that cholesterol has reached and maintains appropriate levels. Your doctor may decide to increase the dose until you are taking the amount of Rosuvastatina Adamed Pharma most suitable for you.
If you take more Rosuvastatina Adamed Pharma 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 Rosuvastatina Adamed Pharma.
If you forget to take Rosuvastatina Adamed Pharma
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 Rosuvastatina Adamed Pharma
Inform your doctor if you intend to stop taking Rosuvastatina Adamed Pharma. If you stop taking Rosuvastatina Adamed Pharma, your cholesterol levels may rise again.
If you have any questions about using this medicine, consult your doctor or pharmacist.
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.
They are usually mild and disappear quickly.
Stop taking Rosuvastatina Adamed Pharma 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 that may cause difficulty swallowing;
severe skin itching (with raised hives);
reddish, non-raised, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe 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).
In addition, stop taking Rosuvastatina Adamed Pharma and contact your doctor immediately:
if you have unusual muscle aches or pains that last 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 disease causing muscle damage, potentially fatal, known as rhabdomyolysis.
If you experience muscle breakdown.
If you develop lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).
Possible common side effects (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 the urine – values usually return to normal on their own without needing to stop taking Rosuvastatina Adamed Pharma (only for Rosuvastatina Adamed Pharma 40 mg);
diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
Possible uncommon side effects (may affect up to 1 in 100 people)
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 needing to stop treatment with Rosuvastatina Adamed Pharma tablets (only for Rosuvastatina Adamed Pharma 5 mg, 10 mg, 15 mg, and 20 mg).
Possible rare side effects (may affect up to 1 in 1,000 people)
severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised hives). If you suspect you are having an allergic reaction, stop taking Rosuvastatina Adamed Pharma and seek immediate medical help;
muscle damage in adults – as a precaution, stop taking Rosuvastatina Adamed Pharma and contact your doctor immediately if you have unusual muscle aches or pains that last longer than expected;
severe stomach pain (inflamed pancreas);
decrease in blood platelets (thrombocytopenia);
increase in liver enzymes in the blood;
bleeding or bruising more easily than normal due to low platelet levels in the blood;
lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).
Possible very rare side effects (may affect up to 1 in 10,000 people)
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, and breast enlargement in men (gynecomastia).
Side effects of unknown frequency may include:
diarrhea (loose stools), cough, shortness of breath, edema (swelling), sleep disorders including insomnia and nightmares, sexual problems, depression, breathing problems including persistent cough and/or shortness of breath or fever, tendon injury, and 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 arm or leg weakness 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, consult 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. Reporting side effects helps provide more information on the safety of this medicine.
How to store Rosuvastatina Adamed Pharma
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and the carton, after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
Contents of the pack and other information
What Rosuvastatina Adamed Pharma contains

The active substance is rosuvastatin. Rosuvastatina Adamed Pharma film-coated tablets contain rosuvastatin calcium salt equivalent to 15 mg or 30 mg of rosuvastatin.
The other components are:

Tablet core
o microcrystalline cellulose, type 102,
o lactose monohydrate,
o crospovidone type A,
o magnesium stearate.
Tablet coating
o lactose monohydrate,
o hypromellose (E464),
o titanium dioxide (E171),
o triacetin (E1518),
o quinoline yellow aluminium lake (E104).
Description of the appearance of Rosuvastatina Adamed Pharma and contents of the pack
Rosuvastatina Adamed Pharma is available in blister packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Rosuvastatin 15 mg film-coated tablets: the tablets are yellowish, round, biconvex, with “15” engraved on one side and “15” on the other side.
Rosuvastatin 30 mg film-coated tablets: the tablets are yellowish, round, biconvex, with “30” engraved on one side.
Marketing authorization holder and manufacturer
Marketing authorization holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milano - Italy
Manufacturer
Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
This medicinal product is authorized in European Economic Area countries
under the following names:
Germany Zahron
Italy Rosuvastatina Adamed Pharma