Package leaflet: Information for the user

Rosuvastatina Adamed 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Rosuvastatin (as rosuvastatin calcium)
Generic medicine
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 they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rosuvastatina Adamed belongs to a group of medicines called statins.
You have been prescribed Rosuvastatina Adamed because:
your cholesterol level is high. This means you are at risk of heart attack or stroke.
Rosuvastatina Adamed 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, you must continue a cholesterol-lowering diet and maintain physical activity.
Or
You have other risk factors that increase the 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 Rosuvastatina Adamed
Rosuvastatina Adamed 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 “good” cholesterol (HDL-C).
Rosuvastatina Adamed can reduce “bad” cholesterol and increase “good” cholesterol.
It works by helping to block the body's production of “bad” cholesterol.
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, 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 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 heart attack, stroke, or related health problems is reduced.
You should continue taking Rosuvastatina Adamed 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 on medical advice or if you become pregnant.

2. What you need to know before taking Rosuvastatin Adamed

Do not take Rosuvastatin Adamed
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 Adamed, stop taking it immediately and inform your doctor.
Women must avoid becoming pregnant while taking Rosuvastatin Adamed by using appropriate contraceptive measures.
If you have liver disease.
If you have severe kidney problems.
If you have repeated or unexplained muscle cramps or muscle pain. If you are taking a combination of medicines
containing sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection known as 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 contact your doctor and inform him/her.
In addition, do not take Rosuvastatin Adamed 40 mg (the highest dose):
If you have moderate kidney problems (if in doubt, consult your doctor).
If your thyroid gland is not functioning properly.
If you have repeated or unexplained muscle cramps or muscle pain, 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 you fall into any of the above categories (or have any doubts), you must contact your doctor and inform him/her.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Adamed.

If you have kidney problems.
If you have liver problems. If you have had repeated or unexplained muscle cramps or muscle pain, 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 cramps or muscle pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness. 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 causing weakness of the eye muscles), because statins may sometimes worsen myasthenia or cause its onset (see section 4).
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatin Adamed or related medicines. If you regularly consume large amounts of alcohol. If your thyroid gland is not functioning properly. If you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol. If you are taking medicines used to treat HIV infection, e.g. lopinavir/ritonavir, read section “Other medicines and Rosuvastatin Adamed”. If you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) taken orally or by injection. The combination of fusidic acid and Rosuvastatin Adamed may lead to serious muscle problems (rhabdomyolysis). If you are over 70 years of age (your doctor needs to choose the appropriate starting dose for you). If you have severe respiratory insufficiency. If 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 Rosuvastatin Adamed 40 mg (the highest dose) and consult your doctor or pharmacist
before starting to take Rosuvastatin Adamed at any dosage.
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 Rosuvastatin Adamed 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 by a simple blood test showing 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 Rosuvastatin Adamed.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, if you are overweight, and if you have high blood pressure.
Children and adolescents
If the patient is under 6 years of age: Rosuvastatin Adamed must not be given to children under 6 years of age.
If the patient is under 18 years of age: Rosuvastatin Adamed 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.
Other medicines and Rosuvastatin Adamed
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),
blood anticoagulants such as warfarin, acenocoumarol, or 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 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 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 Rosuvastatin Adamed, or the effect of Rosuvastatin Adamed 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 Rosuvastatin Adamed. Taking Rosuvastatin Adamed with fusidic acid may rarely lead to weakness, tenderness, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
Rosuvastatin Adamed with food
Rosuvastatin Adamed can be taken with or without food.
Pregnancy and breastfeeding
Do not take Rosuvastatin Adamed if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Adamed, you must stop taking it immediately
and inform your doctor. Women must avoid becoming pregnant during treatment with Rosuvastatin Adamed by using appropriate contraceptive measures. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can drive and operate machinery while taking Rosuvastatin Adamed – it does not affect their ability to drive or use tools or machinery.
However, some people may experience dizziness during treatment with Rosuvastatin Adamed. If you experience dizziness, consult your doctor before driving or using machinery.
Rosuvastatin Adamed contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Rosuvastatin Adamed 5 mg contains quinoline yellow aluminium lake (E104)
May cause allergic reactions.
Rosuvastatin Adamed 10 mg contains allura red aluminium lake (E129)
May cause allergic reactions.
Rosuvastatin Adamed 40 mg contains sunset yellow (E110) and carmine red aluminium lake (E124)
May cause allergic reactions.
For the full list of other ingredients, see section “Contents of the pack and other information”.

3. How to take Rosuvastatina Adamed

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Usual dosage in adults
If you are taking Rosuvastatina Adamed for high cholesterol:
Starting dose
Treatment with Rosuvastatina Adamed 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;
the presence of any factors that may make you more sensitive to possible side effects.
Check with your doctor or pharmacist to determine the most appropriate starting dose of Rosuvastatina Adamed 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);
are over 70 years of age;
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 for you. If you start with a 5 mg dose, your doctor may, if necessary, 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, if necessary, decide 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 Rosuvastatina Adamed is 40 mg. This dose is given only to patients with high cholesterol 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 Rosuvastatina Adamed 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 dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the most appropriate dose of Rosuvastatina Adamed for you. The maximum daily dose of Rosuvastatina Adamed is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. The dose should be taken once daily. Rosuvastatina Adamed 40 mg tablets must not be used in children.
Administration of tablets
Swallow each tablet whole with a glass of water.
Rosuvastatina Adamed must be taken once daily
It can be taken at any time of day, with or without food. Try to take the tablet at the same time each day, as this may help you remember.
Regular cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that your cholesterol has reached and remains at the correct levels. Your doctor may decide to increase your dose to achieve the most appropriate amount of Rosuvastatina Adamed for you.
If you take more Rosuvastatina Adamed 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.
If you forget to take Rosuvastatina Adamed
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Rosuvastatina Adamed
Inform your doctor if you intend to stop taking Rosuvastatina Adamed. If you stop taking Rosuvastatina Adamed, your cholesterol levels may rise again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
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 quickly.
Stop taking Rosuvastatina Adamed and seek immediate medical help
if any of the following allergic reactions occur:

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);
Flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers in 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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking Rosuvastatina Adamed 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 in rare cases these have progressed to a condition causing muscle damage, potentially fatal, known as rhabdomyolysis.
If you experience muscle tearing.
If you develop lupus-like syndrome (characterized by skin rash, joint disorders, and effects on blood cells).

Possible common side effects (may affect up to 1 in 10 patients)
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 Rosuvastatina Adamed tablets (only for Rosuvastatina Adamed 40 mg).
Diabetes. This is more likely if you have high levels of sugar and fats in the 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 patients)
Skin rash, itching, and other skin reactions.
An increase in the amount of protein in the urine – values usually return to normal on their own without needing to stop treatment with Rosuvastatina Adamed tablets (only for Rosuvastatina Adamed 5 mg, 10 mg, and 20 mg).
Possible rare side effects (may affect up to 1 in 1,000 patients)
Severe allergic reaction – 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 an allergic reaction, stop taking Rosuvastatina Adamed and seek immediate medical help.
Muscle damage in adults – as a precaution, stop taking Rosuvastatina Adamed and contact your doctor immediately if you experience unusual muscle aches or pains that last longer than expected.
Severe stomach pain (inflamed pancreas).
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 (characterized by skin rash, joint disorders, 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, 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, sometimes complicated by rupture, 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 labored breathing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may 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
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 packaging, following "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 you no longer use. This will help protect the environment.
Contents of the pack and other information
What Rosuvastatina Adamed contains

The active substance is rosuvastatin. Rosuvastatina Adamed film-coated tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
The other components are: Tablet core microcrystalline cellulose type 102, monohydrate lactose, crospovidone type A, magnesium stearate.

Film coating of Rosuvastatina Adamed 5 mg tablets:
monohydrate lactose
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
quinoline yellow aluminum lake (E104)
Film coating of Rosuvastatina Adamed 10 mg tablets:
monohydrate lactose
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
allura red aluminum lake (E129)
Film coating of Rosuvastatina Adamed 20 mg tablets:
monohydrate lactose
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
carmine (E120)
Film coating of Rosuvastatina Adamed 40 mg tablets:
monohydrate lactose
hypromellose (E464)
titanium dioxide (E171)
triacetin (E1518)
sunset yellow (E110)
cochineal red aluminum lake (E124)
Description of the appearance of Rosuvastatina Adamed and contents of the pack
Rosuvastatina Adamed is available in packs containing 28, 56, and 98 tablets.
Not all pack sizes may be marketed.
Rosuvastatina Adamed 5 mg film-coated tablets are yellowish, round, biconvex, with "5" engraved on one side.
Rosuvastatina Adamed 10 mg film-coated tablets are light pink, round, biconvex, with "10" engraved on one side.
Rosuvastatina Adamed 20 mg film-coated tablets are dark pink, round, biconvex, with "20" engraved on one side.
Rosuvastatina Adamed 40 mg film-coated tablets are red, round, biconvex, with "40" 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 the European Economic Area countries under the following names:
Germany Zahron
Italy Rosuvastatina Adamed
Spain Vaxar