Patient Information Leaflet: Important Information for the User

ROSETEM 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Rosuvastatin and Ezetimibe
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 others, even if they have the same symptoms as you, because it could 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 ROSETEM is and what it is used for
What you need to know before taking ROSETEM
How to take ROSETEM
Possible side effects
How to store ROSETEM
Contents of the pack and other information

1. What ROSETEM is and what it is used for

ROSETEM contains two different active substances in one tablet. One active substance is rosuvastatin,
which belongs to a group of medicines called "statins", the other is ezetimibe.
ROSETEM tablets are a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances in the blood called triglycerides. In addition, it increases levels of "good" cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: by decreasing the amount absorbed from the digestive tract and by reducing the body's own production of cholesterol.
In most people, high cholesterol levels produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow. Sometimes, this narrowing of blood vessels can block blood flow to the heart or brain, leading to heart attack or stroke. Lowering cholesterol levels may reduce the risk of heart attack, stroke, or other related health problems.
ROSETEM tablets are used for patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe ROSETEM tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
ROSETEM tablets are used if you have:

increased cholesterol levels in the blood (primary hypercholesterolemia)
heart disease, in which case ROSETEM reduces the risk of heart attack, stroke, surgical intervention to improve blood flow to the heart, or hospitalization due to chest pain 1/9

ROSETEM tablets do not help with weight loss.

2. What you should know before taking ROSETEM tablets

Do not take ROSETEM tablets

if you have previously had an allergic reaction to rosuvastatin, ezetimibe, 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 ROSETEM, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking ROSETEM by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
if you have liver disease;
if you have severe kidney impairment;
if you have unexplained, repeated muscle pain or tenderness (myopathy);
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking ROSETEM or other related medicines.

If any of these apply to you (or if you have any doubts), consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ROSETEM if:

you have kidney problems;
you have liver problems;
you have experienced unexplained, repeated muscle pain or tenderness, or have a personal or family history of muscle disorders, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor or pharmacist immediately if you experience unexplained muscle pain or tenderness, 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;
you have an underactive thyroid (hypothyroidism);
you are taking other cholesterol-lowering medicines called fibrates. See “Other medicines and ROSETEM tablets”;
you are taking medicines used to treat HIV infections, e.g. lopinavir/ritonavir and/or atazanavir. See “Other medicines and ROSETEM tablets”;
you are over 70 years of age (your doctor needs to select the appropriate dose for you);
you have severe respiratory failure;
you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to select the appropriate dose 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 ROSETEM may lead to serious muscle problems (rhabdomyolysis);
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 or trigger its onset (see section 4).

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If any of these apply to you (or if you have any doubts): consult your doctor or pharmacist before
starting to take any dose of ROSETEM tablets.
In a small number of people, statins may affect liver function, which can be detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) during treatment with ROSETEM tablets. It is important to attend all scheduled laboratory appointments with your doctor.
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 fat in the blood, are overweight, and have high blood pressure.
If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking ROSETEM tablets.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with ROSETEM.
Stop taking ROSETEM and seek immediate medical attention if you notice any of the symptoms described in section 4.
Children and adolescents
The use of ROSETEM tablets is not recommended in children and adolescents under 18 years of age.
Other medicines and ROSETEM
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 to prevent organ rejection). The effect of rosuvastatin increases when taken together with this medicine. Do not take ROSETEM concomitantly with cyclosporine;
anticoagulants such as warfarin, acenocoumarol, phenindione (their anticoagulant effect and risk of bleeding may increase if taken together with ROSETEM), ticagrelor, or clopidogrel;
other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). Concomitant use increases the effect of rosuvastatin;
colestyramine (a medicine to lower cholesterol levels), as it alters the function of ezetimibe;
antacids containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin blood levels). This effect may be minimized by taking these medicines 2 hours after taking rosuvastatin;
erythromycin (an antibiotic). Concomitant use of this antibiotic reduces the effect of rosuvastatin;
fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart ROSETEM tablets. Taking ROSETEM tablets with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;

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an oral contraceptive (the pill). These increase the absorbed hormone levels from the pill;
hormone replacement therapy (increases hormone levels in the blood);
regorafenib (used to treat tumors);
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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking ROSETEM tablets.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take ROSETEM tablets if you are pregnant, suspect you are pregnant, or are planning a pregnancy. If you become pregnant while taking ROSETEM, stop taking it immediately and inform your doctor. Women must always use contraceptive measures during treatment with ROSETEM tablets.
Breastfeeding
Do not take ROSETEM tablets during breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Driving and using machines
ROSETEM tablets should not affect your ability to drive or operate machinery. However, you should consider that some people may experience dizziness after taking ROSETEM tablets. If you experience dizziness, consult your doctor before driving or using machinery.
ROSETEM contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ROSETEM tablets

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and engage in physical activity while taking ROSETEM tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take ROSETEM tablets once daily.
It can be taken at any time of day, with or without food. Swallow each tablet whole with a glass of water.
Try to take the tablets at approximately the same time each day.
ROSETEM tablets are not suitable for initial therapy. The initiation of treatment or dose adjustment, if necessary, must only be carried out by administering the active substances separately; once the appropriate doses have been established, switching to ROSETEM tablets may be considered.
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Periodic cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains within normal limits.
If you take more ROSETEM tablets than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take ROSETEM tablets
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 ROSETEM tablets
Inform your doctor if you intend to stop taking ROSETEM tablets. If you discontinue treatment with ROSETEM tablets, your cholesterol levels may rise again.
If you have any questions about how to use this medicine, consult 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 the possible side effects. They are usually mild and disappear in a short time.
Stop taking ROSETEM tablets and go to a doctor immediately if you experience any of the following allergic reactions:

swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and swallowing;
lupus-like symptoms (including skin rash, joint disorders and effects on blood cells);
muscle rupture;
flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. 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).

Contact your doctor immediately if you have unusual muscle tenderness or pain lasting longer than expected. These may rarely progress to a fatal muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney dysfunction.
The following terms are used to describe how often the side effects have been reported:

very common (may affect more than 1 in 10 people)
common (may affect up to 1 in 10 people)
uncommon (may affect up to 1 in 100 people)
rare (may affect up to 1 in 1,000 people)
very rare (may affect up to 1 in 10,000 people, including isolated cases).

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Common side effects

headache;
stomach pain;
constipation;
feeling unwell;
muscle pain;
feeling weak;
dizziness;
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;
feeling tired;
diarrhoea;
flatulence (excess gas in the intestine);
increased transaminase levels in laboratory blood tests related to liver function.

Uncommon side effects

skin rash, itching, urticaria;
increase in the amount of protein in the urine – this usually returns to normal without needing to stop rosuvastatin;
cough;
indigestion;
heartburn;
joint pain;
muscle spasms;
neck pain;
decreased appetite;
pain;
chest pain;
hot flushes;
high blood pressure;
tingling sensation;
dry mouth;
stomach inflammation;
back pain;
muscle weakness;
pain in arms and legs;
swelling, especially of hands and feet.

Rare side effects
Pancreatitis, causing severe stomach pain spreading to the back, reduction in platelet count.
Very rare side effects
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), blood in the urine, nerve damage in the arms and legs (such as numbness), memory loss, breast enlargement in men (gynaecomastia).
Not known
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Shortness of breath, oedema (swelling), sleep disorders, including difficulty sleeping and nightmares, sexual problems, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon disorders, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting).
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 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 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 ROSETEM tablets

Keep in the original packaging to protect the medicine from light.
This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What ROSETEM tablets contain
The active substances are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, and 20 mg of rosuvastatin and 10 mg of ezetimibe.
The other components are: monohydrate lactose, microcrystalline cellulose type 101, microcrystalline cellulose type 102, sodium croscarmellose, crospovidone, povidone, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of ROSETEM tablets and package contents
ROSETEM 5 mg/10 mg tablets: white or almost white, round, flat tablet, with "E2" engraved on one side and "2" on the other side. The tablet diameter is 10 mm.
ROSETEM 10 mg/10 mg tablets: white or almost white, oval, biconvex tablet, with "E1" engraved on one side and "1" on the other side. The tablet dimensions are 15 mm x 7 mm.
ROSETEM 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. The tablet diameter is 11 mm.
Pack size: 28 tablets in blisters (PA/AL/PVC//Al), packed in a cardboard box with the package leaflet.
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Not all pack sizes may be marketed.

Marketing Authorization Holder
Scharper S.p.A. - Viale Ortles, 12 – 20139 Milano
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
30012 Anagni (FR)
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95 ‐ 200 Pabianice
Poland
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