ROSETEM 5 mg/10 mg Tablets

Зміст інструкції

1. ROSETEM 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets
   1. What is ROSETEM and what is it used for
   2. What you need to know before taking ROSETEM tablets
   3. How to take ROSETEM tablets
   4. Possible side effects
   5. How to store ROSETEM tablets
   6. Contents of the pack and other information

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

Rosuvastatin and Ezetimibe

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 ROSETEM is and what it is used for
• 2. What you need to know before you take ROSETEM
• 3. How to take ROSETEM
• 4. Possible side effects
• 5. How to store ROSETEM
• 6. Contents of the pack and other information

1. What is ROSETEM and what is it used for

ROSETEM contains two different active ingredients in one tablet. One active ingredient is rosuvastatin,
belonging to a group of medicines called “statins”, the other is ezetimibe.
ROSETEM tablets is a medicine used to lower total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fats
in the blood called triglycerides. It also increases levels of “good” cholesterol (HDL cholesterol). This medicine
reduces cholesterol in two ways: it reduces the level absorbed from the digestive tract and decreases its
production by the body itself.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fat deposits
can accumulate in the walls of blood vessels causing them to narrow. Sometimes, this narrowing of the blood
vessels can cause blockage of blood flow to the heart or brain resulting in a heart attack or stroke. By lowering
cholesterol levels, it can reduce the risk of a heart attack, stroke or other health problems related to it.
ROSETEM tablets is used for those patients whose cholesterol levels can no longer be controlled solely through
a low-cholesterol diet. You must continue to follow a diet to reduce cholesterol during therapy with this medicine.
Your doctor may prescribe ROSETEM tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
ROSETEM tablets is used if you have:

• an elevated blood cholesterol level (primary hypercholesterolemia)
• heart disease, ROSETEM reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain 1/9

ROSETEM tablets does not help with weight loss.

2. What you need to 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, using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
• if you have a liver disease;
• if you have severe kidney damage;
• if you have recurrent or unexplained muscle soreness or pain (myopathy);
• if you are taking a medicine called cyclosporine (used for example after organ transplantation);
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking ROSETEM or other related medicines .

If you are in any of these situations (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 had recurrent or unexplained muscle soreness or pain, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Inform your doctor or pharmacist immediately if you have unexplained muscle soreness or pain, 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;
• your thyroid is not functioning properly (hypothyroidism);
• you are taking other medicines to lower cholesterol called fibrates. See “Other medicines and ROSETEM tablets”;
• you are taking medicines used to treat HIV infections, such as lopinavir/ritonavir and/or atazanavir. See “Other medicines and ROSETEM tablets”;
• you are over 70 years of age (your doctor needs to choose the correct dosage suitable for you);
• you have severe respiratory failure;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the correct dosage 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 ROSETEM may lead to serious muscle problems (rhabdomyolysis)
• 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 appear (see section 4).

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If any of these situations apply to you (or if you have any doubts): consult your doctor or pharmacist before
actually starting to take any dose of ROSETEM tablets.
In a small number of people, statins can alter liver function, which can
be identified with a simple test that detects increased levels of liver enzymes in the blood. For
this reason, your doctor will ask you to have this test (liver function test) during
treatment with ROSETEM tablets. It is important to go to your doctor for the prescribed laboratory
tests.
During treatment with this medicine, your 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 your blood, if you are overweight and have high blood pressure.
If you are hospitalized or treated for another 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 in association with treatment with ROSETEM.
Stop using 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
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 to prevent rejection of the transplanted organ). The effect of rosuvastatin is increased when used at the same time with this medicine. Do not take ROSETEM in combination with cyclosporine;
• anticoagulants such as warfarin, acenocoumarol, fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with ROSETEM) ticagrelor or clopidogrel;
• other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels (for example gemfibrozil or other fibrates). During concomitant use, the effect of rosuvastatin is increased;
• cholestyramine (a medicine to lower cholesterol levels), as it alters the functioning of ezetimibe
• remedies for indigestion containing aluminum and magnesium (used to neutralize acids in the stomach; these metals decrease the levels of rosuvastatin in the blood). This effect may be mitigated by administering this type of medicine 2 hours after taking rosuvastatin;
• erythromycin (an antibiotic). Concomitant use of this antibiotic decreases the effect of rosuvastatin;
• fusidic acid. If you need to take oral fusidic acid for the treatment of a bacterial infection, you will need to temporarily interrupt the use of this medicine. Your doctor will tell you when to safely restart ROSETEM tablets. Taking ROSETEM tablets with fusidic acid can rarely cause weakness, soreness or muscle pain (rhabdomyolysis). See section 4 for more information regarding rhabdomyolysis;

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take ROSETEM tabletsif you are pregnant, suspect you are pregnant or are planning a
pregnancy. If you become pregnant while taking ROSETEM, stop taking it immediatelyand
inform your doctor. Women must always use contraceptive measures during treatment with
ROSETEM tablets.

Breastfeeding
Do not take ROSETEM tabletswhile breastfeeding, as it is not known whether the medicine is excreted
in breast milk.

Driving and using machines
ROSETEM tablets should not interfere with your ability to drive or operate machinery. However,
it should be considered that some people may experience dizziness after taking
ROSETEM tablets. If you experience dizziness, consult your doctor before driving vehicles or operating
machinery.
ROSETEM contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take ROSETEM tablets

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
You should continue to follow a low-cholesterol diet and engage in physical activity during
the intake of ROSETEM tablets.
The recommended daily dose for adults is one tablet of the specific dosage.

Take ROSETEM tablets once a day.
It can be taken at any time of the 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 start of treatment or dose adjustment, if necessary, must be carried out only by administering the active substances separately and after
setting the appropriate doses, it is possible to switch to ROSETEM tablets.
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Periodic cholesterol checks
It is important to return to your doctor for periodic cholesterol level checks, to ensure that the cholesterol has reached and maintains normal values.

If you take moreROSETEM tablets than you should
Contact your doctor or the emergency room of the nearest hospital as you may need
medical assistance.

If you forget to take ROSETEM tablets
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 ROSETEM tablets
Inform your doctor if you intend to stop taking ROSETEM tablets. If you stop
taking ROSETEM tablets, your cholesterol levels may increase 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 possible side effects. They are usually mild and
disappear in a short time.

Stop taking ROSETEM tablets and see your doctor immediatelyif you
experience any of the following allergic reactions:

• swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing;
• a collection of symptoms like lupus (which include skin rash, joint disorders and effects on blood cells);
• muscle tearing;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and 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).

Contact your doctor immediately if you have unusual muscle pain or tendernessthat lasts longer
than expected. These can rarely develop into life-threatening muscle damage known as
rhabdomyolysis, which leads to feeling unwell, fever and kidney problems.
The following terms are used to describe how often 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 sugar and fat levels in your blood, if you 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 intestines);
• increased transaminases during laboratory blood tests related to liver function.

Uncommon side effects

• skin rash, itching, hives;
• an increase in the amount of protein in the urine may occur - which usually returns to normal, without having to stop taking rosuvastatin;
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• loss of appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure;
• tingling sensation;
• dry mouth;
• inflammation of the stomach;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.

Rare side effects
Pancreatitis, which causes severe stomach pain that extends to the back, reduced
platelets.

Very rare side effects
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), traces of blood in the
urine, nerve damage in the legs and arms (such as numbness), memory loss,
growth of breast tissue in men (gynecomastia).

Not known
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Shortness of breath, edema (swelling), sleep disorders, including difficulty sleeping and nightmares, sexual difficulties, 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 can cause
stomach pain, nausea, vomiting).
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 effect, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 ROSETEM tablets

Store in the original package to protect the medicine from light.
This medicine does not require any particular 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 package and blister.
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. Contents of the pack and other information

What ROSETEM tablets contain
The active ingredients 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 ingredients are: lactose monohydrate, 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 contents of the pack
ROSETEM 5 mg/10 mg tablets: white or almost white, round, flat tablet, with
E2 imprinted on one side and 2 on the other side. The diameter of the tablet is 10 mm.
ROSETEM 10 mg/10 mg tablets: white or almost white, oval, biconvex tablet, with
E1 imprinted on one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm.
ROSETEM 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. The
diameter of the tablet is 11 mm.
Packs of 28 tablets in blisters (PA/AL/PVC//Al) placed in a cardboard box with the package
leaflet.
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Not all pack sizes may be marketed.

Marketing Authorisation Holder
Scharper S.p.A. - Viale Ortles, 12 – 20139 Milan

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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