Package leaflet: Information for the user

Rozetimad 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Rosuvastatin and Ezetimibe
Please read all of 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 pass it on to others, even if their symptoms seem identical to yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rozetimad is and what it is used for

Rozetimad contains two different active substances in one tablet. One active substance is rosuvastatin, belonging to a group of medicines called “statins”, the other is ezetimibe.
Rozetimad tablets is a medicine used to lower total cholesterol levels, “bad” cholesterol (LDL cholesterol), and blood fats called triglycerides.
In addition, it increases levels of “good” cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: by reducing the amount absorbed from the gastrointestinal tract and by decreasing its production in the body.
For most people, high cholesterol levels do not cause any 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 can reduce the risk of heart attack, stroke, or other related health problems.
Rozetimad tablets are used for patients whose cholesterol levels cannot be controlled by a low-cholesterol diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe Rozetimad tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
Rozetimad tablets are used if you have:

increased cholesterol levels in the blood (primary hypercholesterolemia)
heart disease; Rozetimad reduces the risk of heart attack, stroke, surgical procedures to increase blood flow to the heart, or hospitalization due to chest pain.

Rozetimad tablets do not help with weight loss.

2. What you should know before taking Rozetimad tablets

Do not take Rozetimad 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 Rozetimad, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rozetimad 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C);
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 Rozetimad 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 Rozetimad 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 have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, which in some cases may include muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4);
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 Rozetimad tablets”;
you are taking medicines used to treat HIV or hepatitis C infections, e.g. lopinavir/ritonavir and/or atazanavir, or simeprevir – see “Other medicines and Rozetimad tablets”;
you are over 70 years of age (your doctor needs to select the appropriate dosage 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 dosage 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 Rozetimad may lead to serious muscle problems (rhabdomyolysis).

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 Rozetimad tablets.
In a small number of people, statins may affect liver function, which can be detected by a simple blood
test measuring liver enzyme levels.
For this reason, your doctor will request this test (liver function test) during treatment with Rozetimad
tablets. It is important to attend your scheduled laboratory appointments.
During treatment with this medicine, your doctor will closely 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 fats in your blood, are overweight, and have high blood pressure.
If you are hospitalized or receiving treatment for another condition, inform the medical staff that you
are taking Rozetimad tablets.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and
systemic symptoms (DRESS), have been reported during treatment with Rozetimad.
Stop taking Rozetimad and seek immediate medical help if you notice any of the symptoms
described in section 4.
Children and adolescents
The use of Rozetimad tablets is not recommended in children and adolescents under 18 years of age.
Other medicines and Rozetimad
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
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 Rozetimad concomitantly with cyclosporine;
blood anticoagulants such as warfarin, acenocoumarol, fluindione (their blood-thinning effect and risk of bleeding may increase when taken together with this medicine), ticagrelor, or clopidogrel;
other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). The effect of rosuvastatin may be increased when used concomitantly;
colestyramine (a medicine to lower cholesterol levels), as it may interfere with the action of ezetimibe;
antacids containing aluminium and magnesium (used to neutralize stomach acid; these metals may reduce rosuvastatin levels in the blood). This effect may be minimized by taking this type of medicine 2 hours after taking rosuvastatin;
erythromycin (an antibiotic). Concomitant use of this antibiotic may reduce 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 Rozetimad tablets. Taking Rozetimad tablets with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
an oral contraceptive (the pill). These may increase the absorbed hormone levels from the pill;
hormone replacement therapy (increases hormone levels in the blood);
regorafenib (used to treat certain cancers);
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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or receiving treatment for another condition, inform the medical staff that you
are taking Rozetimad tablets.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Rozetimad tablets if you are pregnant, think you may be pregnant, or are planning to
become pregnant. If you become pregnant while taking Rozetimad tablets, stop taking it immediately
and inform your doctor. Women must always use effective contraception during treatment with Rozetimad
tablets.
Breastfeeding
Do not take Rozetimad tablets while breastfeeding, as it is not known whether the medicine is
excreted in breast milk.
Driving and using machines
Rozetimad tablets should not affect your ability to drive or use machines. However, you should consider
that some people may experience dizziness after taking Rozetimad tablets. If you experience dizziness,
consult your doctor before driving or operating machinery.
Rozetimad contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before
taking this medicine.
Rozetimad contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Rozetimad tablets

Take this medicine exactly as your doctor has told you. If you are not sure, ask your
doctor or pharmacist.
You must continue to follow a cholesterol-lowering diet and maintain physical activity while taking
Rozetimad tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take Rozetimad 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.
Rozetimad tablets are not suitable for initial therapy. Treatment initiation or dose adjustment, if needed,
should only be performed by administering the active substances separately; switching to Rozetimad
tablets is possible only after appropriate doses have been established.
Regular cholesterol monitoring
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that
cholesterol has reached and remains within normal target values.
If you take more Rozetimad tablets than you should
Contact your doctor or the nearest hospital emergency department immediately, as you may require
medical attention.
If you forget to take a Rozetimad tablet
Do not panic. Take the next dose at the usual time. Do not take a double dose to make up for the
missed dose.
If you stop taking Rozetimad tablets
Inform your doctor if you intend to stop taking Rozetimad tablets. If you stop taking Rozetimad tablets,
your cholesterol levels may rise again.
If you have any further questions 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 everyone gets them. It is important to be aware of the possible side effects. Usually they are mild and disappear in a short time.
Stop taking Rozetimad 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 breathing and swallowing;
muscle rupture;
lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
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 that lasts longer than expected. These symptoms may rarely develop into 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).

Common side effects

headache;
stomach pain;
constipation;
feeling unwell;
muscle pain;
feeling of weakness;
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 transaminases in laboratory blood tests related to liver function.

Uncommon side effects

rash, itching, hives;
increase in the amount of protein in the urine – this usually returns to normal without stopping 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
Inflammation of the pancreas, 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 arms and legs (such as numbness), memory loss, breast enlargement in men (gynecomastia).
Not known
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 worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or laboured breathing.
Reporting of side effects
If you get 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 the website
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 Rozetimad 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 carton and on the 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 Rozetimad tablets contain
The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe. The tablets contain rosuvastatin calcium 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 Rozetimad tablets and package contents
Rozetimad 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.
Rozetimad 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.
Rozetimad 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. The tablet diameter is 11 mm.
Pack sizes of 28 and 30 tablets in blisters (PA/AL/PVC//Al), placed in cardboard boxes with the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Adamed s.r.l.
Via G. Mazzini, 20
20123 - Milano
Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice,
Poland

Package leaflet: information for the user

Rozetimad 15 mg/10 mg tablets, 30 mg/10 mg tablets, 40 mg/10 mg tablets

Rosuvastatin and Ezetimibe
Please read all of 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 other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

3. What Rozetimad is and what it is used for

Rozetimad contains two different active substances in one tablet. One active substance is
rosuvastatin, belonging to a group of medicines called "statins", the other is ezetimibe.
Rozetimad tablets are a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances in the blood called triglycerides.
Additionally, it increases levels of "good" cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: by reducing the amount absorbed from the digestive tract and by decreasing the body's own production of cholesterol.
For most people, high cholesterol levels do not cause any 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 can reduce the risk of heart attack, stroke, or other related health problems.
Rozetimad tablets are used for patients whose cholesterol levels cannot be controlled by a low-cholesterol diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe Rozetimad tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
Rozetimad tablets are used if you have:

increased cholesterol levels in the blood (primary hypercholesterolaemia)
heart disease; Rozetimad reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalisation due to chest pain.

Rozetimad tablets do not help with weight loss.

4. What you need to know before taking Rozetimad tablets

Do not take Rozetimad 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 Rozetimad, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rozetimad 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral liver infection called hepatitis C);
if you are taking a medicine called cyclosporine (used, for example, after organ transplant);
if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rozetimad or other related medicines.

If any of these apply to you (or if you have any doubts), consult your doctor.
Also, do not take Rozetimad 30 mg/10 mg or 40 mg/10 mg tablets (the higher dose) if:

you have moderate kidney problems (if in doubt, consult your doctor);
you have an underactive thyroid (hypothyroidism);
you have experienced unexplained repeated muscle pain or tenderness, have a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
you regularly consume large amounts of alcohol;
you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
you are taking other cholesterol-lowering medicines called fibrates (see section “Other medicines and Rozetimad”).

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 Rozetimad if:

you have kidney problems;
you have liver problems;
you have experienced unexplained repeated muscle pain or tenderness, have a personal or family history of muscle disorders, or have previously experienced 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 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);
you regularly consume large amounts of alcohol;
your thyroid is not functioning properly (hypothyroidism);
you are taking other cholesterol-lowering medicines called fibrates. See “Other medicines and Rozetimad tablets”;
you are taking medicines used to treat HIV or hepatitis C infections, e.g. lopinavir/ritonavir and/or atazanavir, or simeprevir – see “Other medicines and Rozetimad tablets”;
you are over 70 years of age (your doctor needs to select the appropriate dosage for you);
you have severe respiratory insufficiency;
you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to select the appropriate dosage 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 Rozetimad may lead to serious muscle problems (rhabdomyolysis).

If any of these apply to you (or if you have any doubts):
Do not take Rozetimad 30 mg/10 mg or 40 mg/10 mg tablets (the higher doses) and consult your
doctor or pharmacist before starting any dose of Rozetimad tablets.
In a small number of people, statins may affect liver function, which can be detected by a simple blood test measuring increased levels of liver enzymes.
For this reason, your doctor may request this test (liver function test) during treatment with Rozetimad tablets. It is important to attend all laboratory appointments scheduled by your doctor.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high blood sugar and fat levels, 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 Rozetimad tablets.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Rozetimad.
Stop taking Rozetimad and seek immediate medical attention if you notice any of the symptoms described in section 4.
Children and adolescents
The use of Rozetimad tablets is not recommended in children and adolescents under 18 years of age.
Other medicines and Rozetimad
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 medicines containing any of the following active substances:

cyclosporine (used, for example, after organ transplant to prevent organ rejection). The effect of rosuvastatin increases when used together with this medicine. Do not take Rozetimad together with cyclosporine;
blood anticoagulants, e.g. warfarin, acenocoumarol, fluindione (their blood-thinning effect and risk of bleeding may increase when taken together with this medicine), ticagrelor or clopidogrel;
other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). The effect of rosuvastatin is increased when used concomitantly. Do not take Rozetimad 30 mg/10 mg or 40 mg/10 mg tablets concomitantly with a fibrate;
colestyramine (a medicine to lower cholesterol levels), as it interferes with the action of ezetimibe;
antacids containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin levels in the blood). This effect may be minimized by taking these medicines 2 hours after 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 Rozetimad tablets. Taking Rozetimad tablets with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
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 tumours);
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, sofosbuvir, voxilaprevir, simeprevir, 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 Rozetimad 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 Rozetimad tablets if you are pregnant, suspect you are pregnant, or are planning a pregnancy. If you become pregnant while taking Rozetimad tablets, stop taking it immediately and inform your doctor. Women must always use contraceptive measures during treatment with Rozetimad tablets.
Breastfeeding
Do not take Rozetimad tablets while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Driving and using machines
Rozetimad tablets should not affect your ability to drive or operate machinery. However, you should consider that some people may experience dizziness after taking Rozetimad tablets. If you experience dizziness, consult your doctor before driving or using machinery.
Rozetimad contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Rozetimad contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Rozetimad tablets

Take this medicine exactly as directed by your doctor or pharmacist. 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
Rozetimad tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take Rozetimad 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.
Rozetimad tablets are not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary,
should only be performed by administering the active substances separately; once the appropriate doses have been established,
switching to Rozetimad tablets is possible.
The maximum dose of rosuvastatin is 40 mg. This dose is intended for patients with high cholesterol levels and at high risk of heart attack or stroke,
whose cholesterol levels have not been sufficiently reduced with the 30 mg dose.
Regular cholesterol monitoring
It is important to visit your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains within the target range.
If you take more Rozetimad tablets than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take a Rozetimad tablet
Do not panic. Do not take the missed dose; instead, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Rozetimad tablets
Inform your doctor or pharmacist if you intend to stop taking Rozetimad tablets. If you stop taking Rozetimad tablets, your cholesterol levels may rise again.
If you have any questions about the use of 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.
Stop taking Rozetimad 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 breathing and swallowing;
muscle tear;
lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
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 aches or pains that last 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).

Common side effects

headache;
stomach pain;
constipation;
feeling unwell;
muscle pain;
feeling weak;
dizziness;
increased amount of protein in the urine – values usually return to normal on their own without stopping Rozetimad (only for rosuvastatin 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;
feeling tired;
diarrhoea;
flatulence (excess gas in the intestine);
increased transaminases in laboratory blood tests related to liver function.

Uncommon side effects

rash, itching, urticaria;
increased amount of protein in the urine – which usually returns to normal without stopping rosuvastatin (only for rosuvastatin 10 and 20 mg);
cough;
indigestion;
heartburn;
joint pain;
muscle spasms;
neck pain;
loss of 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
Inflammation of the pancreas, 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 arms and legs (such as numbness), memory loss, breast enlargement in men (gynecomastia).
Not known
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 arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.
Reporting of side effects
If you get 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 Rozetimad tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after the word "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. This medicine does not require any special storage temperature.
Do not dispose of any medicine 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 Rozetimad tablets contain
The active substances are rosuvastatin and ezetimibe.
The tablets contain 15 mg, 30 mg or 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
crospovidone type A, povidone K 30, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of Rozetimad tablets and package contents
Rozetimad 15 mg/10 mg: white or almost white, hexagonal, biconvex, film-coated tablet, imprinted with "E3" on both sides. Approximate tablet dimensions are 9 x 8 mm.
Rozetimad 30 mg/10 mg: white or almost white, rectangular, biconvex, film-coated tablet, imprinted with "X" on both sides. Tablet dimensions are 12 x 6 mm.
Rozetimad 40 mg/10 mg: white or almost white, elliptical, biconvex, film-coated tablet, imprinted with "E6" on both sides. Approximate tablet dimensions are 13 x 6 mm.
Pack size: 30 tablets in PA/AL/PVC-AL blisters, packed in a cardboard box with the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed s.r.l.
Via G. Mazzini 20
20123 Milano
Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice,
Poland