Patient Information Leaflet: Information for the User

Rosuvastatina e Ezetimibe Pensa 5 mg/10 mg film-coated tablets, 10 mg/10 mg film-coated tablets, 20 mg/10 mg film-coated tablets, 40 mg/10 mg film-coated tablets

rosuvastatin/ezetimibe
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rosuvastatina and Ezetimibe Pensa is and what it is used for

Rosuvastatina and Ezetimibe Pensa contains two different active substances in one tablet. One of the active substances is rosuvastatin, belonging to the group of medicines known as statins, and the other active substance is ezetimibe.
Rosuvastatina and Ezetimibe Pensa is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat-like substances called triglycerides in the blood.
In addition, it also increases levels of "good" cholesterol (HDL cholesterol). This medicine works to reduce cholesterol in two ways: by reducing cholesterol absorbed in the digestive tract and by decreasing the body's own production of cholesterol.
For most people, high cholesterol does not affect how they feel, as it produces no symptoms. However, if left untreated, fatty deposits may build up in the walls of blood vessels, causing them to narrow.
Sometimes, these narrowed blood vessels may become blocked, which can interrupt blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, it is possible to reduce the risk of heart attack, stroke, or related health problems.
Rosuvastatina and Ezetimibe Pensa is used in patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. You must continue your cholesterol-lowering diet while taking this medicine.
Your doctor may prescribe Rosuvastatina and Ezetimibe Pensa if you are already taking both rosuvastatin and ezetimibe at the same dosage.
Rosuvastatina and Ezetimibe Pensa is used in cases where you have:

high levels of cholesterol in the blood (primary hypercholesterolaemia)
heart disease – Rosuvastatina and Ezetimibe Pensa reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalisation due to chest pain.

Rosuvastatina and Ezetimibe Pensa does not help with weight loss.

2. What you should know before taking Rosuvastatina e Ezetimibe Pensa

Do not take Rosuvastatina e Ezetimibe Pensa:

if you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
if you have liver disease
if you have severe kidney problems
if you experience repeated and unexplained muscle pain (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 are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina e Ezetimibe Pensa, stop taking it immediately and contact your doctor. Women must avoid pregnancy while taking Rosuvastatina e Ezetimibe Pensa by using appropriate contraceptive measures
if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatina e Ezetimibe Pensa or other related medicines.

Additionally, do not take Rosuvastatina e Ezetimibe Pensa 40 mg/10 mg (the highest dose):

if you have moderate kidney problems (if in doubt, ask your doctor)
if you have an underactive thyroid gland (hypothyroidism)
if you have experienced repeated or unexplained muscle pain, have a personal or family history of muscle problems, or a previous history of 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, and Indian)
if you are taking other medicines called fibrates to lower cholesterol (see section “Other medicines and Rosuvastatina e Ezetimibe Pensa”).

If any of the above situations apply to you (or if you have any doubts), contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina e Ezetimibe Pensa if:

you have kidney problems.
you have liver problems.
you have experienced repeated or unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.
you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor must choose the appropriate dose of Rosuvastatina e Ezetimibe Pensa for you.
you are taking medicines used to treat infections, including HIV or hepatitis C infection, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir. See section “Other medicines and Rosuvastatina e Ezetimibe Pensa”.
you have severe respiratory insufficiency.
you are taking other medicines called fibrates to lower cholesterol. See section “Other medicines and Rosuvastatina e Ezetimibe Pensa”.
you are scheduled for surgery. You may need to temporarily stop taking Rosuvastatina e Ezetimibe Pensa.
you regularly drink large amounts of alcohol.
you have an underactive thyroid gland (hypothyroidism).
you are over 70 years old (as your doctor must choose the most appropriate dose of Rosuvastatina e Ezetimibe Pensa for you).
you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used for bacterial infections). The combination of fusidic acid and Rosuvastatina e Ezetimibe Pensa can cause serious muscle problems (rhabdomyolysis).
you are taking regorafenib (a medicine used to treat cancer).
you have or have had myasthenia (a disease causing general muscle weakness, sometimes affecting the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may occasionally worsen the condition or trigger the onset of myasthenia (see section 4).

If any of the above conditions apply to you (or if you are in doubt): consult your doctor or pharmacist before starting any dose of Rosuvastatina e Ezetimibe Pensa.
In a small number of people, statins may affect the liver. This is detected through a simple blood test measuring elevated levels of liver enzymes. For this reason, your doctor will regularly perform this blood test (liver function test) during treatment with Rosuvastatina e Ezetimibe Pensa. It is important to attend all scheduled laboratory check-ups.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Rosuvastatina e Ezetimibe Pensa. Discontinue use of Rosuvastatina e Ezetimibe Pensa and seek immediate medical attention if you notice any of the symptoms described in section 4.
While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is particularly high if you have high blood sugar and fat levels, are overweight, or have high blood pressure.
Children and adolescents
The use of Rosuvastatina e Ezetimibe Pensa is not recommended in children and adolescents under 18 years of age.
Other medicines and Rosuvastatina e Ezetimibe Pensa
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform 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 with cyclosporine. Do not take Rosuvastatina e Ezetimibe Pensa while taking cyclosporine.
Anticoagulants such as warfarin, acenocoumarol, or phenindione (their anticoagulant effect and risk of bleeding may increase when taken together with Rosuvastatina e Ezetimibe Pensa), ticagrelor, or clopidogrel.
Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). When used concomitantly, the effect of rosuvastatin increases.
Colestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
Antacids containing aluminium and magnesium (used to neutralize stomach acid; they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after taking rosuvastatin.
Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken together.
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 tell you when it is safe to resume taking Rosuvastatina e Ezetimibe Pensa. Taking Rosuvastatina e Ezetimibe Pensa with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
An oral contraceptive (the pill). Absorbed sex hormone levels from the pill may increase.
Hormone replacement therapy (increased hormone levels in the blood).
Regorafenib (used to treat cancer)
any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section “Warnings and precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, sofosbuvir, voxilaprevir.

If you are hospitalized or receiving treatment for another condition, inform the medical staff that you are taking Rosuvastatina e Ezetimibe Pensa.
Rosuvastatina e Ezetimibe Pensa and alcohol
Do not take Rosuvastatina e Ezetimibe Pensa 40 mg/10 mg (the highest dose) if you regularly consume large amounts of alcohol.
Pregnancy and breastfeeding
Do not take Rosuvastatina e Ezetimibe Pensa if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking Rosuvastatina e Ezetimibe Pensa, stop taking it immediately and inform your doctor. Women must use effective contraception during treatment with Rosuvastatina e Ezetimibe Pensa.
Do not take Rosuvastatina e Ezetimibe Pensa while breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and using machines
Rosuvastatina e Ezetimibe Pensa should not affect your ability to drive or operate machinery. However, keep in mind that some people may experience dizziness after taking Rosuvastatina e Ezetimibe Pensa. If you experience dizziness, do not drive or operate machinery.
Rosuvastatina e Ezetimibe Pensa contains lactose
Rosuvastatina e Ezetimibe Pensa contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Rosuvastatina e Ezetimibe Pensa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially 'sodium-free'.

3. How to take Rosuvastatin and Ezetimibe Pensa

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and exercise regularly while taking Rosuvastatin and Ezetimibe Pensa.
The recommended daily dose for adults is one tablet of the prescribed strength.
Take Rosuvastatin and Ezetimibe Pensa once daily.
You may take it at any time of day, with or without food. Swallow each tablet whole with a glass of water.
Take the tablet at the same time every day.
Rosuvastatin and Ezetimibe Pensa is not intended for initiating treatment. The start of treatment or dose adjustment, if needed, should only be done by administering the active substances separately; once the appropriate dosages have been established, you may switch to the appropriate strength of Rosuvastatin and Ezetimibe Pensa.
If your doctor has prescribed Rosuvastatin and Ezetimibe Pensa together with another lipid-lowering medicine containing the active ingredient cholestyramine or any other medicine containing a bile acid sequestrant, you must take Rosuvastatin and Ezetimibe Pensa at least 2 hours before or 4 hours after taking these medicines.
Regular cholesterol checks
It is important to have your cholesterol levels checked regularly by your doctor to ensure that cholesterol reaches and maintains the correct level.
If you take more Rosuvastatin and Ezetimibe Pensa than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take Rosuvastatin and Ezetimibe Pensa
If you forget to take Rosuvastatin and Ezetimibe Pensa, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Rosuvastatin and Ezetimibe Pensa
Talk to your doctor if you wish to stop taking Rosuvastatin and Ezetimibe Pensa. Your cholesterol levels may rise again if you stop taking Rosuvastatin and Ezetimibe Pensa.
If you have any doubts 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 everyone gets them.
It is important to be aware of the possible side effects.
Stop taking Rosuvastatin and Ezetimibe Pensa and seek immediate medical help
if you experience any of the following symptoms:

if you experience unusual muscle pain, tenderness or weakness that lasts longer than expected,
as muscle problems, including muscle breakdown, can lead to kidney damage, which may be
severe and potentially fatal (rhabdomyolysis). This is rare (may affect up to 1 in
1,000 people).
severe allergic reaction (angioedema). Signs include: swelling of the face, lips, tongue and/or throat, difficulty breathing and swallowing, and severe skin itching (with appearance of lumps). This is rare (may affect up to 1 in 1,000 people).
severe skin ulcers or blisters, affecting the mouth, eyes and genitals. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). Frequency is unknown (cannot be estimated from available data).
widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
muscle breakdown.
if you develop a lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Other known side effects
Common (may affect up to 1 in 10 people):

headache
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 while you are taking this medicine.
stomach discomfort
diarrhoea
flatulence (excess gas in the intestinal tract)
feeling of tiredness
increase in certain liver function blood test values (transaminases)
increased amount of protein in the urine, which usually returns to normal without discontinuing Rosuvastatin and Ezetimibe Pensa (only for rosuvastatin 40 mg).

Uncommon (may affect up to 1 in 100 people)

rash, itching, urticaria
increased amount of protein in the urine, which usually returns to normal without discontinuing Rosuvastatin and Ezetimibe Pensa (only for rosuvastatin 10 mg and 20 mg)
increase in certain blood tests related to muscle function (Creatine Kinase test)
cough
indigestion
heartburn
joint pain
muscle spasms
neck pain
decreased appetite
pain
chest pain
hot flushes
high blood pressure
tingling sensation
dry mouth
inflammation of the stomach
back pain
muscle weakness
pain in arms and legs
swelling, especially in hands and feet.

Rare (may affect up to 1 in 1,000 people)

reduction in blood platelets, which may cause bruising/bleeding
inflammation of the pancreas, causing severe stomach pain that may extend to the back
lupus-like syndrome (including rash, joint disorders and effects on blood cells)
muscle breakdown.

Very rare (may affect up to 1 in 10,000 people)

jaundice (yellowing of the skin and eyes)
inflammation of the liver (hepatitis)
presence of blood in the urine
nerve damage in arms and legs (such as numbness)
memory loss
breast enlargement in men (gynecomastia).

Not known (frequency cannot be estimated from available data)

shortness of breath
oedema (swelling)
sleep disorders, including insomnia and nightmares
sexual problems
depression
respiratory problems including persistent cough and/or shortness of breath or fever
tendon injury
persistent muscle weakness
gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting)
severe myasthenia (a disease causing generalized muscle weakness, in some cases affecting muscles involved in breathing)
ocular myasthenia (a disease causing weakness of eye muscles)
muscle tenderness
raised red rash, sometimes with target-shaped lesions (erythema multiforme).

Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Reporting of side effects
If you experience any side effect, talk to your doctor, pharmacist or nurse. This
includes any possible side effect not listed in this leaflet. 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 Rosuvastatin and Ezetimibe Pensa

Keep in the original packaging to protect the medicine from moisture and light.
This medicine does not require special storage conditions at room 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 blister after EXP.
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 Rosuvastatina e Ezetimibe Pensa contains
The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
Rosuvastatina e Ezetimibe Pensa 5 mg/10 mg:
Each film-coated tablet contains 5.20 mg of rosuvastatin calcium (equivalent to 5 mg of
rosuvastatin) and 10 mg of ezetimibe.
Rosuvastatina e Ezetimibe Pensa 10 mg/10 mg:
Each film-coated tablet contains 10.40 mg of rosuvastatin calcium (equivalent to 10 mg of
rosuvastatin) and 10 mg of ezetimibe.
Rosuvastatina e Ezetimibe Pensa 20 mg/10 mg:
Each film-coated tablet contains 20.80 mg of rosuvastatin calcium (equivalent to 20 mg of
rosuvastatin) and 10 mg of ezetimibe.
Rosuvastatina e Ezetimibe Pensa 40 mg/10 mg:
Each film-coated tablet contains 41.60 mg of rosuvastatin calcium (equivalent to 40 mg of
rosuvastatin) and 10 mg of ezetimibe.

Other components are:
Tablet core (identical for all strengths):
Microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572),
povidone (E1201), sodium croscarmellose (E468), sodium lauryl sulfate (E487), lactose monohydrate,
hypromellose (E464).

Coating:
Opadry Yellow (tablets 5 mg/10 mg) containing: hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), yellow iron oxide (E172), talc (E553b), red iron oxide (E171).
Opadry Beige (tablets 10 mg/10 mg) containing: hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), yellow iron oxide (E172), talc (E553b).
Vivacoat Yellow (tablets 20 mg/10 mg) containing: hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), yellow iron oxide (E172), talc (E553b).
Opadry White (tablets 40 mg/10 mg) containing: lactose monohydrate, hypromellose (E464),
titanium dioxide (E171), macrogol (E1521).

Description of the appearance of Rosuvastatina e Ezetimibe Pensa and contents of the pack
Rosuvastatina e Ezetimibe Pensa 5 mg/10 mg film-coated tablets: light yellow, round, biconvex film-coated tablets approximately 10 mm in diameter, marked "EL 5" on one side.
Rosuvastatina e Ezetimibe Pensa 10 mg/10 mg film-coated tablets: beige, round, biconvex film-coated tablets approximately 10 mm in diameter, marked "EL 4" on one side.
Rosuvastatina e Ezetimibe Pensa 20 mg/10 mg film-coated tablets: yellow, round, biconvex film-coated tablets approximately 10 mm in diameter, marked "EL 3" on one side.
Rosuvastatina e Ezetimibe Pensa 40 mg/10 mg film-coated tablets: white, round, biconvex film-coated tablets approximately 10 mm in diameter, marked "EL 2" on one side.
Pack sizes of 28 and 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturers:
ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95
Pikermi Attiki 19009
Greece
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O Box 3012 Larissa Industrial Area,
41500, Larissa
Greece

This medicinal product is authorised in the European Economic Area member states under the
following names:
Italy: Rosuvastatina e Ezetimibe Pensa
Czech Republic: Rosuvastatin/Ezetimibe Alvion

This patient information leaflet was last revised on <{MM/YYYY}>.

Rosuvastatin and ezetimibe PensA