ROSUVASTATINA 5 mg/10 mg Tabletki Powlekane

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1. 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
   1. What is Rosuvastatina e Ezetimibe Pensa and what is it used for
   2. What you need to know before taking Rosuvastatina e Ezetimibe Pensa
   3. How to take Rosuvastatina e Ezetimibe Pensa
   4. Possible side effects
   5. How to store Rosuvastatina e Ezetimibe Pensa
   6. Package contents and other information

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

rosuvastatina/ezetimibe
Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Rosuvastatina e Ezetimibe Pensa is and what it is used for
• 2. What you need to know before you use Rosuvastatina e Ezetimibe Pensa
• 3. How to take Rosuvastatina e Ezetimibe Pensa
• 4. Possible side effects
• 5. How to store Rosuvastatina e Ezetimibe Pensa
• 6. Contents of the pack and other information

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

Rosuvastatina e Ezetimibe Pensa contains two different active ingredients in one tablet. One of the
active ingredients is rosuvastatin, belonging to the group of medicines called statins, the other active
ingredient is ezetimibe.
Rosuvastatina e Ezetimibe Pensa is a medicine used to lower levels of total cholesterol, of
"bad" cholesterol (LDL cholesterol) and of fatty substances called triglycerides in the blood.
It also increases levels of "good" cholesterol (HDL cholesterol). This medicine works
by reducing cholesterol in two ways: it reduces the cholesterol absorbed from the digestive tract, as well as
decreasing the production of cholesterol by the body itself.
For most people, high cholesterol does not affect how they feel because
it does not produce any symptoms. However, if left untreated, deposits of fat can accumulate
in the walls of blood vessels, causing them to narrow.
Sometimes, these narrowed blood vessels can become blocked, which can interrupt the flow of blood to the
heart or brain, causing a heart attack or stroke. By reducing cholesterol levels, it is possible to
reduce the risk of having a heart attack, stroke or related health problems.
Rosuvastatina e Ezetimibe Pensa is used in patients whose cholesterol levels cannot be
controlled by a low-cholesterol diet alone. You should continue your low-cholesterol
diet while taking this medicine.
Your doctor may prescribe Rosuvastatina e Ezetimibe Pensa if you are already taking both rosuvastatin
and ezetimibe at the same dosage.
Rosuvastatina e Ezetimibe Pensa is used in cases where you have:

• a high level of cholesterol in the blood (primary hypercholesterolemia)
• heart disease - Rosuvastatina e Ezetimibe Pensa reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Rosuvastatina e Ezetimibe Pensa does not help you lose weight.

2. What you need to 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 medicines sofosbuvir/ velpatasvir / voxilaprevir (used for liver viral infection called hepatitis C)
• if you are taking a medicine called cyclosporine (used for example after an organ transplant)
• if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina e Ezetimibe Pensa, stop taking it immediately and consult your doctor. Women must avoid pregnancy while taking Rosuvastatina e Ezetimibe Pensa using suitable contraceptive measures
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking Rosuvastatina e Ezetimibe Pensa or other related medicines.

Also, 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 had repeated or unexplained muscle pain, a personal or family history of muscle problems or a previous history of muscle problems while taking other medicines to lower cholesterol
• if you regularly consume significant 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 are unsure), 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 had repeated or unexplained muscle pain, a personal or family history of muscle problems or a previous history of muscle problems while taking other medicines to lower cholesterol. Tell your doctor immediately if you have unexplained muscle pain, especially if you don't feel well or have a fever. Also tell your doctor or pharmacist if you have persistent muscle weakness.
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor may need to choose the right dose of Rosuvastatina e Ezetimibe Pensa that is right for you.
• you are taking medicines used to fight infections, including HIV or hepatitis C infections, 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 suffer from severe breathing difficulties.
• you are taking other medicines called fibrates to lower cholesterol. See section “Other medicines and Rosuvastatina e Ezetimibe Pensa”.
• you are going to have surgery. You may need to stop taking Rosuvastatina e Ezetimibe Pensa for a short period.
• you drink regularly large amounts of alcohol.
• you have an underactive thyroid gland (hypothyroidism).
• you are over 70 years old (as your doctor may need to choose the right dose of Rosuvastatina e Ezetimibe Pensa that is most suitable for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic for bacterial infections) by mouth or by injection. 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 suffer from or have suffered from myasthenia (a disease with general muscle weakness that in some cases involves the muscles used during breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles) as statins can sometimes worsen the condition or lead to the onset of myasthenia (see section 4).

If any of the above conditions apply to you (or if you are unsure): consult your doctor or
pharmacist before starting to take any dose of Rosuvastatina e Ezetimibe Pensa.
In a small number of people, statins can cause effects on the liver. This is identified
through a simple test that looks for high levels of liver enzymes in the blood. 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 go to your doctor for the prescribed
laboratory checks.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with
Rosuvastatina e Ezetimibe Pensa. Stop using Rosuvastatina e Ezetimibe Pensa and consult
your doctor immediately if you notice any of the symptoms described in section 4.
While taking this medicine, your doctor will carefully monitor you if you suffer from diabetes or are at
risk of developing diabetes. The risk of developing diabetes is very high if you have high levels of
sugar and fats in your blood, if you are overweight or if you have high blood pressure.

Children and adolescents
The use of Rosuvastatina e Ezetimibe Pensa is not recommended in children and adolescents under the age of
18 years.

Other medicines and Rosuvastatina e Ezetimibe Pensa
Tell your doctor if you are taking or have recently taken any other medicines, including
those without a prescription.
Tell your doctor if you are taking any of the following medicines:

• Cyclosporine (used for example after organ transplants to prevent the transplanted organ from being rejected. The effect of rosuvastatin increases if used together with cyclosporine). Donottake Rosuvastatina e Ezetimibe Pensa while taking cyclosporine.
• Anticoagulants such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken at the same time as Rosuvastatina e Ezetimibe Pensa), ticagrelor or clopidogrel.
• Other medicines to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g. gemfibrozil and other fibrates). During concomitant use, the effect of rosuvastatin increases.
• Cholestyramine (a medicine to lower cholesterol), because it affects how ezetimibe works.
• Heartburn remedies containing aluminum and magnesium (used to neutralize stomach acid; they reduce the plasma level of rosuvastatin). This effect can be mitigated by taking this type of medicine 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with their concomitant use.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it will be safe to resume taking Rosuvastatina e Ezetimibe Pensa. Taking Rosuvastatina e Ezetimibe Pensa with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• An oral contraceptive (the pill). The levels of sex hormones absorbed by the pill increase.
• Hormone replacement therapy (increased levels of hormones 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 admitted to hospital or are being treated for another condition, tell the medical staff that you are taking Rosuvastatina e Ezetimibe Pensa.

Rosuvastatina e Ezetimibe Pensa with 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, if you suspect 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
contraceptive measures 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 interfere with your ability to drive or operate
machinery. However, you should be aware that some people may experience dizziness after
taking Rosuvastatina e Ezetimibe Pensa. If you feel dizzy, 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 intolerance to some sugars, contact him 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 Rosuvastatina e Ezetimibe Pensa

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and exercise while
taking Rosuvastatina e Ezetimibe Pensa.
The recommended daily dose for adults is one tablet of the indicated dosage.

Take Rosuvastatina e Ezetimibe Pensa once a day.
You can take it at any time of the day, with or without food. Swallow each tablet
whole with a glass of water.
Take the tablet every day at the same time.
Rosuvastatina e Ezetimibe Pensa is not suitable for starting treatment. The initiation of treatment or
dose adjustment, if necessary, must be carried out only by administering the active
ingredients separately and, after setting the appropriate dosages, it is possible to switch to Rosuvastatina
and Ezetimibe Pensa of the appropriate concentration.
If your doctor has prescribed Rosuvastatina e Ezetimibe Pensa together with another medicine
to lower cholesterol containing the active ingredient colestyramine or any other medicine
containing a bile acid sequestrant, you must take Rosuvastatina e Ezetimibe Pensa at least
2 hours before or 4 hours after these medicines.

Regular cholesterol checks
It is important to have your cholesterol levels checked regularly by your doctor, to make sure
that your cholesterol reaches and maintains the correct level

If you take more Rosuvastatina e Ezetimibe Pensa than you should
Contact your doctor or the nearest hospital emergency room because you may need
medical assistance.

If you forget to take Rosuvastatina e Ezetimibe Pensa
If you forget to take Rosuvastatina e Ezetimibe Pensa, skip the missed dose and take the next
scheduled dose at the correct time. Do not take a double dose to make up for a missed dose.

If you stop taking Rosuvastatina e Ezetimibe Pensa
Talk to your doctor if you want to stop taking Rosuvastatina e Ezetimibe Pensa. Your
cholesterol levels may increase again if you stop taking Rosuvastatina and
Ezetimibe Pensa.
If you have any further questions on 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 will experience them.
It is important to be aware of possible side effects.

Stop taking Rosuvastatina and Ezetimibe Pensaand 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 breakdown can lead to kidney damage, which can be
serious and can potentially be 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 the appearance of bumps). This is rare (may affect up to 1 in 1,000 people)
• severe skin ulcers or blisters, mouth, eyes and genitals. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). Frequency is not known (cannot be estimated based on available data).
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• muscle breakdown.
• if you have a lupus-like syndrome (including rash, joint disorders 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 weak
• dizziness
• diabetes. This is more likely if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• stomach pain
• diarrhoea
• flatulence (excess gas in the intestinal tract)
• feeling tired
• increased levels of some laboratory values from blood tests to assess liver function (transaminases)
• an increase in the amount of protein in the urine, which usually returns to normal without having to stop taking Rosuvastatina and Ezetimibe Pensa (only for rosuvastatin 40 mg).

Uncommon (may affect up to 1 in 100 people)

• skin rash, itching, hives
• an increase in the amount of protein in the urine, which usually returns to normal without having to stop taking Rosuvastatina and Ezetimibe Pensa (only rosuvastatin 10 mg and 20 mg)
• increased levels of some blood tests related to muscle function (Creatine Kinase test)
• cough
• indigestion
• heartburn
• joint pain
• muscle spasms
• neck pain
• loss of appetite
• pain
• chest pain
• hot flushes
• high blood pressure
• feeling of pins and needles
• dry mouth
• inflammation of the stomach
• back pain
• muscle weakness
• pain in the arms and legs
• swelling, especially in the hands and feet.

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

• reduced platelets in the blood, which may cause bruising/bleeding
• inflammation of the pancreas, which causes severe stomach pain that can spread 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)
• traces of blood in the urine
• nerve damage in the legs and arms (such as numbness)
• memory loss
• breast enlargement in men (gynecomastia).

Not known (frequency cannot be estimated based on available data)

• shortness of breath
• edema (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 can cause stomach pain, nausea, vomiting)
• myasthenia gravis (a disease that causes generalized muscle weakness, sometimes even of the muscles involved in breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)
• muscle tenderness
• Red, raised skin rash, sometimes with target-like lesions (erythema multiforme).

See a 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, pharmacist or nurse. This includes any possible 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 Rosuvastatina e Ezetimibe Pensa

Store in the original package 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 which is stated on the box and blister after EXP.
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. Package contents and other information

What Rosuvastatina e Ezetimibe Pensa contains
The active ingredients 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 ingredients are:

Tablet core (same 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 (5 mg/10 mg tablets) containing: Hypromellose (E464), Titanium dioxide
(E171), Macrogol (E1521), Yellow iron oxide (E172), Talc (E553b), Red iron oxide
(E171).
Opadry Beige (10 mg/10 mg tablets) containing: Hypromellose (E464), Titanium dioxide
(E171), Macrogol (E1521), Yellow iron oxide (E172), Talc (E553b).
Vivacoat Yellow (20 mg/10 mg tablets) containing: Hypromellose (E464), Titanium dioxide
(E171), Macrogol (E1521), Yellow iron oxide (E172), Talc (E553b).
Opadry white (40 mg/10 mg tablets) containing: Lactose monohydrate, Hypromellose (E464),
Titanium dioxide (E171), Macrogol (E1521).

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

Marketing authorization holder and manufacturer
Marketing authorization 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 Member States of the European Economic Area with the
following denominations:
Italy: Rosuvastatina e Ezetimibe Pensa
Czech Republic: Rosuvastatin/Ezetimibe Alvion