Rosuvastatin and ezetimibe Doc Generici

Package leaflet: Information for the patient

ROSUVASTATIN AND EZETIMIBE DOC Generics 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

Read this entire leaflet carefully before using 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, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ROSUVASTATIN AND EZETIMIBE DOC Generics is and what it is used for
2. What you need to know before taking ROSUVASTATIN AND EZETIMIBE DOC Generics
3. How to take ROSUVASTATIN AND EZETIMIBE DOC Generics
4. Possible side effects
5. How to store ROSUVASTATIN AND EZETIMIBE DOC Generics
6. Contents of the pack and other information

1. What ROSUVASTATINA E EZETIMIBE DOC Generics is and what it is used for

ROSUVASTATINA E EZETIMIBE DOC Generics contains two different active substances in one tablet. One of the active substances is rosuvastatin, belonging to the group of medicines known as statins; the other active substance is ezetimibe.
ROSUVASTATINA E EZETIMIBE DOC Generics is a medicine used to lower blood levels of total cholesterol, of so-called "bad" cholesterol (LDL cholesterol), and of other fatty substances called triglycerides. It also increases levels of so-called "good" cholesterol (HDL cholesterol).
This medicine works in two ways: by reducing the amount of cholesterol absorbed in the digestive tract and by reducing the body's own production of cholesterol.
For most people, high cholesterol levels do not affect how they feel, as they cause no symptoms. However, if left untreated, high cholesterol may lead to the buildup of fatty deposits in the walls of blood vessels, causing them to narrow.
Sometimes these narrowed blood vessels can become blocked, interrupting blood flow to the heart and 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 E EZETIMIBE DOC Generics is used in patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. A cholesterol-lowering diet must be maintained throughout treatment with this medicine.
Your doctor may prescribe ROSUVASTATINA E EZETIMIBE DOC Generics if you are already taking both rosuvastatin and ezetimibe at the same dosage.
ROSUVASTATINA E EZETIMIBE DOC Generics is used in the following cases:

• high blood cholesterol levels (primary hypercholesterolemia)
• heart disease – ROSUVASTATINA E EZETIMIBE DOC Generics reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

ROSUVASTATINA E EZETIMIBE DOC Generics does not help with weight loss.

2. What you need to know before taking ROSUVASTATIN AND EZETIMIBE DOC Generics

Do not take ROSUVASTATIN AND EZETIMIBE DOC Generics:

• 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 have recurrent and unexplained muscle pain (myopathy).
• 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 ROSUVASTATIN AND EZETIMIBE DOC Generics, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking ROSUVASTATIN AND EZETIMIBE DOC Generics by using adequate contraceptive measures.
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking ROSUVASTATIN AND EZETIMIBE DOC Generics or other related medicines.
• if you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).

Additionally, do not take ROSUVASTATIN AND EZETIMIBE DOC Generics 40/10 mg (the highest dose):

• if you have moderate kidney problems (if in doubt, consult your doctor).
• if your thyroid gland is not functioning properly (hypothyroidism).
• if you have had recurrent or unexplained muscle pain, a personal or family history of muscle disorders, or have experienced 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 ROSUVASTATIN AND EZETIMIBE DOC Generics").

If any of the above conditions apply to you (or if you have any doubts), contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ROSUVASTATIN AND EZETIMIBE DOC Generics:

• if you have kidney problems.
• if you have liver problems.
• if you have had recurrent or unexplained muscle pain, a personal or family history of muscle disorders, or have previously experienced 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 experience persistent muscle weakness.
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). Your doctor will need to determine the most appropriate dose of ROSUVASTATIN AND EZETIMIBE DOC Generics for you.
• if you are taking medicines used to treat infections, including HIV or hepatitis C, such as lopinavir, ritonavir and/or atazanavir or simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir; see "Other medicines and ROSUVASTATIN AND EZETIMIBE DOC Generics".
• if you have severe respiratory failure.
• if you are taking other medicines called fibrates to lower cholesterol. See "Other medicines and ROSUVASTATIN AND EZETIMIBE DOC Generics".
• if you are scheduled for surgery. You may need to temporarily stop taking ROSUVASTATIN AND EZETIMIBE DOC Generics.
• if you regularly consume large amounts of alcohol.
• if your thyroid gland is not functioning properly (hypothyroidism).
• if you are over 70 years old (as your doctor must choose the most appropriate dose of ROSUVASTATIN AND EZETIMIBE DOC Generics for you).
• if you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and ROSUVASTATIN AND EZETIMIBE DOC Generics can cause serious muscle problems (rhabdomyolysis).
• if you are taking regorafenib (a medicine used to treat cancer).
• if you have or have had myasthenia (a disease causing generalized muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If any of the above conditions apply to you (or if you have any doubts), consult your doctor or pharmacist before starting any dose of ROSUVASTATIN AND EZETIMIBE DOC Generics.
In a small number of people, statins may affect the liver. This can be detected by a simple blood test measuring increased levels of liver enzymes. For this reason, your doctor will regularly perform this blood test (liver function test) during treatment with ROSUVASTATIN AND EZETIMIBE DOC Generics. 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 treatment with ROSUVASTATIN AND EZETIMIBE DOC Generics. Stop using ROSUVASTATIN AND EZETIMIBE DOC Generics and consult a doctor immediately if you notice any of the symptoms described in section 4.
During treatment with this medicine, your doctor will closely monitor you for diabetes or risk factors for developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
Children and adolescents
The use of ROSUVASTATIN AND EZETIMIBE DOC Generics is not recommended in children and adolescents under 18 years of age.
Other medicines and ROSUVASTATIN AND EZETIMIBE DOC Generics
Inform your doctor if you are taking or have recently taken 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 is increased when used together with cyclosporine). Do not take ROSUVASTATIN AND EZETIMIBE DOC Generics while taking cyclosporine.
• Anticoagulants such as warfarin, acenocoumarol, or phenindione (their anticoagulant effect and risk of bleeding may be increased when taken together with ROSUVASTATIN AND EZETIMIBE DOC Generics), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin is increased when used concomitantly.
• Colestyramine (a medicine to lower cholesterol), as it affects the mechanism of action of ezetimibe.
• Antacids containing aluminium and magnesium (used to neutralize stomach acidity; they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin is reduced when taken concomitantly.
• 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 when it is safe to resume ROSUVASTATIN AND EZETIMIBE DOC Generics. Taking ROSUVASTATIN AND EZETIMIBE DOC Generics with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• An oral contraceptive (the pill). Levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased hormone levels in the blood).
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• Capmatinib (used to treat cancer).
• Teriflunomide (used to treat multiple sclerosis).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in the blood).
• 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, simeprevir, ombitasvir, paritaprevir, sofosbuvir, voxilaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Roxadustat (used to treat anaemia in patients with chronic kidney disease).
• Tafamidis (used to treat a disease called transthyretin amyloidosis).

If you are admitted to hospital or receiving treatment for another condition, inform the medical staff that you are taking ROSUVASTATIN AND EZETIMIBE DOC Generics.
ROSUVASTATIN AND EZETIMIBE DOC Generics and alcohol
Do not take ROSUVASTATIN AND EZETIMIBE DOC Generics 40 mg/10 mg (the highest dose) if you regularly consume large amounts of alcohol.
Pregnancy and breastfeeding
Do not take ROSUVASTATIN AND EZETIMIBE DOC Generics if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking ROSUVASTATIN AND EZETIMIBE DOC Generics, stop immediately and inform your doctor. Women must use contraceptive measures during treatment with ROSUVASTATIN AND EZETIMIBE DOC Generics.
Do not take ROSUVASTATIN AND EZETIMIBE DOC Generics if you are breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and using machines
ROSUVASTATIN AND EZETIMIBE DOC Generics should not impair your ability to drive or operate machinery. However, consider that some people have experienced dizziness after taking ROSUVASTATIN AND EZETIMIBE DOC Generics. If you experience dizziness, do not drive or operate machinery.
ROSUVASTATIN AND EZETIMIBE DOC Generics contains lactose
ROSUVASTATIN AND EZETIMIBE DOC Generics tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
ROSUVASTATIN AND EZETIMIBE DOC Generics contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to use ROSUVASTATIN AND EZETIMIBE DOC Generics

Use this medicine exactly as prescribed 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 exercise regularly while taking
ROSUVASTATIN AND EZETIMIBE DOC Generics.
The recommended daily dose for adults is one tablet of the prescribed strength.
Take ROSUVASTATIN AND EZETIMIBE DOC Generics once daily.
You may take it at any time of day, with or without food. Swallow each tablet whole
with water.
Take your medicine at the same time each day.
ROSUVASTATIN AND EZETIMIBE DOC Generics is not intended for initiating treatment.
Treatment initiation or dose adjustment, if necessary, should only be done using the individual active substances. Once appropriate doses have been established, you may switch to treatment with ROSUVASTATIN AND EZETIMIBE DOC Generics at the appropriate strength.
The maximum daily dose of rosuvastatin is 40 mg. This dose is intended only for patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels are not sufficiently reduced with 20 mg.
If your doctor has prescribed ROSUVASTATIN AND EZETIMIBE DOC Generics together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take ROSUVASTATIN AND EZETIMIBE DOC Generics 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 your cholesterol reaches and remains at the correct level.
If you take more ROSUVASTATIN AND EZETIMIBE DOC Generics than you should
Contact your doctor or the nearest hospital emergency department immediately, as you may require medical assistance.
If you forget to take ROSUVASTATIN AND EZETIMIBE DOC Generics
If you forget to take a dose, skip the missed dose and take your next scheduled dose at the regular time. Do not take a double dose to make up for the forgotten dose.
If you stop taking ROSUVASTATIN AND EZETIMIBE DOC Generics
Talk to your doctor if you wish to stop taking ROSUVASTATIN AND EZETIMIBE DOC Generics. Your cholesterol levels may rise again if you stop taking this medicine.
If you have any 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 everybody gets them.
It is important that you are aware of which side effects might occur.
Stop taking ROSUVASTATIN AND EZETIMIBE DOC Generics and seek immediate medical help
if you experience any of the following symptoms:

• any unexplained muscle pain, tenderness or weakness that lasts longer than expected. This is because muscle problems, including muscle breakdown that can lead to kidney damage, can be serious and may become a potentially life-threatening condition (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 swallowing and breathing, and severe itching of the skin (with appearance of lumps). This is rare (may affect up to 1 in 1,000 people).
• flat, red, target-like or circular spots on the trunk, often with central blisters, peeling of the skin, mouth, throat, nose, genital or 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).
• muscle breakdown.
• lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other known side effects
Common side effects (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 your blood, are overweight and have high blood pressure. Your doctor should monitor you during treatment.
• stomach pain
• diarrhoea
• flatulence (excess gas in the digestive tract)
• feeling of tiredness
• increase in certain blood tests related to liver function (transaminases)
• increase in the amount of protein in the urine – values usually return to normal on their own without needing to stop taking ROSUVASTATIN AND EZETIMIBE DOC Generics (only for rosuvastatin 40 mg).

Uncommon side effects (may affect up to 1 in 100 people):

• rash, itching, urticaria
• increase in the amount of protein in the urine may occur –
• values usually return to normal on their own without needing to stop taking ROSUVASTATIN AND EZETIMIBE DOC Generics (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
• 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 arms and legs
• swelling, especially in hands and feet.

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

• inflammation of the pancreas, causing severe stomach pain that may spread to the back
• bleeding or bruising more easily than normal due to low platelet levels in the blood
• lupus-like syndrome (including rash, joint disorders and effects on blood cells)
• muscle breakdown

Very rare side effects (may affect up to 1 in 10,000 patients):

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

Not known (frequency cannot be estimated from available data):

• shortness of breath
• oedema (swelling)
• sleep disorders, including insomnia and nightmares
• sexual difficulties
• depression
• breathing 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)
• myasthenia gravis (a condition causing widespread muscle weakness, including in some cases the muscles used for breathing)
• ocular myasthenia (a condition causing weakness of the eye muscles)
• muscle tenderness
• raised red skin rash, sometimes with target-shaped lesions (erythema multiforme)

Talk to your doctor if you experience weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
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 ROSUVASTATIN AND EZETIMIBE DOC Generics

Keep in the original packaging to protect the medicine from moisture and 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 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 DOC Generics contains
The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
ROSUVASTATINA E EZETIMIBE DOC Generics 5 mg/10 mg:
Each tablet contains 5.20 mg of rosuvastatin calcium (equivalent to 5 mg of rosuvastatin) and 10 mg of ezetimibe.
ROSUVASTATINA E EZETIMIBE DOC Generics 10 mg/10 mg:
Each tablet contains 10.40 mg of rosuvastatin calcium (equivalent to 10 mg of rosuvastatin) and 10 mg of ezetimibe.
ROSUVASTATINA E EZETIMIBE DOC Generics 20 mg/10 mg:
Each tablet contains 20.80 mg of rosuvastatin calcium (equivalent to 20 mg of rosuvastatin) and 10 mg of ezetimibe.
ROSUVASTATINA E EZETIMIBE DOC Generics 40 mg/10 mg:
Each 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).

Film coating:
Opadry Yellow (5 mg/10 mg) containing: Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521), Iron oxide yellow (E172), Talc (E553b), Iron oxide red (E171).
Opadry Beige (10 mg/10 mg) containing: Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521), Iron oxide yellow (E172), Talc (E553b).
Vivacoat Yellow (20 mg/10 mg) containing: Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521), Iron oxide yellow (E172), Talc (E553b).
Opadry White (40 mg/10 mg) containing: Lactose monohydrate, Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521).

Description of the appearance of ROSUVASTATINA E EZETIMIBE DOC Generics and package contents
ROSUVASTATINA E EZETIMIBE DOC Generics 5 mg/10 mg film-coated tablets:
Light yellow, round, biconvex film-coated tablets with a diameter of approximately 10 mm, marked "EL 5" on one side.
ROSUVASTATINA E EZETIMIBE DOC Generics 10 mg/10 mg film-coated tablets:
Beige, round, biconvex film-coated tablets with a diameter of approximately 10 mm, marked "EL 4" on one side.
ROSUVASTATINA E EZETIMIBE DOC Generics 20 mg/10 mg film-coated tablets:
Yellow, round, biconvex film-coated tablets with a diameter of approximately 10 mm, marked "EL 3" on one side.
ROSUVASTATINA E EZETIMIBE DOC Generics 40 mg/10 mg film-coated tablets:
White, round, biconvex film-coated tablets with a diameter of approximately 10 mm, marked "EL 2" on one side.

Pack sizes of 28 and 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40, 20121 Milan
Italy

Manufacturer
ELPEN Pharmaceutical Co. Inc.
Marathonos Avenue 95
Pikermi Attiki 190 09
Greece
Rontis Hellas Medical And Pharmaceutical Product S.A.
Larisa Industrial Area
p.o. box 3012
415 00 Larisa
Greece

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic: ROSUVASTATIN/EZETIMIBE DOC Generics
Italy: ROSUVASTATINA E EZETIMIBE DOC Generics