Rosuvastatin and ezetimibe Doc Generici

Patient Information Leaflet

ROSUVASTATIN AND EZETIMIBE DOC 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Please read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• 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 is and what it is used for
2. What you need to know before taking ROSUVASTATIN AND EZETIMIBE DOC
3. How to take ROSUVASTATIN AND EZETIMIBE DOC
4. Possible side effects
5. How to store ROSUVASTATIN AND EZETIMIBE DOC
6. Contents of the pack and other information

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

ROSUVASTATINA E EZETIMIBE DOC 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.
ROSUVASTATINA E EZETIMIBE DOC 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 digestive tract and by decreasing its production by the body itself.
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. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
ROSUVASTATINA E EZETIMIBE DOC is 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 ROSUVASTATINA E EZETIMIBE DOC if you are already taking rosuvastatin and ezetimibe at the same doses.
ROSUVASTATINA E EZETIMIBE DOC is used if you have:

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

ROSUVASTATINA E EZETIMIBE DOC does not help with weight loss.

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

Do not take ROSUVASTATIN AND EZETIMIBE DOC

• if you are allergic 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 ROSUVASTATIN AND EZETIMIBE DOC, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with ROSUVASTATIN AND EZETIMIBE DOC by using appropriate contraceptive measures (see "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 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 ROSUVASTATIN AND EZETIMIBE DOC or other related medicines.

If any of these apply to you (or if you have any doubts), consult your doctor.
Warnings and precautions – Be especially careful with ROSUVASTATIN AND
EZETIMIBE DOC:
Talk to your doctor or pharmacist before taking ROSUVASTATIN AND EZETIMIBE
DOC 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 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 ROSUVASTATIN AND EZETIMIBE DOC";
• you are taking medicines used to treat infections, including HIV or hepatitis C, e.g., lopinavir/ritonavir and/or atazanavir. See "Other medicines and ROSUVASTATIN AND EZETIMIBE DOC";
• you are over 70 years of age (your doctor needs to choose the correct dosage suitable for you);
• you have severe respiratory failure;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the correct dosage suitable 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 ROSUVASTATIN AND EZETIMIBE DOC can 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 ROSUVASTATIN AND EZETIMIBE DOC.
In a small number of people, statins may affect liver function, which can be detected through a simple blood test measuring increased levels of liver enzymes. For this reason, your doctor will ask you to undergo this test (liver function test) during treatment with ROSUVASTATIN AND EZETIMIBE DOC.
It is important to attend your doctor’s appointments for the prescribed laboratory tests.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with ROSUVASTATIN AND EZETIMIBE DOC. Stop taking ROSUVASTATIN AND EZETIMIBE DOC and seek immediate medical attention if you notice any of the symptoms described in section 4.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
If you are hospitalized or undergoing treatment for other medical conditions, inform the medical staff that you are taking ROSUVASTATIN AND EZETIMIBE DOC.
Children and adolescents
The use of ROSUVASTATIN AND EZETIMIBE DOC is not recommended in children and adolescents under 18 years of age.
Other medicines and ROSUVASTATIN AND EZETIMIBE DOC
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 any of the following medicines:

• cyclosporine (used, for example, after organ transplantation to prevent organ rejection). The effect of rosuvastatin increases when used together with this medicine. Do not take ROSUVASTATIN AND EZETIMIBE DOC concomitantly with cyclosporine;
• blood anticoagulants such as warfarin, acenocoumarol, or phenindione (their blood-thinning effect and risk of bleeding may increase when taken together with ROSUVASTATIN AND EZETIMIBE DOC), ticagrelor, or clopidogrel;
• other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g., gemfibrozil or other fibrates). Concomitant use increases the effect of rosuvastatin;
• colestyramine (a medicine to lower cholesterol levels), as it may interfere with ezetimibe’s action;
• antacids or medicines for indigestion containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin blood levels). This effect may be minimized by taking these remedies or medicines 2 hours after taking 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 ROSUVASTATIN AND EZETIMIBE DOC. Your doctor will advise you when it is safe to restart treatment. Taking ROSUVASTATIN AND EZETIMIBE DOC with fusidic acid may, rarely, cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
• oral contraceptives (the "pill"). These may increase hormone levels absorbed from the pill;
• hormone replacement therapy (increases hormone levels in the blood);
• regorafenib (used to treat tumors);
• 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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or undergoing treatment for other medical conditions, inform the medical staff that you are taking ROSUVASTATIN AND EZETIMIBE DOC.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ROSUVASTATIN AND EZETIMIBE DOC if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking ROSUVASTATIN AND EZETIMIBE DOC, stop taking it immediately and inform your doctor. Women must always use effective contraception during treatment with ROSUVASTATIN AND EZETIMIBE DOC.
Breastfeeding
Do not take ROSUVASTATIN AND EZETIMIBE DOC during breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and using machines
ROSUVASTATIN AND EZETIMIBE DOC should not affect your ability to drive or operate machinery. However, you should consider that some people may experience dizziness after taking ROSUVASTATIN AND EZETIMIBE DOC. If you experience dizziness, consult your doctor before driving or using machinery.
ROSUVASTATIN AND EZETIMIBE DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
ROSUVASTATIN AND EZETIMIBE DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take ROSUVASTATIN AND EZETIMIBE DOC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
You must continue to follow a cholesterol-lowering diet and maintain physical activity while taking ROSUVASTATIN AND EZETIMIBE DOC.
The recommended daily dose for adults is one tablet of the specific strength prescribed by your doctor.
Take ROSUVASTATIN AND EZETIMIBE DOC once daily.
The ROSUVASTATIN AND EZETIMIBE DOC tablet can be taken at any time of day, with or without food. Swallow the tablet whole with a glass of water.
Try to take the tablets at approximately the same time each day.
ROSUVASTATIN AND EZETIMIBE DOC is not suitable for initial therapy. Treatment initiation or dose adjustment, if needed, should only be performed by administering the two active substances separately; switching to ROSUVASTATIN AND EZETIMIBE DOC is possible only after appropriate doses have been established.

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 ROSUVASTATIN AND EZETIMIBE DOC than you should
Contact your doctor or go to the nearest hospital emergency department, as you may require medical attention.

If you forget to take ROSUVASTATIN AND EZETIMIBE DOC
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 ROSUVASTATIN AND EZETIMIBE DOC
Inform your doctor if you intend to stop taking ROSUVASTATIN AND EZETIMIBE DOC. If you stop taking ROSUVASTATIN AND EZETIMIBE DOC tablets, your cholesterol levels may rise again.

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 everyone experiences them. It is important to be aware of the possible side effects. They are usually mild and disappear within a short time.

Stop taking ROSUVASTATIN AND EZETIMIBE DOC and seek immediate medical help if you experience any of the following symptoms:

• Allergic reactions: swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and swallowing.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells);
• Muscle breakdown;
• 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 reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Contact your doctor immediately if you have unusual muscle pain or tenderness that lasts longer than expected. These symptoms may rarely progress to a fatal muscle damage known as rhabdomyolysis, which can lead 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 of tiredness;
• Diarrhoea;
• Flatulence (excess gas in the intestine);
• Increase in transaminases during 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 treatment with ROSUVASTATIN AND EZETIMIBE DOC;
• Increases in certain laboratory blood tests related to muscle function (CK);
• 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 of hands and feet.

Rare side effects
Inflammation of the pancreas, causing severe stomach pain radiating to the back, reduction in platelets.

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

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).

Reporting of side effects
If you experience any side effect, 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 following 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 ROSUVASTATIN AND EZETIMIBE DOC

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 packaging and 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 ROSUVASTATINA E EZETIMIBE DOC contains
The active substances are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe.
The tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg, and 20 mg of rosuvastatin and 10 mg of ezetimibe.
The other components are: monohydrate lactose, microcrystalline cellulose type 101, microcrystalline cellulose type 102, sodium croscarmellose type A, crospovidone, povidone K-30, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of ROSUVASTATINA E EZETIMIBE DOC and package contents
ROSUVASTATINA E EZETIMIBE DOC 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.
ROSUVASTATINA E EZETIMIBE DOC 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.
ROSUVASTATINA E EZETIMIBE DOC 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. The tablet diameter is 11 mm.
Pack sizes of 28 or 30 tablets in blisters (PA/Al/PVC-Al), placed in a cardboard box with the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland
or
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy