Aurozeb

Patient Information Leaflet: Information for the User

Aurozeb 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg film-coated tablets

Rosuvastatin and Ezetimibe
Please read this 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.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Aurozeb is and what it is used for

Aurozeb contains two different active substances in a single film-coated tablet. One of the active substances is
rosuvastatin calcium, belonging to the group of medicines known as statins; the other active substance is
ezetimibe.
Aurozeb is a medicine used to reduce levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fat substances in the blood called triglycerides. In addition, it increases levels of “good” cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: by decreasing cholesterol absorbed from the digestive tract and cholesterol produced by the body.
In most people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if left untreated, fatty deposits can accumulate 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, it is possible to reduce the risk of heart attack, stroke, or other health problems related to high cholesterol.
Aurozeb is used for patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. You should continue to follow a cholesterol-lowering diet during treatment with this medicine.
Your doctor may prescribe Aurozeb to you if you are already taking rosuvastatin and ezetimibe at the same doses.
Aurozeb is used if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia)

Aurozeb does not help with weight loss.

2. What you need to know before taking Aurozeb

Do not take Aurozeb if:

• • you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
• • you have liver disease.
• • you have severe kidney impairment.
• • you have unexplained, repeated muscle pain or tenderness (myopathy).
• • you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• • you are pregnant or breastfeeding. If you become pregnant while taking Aurozeb, stop treatment immediately and inform your doctor. Women must avoid pregnancy while taking Aurozeb by using appropriate contraceptive measures. In addition, do not take rosuvastatin 40 mg (the highest dose) if:
• • you have moderate kidney problems (if in doubt, consult your doctor).
• • your thyroid gland is not working properly (hypothyroidism).
• • you regularly drink large amounts of alcohol.
• • you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• • you are taking other medicines called fibrates to lower cholesterol levels (see section “Other medicines and Aurozeb”). If you fall into any of these categories (or have any doubts), consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aurozeb 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 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 are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must choose the appropriate dose of Aurozeb for you.
• • you are taking medicines used to treat infections, including HIV or hepatitis C infections, such as lopinavir/ritonavir and/or atazanavir or simeprevir; see “Other medicines and Aurozeb”.
• • you have severe respiratory insufficiency.
• • you are taking other cholesterol-lowering medicines called fibrates. See “Other medicines and Aurozeb”.
• • you regularly drink large amounts of alcohol.
• • your thyroid gland is not functioning properly (hypothyroidism).
• • you are over 70 years old (as your doctor must choose the appropriate dose of Aurozeb for you).
• • 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 Aurozeb may lead to serious muscle problems (rhabdomyolysis). If any of these situations apply to you (or if you have any doubts), consult your doctor or pharmacist before starting any dose of Aurozeb.

In a small number of people, statins may affect liver function. This effect can be detected by a simple blood test that shows increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) during treatment with Aurozeb. It is important to attend all laboratory appointments scheduled by your doctor.

Your doctor will closely monitor you during treatment with this medicine if you have diabetes or are at risk of developing it. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Children and adolescents
The use of Aurozeb is not recommended in children and adolescents under 18 years of age.

Other medicines and Aurozeb
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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 Aurozeb concomitantly with cyclosporine.
• • Anticoagulants such as warfarin, acenocoumarol, or fluindione (their anticoagulant effect and risk of bleeding may increase if taken together with Aurozeb), or clopidogrel.
• • Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). When used together, the effect of rosuvastatin increases.
• • Colestipol (a medicine to lower cholesterol levels), as it alters the way ezetimibe works.
• • Antiviral drugs such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C). See section “Warnings and precautions”.
• • Antacids containing aluminium and magnesium (used to neutralize stomach acid; they reduce rosuvastatin plasma levels). This effect may be minimized if these medicines are taken 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 tell you when it is safe to restart Aurozeb. Taking Aurozeb with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information about rhabdomyolysis.
• • An oral contraceptive (the pill). Increases the levels of sex hormones absorbed from the pill.
• • Hormone replacement therapy (higher hormone levels in the blood).
• • Regorafenib (used to treat tumours).
• • Simeprevir (used to treat chronic hepatitis C infection).

If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking Aurozeb.

Aurozeb and alcohol
Do not take Aurozeb 40 mg/10 mg (the highest dose) if you regularly drink large amounts of alcohol.

Pregnancy and breastfeeding
Do not take Aurozeb if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking Aurozeb, stop treatment immediately and inform your doctor. Women must use effective contraception during treatment with Aurozeb.
Do not take Aurozeb while breastfeeding, as it is not known whether the medicine is excreted in breast milk.

Driving and using machines
Aurozeb should not affect your ability to drive or operate machinery.
However, you should be aware that some people may experience dizziness after taking Aurozeb. If you experience dizziness, consult your doctor before driving or operating machinery.

Aurozeb contains lactose
Aurozeb 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.

Aurozeb contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Aurozeb

Use this medicine exactly as instructed 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 Aurozeb.
The recommended daily dose for adults is one tablet of the specific strength.
Take Aurozeb once daily.
It can be taken at any time of day, with or without food. Swallow the tablet whole with a glass of water.
Take the medicine at the same time each day.
Aurozeb is not suitable for initial therapy. The initiation of treatment or dose adjustment, if necessary, must be performed only with the individual components; once the appropriate dose has been established, switching to the corresponding strength of Aurozeb is possible.
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 lowered with 20 mg.
Regular cholesterol monitoring
It is important to have your cholesterol levels checked regularly by your doctor to ensure that cholesterol has reached and remains within the target range.
If you take more Aurozeb than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical assistance.
If you forget to take Aurozeb
Do not panic. Skip the missed dose and 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 Aurozeb
Inform your doctor if you intend to discontinue taking Aurozeb. Your cholesterol levels may rise again if you stop taking Aurozeb.
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 will experience them.
It is important to be aware of the possible side effects.
Stop taking Aurozeb and seek immediate medical help 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
• lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells)
• muscle rupture.

Contact your doctor immediately if you have unusual muscle pain or tenderness that lasts longer than expected. Rarely, these symptoms may lead to potentially fatal muscle tissue damage known as rhabdomyolysis, which can cause malaise, fever, and kidney impairment.
Not known (frequency cannot be estimated from the available data):
Ulcers or blistering of the skin in the mouth, eyes, and genital areas. These could be symptoms of Stevens-Johnson syndrome (a potentially life-threatening allergic reaction affecting the skin and mucous membranes).
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
• Constipation
• Feeling unwell
• Muscle pain
• Feeling weak
• 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 will monitor you during treatment with this medicine.
• Stomach discomfort
• Diarrhea
• Flatulence (excess gas in the intestine)
• Feeling tired
• Increase in certain laboratory blood test values related to liver function (transaminases).

Uncommon side effects

• Skin rash, itching, hives
• Increased levels of protein in the urine may occur. This usually returns to normal without discontinuing rosuvastatin.
• Increase in certain laboratory blood test values related to muscle function (creatine kinase - 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, particularly in 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), presence of blood in the urine, nerve damage in the arms and legs (such as numbness), memory loss, breast enlargement in men (gynecomastia).
Not known:
Shortness of breath, edema (swelling), sleep disorders including difficulty sleeping and nightmares, sexual dysfunction, 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, pharmacist, or nurse. 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 Aurozeb

Keep in the original packaging to protect 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. Contents of the pack and other information

What Aurozeb contains
The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
Aurozeb 5 mg/10 mg:
Each tablet contains 5.20 mg of rosuvastatin calcium (equivalent to 5 mg of rosuvastatin) and
10 mg of ezetimibe.
Aurozeb 10 mg/10 mg:
Each tablet contains 10.40 mg of rosuvastatin calcium (equivalent to 10 mg of rosuvastatin) and
10 mg of ezetimibe.
Aurozeb 20 mg/10 mg:
Each tablet contains 20.80 mg of rosuvastatin calcium (equivalent to 20 mg of rosuvastatin) and
10 mg of ezetimibe.
Aurozeb 40 mg/10 mg:
Each tablet contains 41.60 mg of rosuvastatin calcium (equivalent to 40 mg of rosuvastatin) and
10 mg of ezetimibe.

The other ingredients are
Tablet core (same for all strengths):
Microcrystalline cellulose (E460), Silica, anhydrous colloidal (E551), Magnesium stearate (E572), Povidone
K30 (E1201), Sodium croscarmellose (E468), Sodium lauryl sulfate (E487), Lactose monohydrate,
Hypromellose 2910 (E464),

Coating:
Opadry Yellow (in Aurozeb 5 mg/10 mg): Hypromellose 2910 (E464), Titanium dioxide (E171), Macrogol
4000 (E1521), Iron oxide yellow (E172), Talc (E553b), Iron oxide red (E171),
Opadry Beige (in Aurozeb 10 mg/10 mg): Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Iron oxide yellow (E172), Talc (E553b),
Vivacoat Yellow (in Aurozeb 20 mg/10 mg): Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Iron oxide yellow (E172), Talc (E553b),
Opadry White (in Aurozeb 40 mg/10 mg): Lactose monohydrate, Hypromellose 2910 (E464), Titanium dioxide
(E171), Macrogol 4000 (E1521).

Description of the appearance of Aurozeb and contents of the pack
Aurozeb film-coated tablets, 5 mg/10 mg: Light yellow, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, marked with "EL 5" on one side.
Aurozeb film-coated tablets, 10 mg/10 mg: Beige, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, marked with "EL 4" on one side.
Aurozeb film-coated tablets, 20 mg/10 mg: Yellow, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, marked with "EL 3" on one side.
Aurozeb film-coated tablets, 40 mg/10 mg: White, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, marked with "EL 2" on one side.
Pack size: 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aurora Biofarma s.r.l.
Via Nicola Antonio Porpora 127,
Milano, 20131
Italy

Manufacturer:
ELPEN Pharmaceutical Co. Inc.
Marathonos 95,
Pikermi, 190 09,
Greece

This medicinal product is authorized in the European Economic Area member states under the
following names:
Netherlands: Rozemib