AUROZEB 5 mg/10 mg Tabletki Powlekane

Treść ulotki

1. Aurozeb 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, 40 mg/10 mg film-coated tablets
   1. What is Aurozeb and what it is used for
   2. What you need to know before using Aurozeb
   3. How to take Aurozeb
   4. Possible side effects
   5. How to store Aurozeb
   6. Package Contents and Other Information

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

Rosuvastatin and Ezetimibe
Read this leaflet carefully before you start taking 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Aurozeb and what it is used for

Aurozeb contains two different active ingredients in a film-coated tablet. One of the active ingredients is
rosuvastatin calcium, belonging to the group of medicines called statins, the other active ingredient is
ezetimibe.
Aurozeb is a medicine used to reduce total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fats in
the blood called triglycerides. 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 and
that produced by the body.
In most people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if left
untreated, fat deposits can build up in the walls of blood vessels causing them to narrow.
Sometimes, this narrowing of the blood vessels can lead to a blockage of blood flow to the heart or brain,
resulting in a 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 it.
Aurozeb is used for those patients whose cholesterol levels can no longer be controlled by diet alone to
reduce cholesterol. Continue to follow a cholesterol-lowering diet during therapy with this medicine.
Your doctor may prescribe Aurozeb if you are already taking rosuvastatin and ezetimibe at the same doses.
Aurozeb is used if you have:

• a high level of cholesterol in the blood (primary hypercholesterolemia)

Aurozeb does not help with weight loss.

2. What you need to know before using Aurozeb

Do not use Aurozeb if:

• - you are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6).
• - you have a liver disease
• - you have severe kidney impairment
• - you have repeated or unexplained muscle aches or pains (myopathy)
• - you are taking a medicine called ciclosporin (used for example after an organ transplant)
• - 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, using appropriate contraceptive measures. Also, do not take rosuvastatin 40 mg (the highest dose) if:
• - you have moderate kidney problems (if in doubt, ask your doctor)
• - your thyroid gland is not functioning properly (hypothyroidism)
• - you regularly drink large amounts of alcohol
• - you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and 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 if you 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 had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Tell your doctor or pharmacist immediately if you have unexplained muscle aches or pains, especially if accompanied by malaise or 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 needs to choose the correct dosage of Aurozeb suitable for you.
• - you are taking medicines used to fight infections, including infections from HIV or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir, see “Other medicines and Aurozeb”.
• - you have severe respiratory failure
• - you are taking other medicines to lower cholesterol 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 of age (as your doctor needs to choose the correct dosage of Aurozeb suitable for you).
• - you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and Aurozeb can 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 actually starting to take any dose of Aurozeb.

In a small number of people, statins can alter liver function. This effect can
be detected with a simple test that detects increased levels of liver enzymes in the blood.
For this reason, your doctor will ask you to have this test (liver function test)
during treatment with Aurozeb. It is important to go to your doctor for the prescribed laboratory tests.
Your doctor will monitor you closely 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 sugars and fats 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 the age of 18 years.

Other medicines and Aurozeb
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:

• - Ciclosporin (used for example after organ transplantation to prevent rejection of the transplanted organ. The effect of rosuvastatin increases if used together with this medicine). Do not takeAurozeb in combination with ciclosporin.
• - Anticoagulants such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with Aurozeb), or clopidogrel
• - Other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels in the blood (e.g. gemfibrozil and other fibrates). If used at the same time, the effect of rosuvastatin increases.
• - Cholestyramine (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 those from HIV or hepatitis C). See section Warnings and precautions.
• - Remedies for indigestion containing aluminum and magnesium (used to neutralize stomach acid; they decrease plasma levels of rosuvastatin). This effect can be mitigated if you take this type of medicine 2 hours after rosuvastatin.
• - Erythromycin (an antibiotic). The concomitant use of this antibiotic decreases the effect of rosuvastatin.
• - 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 to safely restart Aurozeb. Taking Aurozeb with fusidic acid can rarely cause weakness, muscle aches or pain (rhabdomyolysis). See section 4 for more information regarding rhabdomyolysis.
• - An oral contraceptive (the pill). It increases the levels of sex hormones absorbed by the pill
• - Hormone replacement therapy (higher levels of hormones in the blood)
• - Regorafenib (used to treat tumors)
• - Simeprevir (used to treat chronic hepatitis C infection)

If you are hospitalized or treated for another condition, tell the medical staff about taking Aurozeb.

Aurozeb with 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 are pregnant or are planning a pregnancy.
If you become pregnant while taking Aurozeb, stop treatment immediately and inform your
doctor. Women must use contraceptive measures while being treated with Aurozeb.
Do not take Aurozeb during breastfeeding, as it is not known whether the medicine is excreted in breast milk.

Driving and using machines
Aurozeb should not interfere with your ability to drive or use machines.
However, you should consider that some people may experience dizziness
after taking Aurozeb. If you experience dizziness, consult your doctor before driving vehicles or
using machinery.

Aurozeb contains lactose
Aurozeb tablets contain a sugar called lactose. If your doctor has diagnosed you with
intolerance to some sugars, contact him 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 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 during
the use of Aurozeb.
The recommended daily dose for adults is one tablet of the specific dosage.

Take Aurozeb once a day.
It can be taken at any time of the day, on an empty stomach or a full stomach. Swallow a
whole tablet with a glass of water.
Take the medicine at the same time each day.
Aurozeb is not suitable for initial therapy. The start of treatment or dose adjustment, if
necessary, must be carried out only with single-component medications and after setting the
correct dosage, it is possible to switch to Aurozeb of the appropriate dosage.
The maximum daily dose of rosuvastatin is 40 mg. This is only suitable for patients with high
cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels are not lowered to
sufficiently with 20 mg.

Periodic cholesterol checks
It is important to have your cholesterol levels checked periodically by your doctor, to make sure
that your cholesterol has reached and maintains normal values.

If you take more Aurozeb than you should
Contact your doctor or the nearest hospital emergency room as you may need
medical assistance.

If you forget to take Aurozeb
Do not worry, skip the missed dose and take the next dose at the usual time. Do not take a
double dose to make up for a missed dose.

If you stop taking Aurozeb
Tell your doctor if you intend to stop taking Aurozeb. Your cholesterol levels
may increase again if you stop taking Aurozeb.
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 will experience them.
It is important to be aware of 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 can 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 soreness or pain that lasts longer than
expected. These can rarely develop into muscle tissue damage
potentially fatal, known as rhabdomyolysis, leading to malaise, fever and kidney impairment.

Not known(frequency cannot be estimated from available data):
Ulcers or blistering, on the mouth, eyes and genitals. These may 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 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 pain
• Diarrhoea
• Flatulence (excess gas in the intestines)
• Feeling tired
• Increase in certain values from laboratory blood tests related to liver function (transaminases).

Uncommon side effects

• Skin rash, itching, hives
• An increase in the amount of protein in the urine may occur. Usually returns to normal without having to stop taking rosuvastatin
• Increase in some values from laboratory blood tests 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 the arms and legs
• Swelling, especially of the hands and feet.

Rare side effects:
Pancreatitis, which causes severe stomach pain that radiates to the back, reduced
platelets.
Very rare side effects:
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), traces of blood
in the urine, nerve damage in the legs and arms (such as numbness), memory loss,
growth of breast tissue in men (gynecomastia).
Not known:
Shortness of breath, edema (swelling), sleep disorders, including difficulty sleeping and nightmares, sexual difficulties, 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
can cause stomach pain, nausea, vomiting).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Aurozeb

Store in the original package to protect from humidity and light. This medicine does not
require any particular storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the box after EXP. The date
of expiry refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Aurozeb contains
The active ingredients 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 dosages):
Microcrystalline cellulose (E460), Colloidal anhydrous silica (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), Yellow iron oxide (E172), Talc (E553b), Red iron oxide (E171),
Opadry beige (in Aurozeb 10 mg/10 mg): Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Yellow iron oxide (E172), Talc (E553b),
Vivacoat yellow (in Aurozeb 20 mg/10 mg): Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Yellow iron oxide (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 and “EL 5” imprinted on one side
Aurozeb film-coated tablets, 10 mg/10 mg: Beige, round, biconvex film-coated tablets,
with a diameter of approximately 10 mm and “EL 4” imprinted on one side
Aurozeb film-coated tablets, 20 mg/10 mg: Yellow, round, biconvex film-coated tablets,
with a diameter of approximately 10 mm and “EL 3” imprinted on one side
Aurozeb film-coated tablets, 40 mg/10 mg: White, round, biconvex film-coated tablets,
with a diameter of approximately 10 mm and “EL 2” imprinted on one side
Packs of 30 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands: Rozemib