STEZEROL 5 mg/10 mg Film-Coated Tablets

Зміст інструкції

1. Stezerol 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 Stezerol is and what it is used for
   2. What you need to know before you use Stezerol
   3. How to use Stezerol
   4. Possible side effects
   5. How to store Stezerol
   6. Package Contents and Other Information

Package Leaflet: Information for the User

Stezerol 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

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

1. What Stezerol is and what it is used for

Stezerol contains two different active ingredients in a film-coated tablet. One of the active ingredients is
rosuvastatin calcium salt, belonging to the group of medicines called statins, the other active ingredient is
ezetimibe.
Stezerol is a medicine used to lower total cholesterol levels, "bad" cholesterol
(LDL cholesterol) and 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 the cholesterol produced by the body.
For most people, high cholesterol does not affect how they feel, as it does not cause
symptoms. However, if left untreated, fat deposits can build up in the walls of blood vessels,
causing them to narrow.
Sometimes, these narrowed blood vessels can become blocked, interrupting the flow of blood to the heart or
brain, causing a heart attack or stroke. By reducing cholesterol levels, you reduce the risk of
having a heart attack, stroke, or related health problems.
Stezerol is used in patients whose cholesterol levels can no longer be controlled by
diet alone to lower cholesterol. You should continue to follow a cholesterol-lowering diet while
taking this medicine.
Your doctor may prescribe Stezerol if you are already taking both rosuvastatin and ezetimibe at the same dose.
Stezerol is used if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia).
• heart disease. Stezerol reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Stezerol does not help you lose weight.

2. What you need to know before you use Stezerol

Do not use Stezerol:

• if you are allergic to rosuvastatin, to ezetimibe or to any of the other ingredients of this medicine (listed in section 6).
• if you have a liver disease.
• if you have severe kidney impairment.
• if you have recurrent, unexplained muscle pains (myopathy).
• if you are taking a medicine called ciclosporin (used, for example, after organ transplants).
• If you are pregnant or breastfeeding. If you become pregnant during the intake of Stezerol, stop the medicine immediately and consult your doctor. Women must avoid becoming pregnant while taking Stezerol, using adequate contraceptive methods.

Also, do not take rosuvastatin 40 mg (the highest dose):

• if you have moderate kidney problems (if you are unsure, ask your doctor).
• if you have a thyroid gland that is not functioning properly (hypothyroidism).
• if you regularly drink 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 Stezerol").
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking Stezerol or other related medicines. If any of the above points apply to you (or if you are unsure), contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Stezerol if:

• you have kidney problems.
• you have liver problems.
• you have had recurrent or unexplained muscle pains, a personal or family history of muscle problems, or a previous history of muscle problems while taking other medicines to lower cholesterol. Contact your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell or have a fever. Also, contact your doctor or pharmacist if you have persistent muscle weakness.
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor will need to choose the right dose of Stezerol for you.
• you are taking medicines used to fight infections, including those for HIV or hepatitis C infection, such as lopinavir/ritonavir and/or atazanavir or simeprevir; see section "Other medicines and Stezerol".
• you have severe breathing difficulties.
• you are taking other medicines called fibrates to lower cholesterol. See section "Other medicines and Stezerol".
• you drink regularly large amounts of alcohol.
• you have a thyroid gland that is not functioning properly (hypothyroidism).
• you are over 70 years old (as your doctor needs to choose the right dose of Stezerol).
• 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 Stezerol can cause serious muscle problems (rhabdomyolysis).
• you have or have had myasthenia (a condition with general muscle weakness, including, in some cases, the muscles used for breathing), or ocular myasthenia (a condition that causes weakness in the eye muscles), as statins can sometimes worsen the condition or cause the onset of myasthenia (see section 4). If any of the above points apply to you (or if you have doubts): consult your doctor or pharmacist before starting to take any dose of Stezerol.

In a small number of people, statins can affect the liver. This can be identified with a
simple test looking for high levels of liver enzymes in the blood. For this reason, your doctor will perform
this blood test (liver function test) regularly during treatment with Stezerol. 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 Stezerol.
Stop using Stezerol and seek immediate medical attention if you notice any of the symptoms described in
section 4.
During treatment with this medicine, your doctor will monitor you closely if you suffer from diabetes or are at
risk of developing it. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats
in your blood, if you are overweight and have high blood pressure.

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

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

• Ciclosporin (used, for example, after organ transplants to prevent rejection of the transplanted organ. The effect of rosuvastatin is increased with concomitant use). Do not take Stezerolwhile taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken at the same time as Stezerol), 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 is increased.
• Cholestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works.
• Antiviral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection). See section "Warnings and precautions".
• Indigestion remedies containing aluminium 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 rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with 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 Stezerol. Taking Stezerol with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis see section 4.
• 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).
• Simeprevir (used to treat chronic hepatitis C infection)
• Anticoagulants ,such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken at the same time as this medicine), ticagrelor or clopidogrel.
• Any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (see section Warnings and precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you go to hospital or receive treatment for another condition, tell the medical staff that you are
taking Stezerol.

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

Pregnancy and breastfeeding
Do not take Stezerol if you are pregnant, if you suspect or are planning a pregnancy. If you become
pregnant while taking Stezerol, stop immediately and consult your doctor. Women
must use contraceptive measures during treatment with Stezerol.
Do not take Stezerol if you are breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
Stezerol is not expected to affect your ability to drive or operate machinery. However,
you should be aware that some people experience dizziness after taking Stezerol. If you
experience dizziness, consult your doctor before driving or operating machinery.
Stezerolcontains lactose
Stezerol tablets contain a sugar called lactose. If your doctor has diagnosed you with
an intolerance to some sugars, contact him before taking this medicine.

3. How to use Stezerol

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and exercise while taking
Stezerol.
The recommended daily dose for adults is one tablet of the prescribed dose.

Take Stezerol 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 medicine at the same time each day.
Stezerol is not suitable for starting treatment. The initiation of treatment or dose adjustment, if
necessary, must be carried out by administering the active ingredients separately and, once the doses are established
appropriate, it is possible to switch to Stezerol by selecting the appropriate dose.
The maximum daily dose of rosuvastatin is 40 mg. This is only for patients with high levels of
cholesterol and a high risk of heart attack or stroke, whose cholesterol levels are not sufficiently
reduced with 20 mg.

Regular cholesterol checks
It is important to return to your doctor for regular cholesterol checks, to ensure that your cholesterol has
reached and remains at the correct levels.

If you use more Stezerol than you should
Contact your doctor or the emergency room of the nearest hospital, as you may need
medical assistance.

If you forget to use Stezerol
Do not worry, skip the missed dose and take the next dose at the scheduled time. Do not take
a double dose to make up for a missed one.

If you stop taking Stezerol
Talk to your doctor if you want to stop taking Stezerol. Your cholesterol levels may
increase again if you stop taking Stezerol.
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 to be aware of possible side effects. Stop taking Stezerol and seek immediate medical
help if you experience any of the following symptoms:
swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and
swallowing.
syndrome resembling lupus erythematosus (including skin rash, joint disorders and effects on the
blood cells).
muscle breakdown.
reddish, non-raised, target-shaped or circular patches on the trunk, often with blisters in the
centre, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe 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 experience unusual muscle pain or weakness that lasts longer than
you expect. Rarely, this can progress to potentially life-threatening muscle damage known as
rhabdomyolysis, which leads to feeling unwell, fever and kidney impairment.
The following terms are used to describe the frequency with which 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 sugar and fat levels in your blood, if you are
overweight and have high blood pressure. Your doctor will need to check you while you are taking this
medicine.
Abdominal pain
Diarrhoea
Flatulence (excess gas in the intestinal tract)
Feeling tired
Increase in some laboratory tests of liver function (transaminases);
Uncommon side effects:
Skin rash, itching, hives
An increase in the amount of protein in the urine can occur – usually returns to normal on
its own without having to stop taking rosuvastatin
Increases in some laboratory tests of 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 the arms and legs
Swelling, especially in the hands and feet.
Rare side effects:
Inflammation of the pancreas, causing severe abdominal pain that may radiate to the back,
decrease in platelets in the blood
Very rare side effects:
jaundice (yellowing of the skin and eyes), inflammation of the liver (hepatitis), traces of blood in
the urine, damage to the nerves of the legs and arms (such as numbness), memory loss, enlargement
of the breasts in men (gynaecomastia)
Not known:
difficulty breathing, oedema (swelling), sleep disorders, including insomnia and nightmares, sexual
difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or
fever, tendon damage, persistent muscle weakness, gallstones or inflammation of the gallbladder (which
can cause stomach pain, nausea, vomiting), myasthenia gravis (a disease that causes general muscle
weakness, including the muscles used for breathing), ocular myasthenia (a disease that causes weakness in
the eye muscles).
Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity,
double vision or drooping eyelids, difficulty swallowing or difficulty breathing.
Reporting of side effects
If you get any side effects, talk to 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 Stezerol

Store in the original package to protect the medicine from moisture and light. This medicinal product does not require special temperature conditions for storage.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is indicated on the package and the bottle after
EXP. The expiry date refers to the last day of the month indicated.
Do not dispose of any medicine in wastewater or 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 Stezerol contains
The active ingredients are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe.
Stezerol 5 mg/10 mg:
Each tablet contains 5.20 mg of rosuvastatin calcium salt (equivalent to 5 mg of rosuvastatin) and 10
mg of ezetimibe.
Stezerol 10 mg/10 mg:
Each tablet contains 10.40 mg of rosuvastatin calcium salt (equivalent to 10 mg of rosuvastatin) and 10
mg of ezetimibe.
Stezerol 20 mg/10 mg:
Each tablet contains 20.80 mg of rosuvastatin calcium salt (equivalent to 20 mg of rosuvastatin) and 10
mg of ezetimibe.
Stezerol 40 mg/10 mg:
Each tablet contains 41.60 mg of rosuvastatin calcium salt (equivalent to 40 mg of rosuvastatin) and 10
mg of ezetimibe.

Other excipients are:
Tablet core (same for all strengths): Microcrystalline cellulose (E460), Colloidal anhydrous silica
(E551), magnesium stearate (E572), Povidone (E1201), Sodium croscarmellose (E468), Sodium lauryl sulfate
(E487), Lactose monohydrate, Hypromellose (E464).
Coating:
Yellow Opadry (5 mg/10 mg): Hypromellose (E464), or titanium dioxide (E171), Macrogol (E1521), Yellow iron oxide
(E172), Talc (E553b), Red iron oxide (E171).
Beige Opadry (10 mg/10 mg): Hypromellose (E464), titanium dioxide (E171), Macrogol (E1521), Yellow iron oxide
(E172), Talc (E553b).
Yellow Vivacoat (20 mg/10 mg): Hypromellose (E464), titanium dioxide (E171), Macrogol (E1521), Yellow iron oxide
(E172), Talc (E553b).
White Opadry (40 mg/10 mg): Lactose monohydrate, Hypromellose (E464), titanium dioxide (E171), Macrogol
(E1521).

Description of Stezerol’s appearance and package contents
Rosuvastatin / Ezetimibe 5 mg / 10 mg film-coated tablets: round, biconvex tablets
with a film coating, light yellow in color, with a diameter of approximately 10 mm and the inscription “MR 5” on one
side.
Rosuvastatin / Ezetimibe 10 mg / 10 mg film-coated tablets: round, biconvex
tablets with a film coating, beige in color, with a diameter of approximately 10 mm and the inscription “MR 4” on one side.
Rosuvastatin / Ezetimibe 20 mg / 10 mg film-coated tablets: round, biconvex,
tablets with a film coating, yellow in color, with a diameter of approximately 10 mm and the inscription “MR 3” on one side.
Rosuvastatin / Ezetimibe 40 mg / 10 mg film-coated tablets: round, biconvex
tablets with a film coating, white in color, with a diameter of approximately 10 mm and the inscription “MR 2” on one side.
Packs of 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
PharmExtracta S.p.A.
Via G. Natta 28
29010 Pontenure (PC)
Italy

Manufacturer 1:
Elpen Pharmaceutical Co.Inc.
Marathonos 95
190 09 Pikermi
Greece

Manufacturer 2:
MEDICAIR BIOSCIENCE LABORATORIES S.A.
61° Km Strada Nazionale Athinon-Lamias, Schimatari
32009
Greece