ROSUVASTATINA 5 mg/10 mg Таблетки

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1. Rosuvastatina e Ezetimibe Teva 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets
   1. What is Rosuvastatina and Ezetimibe Teva and what is it used for
   2. What you need to know before taking Rosuvastatina and Ezetimibe Teva
   3. How to take Rosuvastatina and Ezetimibe Teva
   4. Possible side effects
   5. How to store Rosuvastatina and Ezetimibe Teva
   6. Contents of the pack and other information

Rosuvastatina e Ezetimibe Teva 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Generic medicine

Read this leaflet carefully before 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 Rosuvastatina e Ezetimibe Teva is and what it is used for
• 2. What you need to know before you take Rosuvastatina e Ezetimibe Teva
• 3. How to take Rosuvastatina e Ezetimibe Teva
• 4. Possible side effects
• 5. How to store Rosuvastatina e Ezetimibe Teva
• 6. Contents of the pack and other information

1. What is Rosuvastatina and Ezetimibe Teva and what is it used for

Rosuvastatina e Ezetimibe Teva contains two different active ingredients in one tablet. One of the active ingredients is rosuvastatin, belonging to the group of medicines called statins, the other active ingredient is ezetimibe.
Rosuvastatina e Ezetimibe Teva is a medicine used to lower levels of total cholesterol in the blood, of the so-called "bad" cholesterol (LDL cholesterol) and other fatty substances called
triglycerides. It also increases levels of "good" cholesterol (HDL cholesterol). This medicine
works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed from the digestive tract, as well as
decreases the production of cholesterol by the body itself.
For most people, high cholesterol levels do not affect how they feel, as
it does not produce any symptoms. However, if left untreated, it can form a buildup of fat deposits in the
walls of blood vessels, causing them to narrow.
Sometimes these narrowed blood vessels can become blocked and interrupt the flow of blood to the heart and
brain causing a heart attack or stroke. By reducing cholesterol levels, it is possible to reduce the
risk of having a heart attack, stroke or health problems related to it.
Rosuvastatina e Ezetimibe Teva is used in patients whose cholesterol levels can no longer be
controlled solely through a cholesterol-lowering diet. This cholesterol-lowering diet
must necessarily be maintained while using the medicine.
Your doctor may prescribe Rosuvastatina e Ezetimibe Teva if you are already taking both rosuvastatin and
ezetimibe at the same dosage.
Rosuvastatina e Ezetimibe Teva is used in the following cases:

• excess cholesterol in the blood (primary hypercholesterolemia);
• heart disease: Rosuvastatina e Ezetimibe Teva reduces the risk of heart attack, stroke, surgeries to increase blood flow to the heart, or hospitalizations for chest pain.

Rosuvastatina e Ezetimibe Teva tablets do not help with weight loss.

2. What you need to know before taking Rosuvastatina and Ezetimibe Teva

Do not take Rosuvastatina and Ezetimibe Teva 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 repeated and unexplained muscle pain (myopathy).
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking Rosuvastatina and Ezetimibe Teva or other related medicines. You are taking a medicine called ciclosporin (used, for example, after organ transplants).
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina and Ezetimibe Teva, stop taking the medicine immediately and consult your doctor. Women must avoid pregnancy while using Rosuvastatina and Ezetimibe Teva by using adequate contraceptive measures (see the section Pregnancy and breastfeeding).

If any of these situations apply to you (or if you are unsure), contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina and Ezetimibe Teva if:

• you have kidney problems.
• you have liver problems.
• you have had repeated or unexplained muscle pain, a personal or family history of muscle problems, or a previous experience of muscle problems while taking other medicines that lower cholesterol. Contact your doctor immediately if you have repeated and unexplained muscle pain, especially if you do not feel well or have a fever. Also contact your doctor or pharmacist if you have constant muscle fatigue.
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). In these cases, your doctor must choose the right dose of Rosuvastatina and Ezetimibe Teva.
• you are taking medicines against infections, including HIV or hepatitis C (for example lopinavir/ritonavir and/or atazanavir or simeprevir). See the section “Other medicines and Rosuvastatina and Ezetimibe Teva”.
• you have severe respiratory failure.
• you are taking other medicines called fibrates to lower your cholesterol levels. See the section “Other medicines and Rosuvastatina and Ezetimibe Teva”.
• you regularly drink large amounts of alcohol.
• you have a thyroid gland that is not functioning properly (hypothyroidism).
• you are over 70 years of age (your doctor must determine the right dose of Rosuvastatina and Ezetimibe Teva that is right 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 Rosuvastatina and Ezetimibe Teva can lead to serious muscle problems (rhabdomyolysis). If any of the above circumstances apply to you (or if you are in doubt), consult your doctor or pharmacist before taking any dose of Rosuvastatina and Ezetimibe Teva.

Take special care with Rosuvastatina and Ezetimibe Teva
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Rosuvastatina and Ezetimibe Teva. Stop using Rosuvastatina and Ezetimibe Teva and seek immediate medical attention if you notice any of the symptoms described in section 4.
Statins can cause liver problems in a small number of people. This situation can be easily identified with a simple test that analyzes the levels of liver enzymes in the blood. For this reason, your doctor must regularly perform this blood test (liver function test) during treatment with Rosuvastatina and Ezetimibe Teva. It is important to go to the doctor for the prescribed laboratory tests.
While you are taking the medicine, your doctor will monitor you carefully if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is very high if you have high levels of sugar and fats in your blood, if you are overweight or if you have high blood pressure.
If you are hospitalized or treated for another condition, inform the medical staff that you are taking Rosuvastatina and Ezetimibe Teva.

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

Other medicines and Rosuvastatina and Ezetimibe Teva
Tell 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:

• Ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organs. The effect of rosuvastatin is increased if used at the same time as this medicine). Do not take Rosuvastatina and Ezetimibe Teva while you are taking ciclosporin.
• Anticoagulants, for example warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with Rosuvastatina and Ezetimibe Teva tablets) or clopidogrel.
• Other medicines used to lower cholesterol levels, called fibrates, which also correct triglyceride levels (for example gemfibrozil and other fibrates). During concomitant use with fibrates, the effect of rosuvastatin is increased.
• Cholestyramine (medicine used to lower cholesterol levels), as it alters the functioning of ezetimibe.
• Regorafenib (used to treat tumors).
• Each of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see the section “Warnings and precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Remedies for indigestion containing aluminum and magnesium (used to neutralize stomach acids; these decrease the levels of rosuvastatin in the blood). This effect may be mitigated by taking this type of medicine 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). Concomitant use of this antibiotic decreases the effects of rosuvastatin.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop treatment with this medicine. Your doctor will tell you when it is safe to restart treatment with Rosuvastatina and Ezetimibe Teva. The combination of

Rosuvastatina and Ezetimibe Teva and fusidic acid can, rarely, cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Oral contraceptives (the pill). They increase the levels of sex hormones regulated by the pill.
• Hormone replacement therapy (increases hormone levels in the blood).

If you are hospitalized or treated for another condition, inform the medical staff that you are taking Rosuvastatina and Ezetimibe Teva.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Rosuvastatina and Ezetimibe Tevaif you are pregnant, suspect you are pregnant or are planning a pregnancy. If you become pregnant while taking Rosuvastatina and Ezetimibe Teva tablets,

stop treatment immediatelyand consult your doctor. Women must always use contraceptive measures during treatment with Rosuvastatina and Ezetimibe Teva.

Breastfeeding
Do not take Rosuvastatina and Ezetimibe Tevawhile breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and operating machinery
It is not expected that Rosuvastatina and Ezetimibe Teva will interfere with your ability to drive vehicles or operate machinery. However, you should consider that some people may experience dizziness after taking Rosuvastatina and Ezetimibe Teva. If you experience dizziness, consult your doctor before driving vehicles or operating machinery.

Rosuvastatina and Ezetimibe Teva contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

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

3. How to take Rosuvastatina and Ezetimibe Teva

Take 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 engage in physical activity during
the intake of Rosuvastatina and Ezetimibe Teva.
The recommended daily dose for adults is one tablet of the prescribed dosage.

Take Rosuvastatina and Ezetimibe Teva once a day.
Take the tablet at any time of the day, on an empty or full stomach. Swallow the tablet whole with
a glass of water.
Take the medicine always at the same time each day.
Rosuvastatina and Ezetimibe Teva is not suitable to initiate a treatment. The start of treatment or, if
necessary, a dosage adjustment, must be done only by administering the active substances
separately, and after establishing the correct dosage it is possible to switch to Rosuvastatina and Ezetimibe
Teva in the appropriate dosage.

Regular cholesterol checks
It is important to have your cholesterol levels checked regularly by your doctor, to ensure that your
cholesterol reaches and maintains the correct level.

If you take more Rosuvastatina and Ezetimibe Teva than you should
Contact your doctor or the Emergency Room of the nearest hospital as you may need
medical assistance.

If you forget to take Rosuvastatina and Ezetimibe Teva
Do not worry, skip the missed dose and take the next scheduled dose (always at the same
time). Do not take a double dose to make up for the missed dose.

If you stop taking Rosuvastatina and Ezetimibe Teva
Consult your doctor if you wish to stop treatment with Rosuvastatina and Ezetimibe Teva.
Keep in mind that in this case your cholesterol levels may increase again.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important to be aware of possible side effects.

Stop taking Rosuvastatina and Ezetimibe Teva immediately and seek medical helpif any of the following allergic reactions occur:

• swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing.
• skin blisters or sores, mouth, eyes and genitals. These could be signs of Stevens-Johnson syndrome (a potentially life-threatening allergic reaction that affects the skin and mucous membranes).

Also, stop taking Rosuvastatina and Ezetimibe Teva and contact your doctor immediately:

• if you experience unusual muscle pain or pain that lasts longer than expected. These can rarely develop into a potentially fatal muscle damage known as rhabdomyolysis, leading to malaise, fever and kidney damage.
• if you have a lupus-like syndrome (including rash, joint disorders and effects on blood cells).
• in case of muscle rupture.

Stop taking Rosuvastatina and Ezetimibe Teva and seek immediate medical attention if you experience any of the following symptoms:

• reddish, non-raised, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes.

These severe skin rashes may be preceded by fever and flu-like symptoms
(Stevens-Johnson syndrome).

• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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 1000 people)
• Very rare (may affect up to 1 in 10,000 people, including isolated cases)

Common side effects

• headache
• constipation
• malaise
• muscle pain
• feeling of weakness
• dizziness
• diabetes. This is more likely if you have high levels of sugar and fat in your blood, if you are overweight and have high blood pressure. Your doctor will need to monitor you during treatment.
• stomach pain
• diarrhoea
• flatulence (excess gas in the intestinal tract)
• feeling tired
• increased levels of some laboratory blood tests related to liver function (transaminases)

Uncommon side effects

• skin rash, itching, hives
• an increase in protein in the urine may occur; these usually return to their normal levels without stopping Rosuvastatina and Ezetimibe Teva.
• increased levels of some laboratory blood tests of muscle function (CK)
• cough
• difficulty digesting
• 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, which causes severe abdominal pain that extends to the back, reduced platelets, lupus-like syndrome, muscle rupture.

Very rare side effects:

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

Not known:

• shortness of breath, edema (swelling), sleep disorders, including insomnia and nightmares, sexual difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injuries, persistent muscle weakness, gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Rosuvastatina and Ezetimibe Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and blister. The expiry date
refers to the last day of that month.
Store in the original package to protect the medicine from light. This medicine does not
require any particular storage temperature.
Do not dispose of any medicine in waste water 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 Rosuvastatina and Ezetimibe Teva contains
The active ingredients are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The tablets
contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg or 20 mg of rosuvastatin. Each
tablet contains 10 mg of ezetimibe.
The other ingredients are: Lactose monohydrate, Microcrystalline cellulose, Sodium croscarmellose,
Croscopovidone type A, Povidone K-30, Sodium lauryl sulfate and Magnesium stearate
Rosuvastatina and Ezetimibe Teva contains lactose and sodium - for further information see paragraph 2.

Description of the appearance of Rosuvastatina and Ezetimibe Teva and contents of the pack
Rosuvastatina and Ezetimibe Teva 5 mg/10 mg tablets: white/off-white, round,
flat, uncoated tablet, bearing E2 on one side and 2 on the other. The diameter of the tablet is 10 mm.
Rosuvastatina and Ezetimibe Teva 10 mg/10 mg tablets: white/off-white, oval,
biconvex, uncoated tablet, bearing E1 on one side and 1 on the other. The size of the tablet is 15
mm x 7 mm.
Rosuvastatina and Ezetimibe Teva 20 mg/10 mg tablets: white/off-white, round,
biconvex, uncoated tablet. The diameter of the tablet is 11 mm.
Packs of 10, 28, 30, 84, 90, 98 or 100 tablets in blisters (PA/AL/PVC/AL).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
TEVA B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:
Adamed Pharma S.A; ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland