QUILOGA 5 мг/10 мг Таблетки

Содержание инструкции

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

Quiloga 20 mg/10 mg tablets, 10 mg/10 mg tablets

Quiloga 5 mg/10 mg tablets
rosuvastatin and ezetimibe

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 could 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 Quiloga tablets are and what they are used for
• 2. What you need to know before you take Quiloga tablets
• 3. How to take Quiloga tablets
• 4. Possible side effects
• 5. How to store Quiloga tablets
• 6. Contents of the pack and other information

1. What Quiloga tablets are and what they are used for

Quiloga tablets contains two different active ingredients in one tablet. One active ingredient is
rosuvastatin, belonging to the group of medicines called statins, the other is ezetimibe.
Quiloga tablets is a medicine used to lower 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
reduces cholesterol in two ways: it reduces the amount absorbed from the digestive tract and decreases its
production by the body itself.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fat deposits
can accumulate in the walls of blood vessels causing them to narrow. Sometimes, this narrowing of the blood
vessels can cause blockage of blood flow to the heart or brain resulting in a heart attack or stroke. By lowering
cholesterol levels, it can reduce the risk of a heart attack, stroke or other health problems related to it.
Quiloga tablets is used for those patients whose cholesterol levels can no longer be controlled solely through a
low-cholesterol diet. You must continue to follow a diet to reduce cholesterol during therapy with this medicine.
The doctor may prescribe Quiloga tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
Quiloga tablets is used if you have:

• an elevated blood cholesterol level (primary hypercholesterolemia)
• heart disease, Quiloga reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain

Quiloga tablets does not help with weight loss.

2. What you need to know before taking Quiloga tablets

Do not take Quiloga tablets 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 problems.
• you have recurrent or unexplained muscle pain or tenderness (myopathy).
• you are taking a medicine called ciclosporin (used, for example, after organ transplantation).
• you are pregnant or breastfeeding. If you become pregnant during treatment with Quiloga tablets, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with Quiloga tablets by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding).
• you are taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat liver viral infection called hepatitis C).

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

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

• you have kidney problems.
• you have liver problems.
• you have had recurrent or unexplained muscle pain or tenderness, a personal or family history of muscle problems, or if you have previously experienced muscle problems during treatment with other medicines that lower cholesterol. Tell your doctor or pharmacist immediately if you experience unexplained muscle pain or tenderness, especially if you feel unwell or have a fever. Also, inform 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 dose of Quiloga tablets suitable for you.
• you are taking medicines used to fight infections, including HIV or hepatitis C infections, such as lopinavir/ritonavir and/or atazanavir, see “Other medicines and Quiloga tablets”.
• you have severe breathing difficulties.
• you are taking other medicines called fibrates to lower cholesterol. See “Other medicines and Quiloga tablets”.
• you regularly consume significant amounts of alcohol.
• you have a thyroid gland that is not functioning properly (hypothyroidism).
• you are over 70 years old (your doctor needs to establish the correct dose of Quiloga tablets suitable for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used for bacterial infections), orally or by injection. The combination of fusidic acid and Quiloga tablets can lead to serious muscle problems (rhabdomyolysis).
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking Quiloga or other related medicines.
• you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

Take special care with Quiloga:
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with Quiloga. Stop using
Quiloga and seek immediate medical attention if you notice any of the symptoms described in section 4.
If any of these apply to you (or if you have any doubts): consult your doctor or pharmacist before
actually starting to take any dose of Quiloga tablets.
Statins can alter liver function in a limited number of people. This is detected with
a simple test, which allows monitoring of increased levels of liver enzymes in the blood. For
this reason, your doctor will usually request this blood test (liver function test) during
treatment with Quiloga tablets. It is important to go to your doctor for the prescribed laboratory tests.
During treatment with this medicine, your doctor will carefully check if you have diabetes or are at
risk of developing diabetes. You are 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.
If you are hospitalized or treated for another condition, inform the medical staff
that you are taking Quiloga tablets.

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

Other medicines and Quiloga tablets
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 organ transplantation to prevent rejection of the transplanted organ). The effect of rosuvastatin is increased when used at the same time with this medicine). Do not take Quiloga tablets in combination with ciclosporin.
• Anticoagulants such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with Quiloga tablets), ticagrelor or clopidogrel.
• Other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). During concomitant use with fibrates, the effect of rosuvastatin is increased.
• Cholestyramine (a medicine to lower cholesterol levels), as it alters the functioning of ezetimibe.
• Remedies for indigestion containing aluminium and magnesium (used to neutralize acids in the stomach; these metals decrease the levels of rosuvastatin in the blood). This effect may be mitigated by administering this type of medicine 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). Concomitant use of this antibiotic decreases the effect of rosuvastatin.
• Fusidic acid. If you need to take oral fusidic acid for the treatment of a bacterial infection, you should temporarily interrupt the use of this medicine. Your doctor will tell you when it is safe to start taking Quiloga tablets again. Taking Quiloga tablets with fusidic acid can rarely cause weakness, fatigue or muscle pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• An oral contraceptive (the pill). They increase the levels of hormones absorbed by the pill.
• Hormone replacement therapy (increases hormone levels in the blood).
• Regorafenib (used to treat tumors).
• One of the following medicines used to treat viral infections, including HIV or Hepatitis C infections, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or treated for another condition, inform the medical staff
that you are taking Quiloga tablets.

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 Quiloga tabletsif you are pregnant, suspect you are pregnant or are planning a pregnancy.
If you become pregnant during treatment with Quiloga tablets, stop taking it immediately
and inform your doctor. Women must always use contraceptive measures during
treatment with Quiloga tablets.

Breastfeeding
Do not take Quiloga tabletsduring breastfeeding, as it is not known whether the medicine is excreted in
breast milk.

Driving and using machines
Quiloga tablets should not interfere with your ability to drive or operate machinery. However,
it should be considered that some people may experience dizziness after taking
Quiloga tablets. If you experience dizziness, consult your doctor before driving or operating machinery.

Quiloga tablets contains lactose monohydrate
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking Quiloga
tablets.

3. How to take Quiloga tablets

Take this medicine following the instructions of your doctor exactly. 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 Quiloga tablets.
The recommended daily dose for adults is one tablet of the specific dose.

Take Quiloga tablets once a day.
It can be taken at any time of day with or without food. Swallow each tablet
whole with a sip of water. Take the medicine at the same time each day.
Quiloga tablets are not suitable for initial therapy.
The start of treatment or dose adjustment, if necessary, must be carried out only by administering the active substances separately and after setting the appropriate doses, it is possible to
switch to Quiloga tablets.

Regular cholesterol checks
It is important to return to your doctor to regularly check your cholesterol levels and ensure that they are
reached and maintained within the normal range.

If you take more Quiloga tablets 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 Quiloga tablets
Do not worry, skip the missed dose and take the next dose at the correct time. Do not take a double
dose to make up for a missed dose.

If you stop taking Quiloga tablets
Talk to your doctor if you want to stop taking Quiloga tablets. Cholesterol levels
may increase again if you stop taking Quiloga tablets.
If you have further questions about the use of the medicine, you can contact 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 Quiloga tablets and see your doctor immediatelyif 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 rash, joint disorders and effects on blood cells).
• muscle breakdown.
• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome - a life-threatening allergic reaction).
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Contact your doctor immediately if you haveunusual muscle soreness or pain that lasts longer than expected. These can rarely develop into fatal muscle damage known as rhabdomyolysis, leading to malaise, fever and kidney dysfunction.

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. You are at risk of developing diabetes if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• Increase in some 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 - which usually returns to normal without having to stop taking rosuvastatin;
• Increases in some laboratory blood tests related to muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased 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, decreased
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, raised red skin rash, sometimes with target-shaped lesions (erythema multiforme), gallstones or inflammation of the gallbladder (which can cause stomach pain, nausea, vomiting), myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing), ocular myasthenia (a disease that causes weakness of the eye muscles).
See 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 shortness of breath.

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 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 Quiloga tablets

Store in the original package to protect the medicine from 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 package and on the blister. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Quiloga tablets contain
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,
Croscarpovidone type A, Povidone K-30, Sodium lauryl sulfate and Magnesium stearate.

Description of the appearance of Quiloga tablets and contents of the pack
Quiloga 20 mg/10 mg tablets: white to off-white, round, biconvex, uncoated tablet. The
diameter of the tablet is 11 mm.
Quiloga 10 mg/10 mg tablets: white to off-white, oval, biconvex, uncoated tablet, with
E1 engraved on one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm.
Quiloga 5 mg/10 mg tablets: white to off-white, round, flat, uncoated tablet, with E2
engraved on one side and 2 on the other side. The diameter of the tablet is 10 mm.
Packs of 14 and 30 tablets in blisters (PA/AL/PVC//Al) inserted in the cardboard box with the package
leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

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

This medicinal product is authorised in the Member States of the European Economic Area with the following
names
Italy
Poland
Quiloga
Rosuvastatin/Ezetimib Zentiva