QuilogA

Patient Information Leaflet

Quiloga 20 mg/10 mg tablets, 10 mg/10 mg tablets, 5 mg/10 mg tablets

rosuvastatin and ezetimibe
Please read this leaflet carefully before taking 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 effect, including those not listed in this leaflet, consult 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 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

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

Quiloga tablets contain two different active substances in a single tablet. One active substance is rosuvastatin, belonging to the family of drugs known as statins; the other is ezetimibe.
Quiloga tablets are a medicine used to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and blood fat substances called triglycerides. In addition, it increases levels of "good" cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: by reducing the amount absorbed from the digestive tract and by decreasing the body's own production of cholesterol.
In most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fatty deposits can build up 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. Lowering cholesterol levels can reduce the risk of heart attack, stroke, or other related health problems.
Quiloga tablets are used for patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe Quiloga tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
Quiloga tablets are used if you have:

• increased cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease, in which case Quiloga reduces the risk of heart attack, stroke, surgical intervention to improve blood flow to the heart, or hospitalization due to chest pain

Quiloga tablets do 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 liver disease.
• you have severe kidney problems.
• you have unexplained, repeated muscle pain or tenderness (myopathy).
• you are taking a medicine called ciclosporin (used, for example, after organ transplant).
• you are pregnant or breastfeeding. If you become pregnant while taking 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 sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver 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 experienced unexplained, repeated muscle pain or tenderness, 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 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, or Indian). Your doctor must choose the correct dose of Quiloga tablets suitable for you.
• you are taking medicines used to treat infections, including HIV or hepatitis C infection, e.g. lopinavir/ritonavir and/or atazanavir; see “Other medicines and Quiloga tablets”.
• you have severe respiratory failure.
• you are taking other medicines called fibrates to lower cholesterol. See “Other medicines and Quiloga tablets”.
• you regularly consume large amounts of alcohol.
• you have an underactive thyroid gland (hypothyroidism).
• you are over 70 years of age (your doctor must determine the appropriate dose of Quiloga tablets for you).
• you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used for bacterial infections), taken 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, skin peeling, 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 causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

Take particular 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 taking 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 starting to take any dose of Quiloga tablets.
Statins may affect liver function in a small number of people. This is detected by a simple blood test that monitors increases in liver enzyme levels. For this reason, your doctor will usually request this blood test (liver function test) during treatment with Quiloga tablets. It is important to attend all scheduled laboratory appointments with your doctor.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
If you are hospitalized or undergoing treatment for another medical 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 18 years of age.
Other medicines and Quiloga tablets
Talk to your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor if you are taking any of the following medicines:

• Ciclosporin (used, for example, after organ transplantation to prevent organ rejection). The effect of rosuvastatin increases when used together with this medicine. Do not take Quiloga tablets together with ciclosporin.
• Anticoagulants such as warfarin, acenocoumarol, or phenindione (their anticoagulant effect and risk of bleeding may increase if taken together with Quiloga tablets), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). When used together with fibrates, the effect of rosuvastatin is increased.
• Colestyramine (a medicine to lower cholesterol levels), as it may alter the action of ezetimibe.
• Antacids containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin levels in the blood). This effect may be reduced by taking such medicines 2 hours after taking 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 advise you when it is safe to restart Quiloga tablets. Taking Quiloga tablets with fusidic acid may rarely cause muscle weakness, fatigue, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
• An oral contraceptive (the pill). These increase the absorbed hormone levels from the pill.
• Hormone replacement therapy (increases hormone levels in the blood).
• Regorafenib (used to treat tumours).
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or undergoing treatment for another medical condition, inform the medical staff that you are taking Quiloga tablets.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Quiloga tablets if you are pregnant, think you may be pregnant, or are planning to become pregnant.
If you become pregnant while taking Quiloga tablets, stop taking it immediately and inform your doctor. Women must always use effective contraception during treatment with Quiloga tablets.
Breastfeeding
Do not take Quiloga tablets while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Driving and using machines
Quiloga tablets should not affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking Quiloga tablets. If you experience dizziness, consult your doctor before driving or using machines.
Quiloga tablets contain lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking Quiloga tablets.

3. How to take Quiloga tablets

Take this medicine exactly as prescribed by your doctor. 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 Quiloga tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take Quiloga tablets once daily.
It can be taken at any time of day, with or without food. Swallow each tablet whole with a glass of water. Take the medicine at the same time every day.
Quiloga tablets are not suitable for initial therapy.
The initiation of treatment or dose adjustment, if necessary, must only be performed by administering the active substances separately; once appropriate doses have been established, switching to Quiloga tablets is possible.
Regular cholesterol monitoring
It is important to visit your doctor regularly to monitor your cholesterol levels and ensure they have reached and remain within normal target ranges.
If you take more Quiloga tablets than you should
Contact your doctor or the nearest hospital emergency department immediately, as you may require medical attention.
If you forget to take Quiloga tablets
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 the missed dose.
If you stop taking Quiloga tablets
Talk to your doctor if you wish to discontinue treatment with Quiloga tablets. Your cholesterol levels may rise again if you stop taking Quiloga tablets.
If you have any further questions 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 everybody gets them.
It is important to be aware of the possible side effects.
Stop taking Quiloga tablets and go to a doctor immediately 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 (which includes skin rash, joint disorders and effects on blood cells).
• muscle breakdown.
• red, flat, target-shaped or circular spots, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes 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 have unusual muscle tenderness or pain lasting longer than expected. These symptoms may rarely progress to 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 levels of sugar and fats in your blood, 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;
• Increased levels in certain laboratory blood tests related to liver function (transaminases).

Uncommon side effects

• Rash, itching, hives;
• Increased amount of protein in the urine – which usually returns to normal without needing to stop rosuvastatin;
• Increases in certain 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 arms and legs;
• Swelling, especially of hands and feet.

Rare side effects
Inflammation of the pancreas, causing severe stomach pain radiating to the back, reduction in platelets.
Very rare side effects
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), blood in the urine, nerve damage in arms and legs (such as numbness), memory loss, breast enlargement in men (gynecomastia).
Not known
Shortness of breath, oedema (swelling), sleep disorders, including difficulty sleeping and nightmares, sexual problems, 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 may cause stomach pain, nausea, vomiting), myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing), ocular myasthenia (a disease causing weakness of the eye muscles).
Contact your doctor if you experience weakness in 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Quiloga tablets

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

6. Package contents and other information

What Quiloga tablets contain
The active substances 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 components are: Monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
crospovidone type A, povidone K-30, sodium lauryl sulfate and magnesium stearate.

Description of the appearance of Quiloga tablets and package contents
Quiloga 20 mg/10 mg tablets: white to off-white, round, biconvex, uncoated tablet. The tablet diameter 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. Tablet dimensions 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 tablet diameter is 10 mm.
Pack sizes of 14 and 30 tablets in blisters (PA/AL/PVC//Al) contained in cardboard boxes with the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the European Economic Area Member States under the following names
Italy Quiloga
Poland Rosuvastatin/Ezetimib Zentiva