Coatoris

Leaflet accompanying the packaging: patient information

Coatoris, 10 mg + 10 mg, film-coated tablets

Coatoris, 10 mg + 20 mg, film-coated tablets

Coatoris, 10 mg + 40 mg, film-coated tablets

Coatoris, 10 mg + 80 mg, film-coated tablets

Ezetimibe + Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Coatoris and what is it used for
• 2. Important information before taking Coatoris
• 3. How to take Coatoris
• 4. Possible side effects
• 5. How to store Coatoris
• 6. Contents of the pack and other information

1. What is Coatoris and what is it used for

Coatoris is a medicine that lowers high cholesterol levels. Coatoris contains ezetimibe and atorvastatin.
Coatoris is used in adult patients to lower the levels of total cholesterol, "bad" cholesterol (LDL) and fatty substances called triglycerides in the blood. Additionally, Coatoris increases the levels of "good" cholesterol (HDL).
Coatoris lowers cholesterol levels in two ways. It reduces the absorption of cholesterol in the digestive tract and its production in the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of "bad" (LDL) and "good" (HDL) cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries and form a plaque that can lead to narrowing of the arteries. Over time, this narrowing can slow down or block the flow of blood to vital organs such as the heart and brain. Blocking blood flow can lead to a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of "bad" cholesterol in the walls of arteries and prevents heart disease.
Triglycerides are other fats in the blood that can increase the risk of heart disease.
Coatoris is used in patients who cannot control their cholesterol levels through diet alone. While taking this medicine, a cholesterol-lowering diet should be followed.

• high levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial or non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidemia)
• inadequate control with statin monotherapy;
• due to the use of statins and ezetimibe in separate tablets.
• inherited disease (homozygous familial hypercholesterolemia) that causes high levels of cholesterol in the blood. Other treatments may also be used.
• heart disease. Coatoris reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Coatoris does not affect weight loss.

2. Important information before taking Coatoris

When not to take Coatoris

• if the patient is allergic to ezetimibe, atorvastatin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• if the patient is of childbearing age and is not using effective methods of contraception,
• if the patient is pregnant, trying to become pregnant, or breastfeeding,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting to take Coatoris, the patient should discuss with their doctor or pharmacist if:

• the patient has had a hemorrhagic stroke or has small cavities in the brain as a result of previous strokes,
• the patient has kidney disease,
• the patient has hypothyroidism,
• the patient has recurring or unexplained muscle pain, as well as muscle disease in the past or in the family,
• the patient has experienced muscle-related side effects while taking other lipid-lowering medicines (e.g., other "statins" or "fibrates"),
• the patient regularly consumes large amounts of alcohol,
• the patient has had liver disease in the past,
• the patient is over 70 years old,
• the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine,
• the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Coatoris may lead to serious muscle problems (rhabdomyolysis).
• the patient has or has had myasthenia gravis (a disease characterized by general muscle weakness, including in some cases muscles used for breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate the condition or lead to the development of myasthenia (see section 4).

The patient should contact their doctor immediately if they experience unexplained muscle pain,

tenderness, or weakness while taking Coatoris.Because in rare cases, muscle disorders can be severe, including muscle breakdown, which can lead to kidney damage. It is known that atorvastatin causes muscle disorders. Cases of muscle disorders have also been reported with ezetimibe.
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
Before taking Coatoris, the patient should consult their doctor or pharmacist:

• if the patient has severe respiratory failure.

In the event of any of the above situations, the patient should consult their doctor or pharmacist, as the doctor will need to perform a blood test before starting treatment with Coatoris and, if possible, during treatment to determine the risk of side effects related to the muscles. It is known that the risk of muscle-related side effects, such as rhabdomyolysis (muscle damage), is increased by certain medications taken at the same time (see section 2 "Coatoris and other medicines").
During treatment with this medicine, the doctor will closely monitor the patient's condition for diabetes or the risk of developing diabetes. The patient is at risk of developing diabetes if they have high levels of sugar and fatty substances in the blood, are overweight, and have high blood pressure.
The patient should inform their doctor about all their illnesses, including allergies.
The patient should avoid taking Coatoris and fibrates (cholesterol-lowering medicines) at the same time, as the combination of Coatoris and fibrates has not been studied.

Children and adolescents

Coatoris is not recommended for use in children and adolescents.

Coatoris and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
There are medicines that can affect the action of Coatoris or whose action may be affected by Coatoris (see section 3). This type of interaction can lead to reduced efficacy of one or both medicines. It can also increase the risk or severity of side effects, including serious muscle damage called "rhabdomyolysis", described in section 4, or worsen its course:

• cyclosporine (a medicine often used in patients who have had organ transplants),
• erythromycin, clarithromycin, telithromycin, fusidic acid **, rifampicin (antibiotics),
• ketokonazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungal medicines),
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestyramine, colestipol (medicines used to regulate lipid levels),
• certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc. (medicines used in the treatment of AIDS),
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

**If it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should temporarily stop taking Coatoris. The doctor will indicate when it is safe to resume taking Coatoris. Taking Coatoris with fusidic acid can rarely lead to weakness, tenderness, or muscle pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

• Other medicines that have been reported to interact with Coatoris:
• oral contraceptives (used to prevent pregnancy),
• stiripentol (an antiepileptic medicine used to treat epilepsy),
• cimetidine (a medicine used to treat heartburn and stomach ulcers),
• phenazone (a pain reliever),
• antacids (medicines used to treat indigestion containing aluminum or magnesium compounds),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines used to prevent blood clots),
• colchicine (used to treat gout),
• St. John's Wort (a medicine used to treat depression).

Coatoris with food, drink, and alcohol

Instructions for taking Coatoris can be found in section 3. The patient should pay attention to the following:

Grapefruit juice
The patient should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can affect the action of Coatoris.
Alcohol
The patient should avoid drinking excessive amounts of alcohol while taking this medicine. More information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Coatoris should not be taken if the patient is pregnant, planning to become pregnant, or thinks they may be pregnant. Coatoris should not be taken if there is a possibility of becoming pregnant, unless the patient is using effective methods of contraception. If the patient becomes pregnant while taking Coatoris, they should stop taking the medicine immediately and inform their doctor.
Coatoris should not be taken during breastfeeding.
The safety of Coatoris during pregnancy and breastfeeding has not been established.
The patient should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Coatoris is not expected to affect the ability to drive or use machines. However, the patient should be aware that some people may experience dizziness after taking Coatoris.

Coatoris contains lactose and sodium

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Coatoris

This medicine should always be taken exactly as prescribed by the doctor. The doctor will prescribe the appropriate strength of tablets based on the patient's current treatment and risk status.
In case of doubts, the patient should consult their doctor or pharmacist.

• Before starting to take Coatoris, the patient should follow a cholesterol-lowering diet.
• The patient should continue to follow a cholesterol-lowering diet while taking Coatoris.

Since the tablet does not have a dividing line, it should be swallowed whole and not divided.
How to dose Coatoris
The recommended dose is one Coatoris tablet, taken orally once a day.
When to take Coatoris
Coatoris can be taken at any time of day, with or without food.
If the doctor has prescribed Coatoris with colestyramine or another bile acid sequestrant (used to lower cholesterol), Coatoris should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Coatoris than recommended

The patient should consult their doctor or pharmacist.

Missing a dose of Coatoris

The patient should not take an extra dose. The patient should take the standard dose of Coatoris at the usual time the next day.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Coatoris can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects or symptoms, they should stop taking Coatoris and contact their doctor immediately or go to the nearest emergency room.

• severe allergic reactions causing swelling of the face, tongue, and throat, which can make breathing difficult;
• severe skin disease with severe peeling and swelling of the skin, with blisters on the skin, in the mouth, eyes, and genitals, and fever;
• weakness, tenderness, or pain in the muscles, or red-brown urine, especially if the patient feels unwell or has a fever, which can be caused by abnormal muscle breakdown, which can lead to kidney damage;
• lupus-like syndrome (including rash, joint diseases, and effects on blood cells).

In case of unexpected or unusual bleeding or bruising, the patient should contact their doctor as soon as possible, as these may be symptoms of liver damage.
The following common side effects (may affect up to 1 in 10 people) have been reported:

• diarrhea,
• muscle pain.

The following uncommon side effects (may affect up to 1 in 100 people) have been reported:

• flu,
• depression, difficulty sleeping, sleep disorders,
• dizziness, headache, tingling sensation,
• slow heart rate,
• hot flashes,
• shortness of breath,
• abdominal pain, bloating, constipation, indigestion, bloating, frequent bowel movements, stomach inflammation, nausea, discomfort in the stomach, stomach problems,
• acne, hives,
• joint pain, back pain, leg cramps, fatigue, muscle cramps or weakness, pain in the hands and feet,
• unusual weakness, feeling of tiredness or malaise, swelling, especially swelling of the ankles,
• increased values of certain blood tests for liver or muscle function (CK),
• weight gain.

The following side effects have been reported with an unknown frequency (frequency cannot be estimated from the available data):

• myasthenia gravis (a disease characterized by general muscle weakness, including in some cases muscles used for breathing),
• ocular myasthenia (a disease that causes muscle weakness in the eyes).

The patient should contact their doctor if they experience weakness in their arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Additionally, the following side effects have been reported in patients taking Coatoris or ezetimibe or atorvastatin tablets:

• allergic reactions, including swelling of the face, lips, tongue, and (or) throat, causing difficulty breathing or swallowing (requiring immediate treatment),
• raised, red rash, sometimes with target-like lesions,
• liver function disorders,
• cough,
• heartburn,
• decreased appetite, loss of appetite,
• high blood pressure,
• skin rash and itching, allergic reactions including rash and hives,
• tendon damage,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting),
• pancreatitis, often with severe abdominal pain,
• decreased numbers of certain blood cells, which can lead to bruising/bleeding (thrombocytopenia),
• nasal congestion, nosebleeds,
• neck pain, pain, chest pain, throat pain,
• increased or decreased blood sugar levels (in the case of diabetes, blood sugar levels should continue to be closely monitored),
• nightmares,
• numbness or tingling in the hands and feet,
• reduced sensation of pain or touch,
• change in taste, dry mouth,
• memory loss,
• ringing in the ears and (or) head, hearing loss,
• vomiting,
• belching,
• hair loss,
• fever,
• positive urine test for white blood cells,
• blurred vision; vision disorders,
• gynecomastia (enlargement of breast tissue in men).

Possible side effects reported with some statins:

• sexual disorders,
• depression,
• breathing difficulties, including persistent cough and (or) shortness of breath or fever,
• diabetes. Its occurrence is more likely in patients with high levels of sugar and fatty substances in the blood, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
• muscle pain, tenderness, or persistent weakness, especially if the patient feels unwell or has a fever, which may not resolve after stopping Coatoris (frequency unknown).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Coatoris

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Store in the original package to protect from moisture.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Coatoris contains

• The active substances of Coatoris are ezetimibe and atorvastatin. Coatoris, 10 mg + 10 mg: Each film-coated tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 10 mg of atorvastatin. Coatoris, 10 mg + 20 mg: Each film-coated tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 20 mg of atorvastatin. Coatoris, 10 mg + 40 mg: Each film-coated tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 40 mg of atorvastatin. Coatoris, 10 mg + 80 mg: Each film-coated tablet contains 10 mg of ezetimibe and atorvastatin calcium trihydrate equivalent to 80 mg of atorvastatin.
• Other ingredients are calcium carbonate, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate, povidone, mannitol, sodium stearyl fumarate, yellow iron oxide (E 172) in the tablet core, and hypromellose, macrogol (E 1521), titanium dioxide (E 171), talc (E 553b), yellow iron oxide (E 172) (only for 10 mg+10 mg, 10 mg+20 mg), red iron oxide (E 172) (only for 10 mg+20 mg, 10 mg+40 mg, 10 mg+80 mg), and black iron oxide (E 172) (only for 10 mg+80 mg) in the coating. See section 2 "Coatoris contains lactose and sodium".

What Coatoris looks like and contents of the pack

Coatoris, 10 mg + 10 mg, film-coated tablets (tablets) are light yellow, oval, biconvex film-coated tablets with the marking A1 on one side of the tablet. The dimensions of the tablet are approximately 13 mm x 6 mm.
Coatoris, 10 mg + 20 mg, film-coated tablets (tablets) are light orange, biconvex film-coated tablets in the shape of a capsule, with the marking A2 on one side of the tablet. The dimensions of the tablet are approximately 14 mm x 6 mm.
Coatoris, 10 mg + 40 mg, film-coated tablets (tablets) are light pink, oval, biconvex film-coated tablets with the marking A4 on one side of the tablet. The dimensions of the tablet are approximately 17 mm x 8 mm.
Coatoris, 10 mg + 80 mg, film-coated tablets (tablets) are light purple, oval, biconvex film-coated tablets with the marking A8 on one side of the tablet. The dimensions of the tablet are approximately 19 mm x 9 mm.
Coatoris is available in cartons containing 10, 20, 30, 60, 90, or 100 film-coated tablets, in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: