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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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. Coatoris contains ezetimibe and atorvastatin.
Coatoris is used in adult patients to lower the level of total cholesterol, "bad" cholesterol (LDL) and fatty substances called triglycerides in the blood. Additionally, Coatoris increases the level of "good" cholesterol (HDL).
Coatoris lowers cholesterol in two ways. It reduces the absorption of cholesterol in the gut and its production in the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol mainly consists 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 plaques. Over time, this buildup can lead to narrowing of the arteries. This narrowing can slow down or block the flow of blood to vital organs such as the heart and brain. Blockage of blood flow can lead to 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 with diet alone. While taking this medicine, you should follow a cholesterol-lowering diet.
Coatoris is used as an addition to a cholesterol-lowering diet in:

• high 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;
• when statins and ezetimibe were previously taken as separate tablets.
• a hereditary disease (homozygous familial hypercholesterolemia) that causes high 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

Warnings and precautions

Before taking Coatoris, discuss with your doctor or pharmacist if:

• you have had a hemorrhagic stroke or have small cavities in the brain as a result of previous strokes,
• you have kidney disease,
• you have hypothyroidism,
• you have recurring or unexplained muscle pain, as well as a history of muscle disease or a family history of muscle disease,
• you have had muscle problems while taking other lipid-lowering medicines (e.g. other "statins" or "fibrates"),
• you regularly drink large amounts of alcohol,
• you have had liver disease in the past,
• you are over 70 years old,
• you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine,
• you are currently taking or have taken in 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).
• you have or have had myasthenia gravis (a disease characterized by general muscle weakness, including in some cases muscles used for breathing) or myasthenic syndrome (a disease that causes muscle weakness), as statins can sometimes exacerbate the condition or lead to myasthenia (see section 4).

Immediately contact your doctor if you 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.
Your 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, consult your doctor or pharmacist:

In the event of any of the above situations, consult your doctor or pharmacist, as your 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 side effects related to the muscles, 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, your doctor will carefully monitor your condition for diabetes or the risk of developing it. You are at risk of developing diabetes if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure.
Tell your doctor about all your illnesses, including allergies.
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 should not be used in children and adolescents.

Coatoris and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
There are medicines that can change the effect of Coatoris or whose effect may be changed 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),
• ketoconazole, 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 for 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 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 you need to take fusidic acid orally to treat a bacterial infection, stop taking this medicine temporarily. Your doctor will tell you when you can safely resume taking Coatoris. Taking Coatoris with fusidic acid can rarely lead to weakness, tenderness, or muscle pain (rhabdomyolysis). More information about 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 for heartburn and stomach ulcers),
• phenazone (a pain reliever),
• antacids (medicines for indigestion containing aluminum or magnesium compounds),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines given 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 are given in section 3. Pay attention to the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Coatoris.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. More information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Do not take Coatoris if you are pregnant, planning to become pregnant, or think you may be pregnant. Do not take Coatoris if you may become pregnant unless you are using effective contraception. If you become pregnant while taking Coatoris, stop taking the medicine immediately and tell your doctor.
Do not take Coatoris while breastfeeding.
The safety of Coatoris in pregnancy and breastfeeding has not been established.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Coatoris is unlikely to affect your ability to drive or use machines. However, keep in mind that some people may experience dizziness after taking Coatoris.

Coatoris contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your 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

Always take this medicine exactly as your doctor has told you. Your doctor will prescribe the appropriate strength of tablets based on your current treatment and risk status.
If you are unsure, ask your doctor or pharmacist.

• Before starting to take Coatoris, you should be on a cholesterol-lowering diet.
• Continue to follow a cholesterol-lowering diet while taking Coatoris.

Because the tablet does not have a dividing line, it should be swallowed whole and not divided.
How to take 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 your doctor has prescribed Coatoris with colestyramine or another bile acid sequestrant (to lower cholesterol), take Coatoris at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Coatoris than recommended

Consult your doctor or pharmacist.

Missing a dose of Coatoris

Do not take an extra dose. Take your normal dose of Coatoris at the usual time the next day.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, stop taking Coatoris and contact your doctor or go to the nearest emergency room immediately.

• 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 muscle pain or muscle rupture, especially if you also feel unwell or have a fever, which can be caused by abnormal muscle breakdown, which can lead to kidney damage;
• a condition that causes general muscle weakness, including in some cases muscles used for breathing (myasthenia-like syndrome).

In case of unexpected or unusual bleeding or bruising, contact your doctor as soon as possible, as these may be signs 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, stomach discomfort, stomach problems,
• acne, hives,
• joint pain, back pain, muscle cramps, fatigue, muscle spasms or weakness, pain in the arms and legs,
• unusual weakness, feeling tired or unwell, swelling, especially swelling of the ankles,
• increased values of some blood tests for liver function or muscle (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),
• myasthenic syndrome (a disease that causes muscle weakness).

Consult 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.
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),
• a 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 number of certain blood cells, which can lead to bruising/bleeding (thrombocytopenia),
• nasal passage inflammation, nosebleeds,
• neck pain, pain, chest pain, throat pain,
• increased or decreased blood sugar levels (in diabetes, continue to monitor blood sugar levels carefully),
• nightmares,
• numbness or tingling in the fingers and toes,
• 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. It is more likely to occur in patients with high sugar and fat levels in the blood, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine.
• muscle pain, tenderness, or persistent weakness, especially if you also feel unwell or have a fever, which may not go away after stopping Coatoris (unknown frequency).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coatoris

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 carton and blister after EXP. The expiry date refers to the last day of that 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, hydroxypropylcellulose, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, silica colloidal anhydrous, magnesium stearate, sodium lauryl sulfate, povidone, mannitol, sodium stearyl fumarate, and the following dyes: 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. Tablet dimensions: 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. Tablet dimensions: 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. Tablet dimensions: 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. Tablet dimensions: 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, contact your 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: