Coatoris

Package leaflet: Information for the user

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
Please 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Coatoris is and what it is used for
2. What you need to know 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 Coatoris is and what it is used for

Coatoris is a medicine that lowers elevated cholesterol levels. Coatoris contains ezetimibe and atorvastatin.
Coatoris is used in adult patients to reduce total cholesterol, "bad" cholesterol (LDL), and blood fat substances known as triglycerides. In addition, Coatoris increases the level of "good" cholesterol (HDL).
Coatoris reduces cholesterol levels in two ways. It reduces cholesterol absorption in the gastrointestinal tract and also reduces its production in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of "bad" (LDL) and "good" (HDL) cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries and form atherosclerotic plaque. Over time, this buildup can lead to narrowing of the arteries. This narrowing may slow down or block blood flow to vital organs such as the heart and brain. Blocked blood flow may lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from depositing in artery walls and helps protect against heart disease.
Triglycerides are other fats present in the blood that may increase the risk of heart disease.
Coatoris is used in patients in whom cholesterol levels cannot be controlled by 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 the following cases:

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial or non-familial]) or elevated blood fat levels (mixed hyperlipidemia)
• inadequate control with statins used as monotherapy
• when statins and ezetimibe have been used as separate tablets
• a hereditary condition (homozygous familial hypercholesterolemia) that causes elevated blood cholesterol levels. Other treatment methods may also be used.
• heart disease. Coatoris reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Coatoris does not affect body weight reduction.

2. Important information before using Coatoris

When not to use 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 currently has or has previously had liver disease,
• if the patient has unexplained abnormal results of liver function blood tests,
• if the patient is of childbearing age and is not using effective contraceptive methods,
• if the patient is pregnant, trying to become pregnant, or breastfeeding,
• if the patient is currently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Coatoris, consult your doctor or pharmacist if:

• the patient has previously had a haemorrhagic stroke or has small fluid-filled cysts in the brain as a result of previous strokes,
• the patient has kidney disease,
• the patient has hypothyroidism,
• the patient has recurrent or unexplained muscle pain, or a history of muscle disorders in the patient or in the family,
• the patient has previously experienced muscle-related side effects during treatment with other lipid-lowering medicines (e.g. other "statins" or "fibrates"),
• the patient regularly consumes large amounts of alcohol,
• the patient has previously had liver disease,
• the patient is over 70 years of age,
• the patient has previously been diagnosed with intolerance to certain sugars; the patient should contact the doctor before taking this medicine,
• the patient is currently taking or has taken within the last 7 days the medicine fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Coatoris may lead to serious muscle problems (rhabdomyolysis).
• the patient currently has or has previously had myasthenia gravis (a disease causing generalised muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), because statins may occasionally worsen the condition or lead to the development of myasthenia (see section 4).

Contact your doctor immediately if unexplained muscle pain,
tenderness or weakness occurs while taking Coatoris. In rare cases,
muscle disorders may be severe, including muscle breakdown, which may lead to
kidney damage. It is known that atorvastatin may cause muscle disorders. Cases of muscle disorders
have also been reported during treatment with ezetimibe.
Inform your doctor or pharmacist also if muscle weakness persists. Additional
tests and additional medicines may be necessary for diagnosis and treatment of this condition.
Before taking Coatoris, consult your doctor or pharmacist:

• if the patient has severe respiratory insufficiency.

If any of the above conditions (or suspected conditions) are present, consult your doctor or pharmacist, as the doctor may need to perform blood tests before starting treatment with Coatoris and periodically during treatment to assess the risk of muscle-related adverse reactions. It is known that the risk of muscle-related adverse reactions, such as rhabdomyolysis (muscle damage), may be increased by certain concomitant medicines (see section 2 "Coatoris with other medicines").
During treatment with this medicine, the doctor will closely monitor the patient for diabetes or risk of developing diabetes. The patient is at risk of developing diabetes if they have high blood sugar and lipid levels, are overweight, and have hypertension.
Inform your doctor about all medical conditions, including allergies.
Avoid concomitant use of Coatoris and fibrates (medicines that lower cholesterol levels), 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription, as well as any medicines the patient plans to take.
Some medicines may alter the effect of Coatoris or may have their effect altered by Coatoris (see section 3). This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk or severity of adverse reactions, including a serious condition causing muscle damage known as "rhabdomyolysis", described in section 4, or worsen its course:

• cyclosporine (a medicine often used in organ transplant patients),
• erythromycin, clarithromycin, telithromycin, fusidic acid **, rifampicin (medicines used to treat bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),
• gemfibrozil, other fibrates, nicotinic acid and its derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels),
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines regulating heart rhythm),
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir combination, etc. (medicines used in AIDS),
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and the fixed-dose combination containing elbasvir and grazoprevir,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

**If oral fusidic acid must be used to treat a bacterial infection,
treatment with this medicine should be temporarily discontinued. Your doctor will advise when
it is safe to resume taking Coatoris. Concomitant use of Coatoris
and fusidic acid may rarely lead to muscle weakness,
tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis
is provided in section 4.

• Other medicines known to interact with Coatoris:
• oral contraceptives (used for birth control),
• stiripentol (an anticonvulsant used to treat epilepsy),
• cimetidine (a medicine used for heartburn and peptic ulcer disease),
• phenazone (a pain-relieving medicine),
• antacids (medicines for indigestion containing aluminium or magnesium compounds),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines given to prevent blood clots),
• colchicine (used in the treatment of gout),
• St John's wort (a herbal remedy used to treat depression).

Coatoris with food, drink and alcohol
Instructions for using Coatoris are provided in section 3. Please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Coatoris.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. Detailed information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Do not take Coatoris if the patient is pregnant, planning to become pregnant, or suspects she may be pregnant. Do not take Coatoris if there is any possibility of pregnancy, unless the patient is using effective contraceptive methods. If pregnancy occurs while taking Coatoris, stop taking the medicine immediately and inform your doctor.
Do not take Coatoris during breastfeeding.
The safety of Coatoris during pregnancy and breastfeeding has not been established.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Coatoris is not expected to affect the ability to drive or operate machinery. However, bear in mind that dizziness may occur in some people after taking Coatoris.

Coatoris contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to take Coatoris

This medicine should always be taken exactly as directed by your doctor. Your doctor will determine the appropriate tablet strength based on your current treatment and risk status.
If in doubt, consult your doctor or pharmacist.

• Before starting treatment with Coatoris, a cholesterol-lowering diet should be initiated.
• A cholesterol-lowering diet should be continued during treatment with Coatoris.

Since the tablet does not have a break line, it should be swallowed whole and not divided.
How to take the medicine
The recommended dose is one Coatoris tablet, taken orally once daily.
When to take the medicine
Coatoris can be taken at any time of day, with or without food.
If your doctor has prescribed Coatoris together with colestyramine or another bile acid-binding medicine (intended to reduce cholesterol levels), Coatoris should be taken at least 2 hours before or 4 hours after taking the bile acid-binding medicine.
Taking more Coatoris than recommended
Seek advice from your doctor or pharmacist.
Missing a dose of Coatoris
Do not take an extra dose. Take the usual dose of Coatoris at the regular time the next day.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Coatoris can cause adverse reactions, although not everyone will experience them.
If any of the following severe adverse reactions or symptoms occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

• severe allergic reactions causing swelling of the face, tongue and throat, which may significantly impair breathing;
• severe illness with extensive skin peeling and swelling, formation of blisters on the skin, inside the mouth, eyes and genital organs, accompanied by fever; skin rash with pink-red spots, particularly on the palms and soles, which may lead to blister formation;
• muscle weakness, tenderness, pain or tearing, or red-brown discoloration of urine, especially if accompanied by malaise or fever, which may be due to abnormal muscle breakdown that can be life-threatening and lead to kidney disorders;
• lupus-like syndrome (including rash, joint disorders and effects on blood cells).

If unexpected or unusual bleeding or bruising occurs, contact your doctor as soon as possible, as these may be symptoms of liver disorders.
The following common adverse reactions have been reported (may affect up to 1 in 10 people):

• diarrhoea,
• muscle pain.

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

• influenza-like illness,
• depression, difficulty falling asleep, sleep disturbances,
• dizziness, headache, tingling sensation,
• slow heart rate,
• hot flushes,
• shortness of breath,
• abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, gastric inflammation, nausea, stomach discomfort, gastrointestinal discomfort,
• acne, urticaria,
• joint pain, back pain, leg cramps, fatigue, muscle cramps or weakness, pain in arms and legs,
• unusual weakness, feeling of tiredness or malaise, swelling, particularly of the ankles,
• increased values in certain blood tests related to liver or muscle function (CK),
• weight gain.

The following adverse reactions have been reported with unknown frequency (frequency cannot be estimated from available data):

• myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles used during breathing),
• ocular myasthenia (a disease causing weakness of eye muscles).

Contact your doctor if the patient experiences weakness in arms or legs that worsens with activity, double vision, drooping eyelids, difficulty swallowing or shortness of breath.
Additionally, the following adverse reactions have been reported in patients taking Coatoris or tablets containing ezetimibe or atorvastatin:

• allergic reactions, including swelling of the face, lips, tongue and (or) throat causing difficulty in breathing or swallowing (requiring immediate treatment),
• raised, red rash, sometimes with target-like lesions,
• liver function disorders,
• cough,
• heartburn,
• decreased appetite, loss of appetite,
• hypertension,
• skin rash and itching, allergic reactions involving rash and urticaria,
• tendon injury,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting),
• pancreatitis, often with severe abdominal pain,
• reduced number of certain blood cells, which may lead to bruising/bleeding (thrombocytopenia),
• inflammation of nasal passages, nosebleeds,
• neck pain, pain, chest pain, sore throat,
• increased or decreased blood glucose levels (in patients with diabetes, careful monitoring of blood glucose levels should be continued),
• nightmares,
• numbness or tingling in fingers of hands and feet,
• reduced sensation of pain or touch,
• altered taste perception, dry mouth,
• memory loss,
• ringing in the ears and (or) head, hearing loss,
• vomiting,
• belching,
• hair loss,
• elevated body temperature,
• positive urine test for white blood cells,
• blurred vision; visual disturbances,
• gynaecomastia (enlargement of breast tissue in men).

Possible adverse reactions reported with some statins:

• sexual dysfunction,
• depression,
• breathing difficulties, including persistent cough and (or) shortness of breath or fever,
• diabetes. The occurrence of diabetes is more likely in patients with high levels of blood glucose and lipids, overweight and hypertension. Your doctor will monitor your condition during treatment with this medicine.
• muscle pain, tenderness or persistent muscle weakness, especially if accompanied by malaise or fever, which may not resolve after discontinuation of Coatoris (frequency unknown).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from moisture.
There are no special requirements for the storage temperature of this medicine.
Medicines must 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 are ezetimibe and atorvastatin. Coatoris 10 mg + 10 mg: Each film-coated tablet contains 10 mg of ezetimibe and calcium atorvastatin trihydrate equivalent to 10 mg of atorvastatin. Coatoris 10 mg + 20 mg: Each film-coated tablet contains 10 mg of ezetimibe and calcium atorvastatin trihydrate equivalent to 20 mg of atorvastatin. Coatoris 10 mg + 40 mg: Each film-coated tablet contains 10 mg of ezetimibe and calcium atorvastatin trihydrate equivalent to 40 mg of atorvastatin. Coatoris 10 mg + 80 mg: Each film-coated tablet contains 10 mg of ezetimibe and calcium atorvastatin trihydrate equivalent to 80 mg of atorvastatin.
• The other ingredients are calcium carbonate, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, 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, marked with "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, capsule-shaped, biconvex film-coated tablets, marked with "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, marked with "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 violet, oval, biconvex film-coated tablets, marked with "A8" on one side of the tablet. Tablet dimensions: approximately 19 mm x 9 mm.
Coatoris is available in cardboard boxes containing 10, 20, 30, 60, 90 or 100 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further information regarding this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500