Ezetimibe and atorvastatin Doc Generici

Patient Information Leaflet

EZETIMIBE AND ATORVASTATIN DOCgen 10 mg/10 mg film-coated tablets, mg/20 mg film-coated tablets, mg/40 mg film-coated tablets, mg/80 mg film-coated tablets

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What EZETIMIBE AND ATORVASTATIN DOCgen is and what it is used for
2. What you need to know before taking EZETIMIBE AND ATORVASTATIN DOCgen
3. How to take EZETIMIBE AND ATORVASTATIN DOCgen
4. Possible side effects
5. How to store EZETIMIBE AND ATORVASTATIN DOCgen
6. Contents of the pack and other information

1. What EZETIMIBE AND ATORVASTATIN DOCgen is and what it is used for

EZETIMIBE AND ATORVASTATIN DOCgen is a medicine used to lower elevated cholesterol levels. EZETIMIBE AND ATORVASTATIN DOCgen contains ezetimibe and atorvastatin.
EZETIMIBE AND ATORVASTATIN DOCgen is a medicine used in adults to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats called triglycerides. It also increases levels of "good" cholesterol (HDL cholesterol).
EZETIMIBE AND ATORVASTATIN DOCgen works in two ways to lower cholesterol: by reducing cholesterol absorbed in the gastrointestinal tract and by reducing cholesterol naturally produced by the body.
Cholesterol is one of several types of fat found in the bloodstream. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage of blood flow may cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from accumulating in the arteries and provides protection against heart disease.
Triglycerides are another type of fat present in the blood that may increase the risk of heart disease.
Your doctor may prescribe EZETIMIBE AND ATORVASTATIN DOCgen if you are already taking both atorvastatin and ezetimibe at the same dosage, but as separate products, in addition to a cholesterol-lowering diet, if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated levels of fats in the blood (mixed hyperlipidemia)
• heart disease. EZETIMIBE AND ATORVASTATIN DOCgen reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

EZETIMIBE AND ATORVASTATIN DOCgen does not help with weight loss.

2. What you need to know before taking EZETIMIBE AND ATORVASTATIN DOCgen

Do not take EZETIMIBE AND ATORVASTATIN DOCgen if:

• you are allergic to atorvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6);
• you have or have ever had liver disease;
• you have had unexplained abnormal blood tests assessing liver function;
• you are a woman of childbearing potential and you are not using a reliable method of contraception;
• you are pregnant, trying to become pregnant, or breastfeeding;
• you are taking the combination glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking EZETIMIBE AND ATORVASTATIN DOCgen if:

• you have previously had a stroke with cerebral hemorrhage or have small accumulations of fluid in the brain due to past strokes;
• you have kidney problems;
• you have an underactive thyroid gland (hypothyroidism);
• you have had repeated or unexplained episodes of muscle discomfort or pain, or have a personal or family history of muscle disorders;
• you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other "statins" or "fibrates");
• you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and EZETIMIBE AND ATORVASTATIN DOCgen may lead to serious muscle problems (rhabdomyolysis);
• you regularly consume large amounts of alcohol;
• you have a history of liver disease;
• you are over 70 years old;
• you have or have previously had myasthenia (a disease characterized by generalized muscle weakness, which in some cases may include muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or trigger its onset (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness
while taking EZETIMIBE AND ATORVASTATIN DOCgen. This is because, on rare occasions, muscle problems can be severe, including muscle breakdown leading to kidney damage. It is known that atorvastatin can cause muscle problems, and cases of muscle-related adverse effects have also been reported with ezetimibe.
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
Before taking EZETIMIBE AND ATORVASTATIN DOCgen, check with your doctor or pharmacist:

• if you have severe respiratory insufficiency. If any of these conditions apply to you (or if you are unsure), consult your doctor or pharmacist before taking EZETIMIBE AND ATORVASTATIN DOCgen, as your doctor may request a blood test before and possibly during treatment with EZETIMIBE AND ATORVASTATIN DOCgen to assess the risk of muscle-related side effects. It is known that the risk of developing muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and EZETIMIBE AND ATORVASTATIN DOCgen”).
  During treatment with this medicine, your doctor will monitor you carefully if you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.
  Inform your doctor about all your medical conditions, including allergies.

Children
The use of EZETIMIBE AND ATORVASTATIN DOCgen is not recommended in children and adolescents.

Other medicines and EZETIMIBE AND ATORVASTATIN DOCgen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Fibrates (medicines used to lower cholesterol) should be avoided during treatment with EZETIMIBE AND ATORVASTATIN DOCgen.
Some medicines may alter the effect of EZETIMIBE AND ATORVASTATIN DOCgen, or their effect may be altered by EZETIMIBE AND ATORVASTATIN DOCgen (see section 3). Such interactions could reduce the effectiveness of one or both medicines. Alternatively, they could increase the risk or severity of adverse effects, including the serious condition of muscle breakdown known as "rhabdomyolysis" described in section 4:

• 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 to treat angina or hypertension, e.g., amlodipine and diltiazem;
• digoxin, verapamil, amiodarone (medicines used to regulate heart rhythm);
• letermovir (a medicine used to help prevent cytomegalovirus disease);
• medicines used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (medicines for treating AIDS);
• certain medicines used to treat hepatitis C, e.g., telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir;
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

Other medicines known to interact with EZETIMIBE AND ATORVASTATIN DOCgen include:

• oral contraceptives (medicines used to prevent pregnancy);
• stiripentol (an anticonvulsant medicine used to treat epilepsy);
• cimetidine (a medicine used to treat heartburn and peptic ulcers);
• phenazone (a pain reliever);
• antacids (medicines used to treat digestive problems containing aluminium or magnesium);
• warfarin, phenprocouone, acenocoumarol, or fluindione (medicines used to prevent blood clots);
• colchicine (used to treat gout);
• St. John’s wort (a herbal remedy used to treat depression).

EZETIMIBE AND ATORVASTATIN DOCgen with food, drinks, and alcohol
For instructions on how to take EZETIMIBE AND ATORVASTATIN DOCgen, see section 3.
Please pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of EZETIMIBE AND ATORVASTATIN DOCgen.

Alcohol
Avoid excessive alcohol consumption during treatment with this medicine. For further information, refer to section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility
Do not take EZETIMIBE AND ATORVASTATIN DOCgen if you are pregnant, planning to become pregnant, or suspect you may be pregnant.
Do not take EZETIMIBE AND ATORVASTATIN DOCgen if you are a woman of childbearing potential unless you are using an effective method of contraception. If you become pregnant during treatment with EZETIMIBE AND ATORVASTATIN DOCgen, stop taking the medicine immediately and consult your doctor.
Do not take EZETIMIBE AND ATORVASTATIN DOCgen if you are breastfeeding.
If you are pregnant, breastfeeding, planning a pregnancy, or suspect you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
EZETIMIBE AND ATORVASTATIN DOCgen is not expected to affect your ability to drive or operate machinery. However, bear in mind that some people may experience dizziness after taking EZETIMIBE AND ATORVASTATIN DOCgen. If you experience dizziness, consult your doctor before driving or operating machinery.

EZETIMIBE AND ATORVASTATIN DOCgen contains lactose
EZETIMIBE AND ATORVASTATIN DOCgen 10 mg/10 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
EZETIMIBE AND ATORVASTATIN DOCgen 10 mg/20 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
EZETIMIBE AND ATORVASTATIN DOCgen 10 mg/40 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
EZETIMIBE AND ATORVASTATIN DOCgen 10 mg/80 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

EZETIMIBE AND ATORVASTATIN DOCgen contains sodium
EZETIMIBE AND ATORVASTATIN DOCgen contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take EZETIMIBE AND ATORVASTATIN DOCgen

Take this medicine exactly as your doctor has instructed you. Your doctor will determine the appropriate tablet dosage for you based on your ongoing treatment and individual risk profile. If you have any doubts, consult your doctor or pharmacist.

• Before starting treatment with EZETIMIBE AND ATORVASTATIN DOCgen, you must already have started a cholesterol-lowering diet.
• During treatment with EZETIMIBE AND ATORVASTATIN DOCgen, you must continue to follow this cholesterol-lowering diet.

What dose to take
The recommended dose is one tablet of EZETIMIBE AND ATORVASTATIN DOCgen once daily, preferably at the same time each day.
The recommended dose is one tablet of EZETIMIBE AND ATORVASTATIN DOCgen taken orally once daily. The tablet should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

When to take the dose
Take EZETIMIBE AND ATORVASTATIN DOCgen at any time of day. You may take it with or without food.
If your doctor has prescribed EZETIMIBE AND ATORVASTATIN DOCgen together with cholestyramine or another bile acid sequestrant (medicines used to lower cholesterol levels), you must take EZETIMIBE AND ATORVASTATIN DOCgen at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE AND ATORVASTATIN DOCgen than you should
Contact your doctor or pharmacist.

If you forget to take EZETIMIBE AND ATORVASTATIN DOCgen
Do not take a double dose to make up for the missed dose. Take your next dose at the usual time with your normal prescribed dose of EZETIMIBE AND ATORVASTATIN DOCgen.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, EZETIMIBE E ATORVASTATINA DOCgen can cause side effects,
although not everyone experiences them.
If you notice any of the following serious side effects or symptoms,
stop taking the tablets immediately and contact your doctor or go to the
nearest hospital emergency department.

• severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe difficulty breathing
• severe illness with extensive skin peeling and swelling, skin blistering, blistering of the mouth, eyes, genitals, and fever; skin rash with pink-red pustules, particularly on the palms of the hands or soles of the feet, which may develop into blisters
• weakness, tenderness, pain or muscle breakdown, or red-brown discoloration of urine, especially if accompanied by feeling unwell and high fever; this may be due to unusual muscle breakdown, which can be life-threatening and may lead to kidney problems
• lupus-like syndrome (including skin rash, joint problems, and effects on blood cells)

If you experience unexpected or unusual bleeding or bruising, consult your doctor as soon as possible, as these may be signs of liver problems.
Other possible side effects of EZETIMIBE E ATORVASTATINA DOCgen:
Common (may affect up to 1 in 10 people):

• diarrhoea,
• muscle pain.

Uncommon (may affect up to 1 in 100 people):

• influenza,
• depression; difficulty falling asleep; sleep disturbances,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flushes,
• shortness of breath,
• abdominal pain; abdominal swelling; constipation; indigestion, flatulence; frequent bowel movements,
• inflammation of the stomach; nausea; stomach discomfort; stomach disorders,
• acne; urticaria,
• joint pain; back pain; leg cramps; fatigue, muscle spasms or weakness; pain in arms and legs,
• unusual weakness; feeling of tiredness or malaise; swelling, especially in the ankles (oedema),
• increases in certain blood test values indicating liver or muscle function (CK),
• weight gain.

Rare (may affect up to 1 in 1,000 people):

• skin rash which may occur on the skin or mouth ulcers (drug-induced lichenoid reaction)
• purpuric skin lesions (signs of inflammation of blood vessels, vasculitis)

Not known (frequency cannot be estimated from the available data):

• 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 the arms or legs that worsens after periods of activity, double vision, drooping eyelids, difficulty swallowing, or shortness of breath.
Additionally, the following side effects have been reported in people taking statin tablets with ezetimibe, or ezetimibe or atorvastatin (medicines used to lower cholesterol):

• allergic reactions including swelling of the face, lips, tongue and/or throat, which may
• cause difficulty breathing or swallowing (a condition requiring immediate intervention),
• raised rash with redness, sometimes accompanied by "target-like" lesions,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including skin rashes and urticaria,
• tendon injury,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea and
• vomiting),
• inflammation of the pancreas, often with severe abdominal pain,
• reduction in blood cell count, which may cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nosebleeds,
• neck pain; pain; chest pain; throat pain,
• increased and decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully),
• nightmares,
• numbness or tingling in the fingers and toes,
• reduced sensitivity to pain or touch,
• altered sense of taste; dry mouth,
• memory loss,
• ringing in the ears and/or head; hearing loss,
• vomiting,
• belching,
• hair loss,
• increased body temperature,
• urine tests positive for white blood cells,
• blurred vision; visual disturbances,
• gynaecomastia (enlargement of the breast in men).

Possible side effects reported with some statins:

• sexual dysfunction,
• depression,
• breathing problems including persistent cough and/or shortness of breath or fever,
• diabetes. More likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine,
• muscle pain, tenderness or weakness that is persistent, and particularly if, at the same time, you feel unwell or have a high fever that does not resolve after stopping treatment with EZETIMIBE E ATORVASTATINA DOCgen (frequency not known).

Reporting of side effects
If you experience any side effects, 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 the following website: 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 EZETIMIBE AND ATORVASTATIN DOCgen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store the medicine in its original packaging to protect it from light.
Do not dispose of medicines 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 EZETIMIBE E ATORVASTATINA DOCgen contains
The active substances are ezetimibe and atorvastatin.
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/10 mg: Each tablet contains 10 mg of
ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/20 mg: Each tablet contains 10 mg of
ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/40 mg: Each tablet contains 10 mg of
ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/80 mg: Each tablet contains 10 mg of
ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components are:
Tablet core
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/10 mg: Monohydrate lactose, microcrystalline
cellulose, croscarmellose sodium, red iron oxide (E172), sodium lauryl sulfate, povidone
K30, magnesium stearate, calcium carbonate, polysorbate 80
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/20 mg: Monohydrate lactose, microcrystalline
cellulose, croscarmellose sodium, red iron oxide (E172), sodium lauryl sulfate, povidone
K30, magnesium stearate, calcium carbonate, polysorbate 80
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/40 mg: Monohydrate lactose, microcrystalline
cellulose, croscarmellose sodium, red iron oxide (E172), sodium lauryl sulfate, povidone
K30, magnesium stearate, calcium carbonate, polysorbate 80
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/80 mg: Monohydrate lactose, microcrystalline
cellulose, croscarmellose sodium, red iron oxide (E172), sodium lauryl sulfate, povidone
K30, magnesium stearate, calcium carbonate, polysorbate 80

Film coating
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/10 mg: White Opadry containing hypromellose
2910 (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520)
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/20 mg: White Opadry containing hypromellose
2910 (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520)
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/40 mg: White Opadry containing hypromellose
2910 (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520)
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/80 mg: White Opadry containing hypromellose
2910 (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520)

Description of the appearance of EZETIMIBE E ATORVASTATINA DOCgen and contents of the
pack
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/10 mg tablets: Film-coated tablets,
oval, biconvex, white and light pink, printed on one side with "10" and blank on the other, approximately 13 mm (length) x 5 mm (width).
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/20 mg tablets: Film-coated tablets,
biconvex, oval, white and light pink, printed on one side with "20" and blank on the other, approximately 15 mm (length) x 6 mm (width).
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/40 mg tablets: Film-coated tablets,
biconvex, oval, white and light pink, printed on one side with "20" and blank on the other, approximately 15 mm (length) x 6 mm (width).
EZETIMIBE E ATORVASTATINA DOCgen 10 mg/80 mg tablets: Film-coated tablets,
biconvex, oval, white and light pink, printed on one side with "20" and blank on the other, approximately 15 mm (length) x 6 mm (width).

Pack sizes of 30 film-coated tablets in cold-formed blisters (OPA/Alu/PVC-Alu).
Pack sizes of 60 film-coated tablets in cold-formed blisters (OPA/Alu/PVC-Alu).

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturers
FACTORY BENNETT PHARMACEUTICALS S.A.
Aigaiou 26, Thesi Karela,
Koropi Attiki, 19441, Greece

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Czech Republic: Ezetimibe/Atorvastatin Genepharm
Italy: EZETIMIBE E ATORVASTATINA DOCgen
Greece: Ezetimibe + Atorvastatin / Genepharm