Package leaflet: Information for the user

LIPAZETOR 10 mg/10 mg film-coated tablets, 10 mg/20 mg film-coated tablets, 10 mg/40 mg film-coated tablets, 10 mg/80 mg film-coated tablets

ezetimibe/atorvastatin
Generic medicine
Read all of 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 they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What LIPAZETOR is and what it is used for
2. What you need to know before taking LIPAZETOR
3. How to take LIPAZETOR
4. Possible side effects
5. How to store LIPAZETOR
6. Contents of the pack and other information

1. What LIPAZETOR is and what it is used for

LIPAZETOR is a medicine used to lower elevated cholesterol levels. LIPAZETOR contains ezetimibe and atorvastatin.
LIPAZETOR is used in adults to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides. In addition, LIPAZETOR increases levels of "good" cholesterol (HDL cholesterol).
LIPAZETOR 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 fatty substances found in the bloodstream. Total cholesterol is mainly composed 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. This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and provides protection against heart disease.
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.
LIPAZETOR is used to treat patients in whom diet alone is not sufficient to control cholesterol levels. While taking this medicine, you must still follow a cholesterol-lowering diet.
LIPAZETOR is used as an add-on therapy to diet to lower cholesterol 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)
that are not adequately controlled with a statin alone;
for which you have previously been treated with a statin and ezetimibe as separate tablets;
a hereditary disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments;
heart disease. LIPAZETOR reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization for chest pain. LIPAZETOR does not help with weight loss.

2. What you need to know before taking LIPAZETOR

Do not take LIPAZETOR if

you are allergic to ezetimibe, atorvastatin, 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 age and 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 LIPAZETOR if

you have previously had a stroke with cerebral haemorrhage or if there are 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 during treatment with other lipid-lowering medicines (e.g. other "statin" or "fibrate" medicines),
you regularly consume large amounts of alcohol,
you have a history of liver disease,
you are over 70 years old,
your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine,
you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and LIPAZETOR may lead to serious muscle problems (rhabdomyolysis),
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), 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 LIPAZETOR. This is because, although rarely, 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 problems have also been reported with ezetimibe.

In addition, inform your doctor or pharmacist if you have persistent muscle weakness.
Further tests and medicines may be needed to diagnose and treat this condition.
Before taking LIPAZETOR, 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 LIPAZETOR, as your doctor may require you to have a blood test before and possibly during treatment with LIPAZETOR to assess the risk of muscle-related side effects. It is known that the risk of developing muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and LIPAZETOR”). During treatment with this medicine, your doctor will monitor you carefully if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Inform your doctor about all your medical conditions, including allergies. The use of LIPAZETOR with fibrates (medicines used to lower cholesterol) should be avoided, as the combination of LIPAZETOR with fibrates has not been studied.

Children
The use of LIPAZETOR is not recommended in children and adolescents.
Other medicines and LIPAZETOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may alter the effect of LIPAZETOR or their effect may be altered by LIPAZETOR (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. Alternatively, it could increase the risk or severity of side 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 antagonists used to treat angina or hypertension, e.g. amlodipine and diltiazem,
digoxin, verapamil, amiodarone (medicines used to regulate heart rhythm),
medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc. (medicines for the treatment of AIDS),
certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination elbasvir/grazoprevir,
daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). **If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with LIPAZETOR. Taking LIPAZETOR with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
other medicines known to interact with LIPAZETOR,
oral contraceptives (medicines to prevent pregnancy),
stiripentol (an anticonvulsant medicine used to treat epilepsy),
cimetidine (a medicine used to treat heartburn and peptic ulcers),
phenazone (a painkiller),
antacids (medicines for digestive problems containing aluminium or magnesium),
warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines to prevent blood clots),
colchicine (used to treat gout),
St John’s wort (a herbal medicine used to treat depression).

LIPAZETOR with food and alcohol
For instructions on how to take LIPAZETOR, see 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 large quantities of grapefruit juice may alter the effects of LIPAZETOR.
Alcohol
Avoid drinking excessive amounts of alcohol during treatment with this medicine. If you regularly consume large amounts of alcohol, consult your doctor or pharmacist before taking LIPAZETOR.
For further information, refer to section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take LIPAZETOR if you are pregnant, planning to become pregnant, or suspect you may be pregnant. Do not take LIPAZETOR if you are a woman of childbearing age unless you are using an effective method of contraception. If you become pregnant while taking LIPAZETOR, stop treatment immediately and consult your doctor.
Do not take LIPAZETOR if you are breastfeeding.
The safety of LIPAZETOR during pregnancy and breastfeeding has not yet been established. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
LIPAZETOR is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking LIPAZETOR.
LIPAZETOR contains lactose and sodium
LIPAZETOR tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take LIPAZETOR

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

Before starting treatment with LIPAZETOR, you should already have started a cholesterol-lowering diet.
During treatment with LIPAZETOR, you must continue to follow this cholesterol-lowering diet.

What dose to take
The recommended dose is one LIPAZETOR tablet taken by mouth once daily.

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

If you take more LIPAZETOR than you should
Contact your doctor or pharmacist.

If you forget to take LIPAZETOR
Do not take a double dose to make up for the missed dose; take only your usual dose of LIPAZETOR at the next scheduled time.

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

4. Possible side effects

Like all medicines, LIPAZETOR 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 breathing difficulties
severe illness with extensive skin peeling and swelling, blistering of the skin, 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
muscle weakness, tenderness, pain or muscle breakdown, or red-brown discoloration of urine, and especially if you simultaneously feel unwell and have a high fever – this may be due to unusual muscle breakdown (rhabdomyolysis), 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 symptoms such as unexpected or unusual bleeding or bruising, consult your doctor as soon as possible, as these may be signs of liver disorder.

Other side effects
The following common side effects have been reported (may affect up to 1 in 10 people):

diarrhoea,
muscle pain.

The following uncommon side effects have been reported (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 distension; constipation; indigestion, flatulence; frequent bowel movements; stomach inflammation; 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 (CK) function,
weight gain.

The following side effects have been reported with unknown frequency (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 worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
In patients treated with LIPAZETOR or with ezetimibe or atorvastatin tablets, the following side effects have also been reported:

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, red skin rash, 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),
pancreatitis, often with severe abdominal pain,
reduced number of blood cells, which may cause bruising/bleeding (thrombocytopenia),
nasal inflammation; nosebleeds,
neck pain; pain; chest pain; throat pain,
increased or decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely),
nightmares,
numbness or tingling in the fingers of hands and feet,
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 breast tissue in men).

Possible side effects reported with some statins:

sexual difficulties,
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, or 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 LIPAZETOR (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 Italian Medicines Agency (Agenzia Italiana del Farmaco) at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LIPAZETOR

Keep this medicine out of the sight and reach of children.
Do not use LIPAZETOR after the expiry date which is stated on the carton after “Exp.” or on the container after “EXP”. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.

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 LIPAZETOR contains
The active substances are ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg of
ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
The other components are:
Monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate,
magnesium stearate, red iron oxide, calcium carbonate, hydroxypropylcellulose, polysorbate 80, anhydrous colloidal silica and magnesium stearate. (see “LIPAZETOR contains lactose and sodium” for further
information on lactose content in section 2).
Film coating:
Hypromellose, titanium dioxide, macrogol 4000, red iron oxide.
Description of the appearance of LIPAZETOR and package contents
Film-coated tablets.
LIPAZETOR 10 mg/10 mg: Pink, oval-shaped, with "V1" engraved on one side.
LIPAZETOR 10 mg/20 mg: Pink, oval-shaped, with "V2" engraved on one side.
LIPAZETOR 10 mg/40 mg: Pink, oval-shaped, smooth on both sides.
LIPAZETOR 10 mg/80 mg: Pink, capsule-shaped, with "VII" engraved on one side.
LIPAZETOR is available in blisters of 30 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratori Guidotti S.p.A.
Via Livornese, 897 - PISA - La Vettola
Manufacturer
Laboratori Fundacio Dau
Calle Lletra C De La Zona Franca 12-14
Poligono Industrial De La Zona Franca De Barcelona
Barcelona
08040 Spain
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
Paola PLA 3000 Malta
This medicinal product is authorised in the European Economic Area countries with the following
names:
Ireland: Ezetimibe/Atorvastatin film-coated tablets
Spain: Ezetimiba/Atorvastatina SCOV3 comprimidos recubiertos con película
Sweden: Altomib