Ezetimibe and atorvastatin Pensà: detailed information

Package leaflet: Information for the patient

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

ezetimibe and atorvastatin
Generic medicine
Please 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 could be harmful.
If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What EZETIMIBE AND ATORVASTATIN PENSA is and what it is used for
What you need to know before taking EZETIMIBE AND ATORVASTATIN PENSA
How to take EZETIMIBE AND ATORVASTATIN PENSA
Possible side effects
How to store EZETIMIBE AND ATORVASTATIN PENSA
Contents of the pack and other information

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

EZETIMIBE AND ATORVASTATIN PENSA is a medicine used to lower elevated cholesterol levels. EZETIMIBE AND ATORVASTATIN PENSA contains ezetimibe and atorvastatin.
EZETIMIBE AND ATORVASTATIN PENSA is used in adults to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats called triglycerides.
In addition, EZETIMIBE AND ATORVASTATIN PENSA increases levels of "good" cholesterol (HDL cholesterol).
EZETIMIBE AND ATORVASTATIN PENSA works by reducing cholesterol in two ways: it reduces cholesterol absorbed through the digestive tract as well as cholesterol naturally produced by the body.
Cholesterol is one of several fatty substances present in the bloodstream. Total cholesterol consists 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 the buildup of bad cholesterol in the arteries and provides protection against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart disease.
EZETIMIBE AND ATORVASTATIN PENSA is used to treat patients in whom diet alone is not sufficient to control cholesterol levels. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
EZETIMIBE AND ATORVASTATIN PENSA is used in addition 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 is not adequately controlled with a statin alone;
for which you have previously used a statin and ezetimibe as separate tablets.
an inherited disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments.
heart disease. EZETIMIBE AND ATORVASTATIN PENSA 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 PENSA does not help with weight loss.

2. What you should know before taking EZETIMIBE AND ATORVASTATIN PENSA

Do not take EZETIMIBE AND ATORVASTATIN PENSA 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 you are not using a reliable method of contraception,
you are pregnant, trying to become pregnant, or breastfeeding,
you are taking the combination of glecaprevir/pibrentasvir, ledipasvir/sofosbuvir for the treatment of hepatitis C.

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

you have previously had a stroke with cerebral haemorrhage or if there are small accumulations of fluid in the brain due to previous strokes,
you have kidney problems,
you have an underactive thyroid gland (hypothyroidism),
you have previously experienced repeated or unexplained muscle 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 drink 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. Talk to your doctor before taking this product.
you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and EZETIMIBE AND ATORVASTATIN PENSA can lead to serious muscle problems (rhabdomyolysis),
you have or have had myasthenia (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), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4). Contact your doctor immediately if you notice the onset of unexplained muscle pain, tenderness, or weakness while taking EZETIMIBE AND ATORVASTATIN PENSA.

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.
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.
Talk to your doctor or pharmacist before taking EZETIMIBE AND ATORVASTATIN PENSA:

if you suffer from severe respiratory insufficiency.

If any of these conditions apply to you (or you are unsure), talk to your doctor or pharmacist before taking EZETIMIBE AND ATORVASTATIN PENSA, as your doctor may need to request a blood test before and possibly during treatment with EZETIMIBE AND ATORVASTATIN PENSA to assess the risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and EZETIMIBE AND ATORVASTATIN PENSA”).
During treatment with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
Inform your doctor about all your medical conditions, including allergies.
The combined use of EZETIMIBE AND ATORVASTATIN PENSA and fibrates (medicines to lower cholesterol) should be avoided, as the use of EZETIMIBE AND ATORVASTATIN PENSA with fibrates has not been studied.

Children
EZETIMIBE AND ATORVASTATIN PENSA is not recommended for use in children and adolescents.

Other medicines and EZETIMIBE AND ATORVASTATIN PENSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
There are some medicines that may alter the effect of EZETIMIBE AND ATORVASTATIN PENSA or whose effects may be altered by EZETIMIBE AND ATORVASTATIN PENSA (see section 3). This type of interaction could make one or both medicines less effective. 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 for bacterial infections),
ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections),
gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines for regulating lipid levels),
certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem,
digoxin, verapamil, amiodarone (medicines for regulating heart rhythm),
medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (medicines for AIDS),
certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir,
letermovir, a medicine that helps prevent cytomegalovirus infection,
daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections).
**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 EZETIMIBE AND ATORVASTATIN. Taking EZETIMIBE AND ATORVASTATIN PENSA 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 EZETIMIBE AND ATORVASTATIN PENSA
oral contraceptives (medicines to prevent pregnancy),
stiripentol (an anticonvulsant medicine for the treatment of epilepsy),
cimetidine (a medicine used to treat heartburn and peptic ulcers),
phenazone (a painkiller),
antacids (medicines containing aluminium or magnesium used for digestive problems),
warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines to prevent blood clots),
colchicine (used to treat gout),
St. John’s wort (a herbal remedy used for depression).

EZETIMIBE AND ATORVASTATIN PENSA with food and alcohol
For instructions on how to take EZETIMIBE AND ATORVASTATIN PENSA, 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 EZETIMIBE AND ATORVASTATIN PENSA.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take EZETIMIBE AND ATORVASTATIN PENSA if you are pregnant, planning to become pregnant, or suspect you may be pregnant. Do not take EZETIMIBE AND ATORVASTATIN PENSA if you are a woman of childbearing age unless you are using reliable contraceptive measures.
If you become pregnant while taking EZETIMIBE AND ATORVASTATIN PENSA, stop treatment immediately and contact your doctor.
Do not take EZETIMIBE AND ATORVASTATIN PENSA if you are breastfeeding.
The safety of EZETIMIBE AND ATORVASTATIN PENSA during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
EZETIMIBE AND ATORVASTATIN PENSA is not considered to affect the ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking EZETIMIBE AND ATORVASTATIN PENSA.

EZETIMIBE AND ATORVASTATIN PENSA contains lactose
The tablets of EZETIMIBE AND ATORVASTATIN PENSA contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

EZETIMIBE AND ATORVASTATIN PENSA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take EZETIMIBE AND ATORVASTATIN PENSA

Always take this medicine exactly as instructed by your doctor. 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 EZETIMIBE AND ATORVASTATIN PENSA, you must already have started a cholesterol-lowering diet.
During treatment with EZETIMIBE AND ATORVASTATIN PENSA, you must continue to follow this cholesterol-lowering diet.

What dose to take
The recommended dose is one tablet of EZETIMIBE AND ATORVASTATIN PENSA taken orally once daily.

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

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

If you forget to take EZETIMIBE AND ATORVASTATIN PENSA
Do not take a double dose; take only the usual dose of EZETIMIBE AND ATORVASTATIN PENSA at the usual time the next day.

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

4. Possible side effects

Like all medicines, EZETIMIBE E ATORVASTATINA PENSA may cause side effects,
although not everyone experiences them.
If you notice any of the following serious side effects or symptoms, stop taking the tablets and contact your doctor immediately 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 peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink-red patches, 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, particularly if you also feel unwell or have a high fever—this could be due to abnormal muscle damage, which may be life-threatening and lead to kidney problems
lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells)
If you experience unexpected or unusual bleeding or bruising, consult your doctor promptly, as this could indicate liver problems.

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 sleeping; sleep disorders,
dizziness; headache; tingling sensation,
slow heartbeat,
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; muscle fatigue, spasms or weakness; pain in arms and legs,
unusual weakness; feeling of tiredness or malaise; swelling, particularly in the ankles (oedema),
increases in certain blood test values related to liver or muscle function (CK),
weight gain.

The following rare side effects have been reported (may affect up to 1 in 1,000 people):

skin rash which may appear on the skin or mouth ulcers (drug-induced lichenoid reaction),
purple skin lesions (signs of blood vessel inflammation, vasculitis).

In addition, the following side effects have been reported in people taking ezetimibe/atorvastatin tablets or ezetimibe or atorvastatin tablets alone:

allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause breathing or swallowing difficulties (a condition requiring immediate treatment),
raised, red rash, sometimes with target-shaped lesions,
liver problems,
cough,
heartburn,
decreased appetite; loss of appetite,
high blood pressure,
rash and itching; allergic reactions including rash and urticaria,
tendon injuries,
gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea),
inflammation of the pancreas, often with severe abdominal pain,
reduced number of blood cells, which may cause bruising/bleeding (thrombocytopenia),
inflammation of the nasal passages; nosebleeds,
neck pain; pain; chest pain; throat pain,
increases and decreases in blood sugar levels (if you have diabetes, you should continue monitoring your blood sugar levels),
nightmares,
numbness or tingling in 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,
eructation,
hair loss,
increased body temperature,
positive urine test for white blood cells,
blurred vision; visual disturbances,
gynaecomastia (enlargement of the breast in males),
severe myopathy (a disease causing generalised 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.
Possible side effects reported with some statins:

sexual dysfunction,
depression,
respiratory problems including persistent cough and/or shortness of breath or fever,
diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine,
persistent muscle pain, tenderness or weakness, particularly if, at the same time, you do not feel well or have a high temperature that may not resolve after stopping treatment with EZETIMIBE E ATORVASTATINA PENSA (frequency not known).

Reporting of side effects
If you experience any side effect, 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 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 PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EZETIMIBE E ATORVASTATINA PENSA 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 calcium carbonate; anhydrous colloidal silicon dioxide; sodium croscarmellose;
hydroxypropylcellulose; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose;
polysorbate 80; sodium lauryl sulfate (E487).
The film coating contains: hypromellose, lactose monohydrate, titanium dioxide, macrogol, talc.

Description of the appearance of EZETIMIBE E ATORVASTATINA PENSA and contents of the
pack
Film-coated, capsule-shaped, biconvex tablets, white to off-white in colour.
EZETIMIBE E ATORVASTATINA PENSA 10 mg/10 mg tablets: “1T” engraved on one side
EZETIMIBE E ATORVASTATINA PENSA 10 mg/20 mg tablets: “2T” engraved on one side
EZETIMIBE E ATORVASTATINA PENSA 10 mg/40 mg tablets: “4T” engraved on one side
EZETIMIBE E ATORVASTATINA PENSA 10 mg/80 mg tablets: “8T” engraved on one side

Pack size:
Blister packs (alu/alu) containing 30 film-coated tablets.

Marketing Authorisation Holder
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6
20154 Milano - ITALY

Manufacturers
Delorbis Pharmaceutical Ltd
17 Athinon Street
Ergates Industrial Area
2643 Ergates/Lefkosia
Cyprus
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta

This medicinal product is authorised in the European Economic Area (EEA) Member States under the
following names:
The Netherlands Ezetimibe/Atorvastatine Tifi 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg filmomhulde tabletten
Italy EZETIMIBE E ATORVASTATINA PENSA