ATHEMIBE 10 mg Film-Coated Tablets

Зміст інструкції

1. ATHEMIBE 10 mg/10 mg film-coated tablets
   1. What is ATHEMIBE and what is it used for
   2. What you need to know before taking ATHEMIBE
   3. How to take ATHEMIBE
   4. Possible side effects
   5. How to store ATHEMIBE
   6. Contents of the pack and other information

ATHEMIBE 10 mg/10 mg film-coated tablets

ATHEMIBE 10 mg/20 mg film-coated tablets
ATHEMIBE 10 mg/40 mg film-coated tablets
ATHEMIBE 10 mg/80 mg film-coated tablets
ezetimibe and atorvastatin
Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What ATHEMIBE is and what it is used for
• 2. What you need to know before you take ATHEMIBE
• 3. How to take ATHEMIBE
• 4. Possible side effects
• 5. How to store ATHEMIBE
• 6. Contents of the pack and other information

1. What is ATHEMIBE and what is it used for

ATHEMIBE is a medicine to lower high cholesterol levels. ATHEMIBE contains ezetimibe
and atorvastatin.
ATHEMIBE is used in adults to lower total cholesterol levels, "bad" cholesterol
(LDL cholesterol) and fatty substances in the blood called triglycerides. In addition, ATHEMIBE increases
levels of "good" cholesterol (HDL cholesterol).
ATHEMIBE works by reducing cholesterol in two ways. It reduces cholesterol absorbed in the digestive
tract, as well as the cholesterol the body produces on its own. Cholesterol is one of many
fatty substances present in the bloodstream. Total cholesterol is mainly composed of
LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the
arteries forming plaques. Eventually, this build-up of plaques can lead to a narrowing of the
arteries. This narrowing can slow down or block the flow of blood 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 protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart disease.
ATHEMIBE is used for patients who cannot control their cholesterol levels with diet alone. You must follow a diet to reduce cholesterol during therapy with this medicine.
ATHEMIBE is used in addition to diet to lower cholesterol levels, if:

• you suffer from a high level of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or high levels of fats in the blood (mixed hyperlipidemia);
• the level is not well controlled with a statin alone;
• you are following a therapy for which you have used a statin and ezetimibe as separate tablets;
• you suffer from a hereditary disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also receive other treatments;
• you suffer from heart disease. ATHEMIBE reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart or hospitalisation for chest pain. ATHEMIBE does not help you lose weight.

2. What you need to know before taking ATHEMIBE

Do not take ATHEMIBE if

• a. you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• b. you have or have ever had a disease that affects the liver,
• c. you have had unexplained abnormal blood tests relating to liver function,
• d. you are a woman who could become pregnant and are not using reliable contraception,
• e. you are pregnant, trying to become pregnant or are breastfeeding,
• f. you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking ATHEMIBE if

• a. you have had a previous stroke with cerebral haemorrhage or have small pockets of fluid in the brain from previous strokes,
• b. you have kidney problems,
• c. you have an underactive thyroid (hypothyroidism),
• d. you have had repeated or unexplained muscle pains, a personal or family history of muscle problems,
• e. you have had previous muscle problems during treatment with other lipid-lowering medicines (e.g. other "statin" or "fibrate" medicines),
• f. you regularly drink large amounts of alcohol,
• g. you have a history of liver disease,
• h. you are over 70 years old,
• i. your doctor has told you that you have an intolerance to some sugars. Contact your doctor before taking this product,
• j. you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections), by mouth or by injection. The combination of fusidic acid and ATHEMIBE can cause serious muscle problems (rhabdomyolysis).
• k. you suffer from or have suffered from myasthenia (a disease with general muscle weakness, including in some cases the muscles used during breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles) as statins can sometimes worsen the condition or lead to the onset of myasthenia (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or
weakness while taking ATHEMIBE.This is because muscle problems can be serious in rare
cases, including muscle breakdown which causes kidney damage. Atorvastatin is known to
cause muscle problems and cases of muscle problems have also been reported with ezetimibe.
Also tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and
medicines may be needed to diagnose and treat this problem.
Consult your doctor or pharmacist before taking ATHEMIBE:

• if you suffer from severe respiratory failure.

If any of these conditions apply to you (or you are not sure), consult your doctor or pharmacist before
taking ATHEMIBE because your doctor will need to have you undergo a blood test before and
possibly during treatment with ATHEMIBE to predict the risk of muscle side effects.
It is known that the risk of muscle side effects, such as rhabdomyolysis, increases
when certain medicines are taken at the same time (see section 2 "Other
medicines and ATHEMIBE").
While you are taking this medicine, your doctor will monitor you closely if you have diabetes or are at
risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high
levels of sugars and fats in your blood, are overweight and have high blood pressure. Tell your doctor
about all your medical conditions, including allergies.
The combined use of ATHEMIBE and fibrates (medicines to lower cholesterol) should be
avoided as the combined use of ATHEMIBE and fibrates has not been studied.

Children
ATHEMIBE is not recommended for children and adolescents.

Other medicines and ATHEMIBE
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 can change the effect of ATHEMIBE or their effect can
be changed by ATHEMIBE (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 important condition of muscle breakdown known as
"rhabdomyolysis" described in section 4:

• cyclosporine (a medicine often used in patients who have had an organ transplant),
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines for bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections),
• gemfibrozil, other fibrates, nicotinic acid and derivatives, colestipol, colestyramine (medicines to regulate lipid levels),
• some calcium antagonists used for angina or high blood pressure, for example, amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines to regulate heart rhythm),
• medicines used in the treatment of HIV, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (medicines for AIDS), some medicines used in the treatment of hepatitis C, for example, telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir",
• letermovir, a medicine that helps prevent getting sick with cytomegalovirus,
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). **If you need to take oral fusidic acid to treat a bacterial infection, you will need totemporarily stop taking this medicine. Your doctor will tell you when it will besafe to restart ATHEMIBE. Taking ATHEMIBE with fusidic acid canrarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For moreinformation on rhabdomyolysis, see section 4.

Other medicines known to interact with ATHEMIBE

• oral contraceptives (medicines to prevent pregnancy),
• stiripentol (an anticonvulsant medicine for epilepsy),
• cimetidine (a medicine used for heartburn and peptic ulcers),
• phenazone (a painkiller),
• antacids (indigestion remedies containing aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots),
• colchicine (used to treat gout),
• St John's wort (a medicine for treating depression).

ATHEMIBE with food and alcohol
See section 3 for instructions on how to take ATHEMIBE. Please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice a day because large amounts of
grapefruit juice can change the effects of ATHEMIBE.

Alcohol
Avoid drinking too much alcohol while taking this medicine. See section 2 "Warnings and
precautions" for details.

Pregnancy and breastfeeding
Do not take ATHEMIBE if you are pregnant, trying to become pregnant or think you might be.
Do not take ATHEMIBE if you are able to become pregnant unless you are using reliable
contraception.
If you become pregnant while taking ATHEMIBE, stop taking it immediately and tell your
doctor. Do not take ATHEMIBE if you are breastfeeding.
The safety of ATHEMIBE during pregnancy and breastfeeding has not yet been demonstrated. Ask
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
ATHEMIBE is not expected to affect your ability to drive or operate machinery.
However, you should be aware that some people may experience dizziness after taking
ATHEMIBE.

ATHEMIBE contains lactose
The tablets of ATHEMIBE contain a sugar called lactose. If your doctor has told you that
you have an intolerance to some sugars, contact your doctor before taking this medicine.

ATHEMIBE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially
"sodium-free".

3. How to take ATHEMIBE

Always take this medicine exactly as your doctor has told you. The doctor will determine
the appropriate dosage of the tablet for you, based on your current treatment and your level of
personal risk. Consult your doctor or pharmacist if you are not sure.

• Before starting ATHEMIBE, you must follow a diet to lower cholesterol.
• You must continue this diet to lower cholesterol while taking ATHEMIBE.

How much to take
The recommended dose is one ATHEMIBE tablet orally once a day.
When to take it
Take ATHEMIBE at any time of the day. You can take it with or without food.
If your doctor has prescribed ATHEMIBE together with colestyramine or any other bile acid sequestrant
(medicines to lower cholesterol), you must take ATHEMIBE at least 2 hours before or 4
hours after taking the bile acid sequestrant.

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

If you forget to take ATHEMIBE
Do not take an extra dose; simply take your normal amount of ATHEMIBE at the usual time
the next day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• severe allergic reaction causing swelling of the face, tongue and throat which can lead to severe breathing difficulty
• severe illness with severe peeling and blistering of the skin, formation of blisters on the skin, in the mouth, eyes, genitals and fever; skin rash with pink-red spots especially on the palms of the hands or soles of the feet, which may form blisters
• muscle weakness, tenderness, pain or breakage or reddish-brown discoloration of the urine and especially, if at the same time you do not feel well or have a high temperature, this may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems
• syndrome with illness similar to lupus (including skin rash, joint disorders and effects on blood cells) You should consult your doctor as soon as possible if you experience problems with unexpected or unusual bleeding or bruising, as these may be indicative of a liver disorder. 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):

• flu,
• depression; difficulty sleeping; sleep disorders,
• dizziness; headache; tingling sensation,
• slow heartbeat,
• hot flushes,
• shortness of breath,
• abdominal pain; abdominal bloating; constipation; indigestion; flatulence; frequent bowel movements; inflammation of the stomach; nausea; stomach discomfort; stomach pain,
• acne; hives,
• joint pain; back pain; leg cramps; muscle fatigue, spasms or weakness; pain in arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema),
• increases in some laboratory blood tests for liver or muscle function (CK),
• weight gain.

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 can cause difficulty breathing or swallowing (requiring immediate treatment),
• raised, red skin rash, sometimes with target-like lesions,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including skin rash and hives,
• tendon injury,
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting),
• inflammation of the pancreas often with severe abdominal pain,
• reduction in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nosebleeds,
• neck pain; pain; chest pain; sore throat,
• increases and decreases in blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels),
• nightmares,
• numbness or tingling in the fingers of the hands and feet,
• decreased 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 temperature,
• urine tests positive for white blood cells,
• blurred vision; visual disturbances,
• gynecomastia (enlargement of the breasts in men).
• myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

Talk to 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.
Possible side effects reported with some statins

• sexual difficulties,
• depression,
• breathing problems including persistent cough and/or shortness of breath or fever,
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness or weakness and especially if, at the same time, you do not feel well or have a high temperature that does not go away after stopping ATHEMIBE (frequency not known).

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store ATHEMIBE

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 the packaging after "Exp". The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ATHEMIBE contains
The active ingredients 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 ingredients are calcium carbonate; colloidal anhydrous silica; croscarmellose sodium;
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 ATHEMIBE and contents of the pack
Film-coated tablets, biconvex, capsule-shaped, from white to almost white in color.
ATHEMIBE 10 mg/10 mg tablets: imprinted on one side with "1T" and smooth on the other side.
ATHEMIBE 10 mg/20 mg tablets: imprinted on one side with "2T" and smooth on the other side.
ATHEMIBE 10 mg/40 mg tablets: imprinted on one side with "4T" and smooth on the other side.
ATHEMIBE 10 mg/80 mg tablets: imprinted on one side with "8T" and smooth on the other side.
Packs:
Packs of 10, 30, 90 and 100 film-coated tablets in Alu/AluA blisters.
Not all pack sizes are marketed.

Marketing Authorisation Holder
Piam Farmaceutici S.p.A.
Via XII Ottobre, 10

• 16121 - Genoa

Italy

Manufacturer
Delorbis Pharmaceuticals Ltd
17 Athinon Street
Ergates Industrial Area
2643 Ergates Lefkosia
Cyprus

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Ezetimibe/atorvastatin Axunio (NL)
Athemibe (IT)