ORVATEZ 10 mg Фильм-Coated Таблетки

Содержание инструкции

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

ORVATEZ 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 and atorvastatin
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 pass it on to others, even if their symptoms are the same as yours, as it could 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 ORVATEZ is and what it is used for
• 2. What you need to know before you take ORVATEZ
• 3. How to take ORVATEZ
• 4. Possible side effects
• 5. How to store ORVATEZ
• 6. Contents of the pack and other information

1. What ORVATEZ is and what it is used for

ORVATEZ is a medicine used to decrease elevated cholesterol levels. ORVATEZ contains
ezetimibe and atorvastatin.
ORVATEZ is used in adults to decrease the levels in the blood of total cholesterol, of “bad” cholesterol (LDL cholesterol) and of fatty substances called triglycerides. Furthermore, ORVATEZ increases the levels of “good” cholesterol (HDL cholesterol).
ORVATEZ works in two ways to lower cholesterol. It reduces the cholesterol absorbed at the level of the digestive tract, as well as the cholesterol produced naturally by the body.
Cholesterol is one of the various 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 the arteries
forming plaques. Over time, this accumulation in the form of plaque 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
accumulating in the arteries and provides protection against heart disease.
Triglycerides are another form of fat present in the blood that can increase the risk of heart disease.
ORVATEZ is used to treat those patients in whom diet alone is not sufficient to keep cholesterol levels under control. While taking this medicine you should still follow a diet to
lower cholesterol.
ORVATEZ is used as an adjunct to diet therapy to lower cholesterol if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidemia)
• which are not adequately controlled with a statin alone;
• for whom you have taken treatment with a statin and ezetimibe in separate tablets.
• an inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be receiving other treatments.
• heart disease. ORVATEZ reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain. ORVATEZ does not help with weight loss.

2. What you need to know before taking ORVATEZ

Do not take ORVATEZ 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 a liver disease,
• you have had blood tests to assess liver function that were inexplicably altered,
• you are a woman of childbearing potential and are not using a reliable contraceptive method,
• you are pregnant, trying to become pregnant or are breastfeeding,
• you are using the glecaprevir/pibrentasvir combination in the treatment of Hepatitis C.

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

• you have had a stroke with cerebral haemorrhage in the past or if there are small collections of fluid in the brain resulting from previous strokes,
• you have kidney problems,
• you have an underactive thyroid gland (hypothyroidism),
• you have experienced repeated or unexplained muscle discomfort or pain, a personal or family history of muscle problems,
• you have had muscle problems in the past while taking other medicines to lower lipids (e.g. other medicines based on “statins” or “fibrates”),
• you regularly consume large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years of age,
• you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine,
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibacterial medicine) orally or by injection. The combination of fusidic acid and ORVATEZ can lead to serious muscle problems (rhabdomyolysis).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness
while taking ORVATEZ.This is because muscle problems can be severe in rare cases,
including muscle breakdown leading to 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 examinations and medicines may be
necessary for the diagnosis and treatment of this condition.
Before taking ORVATEZ, check with your doctor or pharmacist:

• if you have severe respiratory failure.

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

Children
The use of ORVATEZ is not recommended in children and adolescents.

Other medicines and ORVATEZ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines may change the effect of ORVATEZ or their effect may be changed by
ORVATEZ (see section 3). This type of interaction may reduce the effectiveness of one or both
medicines. Alternatively, it may increase the risk of developing side effects or the severity of
side effects, including the serious condition of muscle breakdown known as “rhabdomyolysis”
described in section 4:

• cyclosporine (a medicine often used in patients undergoing organ transplantation),
• 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, derivatives, colestipol, colestyramine (medicines used to regulate lipid levels),
• some calcium antagonists used for the treatment of angina or hypertension, e.g. amlodipine and diltiazem,
• digoxin, verapamil, amiodarone (medicines used to regulate heart rhythm),
• medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the tipranavir/ritonavir combination etc. (medicines for the treatment of AIDS),
• some medicines used for the treatment of Hepatitis C, e.g. telaprevir, boceprevir and the elbasvir/grazoprevir combination,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

**If you need to take fusidic acid orally to treat a bacterial infection, you will
need to temporarily stop taking this medicine. Your doctor will tell you when it is safe
to restart treatment with ORVATEZ. Taking ORVATEZ with fusidic acid can
rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more
information on rhabdomyolysis in section 4.

• other medicines known to interact with ORVATEZ
• 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 for the treatment of 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 medicine for the treatment of depression).

ORVATEZ with food and alcohol
For instructions on how to take ORVATEZ see section 3. Pay attention to the following:

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

Alcohol
Avoid drinking excessive amounts of alcohol during treatment with this medicine. For more information
see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take ORVATEZ if you are pregnant, planning a pregnancy or suspect you may be
pregnant. Do not take ORVATEZ if you are a woman of childbearing potential unless you are using effective
contraception. If you become pregnant during therapy with ORVATEZ, stop taking it immediately
and consult your doctor.
Do not take ORVATEZ if you are breastfeeding.
The safety of ORVATEZ during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
ORVATEZ is not expected to interfere with your ability to drive or operate machinery. However,
you should be aware that some people may experience dizziness after taking ORVATEZ.

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

ORVATEZ contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take ORVATEZ

Take this medicine following the instructions of your doctor exactly. The doctor will establish the dosage
of the tablet suitable for you based on the ongoing treatment and your risk profile. If you have any doubts, consult your
doctor or pharmacist.

• Before starting treatment with ORVATEZ you should have already started a diet to reduce cholesterol levels.
• During treatment with ORVATEZ you should continue to follow this diet to reduce cholesterol levels.

What dose to take
The recommended dose is one ORVATEZ tablet by mouth once a day.
When to take the dose
Take ORVATEZ at any time of the day. You can take it with or without food.
If your doctor has prescribed ORVATEZ in association with colestyramine or another bile acid sequestrant
(medicines used to lower cholesterol levels) you must take ORVATEZ at least 2 hours before or
4 hours after taking the bile acid sequestrant.

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

If you forget to take ORVATEZ
Do not take a double dose to make up for a missed dose; take only the normal dose of
ORVATEZ the next day at the usual time.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• severe allergic reaction which causes swelling of the face, tongue and throat, which can cause great difficulty in breathing
• severe illness with severe skin peeling and swelling, blistering of the skin, mouth, eyes, genitals and fever; skin rash with pink-red pustules, especially on the palms of the hands or soles of the feet, which may become covered with blisters
• weakness, tenderness, pain or muscle breakdown or reddish-brown urine, and especially if you feel unwell and have a high fever at the same time, this may be caused by an unusual muscle breakdown which can be life-threatening and can lead to kidney problems
• lupus-like syndrome (including skin rash, joint problems and effects on blood cells)

If you experience problems characterized by unexpected or unusual bleeding or bruising, consult your doctor as soon as possible as these may be signs 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,
• slowed heartbeat,
• hot flushes,
• shortness of breath,
• abdominal pain; abdominal bloating; constipation; indigestion; flatulence; frequent bowel movements; inflammation of the stomach; nausea; stomach discomfort; stomach disorders,
• acne; hives,
• joint pain; back pain; leg cramps; fatigue; muscle spasms or weakness; pain in the arms and legs,
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (edema),
• increases in certain values regarding liver or muscle function (CK) detected in blood tests,
• weight gain.

The following side effects have also been reported in people treated with ORVATEZ or with ezetimibe or atorvastatin tablets:

• allergic reactions including swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing or swallowing (a situation that requires immediate medical attention),
• raised skin rash with redness, sometimes accompanied by “target” lesions,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including skin rashes and hives,
• tendon injury,
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea and 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,
• increase and decrease in blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully),
• 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,
• burping,
• hair loss,
• increased temperature,
• urine tests that are positive for white blood cells,
• blurred vision; visual disturbances,
• gynecomastia (enlargement of the breasts 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 blood sugar and fat levels, if you are overweight and if you have high blood pressure. Your doctor will monitor you during treatment with this medicine,
• muscle pain, tenderness or weakness that is constant and especially if, at the same time, you do not feel well or have a high fever that does not go away after stopping treatment with ORVATEZ (frequency not known).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
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 ORVATEZ

• Keep this medicine out of the sight and reach of children.
• Do not use ORVATEZ after the expiry date that is stated on the package after “Scad.” or on the container after “EXP.” The expiry date refers to the last day of that month.
• Store in the original packaging to protect the medicine from oxygen.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ORVATEZ 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; anhydrous colloidal silicon dioxide; sodium croscarmellose;
hydroxypropylcellulose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polysorbate; povidone;
sodium lauryl sulfate.
The film coating contains: hypromellose, macrogol 8000, titanium dioxide (E171), talc.

Description of the appearance of ORVATEZ and contents of the pack
Film-coated tablets, capsule-shaped, biconvex, from white to off-white in colour.
ORVATEZ 10 mg/10 mg tablets: “257” imprinted on one side
ORVATEZ 10 mg/20 mg tablets: “333” imprinted on one side
ORVATEZ 10 mg/40 mg tablets: “337” imprinted on one side
ORVATEZ 10 mg/80 mg tablets: “357” imprinted on one side
Packs:
Packs of 10, 30, 90 and 100 film-coated tablets in aluminium/aluminium blisters under nitrogen (cavity
in oPA-Al-PVC and covering foil in Al).
Packs of 30 x 1 and 45 x 1 film-coated tablets in single-dose aluminium/aluminium blisters under
nitrogen (cavity in oPA-Al-PVC and covering foil in Al).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome

Manufacturer
Merck Sharp & Dohme B.V.,
Waarderweg 39,
2031 BN Haarlem,
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
ORVATEZ: Germany, Greece, Italy, Portugal, Slovak Republic, Spain
TIOBLIS: Belgium, Luxembourg