EZETIMIBE 10 mg/10 mg Жесткие Капсулы

Содержание инструкции

1. EZETIMIBE E ATORVASTATINA DOC 10 mg/10 mg hard capsules, mg/20 mg hard capsules, mg/40 mg hard capsules
   1. What is EZETIMIBE E ATORVASTATINA DOC and what is it used for
   2. What you need to know before taking EZETIMIBE AND ATORVASTATIN DOC
   3. How to take EZETIMIBE E ATORVASTATINA DOC
   4. Possible side effects
   5. How to store EZETIMIBE E ATORVASTATINA DOC
   6. Package contents and other information

EZETIMIBE E ATORVASTATINA DOC 10 mg/10 mg hard capsules, mg/20 mg hard capsules, mg/40 mg hard capsules

Read this leaflet carefully before you start 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 they have the same symptoms as you, 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 EZETIMIBE E ATORVASTATINA DOC is and what it is used for
• 2. What you need to know before you take EZETIMIBE E ATORVASTATINA DOC
• 3. How to take EZETIMIBE E ATORVASTATINA DOC
• 4. Possible side effects
• 5. How to store EZETIMIBE E ATORVASTATINA DOC
• 6. Contents of the pack and other information

1. What is EZETIMIBE E ATORVASTATINA DOC and what is it used for

EZETIMIBE E ATORVASTATINA DOC contains two different active ingredients within a capsule. One of the two active substances is ezetimibe, the other is atorvastatin, which belongs to the group of so-called statins.
EZETIMIBE E ATORVASTATINA DOC is a medicine 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, it increases the levels of "good" cholesterol (HDL cholesterol).
This medicine 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.
For most people, high cholesterol does not change their state of health, as it does not cause any symptoms. However, if left untreated, fat deposits can form on the walls of blood vessels causing them to narrow. Sometimes narrowed blood vessels can become blocked causing a lack of blood supply to the heart or brain, which can lead to heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems is reduced.
EZETIMIBE E ATORVASTATINA DOC is used to treat patients in whom diet alone to reduce cholesterol is not sufficient to keep cholesterol levels under control. While taking this medicine you should still follow a diet to lower cholesterol.
Your doctor may prescribe EZETIMIBE E ATORVASTATINA DOC if you are already taking both ezetimibe and atorvastatin at the same dosage.
EZETIMIBE E ATORVASTATINA DOC does not help with weight loss.

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

Do not take EZETIMIBE AND ATORVASTATIN DOC

• if you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in section 6).
• if you have or have ever had a liver disease
• if you have had blood test results, performed to assess liver function, inexplicably altered
• if you are a woman of childbearing potential and are not using a reliable contraceptive method
• if you are pregnant or trying to become pregnant
• if you are breastfeeding
• if you are using the combination of medicines glecaprevir/pibrentasvir for the treatment of hepatitis C

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

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and EZETIMIBE AND ATORVASTATIN DOC can lead to serious muscle problems (rhabdomyolysis). (See section “Other medicines and EZETIMIBE AND ATORVASTATIN DOC”.)
• 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
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have experienced repeated or unexplained muscle discomfort or pain, a personal or family history of muscle problems
• if you have had muscle problems in the past while taking other medicines to lower lipid levels in the blood (e.g., other medicines based on “statins” or “fibrates”),
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years of age

Immediately contact your doctor if you experience unexplained muscle pain, tenderness or weakness
while taking EZETIMIBE AND ATORVASTATIN DOC.This is because, in rare cases, muscle
problems can be serious, including muscle breakdown leading to kidney damage. It is known that
atorvastatin causes 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 for diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will carefully monitor you if you suffer from diabetes or if
you 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 EZETIMIBE AND ATORVASTATIN DOC with fibrates (medicines used to
lower cholesterol) should be avoided as the use of EZETIMIBE AND ATORVASTATIN DOC
with fibrates has not been studied.

Children and adolescents
The use of EZETIMIBE AND ATORVASTATIN DOC is not recommended in children and adolescents of
under 18 years of age.

Other medicines and EZETIMIBE AND ATORVASTATIN DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines may change the effect of EZETIMIBE AND ATORVASTATIN DOC or their
effect may be changed by EZETIMIBE AND ATORVASTATIN DOC. 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 important condition of
muscle wasting known as “rhabdomyolysis”, described in section 4:

• medicines used to change the functioning of the immune system, e.g., cyclosporine
• some antibiotics e.g., erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
• some antifungal medicines e.g., ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole
• other medicines used to regulate lipid levels e.g., gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol, colestyramine
• some calcium antagonists used for the treatment of angina or hypertension, e.g., amlodipine and diltiazem,
• medicines used to regulate heart rhythm e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent you from getting sick with cytomegalovirus
• medicines used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, tipranavir/ritonavir combination, etc.
• some medicines used to treat hepatitis C (liver inflammation), e.g., telaprevir, boceprevir and the elbasvir/grazoprevir, ledipasvir/sofosbuvir combination
• Fusidic acid 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 start treatment with EZETIMIBE AND ATORVASTATIN DOC again. Taking EZETIMIBE AND ATORVASTATIN DOC 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 EZETIMIBE AND ATORVASTATIN DOC
 warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots)

• oral contraceptives
• stiripentol (an anticonvulsant medicine for the treatment of epilepsy)
• cimetidine (a medicine used to treat heartburn and peptic ulcers)
• phenazone (a painkiller)
• colchicine (used to treat gout)
• antacids (medicines for the treatment of digestive problems containing aluminium or magnesium)
• St John's wort (a medicine for the treatment of depression)

EZETIMIBE AND ATORVASTATIN DOC with food, beverages and alcohol
For instructions on how to take EZETIMIBE AND ATORVASTATIN DOC 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 may change the effects of EZETIMIBE AND ATORVASTATIN DOC.

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

Pregnancy, breastfeeding and fertility
Do not take EZETIMIBE AND ATORVASTATIN DOC if you are pregnant, if you are planning a
pregnancy or if you suspect you may be pregnant.
Do not take EZETIMIBE AND ATORVASTATIN DOC if you are a woman of childbearing potential unless you are using
an effective contraceptive method. If you become pregnant during therapy with EZETIMIBE AND
ATORVASTATIN DOC, stop treatment immediately and consult your doctor.
Do not take EZETIMIBE AND ATORVASTATIN DOC if you are breastfeeding.
The safety of EZETIMIBE AND ATORVASTATIN DOC during pregnancy and breastfeeding has not
yet been demonstrated. If you are pregnant or breastfeeding, if you are planning a pregnancy or if
you suspect you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
EZETIMIBE AND ATORVASTATIN DOC is not expected to interfere with the ability to drive or
use machines. However, it should be noted that some people may experience dizziness after
taking EZETIMIBE AND ATORVASTATIN DOC. If you experience dizziness, ask your
doctor for advice before driving or using machines.

EZETIMIBE AND ATORVASTATIN DOC contains sucrose and sodium.
Each capsule of EZETIMIBE AND ATORVASTATIN DOC 10 mg/10 mg contains 13 mg of sucrose, each
capsule EZETIMIBE AND ATORVASTATIN DOC 10 mg/20 mg capsule contains 26 mg of sucrose and
each capsule of EZETIMIBE AND ATORVASTATIN DOC 10 mg/40 mg capsule contains 51.5 mg of
sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take EZETIMIBE E ATORVASTATINA DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
During treatment with EZETIMIBE E ATORVASTATINA DOC you must continue to follow this diet
to reduce cholesterol levels.
The recommended daily dose for adults is one capsule of the prescribed dosage.

Take EZETIMIBE E ATORVASTATINA DOC once a day.
The capsules can be taken at any time of the day with or without food. However, you may try
to take the capsule every day at the same time.
Swallow each capsule whole with a glass of water.
EZETIMIBE E ATORVASTATINA DOC is not suitable for starting treatment. Starting treatment
or adjusting the dose, if necessary, must be done only by administering the active substances
separately and, only after establishing the correct dose, can you switch to using EZETIMIBE E
ATORVASTATINA DOC in the appropriate dosage.
If your doctor has prescribed EZETIMIBE E ATORVASTATINA DOC in association with other medicines
used to lower cholesterol levels containing as active ingredients colestyramine or another
bile acid sequestrant, you must take EZETIMIBE E ATORVASTATINA DOC at least 2 hours
before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE E ATORVASTATINA DOC than you should
If you accidentally take more capsules than you should (more than the recommended daily dose), contact
your doctor or the nearest hospital.

If you forget to take EZETIMIBE E ATORVASTATINA DOC
If you forget to take a dose, take only the dose scheduled for the next day at the usual time.
Do not take a double dose to make up for the forgotten capsule.

If you stop taking EZETIMIBE E ATORVASTATINA DOC
Contact your doctor if you intend to stop treatment with EZETIMIBE E ATORVASTATINA
DOC. If you stop treatment with EZETIMIBE E ATORVASTATINA DOC, your cholesterol levels
may increase again.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or symptoms, stop taking this medicine and immediately inform your doctor or go to the nearest hospital emergency room:
Rare (may affect up to 1 in 1,000 people)

• severe allergic reaction that causes swelling of the face, tongue and throat, which can cause great difficulty in breathing.
• severe illness with severe exfoliation and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever. Skin rash with pink-red patches, especially on the palm of the hands or the sole of the feet, which may become covered with blisters. Muscle weakness, tenderness, pain or rupture, or change in the color of urine to red-brown and especially if, at the same time, you do not feel well and have a high fever, this may be caused by abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear after stopping treatment with EZETIMIBE AND ATORVASTATIN DOC, and can be life-threatening and lead to kidney problems.

Very rare (may affect up to 1 in 10,000 people)

• In case of unexpected or unusual bleeding or bruising, it may indicate a liver disorder. You should see a doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).

Other possible side effects
Common (may affect up to 1 in 10 people)

• common cold (nasopharyngitis).
• allergic reactions.
• high blood sugar levels.
• Headache.
• sore throat.
• nosebleed.
• constipation.
• flatulence (excess gas in the digestive tract).
• Dyspepsia.
• feeling unwell (nausea).
• Diarrhea.
• abdominal pain.
• muscle pain.
• Joint pain.
• pain in the arms and legs.
• muscle spasms.
• swollen joints.
• back pain.
• feeling tired (fatigue).
• increases in some values ​​regarding muscle function (CK) revealed in the blood test.
• alteration of liver function parameters, increases in some values ​​regarding liver function revealed in the blood test (transaminases).

Not common (may affect up to 1 in 100 people)

• low blood sugar levels.
• weight gain.
• decreased appetite.
• nightmares.
• insomnia.
• dizziness.
• numbness or tingling in the fingers of hands and feet.
• reduced sensitivity to pain or touch.
• altered sense of taste.
• memory loss.
• blurred vision.
• ringing in the ears.
• hot flush.
• high blood pressure.
• cough.
• vomiting.
• belching.
• inflammation of the pancreas, which can cause severe abdominal pain that can extend to the back.
• heartburn.
• dry mouth.
• inflammation of the stomach (gastritis).
• inflammation of the liver (hepatitis).
• hives.
• itching.
• skin rash.
• hair loss.
• neck pain.
• muscle weakness.
• discomfort (a feeling of general weakness).
• asthenia (lack of energy and strength).
• chest pain.
• pain.
• swelling, especially in the hands and feet.
• fever.
• urine tests that are positive for white blood cells.
• increased levels of liver enzymes in the blood.

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

• reduction in the number of platelets in the blood, which increases the risk of bruising/bleeding (thrombocytopenia).
• damage to the nerves of the legs and arms (such as numbness).
• visual disturbances.
• cholestasis (yellowing of the skin and whites of the eyes).
• red, raised skin rash, sometimes with target-shaped lesions (erythema multiforme)
• muscle disease accompanied by muscle weakness (myopathy).
• muscle inflammation.
• tendon injury.

Very rare (may affect up to 1 in 10,000 people)

• hearing loss.
• increased breast volume in men (gynecomastia).

Not known (frequency cannot be estimated based on available data)

• depression.
• shortness of breath.
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• muscle weakness that is constant (immune-mediated necrotizing myopathy).

Possible side effects reported with some statins:

• sexual difficulties.
• 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.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 E ATORVASTATINA DOC

Keep this medicine out of the sight and reach of children.
Store at temperatures below 30 °C in the original packaging to protect the medicine
from humidity.
Do not use this medicine after the expiry date (Exp.) which is stated on the pack. The expiry date
refers to the last day of that month.
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. Package contents and other information

What EZETIMIBE E ATORVASTATINA DOC contains

• The active ingredients are ezetimibe and atorvastatin (as atorvastatin calcium trihydrate). Each capsule contains 10 mg of ezetimibe and 10 mg, 20 mg or 40 mg of atorvastatin.
• The other ingredients are:

Core: Calcium Carbonate (E170), hydroxypropylcellulose (E463), polysorbate 80 (E433),
sodium croscarmellose (E468), sugar spheres, talc (E553B), mannitol (E421), microcrystalline
cellulose (E460(i)), low substitution hydroxypropylcellulose (E463), povidone (E1201),
sodium lauryl sulfate (E487), magnesium stearate (E572)
Capsule shell:
The head of the hard capsules of EZETIMIBE E ATORVASTATINA DOC 10 mg/10 mg: Titanium
dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172), Black Iron Oxide
(E172), Gelatin (E441).
The head of the hard capsules of EZETIMIBE E ATORVASTATINA DOC 10 mg/20 mg: Titanium
dioxide (E171), Red Iron Oxide (E172), Gelatin (E441)
The head of the hard capsules of EZETIMIBE E ATORVASTATINA DOC 10 mg/40 mg: Titanium
dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172), Black Iron Oxide
(E172), Gelatin (E441)
The body of the capsule for all dosages: Titanium dioxide (E171), Yellow Iron Oxide (E172),
Gelatin (E441)

Description of the appearance of EZETIMIBE E ATORVASTATINA DOC and package contents
EZETIMIBE E ATORVASTATINA DOC 10 mg/10 mg hard capsules:Hard gelatin capsule with
unmarked closure of size 0, with a caramel-colored head and a yellow body, filled
with pellets and a tablet.
EZETIMIBE E ATORVASTATINA DOC 10 mg/20 mg hard capsules:Hard gelatin capsule with
unmarked closure of size 0, with a reddish-brown head and a yellow body,
filled with pellets and a tablet
EZETIMIBE E ATORVASTATINA DOC 10 mg/40 mg hard capsules:Hard gelatin capsule with
unmarked closure of size 0, with a dark brown head and a yellow body,
filled with pellets and a tablet.
OPA/Al/PVC//Al blister packs of 30 hard capsules packaged in cardboard boxes.

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

Manufacturers
Egis Pharmaceuticals PLC
Bokenyfoldi út 118-120.
Budapest
1165 Hungary
Egis Pharmaceuticals PLC
Matyas Kiraly Utca 65.
Kormend
Vas
9900 Hungary

This medicinal product has been authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands: Ezetimibe/Atorvastatin DOC 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg hard capsules
Italy: EZETIMIBE E ATORVASTATINA DOC