COMPUNA <5 mg/10 mg Таблетки

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1. COMPUNA 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets
   1. What is COMPUNA and what it is used for
   2. What you need to know before taking COMPUNA tablets
   3. How to take COMPUNA tablets
   4. Possible side effects
   5. How to store COMPUNA tablets
   6. Package Contents and Other Information

COMPUNA 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Rosuvastatin and Ezetimibe

Read this leaflet carefully before you start to take 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 COMPUNA is and what it is used for
• 2. What you need to know before you take COMPUNA
• 3. How to take COMPUNA
• 4. Possible side effects
• 5. How to store COMPUNA
• 6. Contents of the pack and other information

1. What is COMPUNA and what it is used for

COMPUNA contains two different active ingredients in one tablet. One active ingredient is rosuvastatin,
belonging to a group of medicines called “statins”, the other is ezetimibe.
COMPUNA tablets is a medicine used to lower total cholesterol levels, “bad” cholesterol
(LDL cholesterol) and fats in the blood called triglycerides. It also increases levels of “good” cholesterol
(HDL cholesterol). This medicine reduces cholesterol in two ways: it reduces the amount absorbed from the
digestive tract and decreases its production by the body itself.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, deposits of fat can
accumulate in the walls of blood vessels causing them to narrow. Sometimes, this
narrowing of the blood vessels can cause blockage of blood flow to the heart or brain resulting in
heart attack or stroke. By lowering cholesterol levels, it can reduce the risk of heart attack, stroke or other
health problems related to it.
COMPUNA tablets is used for those patients whose cholesterol levels can no longer be controlled solely
through a low-cholesterol diet. You must continue to follow a diet to reduce cholesterol during
therapy with this medicine. Your doctor may prescribe COMPUNA tablets if you are already taking
rosuvastatin and ezetimibe at the same doses.
COMPUNA tablets is used if you have:

• an elevated blood cholesterol level (primary hypercholesterolemia);
• heart disease, COMPUNA reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

COMPUNA tablets does not help with weight loss.

2. What you need to know before taking COMPUNA tablets

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Do not take COMPUNA tablets

• if you have had an allergic reaction to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding. If you become pregnant while taking COMPUNA, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking COMPUNA, using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
• if you have a liver disease;
• if you have severe kidney damage;
• if you have recurrent or unexplained muscle aches or tenderness (myopathy);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking Compuna.

If any of these apply to you (or if you are unsure), consult your doctor.

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

• you have kidney problems;
• you have liver problems;
• you have had recurrent or unexplained muscle aches or tenderness, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Tell your doctor or pharmacist immediately if you experience unexplained muscle aches or tenderness, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• you regularly consume large amounts of alcohol;
• your thyroid gland is not functioning properly (hypothyroidism);
• you are taking other medicines to lower cholesterol called fibrates. See “Other medicines and COMPUNA tablets”;
• you are taking medicines used to treat HIV infections, such as lopinavir/ritonavir and/or atazanavir. See “Other medicines and COMPUNA tablets”;
• you are over 70 years old (your doctor needs to choose the correct dosage suitable for you);
• you have severe respiratory failure;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the correct dosage suitable for you;
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and COMPUNA may lead to serious muscle problems (rhabdomyolysis).
• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with Compuna. Stop using Compuna and seek immediate medical attention if you notice any of the symptoms described in section 4.
• 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 that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

If any of these apply to you (or if you have any doubts): consult your doctor or pharmacist before actually starting to take any dose of COMPUNA tablets.
In a small number of people, statins can alter liver function, which can be identified with a
simple test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will ask
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to perform this test (liver function test) during treatment with COMPUNA tablets. It
is important to go to the doctor for the prescribed laboratory tests.
During treatment with this medicine, your doctor will carefully monitor you for 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 have high blood pressure.
If you are hospitalized or treated for another condition, inform the medical staff
that you are taking COMPUNA tablets.

Children and adolescents
The use of COMPUNA tablets is not recommended in children and adolescents under 18 years of age.

Other medicines and COMPUNA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation to prevent rejection of the transplanted organ). The effect of rosuvastatin is increased when used at the same time with this medicine. Do not takeCOMPUNA in combination with cyclosporine;
• anticoagulants such as warfarin, acenocoumarol, fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with COMPUNA), ticagrelor or clopidogrel);
• other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels (for example gemfibrozil or other fibrates). During concomitant use, the effect of rosuvastatin is increased;
• cholestyramine (a medicine to lower cholesterol levels), as it alters the functioning of ezetimibe;
• remedies for indigestion containing aluminum and magnesium (used to neutralize acids in the stomach; these metals decrease the levels of rosuvastatin in the blood). This effect may be mitigated by administering this type of medicine 2 hours after taking rosuvastatin;
• erythromycin (an antibiotic). Concomitant use of this antibiotic decreases the effect of rosuvastatin;
• fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when to safely restart COMPUNA tablets. Taking COMPUNA tablets with fusidic acid can rarely cause weakness, aches or muscle pain (rhabdomyolysis). See section 4 for more information regarding rhabdomyolysis;
• an oral contraceptive (the pill). They increase the levels of hormones absorbed by the pill;
• hormone replacement therapy (increases hormone levels in the blood);
• regorafenib (used to treat tumors);

one of the following medicines used to treat viral infections, including HIV or Hepatitis
C, alone or in combination (see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, ombitasvir,
paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. If you are hospitalized
or treated for another condition, inform the medical staff that you are taking COMPUNA
tablets.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take COMPUNA tabletsif you are pregnant, suspect you may be pregnant or are planning to become pregnant. If
you become pregnant while taking COMPUNA, stop taking it immediatelyand inform your doctor. Women must always use contraceptive measures during treatment with COMPUNA tablets.
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Breastfeeding
Do not take COMPUNA tabletswhile breastfeeding, as it is not known whether the medicine is excreted in breast
milk.

Driving and using machines
COMPUNA tablets should not interfere with your ability to drive or operate machinery. However, you should
consider that some people may experience dizziness after taking COMPUNA
tablets. If you experience dizziness, consult your doctor before driving or operating machinery.
COMPUNA contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take COMPUNA tablets

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or your
pharmacist.
You must continue to follow a low-cholesterol diet and exercise during the intake of
COMPUNA tablets.
The recommended daily dose for adults is one tablet of the specific dosage.

Take COMPUNA tablets once a day.
It can be taken at any time of the day with or without food. Swallow each tablet whole with a
glass of water.
Try to take the tablets at approximately the same time each day;
COMPUNA tablets is not suitable for initial therapy. The start of treatment or dose adjustment, if
necessary, must be carried out only by administering the active substances separately and after setting the
appropriate doses, it is possible to switch to COMPUNA tablets.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to be sure that the
cholesterol has reached and maintains normal values.

If you take moreCOMPUNA tablets than you should
Contact your doctor or the nearest hospital emergency room as you may need medical assistance.

If you forget to take COMPUNA tablets
Do not worry, take the next dose at the usual time. Do not take a double dose to compensate for forgetting
the dose.

If you stop taking COMPUNA tablets
Tell your doctor if you intend to stop taking COMPUNA tablets. If you stop
taking COMPUNA tablets, 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 everybody gets them.
It is important to be aware of possible side effects. They are usually mild and disappear quickly
over time.
Stop taking Compuna and seek immediate medical attention if you experience any of the following
symptoms:

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 4/7

skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

Rare (may affect up to 1 in 1000 people):

• severe allergic reaction (angioedema): symptoms include swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing;
• lupus-like syndrome (including rash, joint disorders and effects on blood cells);
• muscle rupture;
• aching, unusual muscle pain or reddish-brown urine, lasting longer than expected. These can rarely develop into a fatal muscle damage known as rhabdomyolysis, leading to malaise, fever and kidney dysfunction.

Other side effects that may occur with COMPUNA
Common (may affect up to 1 in 10 people):

• headache;
• stomach pain;
• constipation;
• feeling unwell;
• muscle pain;
• feeling weak;
• dizziness;
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine;
• feeling tired;
• diarrhoea;
• flatulence (excess gas in the intestines);
• increased transaminases during laboratory blood tests related to liver function.

Uncommon (may affect up to 1 in 100 people):

• skin rash, itching, hives;
• an increase in the amount of protein in the urine may occur - which usually returns to normal, without having to stop taking rosuvastatin;
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• loss of appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure;
• tingling sensation;
• dry mouth;

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• inflammation of the stomach;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.

Rare (may affect up to 1 in 1000 people):

• inflammation of the pancreas, causing severe stomach pain that radiates to the back;
• reduction in platelets;
• blurred vision and impaired vision. Very rare (may affect up to 1 in 10000 people):
• jaundice (yellowing of the skin and eyes);
• liver inflammation (hepatitis);
• traces of blood in the urine;
• damage to the nerves of the legs and arms (such as numbness) (polyneuropathy);
• memory loss;
• growth of breast tissue in men (gynecomastia);
• rash that may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions).

Not known (frequency cannot be estimated from available data):
Shortness of breath, sleep disorders, including difficulty sleeping and nightmares, sexual difficulties, depression,
breathing problems, including persistent cough and/or shortness of breath, or fever, tendon disorders, persistent muscle weakness, gallstones or inflammation of the gallbladder (which can cause stomach pain, nausea, vomiting).
Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles
used for breathing).
Ocular myasthenia (a disease that causes weakness of the eye muscles).
See 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.

Reporting of side effects
If you get any side effects, talk to 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 COMPUNA tablets

Store in the original package to protect the medicine from light.
This medicine does not require any particular storage temperature.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the package and blister.
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 eliminate the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

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What COMPUNA tablets contain
The active ingredients are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The tablets contain
rosuvastatin calcium salt equivalent to 5 mg, 10 mg and 20 mg of rosuvastatin and 10 mg of ezetimibe.
The other ingredients are: lactose monohydrate, microcrystalline cellulose type 101, microcrystalline cellulose type 102,
sodium croscarmellose, crospovidone, povidone, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of COMPUNA tablets and package contents
COMPUNA 5 mg/10 mg tablets: white or almost white, round, flat tablet, with E2 imprinted on
one side and 2 on the other side. The diameter of the tablet is 10 mm.
COMPUNA 10 mg/10 mg tablets: white or almost white, oval, biconvex tablet, with E1 imprinted on
one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm.
COMPUNA 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. The diameter
of the tablet is 11 mm.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bruno Farmaceutici S.p.A.
Via delle Ande n.15
00144 Roma

Manufacturer
Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland
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