Patient Information Leaflet: Information for the User

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

Rosuvastatin and Ezetimibe
Please read 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COMPUNA is and what it is used for

COMPUNA contains two different active substances in one tablet. One active substance is rosuvastatin, belonging to a group of medicines called "statins", the other is ezetimibe.
COMPUNA tablets are a medicine used to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and levels of fats in the blood called triglycerides. In addition, it increases levels of "good" cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: by decreasing the amount absorbed from the digestive tract and by reducing the body's own production of cholesterol.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow. Sometimes, this narrowing of blood vessels can block blood flow to the heart or brain, leading to heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other health problems related to high cholesterol can be reduced.
COMPUNA tablets are used for patients whose cholesterol levels cannot be controlled by a low-cholesterol diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe COMPUNA tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
COMPUNA tablets are used if you have:

increased cholesterol levels in the blood (primary hypercholesterolaemia);
heart disease; COMPUNA reduces the risk of heart attack, stroke, surgical procedures to increase blood flow to the heart, or hospitalisation due to chest pain.

COMPUNA tablets do not help with weight loss.

2. What you need to know before taking COMPUNA tablets

1/7
Do not take COMPUNA tablets

if you have previously 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 during treatment with COMPUNA by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
if you have liver disease;
if you have severe kidney impairment;
if you have unexplained, repeated muscle pain 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, skin peeling, blisters, and/or mouth ulcers after taking Compuna.

If any of these apply to you (or if you have any doubts), 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 experienced unexplained, repeated muscle pain or tenderness, or have a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor or pharmacist immediately if you experience unexplained muscle pain 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;
you have an underactive thyroid (hypothyroidism);
you are taking other cholesterol-lowering medicines called fibrates. See "Other medicines and COMPUNA tablets";
you are taking medicines used to treat HIV infections, e.g. lopinavir/ritonavir and/or atazanavir. See "Other medicines and COMPUNA tablets";
you are over 70 years of age (your doctor needs to select the appropriate dose for you);
you have severe respiratory failure;
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to select the appropriate dose for you;
if 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 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. Discontinue use of 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 causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

If any of these situations apply to you (or if you have any doubts): consult your doctor or pharmacist before starting to take any dose of COMPUNA tablets.
In a small number of people, statins may affect liver function, which can be detected by a simple blood test measuring increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) during treatment with COMPUNA tablets. It is important to attend your scheduled laboratory tests as advised by your doctor.
2/7
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.
If you are hospitalized or receiving treatment for another medical 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
Inform your doctor or pharmacist if you are currently 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 organ rejection). The effect of rosuvastatin increases when used together with this medicine. Do not take COMPUNA concomitantly with cyclosporine;
anticoagulants such as warfarin, acenocoumarol, phenindione (their anticoagulant effect and risk of bleeding may increase if taken together with COMPUNA), ticagrelor, or clopidogrel;
other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). Concomitant use increases the effect of rosuvastatin;
colestyramine (a medicine to lower cholesterol levels), as it interferes with the action of ezetimibe;
indigestion remedies containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin levels in the blood). This effect may be minimized by taking such medicines 2 hours after taking rosuvastatin;
erythromycin (an antibiotic). Concomitant use of this antibiotic reduces 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 taking this medicine. Your doctor will advise you when it is safe to restart COMPUNA tablets. Taking COMPUNA tablets with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information about rhabdomyolysis;
an oral contraceptive (the pill). These increase the absorbed hormone levels from the pill;
hormone replacement therapy (increases hormone levels in the blood);
regorafenib (used to treat tumours);

any 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 receiving treatment for another medical condition, inform the medical staff that you are taking COMPUNA tablets.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take COMPUNA tablets if you are pregnant, suspect you may be pregnant, or are planning to become pregnant. If you become pregnant while taking COMPUNA, stop taking it immediately and inform your doctor. Women must always use effective contraceptive measures during treatment with COMPUNA tablets.
Breastfeeding
3/7
Do not take COMPUNA tablets while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Driving and use of machines
COMPUNA tablets should not affect your ability to drive or operate machinery. However, you should be aware 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 an intolerance to certain sugars, contact them before taking this medicine.

3. How to take COMPUNA tablets

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and maintain regular physical activity while taking COMPUNA tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take COMPUNA tablets once daily.
It can be taken at any time of 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 are not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, must only be performed by administering the active substances separately; once appropriate doses have been established, switching to COMPUNA tablets may be considered.
Regular cholesterol monitoring
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains within normal limits.
If you take more COMPUNA tablets than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take a COMPUNA tablet
Do not panic. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking COMPUNA tablets
Inform your doctor if you intend to stop taking COMPUNA tablets. If you discontinue treatment with COMPUNA tablets, your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
It is important to be aware of the possible side effects. Usually they are mild and disappear in a short time.
Stop taking Compuna and seek immediate medical attention if you experience any of the following
symptoms:

flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). 4/7
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If you notice any of the serious side effects or symptoms listed below, stop taking
the tablets and contact your doctor immediately or go to the nearest hospital emergency department.
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 may cause difficulty breathing and swallowing;
lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
muscle breakdown;
unusual muscle tenderness, muscle pain, or red-brown discoloration of the urine, lasting longer than expected. These may rarely progress to fatal muscle damage known as rhabdomyolysis, which leads 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 the blood, 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 intestine);
increased transaminase levels in laboratory blood tests assessing liver function.

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

rash, itching, hives;
increased amount of protein in the urine – this usually returns to normal without discontinuing rosuvastatin;
cough;
indigestion;
heartburn;
joint pain;
muscle spasms;
neck pain;
decreased appetite;
pain;
chest pain;
hot flushes;
high blood pressure;
tingling sensation;
dry mouth;
stomach inflammation;
back pain;

5/7

muscle weakness;
pain in arms and legs;
swelling, especially of hands and feet.

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

inflammation of the pancreas, causing severe stomach pain radiating to the back;
reduced platelet count;
blurred vision and visual disturbances. Very rare (may affect up to 1 in 10,000 people):
jaundice (yellowing of the skin and eyes);
liver inflammation (hepatitis);
traces of blood in the urine;
nerve damage in arms and legs (such as numbness) (peripheral neuropathy);
memory loss;
breast enlargement in men (gynaecomastia);
skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Not known (frequency cannot be estimated from available data):
Shortness of breath, sleep disturbances including difficulty sleeping and nightmares, sexual problems, depression, respiratory
problems, including persistent cough and/or shortness of breath or fever, tendon disorders, persistent muscle weakness,
gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting).
Myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing).
Ocular myasthenia (a condition causing weakness of the eye muscles).
Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
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 COMPUNA tablets

Store in the original packaging to protect the medicine from light.
This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 COMPUNA tablets contain
6/7
The active substances 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 components are: monohydrate lactose, 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" engraved on one side and "2" on the other side. The tablet diameter is 10 mm.
COMPUNA 10 mg/10 mg tablets: white or almost white, oval, biconvex tablet, with "E1" engraved on one side and "1" on the other side. The tablet dimensions are 15 mm x 7 mm.
COMPUNA 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. The tablet diameter is 11 mm.
Pack containing 28 tablets in blisters (PA/AL/PVC/Al) placed in a cardboard box with the package leaflet.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bruno Farmaceutici S.p.A.
Via delle Ande n.15
00144 Rome, Italy
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland
7/7

Package leaflet: information for the user

COMPUNA 40 mg/10 mg film-coated tablets film-coated tablets

Rosuvastatin and Ezetimibe
Please read 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

3. What COMPUNA is and what it is used for

COMPUNA contains two different active substances in a film-coated tablet. One active substance is rosuvastatin, belonging to a group of medicines called "statins", the other is ezetimibe.
COMPUNA film-coated tablets are a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat-like substances in the blood called triglycerides.
Additionally, this medicine increases levels of "good" cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways:
by reducing the amount absorbed from the digestive tract and by decreasing its production by the body itself.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow. Sometimes, this narrowing of blood vessels can block blood flow to the heart or brain, leading to a heart attack or stroke. Lowering cholesterol levels can reduce the risk of heart attack, stroke, or other health-related problems.
COMPUNA film-coated tablets are used for patients whose cholesterol levels cannot be controlled by a low-cholesterol diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe you COMPUNA film-coated tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
COMPUNA film-coated tablets are used if you have:

increased cholesterol levels in the blood (primary hypercholesterolemia);
heart disease, in which case COMPUNA reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

COMPUNA film-coated tablets do not help with weight loss.

4. What you need to know before taking COMPUNA film-coated tablets

Do not take COMPUNA film-coated tablets

if you have previously had an allergic reaction to rosuvastatin, ezetimibe, or any of the other components 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 by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
if you have liver disease;
if you have moderate or severe kidney impairment;
if you have unexplained, repeated muscle pain or tenderness (myopathy);
if you have a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
if you are taking a combination of medicines consisting of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking COMPUNA or related medicines;
if your thyroid gland is not functioning properly (hypothyroidism);
if you regularly drink large amounts of alcohol;
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian);
if you are taking other cholesterol-lowering medicines called fibrates (see section “Other medicines and COMPUNA”).

If any of these apply to you (or if you have any doubts), 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 experienced unexplained, repeated muscle pain or tenderness, have a personal or family history of muscle problems, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor or pharmacist immediately if you experience unexplained muscle pain 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 cholesterol-lowering medicines called fibrates. See “Other medicines and COMPUNA film-coated tablets”;
you are taking medicines used to treat HIV infections, e.g. lopinavir/ritonavir and/or atazanavir. See “Other medicines and COMPUNA film-coated tablets”;
you are over 70 years of age (your doctor needs to choose the appropriate dose 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 dose of COMPUNA suitable for you;
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 COMPUNA can lead to serious muscle problems (rhabdomyolysis);
you have or have had myasthenia gravis (a disease characterized by generalized 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 myasthenia or trigger its onset (see section 4). If any of these situations apply to you (or if you have any doubts): consult your doctor or pharmacist before starting to take any dose of COMPUNA film-coated tablets.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with COMPUNA. Discontinue use of COMPUNA and seek immediate medical attention if you notice any of the symptoms described in section 4.
In a small number of people, statins may affect liver function, which can be detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor may request this test (liver function test) during treatment with COMPUNA film-coated tablets. It is important to attend scheduled laboratory appointments with your doctor.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking COMPUNA film-coated tablets.
Children and adolescents
The use of COMPUNA film-coated tablets is not recommended in children and adolescents under 18 years of age.
Other medicines and COMPUNA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

cyclosporine (used, for example, after organ transplantation to prevent organ rejection). The effect of rosuvastatin increases when used together with this medicine. Do not take COMPUNA concomitantly with cyclosporine;
anticoagulants such as warfarin, acenocoumarol, phenindione (their anticoagulant effect and risk of bleeding may increase when taken together with COMPUNA), ticagrelor, or clopidogrel;
other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). Concomitant use increases the effect of rosuvastatin. Do not take COMPUNA 40 mg/10 mg film-coated tablets concomitantly with a fibrate;
colestyramine (a medicine to lower cholesterol levels), as it may interfere with the action of ezetimibe;
antacids containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin levels in the blood). This effect may be minimized by taking these medicines 2 hours after taking rosuvastatin;
erythromycin (an antibiotic). Concomitant use of this antibiotic reduces 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 taking this medicine. Your doctor will advise you when it is safe to restart COMPUNA film-coated tablets. Taking COMPUNA film-coated tablets with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
an oral contraceptive (the pill). These increase the absorbed hormone levels from the pill;
hormone replacement therapy (increases hormone levels in the blood);
regorafenib (used to treat tumors);
darolutamide (used to treat tumors);
capmatinib (used to treat tumors);
fostamatinib (used to treat low platelet count);
febuxostat (used to treat and prevent high levels of uric acid in the blood);
teriflunomide (used to treat multiple sclerosis);
any 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or receiving treatment for another medical condition, inform the medical staff that you are taking COMPUNA film-coated tablets.
COMPUNA and alcohol
Do not take COMPUNA 40 mg/10 mg film-coated tablets (the highest dose) if you regularly drink large amounts of alcohol.
Pregnancy
Do not take COMPUNA film-coated tablets if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking COMPUNA, stop taking it immediately and inform your doctor. Women must always use effective contraceptive measures during treatment with COMPUNA film-coated tablets.
Breastfeeding
Do not take COMPUNA film-coated tablets during breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Driving and using machines
COMPUNA film-coated tablets should not affect your ability to drive or operate machinery. However, you should consider that some people may experience dizziness after taking COMPUNA film-coated tablets. If you experience dizziness, consult your doctor before driving or using machinery.
COMPUNA contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take COMPUNA film-coated tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and engage in physical activity while taking COMPUNA film-coated tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take COMPUNA film-coated tablets once daily.
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 film-coated tablets at approximately the same time each day.
COMPUNA film-coated tablets are not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, should only be performed by administering the active substances separately; once appropriate doses have been established, switching to COMPUNA film-coated tablets may be considered.
The maximum daily dose of rosuvastatin is 40 mg. This dose is suitable only for patients with high cholesterol levels and at high risk of heart attack or stroke, in whom cholesterol levels have not sufficiently decreased with a 20 mg dose.
If your doctor has prescribed COMPUNA together with another cholesterol-lowering medicine containing cholestyramine as the active ingredient or any other medicine containing a bile acid sequestrant, you must take COMPUNA at least 2 hours before or 4 hours after taking those medicines.
11/7
Periodic cholesterol monitoring
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains within normal target values.
If you take more COMPUNA film-coated tablets than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take COMPUNA film-coated tablets
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking COMPUNA film-coated tablets
Inform your doctor if you intend to discontinue treatment with COMPUNA film-coated tablets. If you stop taking COMPUNA film-coated tablets, your cholesterol levels may rise again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important to be aware of the possible side effects. They are usually mild and disappear within a short time.
Stop taking COMPUNA and seek immediate medical help if you experience any of the following symptoms:

red, flat, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious 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 any of the serious side effects or symptoms listed below, stop taking the film-coated tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.
Rare (may affect up to 1 in 1,000 people):

severe allergic reaction (angioedema): symptoms include swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing;
lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
muscle breakdown;
muscle tenderness, unusual muscle pain, or red-brown discoloration of the urine that lasts longer than expected. Muscle symptoms are more common in children and adolescents than in adults. These may rarely progress to 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 of weakness; 12/7
dizziness;
diabetes. This is more likely if you have high levels of sugars and fats in the blood, 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 intestine);
increase in transaminases during laboratory blood tests related to liver function;
increase in the amount of protein in the urine – this usually returns to normal without needing to stop rosuvastatin.

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

rash, itching, hives;
increased muscle function (CK) in certain blood tests;
cough;
indigestion;
heartburn;
joint pain;
muscle spasms;
neck pain;
loss of appetite;
pain;
chest pain;
hot flushes;
high blood pressure;
tingling sensation;
dry mouth;
stomach inflammation;
back pain;
muscle weakness;
pain in arms and legs;
swelling, especially of hands and feet.

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

inflammation of the pancreas, causing severe stomach pain spreading to the back;
reduction in platelets;
blurred vision and impaired vision.

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

jaundice (yellowing of the skin and eyes);
liver inflammation (hepatitis);
traces of blood in the urine;
nerve damage in arms and legs (such as numbness) (peripheral neuropathy);
memory loss;
breast enlargement in men (gynaecomastia);
skin rash or mouth ulcers (drug-induced lichenoid eruptions).

Not known (frequency cannot be estimated from available data):
Shortness of breath, sleep disturbances including difficulty sleeping and nightmares, sexual problems, depression, respiratory problems including persistent cough and/or shortness of breath or fever, tendon disorders, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting), raised rash, sometimes with target-shaped lesions (erythema multiforme).
13/7
Myasthenia gravis (a disease causing generalized 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 arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or laboured breathing.

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 COMPUNA film-coated tablets

Keep in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 COMPUNA film-coated tablets contain
The active substances are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The film-coated tablets contain rosuvastatin calcium salt equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.
The other components are: Monohydrate lactose; Microcrystalline cellulose type 102; Sodium croscarmellose; Povidone K30; Sodium lauryl sulfate; Magnesium stearate; Hypromellose 2910; Anhydrous colloidal silica; Hypromellose E464; Titanium dioxide E171; Macrogol E1521.

Description of the appearance of COMPUNA film-coated tablets and package contents
COMPUNA 40 mg/10 mg film-coated tablets: white or almost white, round, biconvex tablets.
The tablet diameter is 10 mm.
Pack size: 30 film-coated tablets in blisters (OPA/AL/PVC/Al), packed in cardboard boxes with the package leaflet.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bruno Farmaceutici S.p.A.
Via delle Ande n.15
00144 Rome, Italy

Manufacturer
ELPEN Pharmaceutical Co Inc
14/7
95, Marathonos Ave., Pikermi 19009
Attica, Greece
RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.
P.O BOX 3012 Larissa Industrial Area,
Larissa, 41500, Greece
15/7