CHOLECOMB 10 mg/10 mg Hard Capsule

Содержание инструкции

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

Cholecomb 5 mg/10 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/10 mg hard capsules

Rosuvastatin and Ezetimibe

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

1. What Cholecomb is and what it is used for

Cholecomb contains two different active substances in one capsule.
One of the active substances is rosuvastatin, belonging to a group of medicines called statins, the other active
substance is ezetimibe.
Cholecomb is a medicine used to lower levels of total cholesterol in the blood, of the so-called
“bad” cholesterol (LDL cholesterol) and of other fatty substances called triglycerides. It also increases the
levels of “good” cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways:
it reduces both the cholesterol absorbed from the digestive tract, as well as decreasing the production of cholesterol
by the body itself.
For most people, high cholesterol levels do not affect how they feel, as it
produces no symptoms. However, if left untreated, it can form a build-up of fat deposits in the walls of the
blood vessels, causing them to narrow.
Sometimes these narrowed blood vessels can become blocked and interrupt the flow of blood to the heart and brain
causing a heart attack or stroke. By reducing cholesterol levels, it is possible to reduce the risk of having a
heart attack, stroke or related health problems.
Cholecomb is used in patients whose cholesterol levels can no longer be controlled solely through
a cholesterol-lowering diet. This cholesterol-lowering diet must necessarily be
maintained while using the medicine.
Your doctor may prescribe Cholecomb if you are already taking both rosuvastatin and ezetimibe at the same
dosage.
Cholecomb is used in patients with heart disease. Cholecomb reduces the risk of heart attack, stroke, of
surgery to increase blood flow to the heart, or of hospitalization for chest pain.
Cholecomb does not help with weight loss.

2. What you need to know before taking Cholecomb

Do not take Cholecomb if:

• you are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6).
• you have a liver disease.
• you have severe kidney impairment.
• you have repeated and unexplained muscle pains (myopathy).
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (a medicine used to treat chronic viral hepatitis C infection)
• you are taking a medicine called cyclosporine (used for example after organ transplants).
• you are pregnant or breastfeeding. If you become pregnant while taking Cholecomb, stop taking it immediately and consult your doctor. Women must avoid pregnancy while using Cholecomb by using adequate contraceptive measures.
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking Cholecomb or other medicines containing rosuvastatin

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

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

• you have kidney problems.
• you have liver problems.
• you have had repeated or unexplained muscle pains, a personal or family history of muscle problems, or a previous experience of muscle problems while taking other medicines that lower cholesterol. Contact your doctor immediately if you have repeated and unexplained muscle pains, especially if you feel unwell or have a fever. Contact your doctor or pharmacist also if you have constant muscle fatigue.
• 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 the
myasthenia or cause it to appear (see section 4).

• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). In these cases, your doctor must choose the right dose of Cholecomb.
• you are taking medicines against infections, including HIV or hepatitis C, for example lopinavir/ritonavir and/or atazanavir. See section “Other medicines and Cholecomb”.
• you have severe respiratory failure.
• you are taking other medicines called fibrates to lower your cholesterol levels. See the section “Other medicines and Cholecomb” for more information.
• you regularly drink large amounts of alcohol.
• you have a thyroid gland that is not functioning properly (Hypothyroidism).
• you are over 70 years of age (your doctor must determine the right dose of Cholecomb that suits 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 Cholecomb can lead to serious muscle problems (rhabdomyolysis).

If any of these circumstances apply to you (or if you are unsure):

Talk to your doctor or pharmacist before taking any dose of Cholecomb.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with Cholecomb. Stop taking
Cholecomb and seek immediate medical attentionif you notice any of the symptoms described in section 4.
Statins can cause liver problems in a small number of people. This situation can be
easily identified with a simple test that analyzes the levels of liver enzymes in the blood. For this reason
your doctor must perform this blood test (liver function test) regularly during the
treatment with Cholecomb. It is important to go to the doctor for the prescribed laboratory tests.
While you are taking the medicine, your doctor will monitor you carefully if you have diabetes or are at risk of
developing diabetes. The risk of developing diabetes is very high if you have high levels of sugar and
fat in the blood, if you are overweight or if you have high blood pressure.

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

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

• Cyclosporine (used, for example, after an organ transplant to prevent rejection of the transplanted organs. The effect of rosuvastatin is increased when used at the same time with this medicine). Do not take Cholecomb while taking cyclosporine.
• Anticoagulants such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with Cholecomb), ticagrelor or clopidogrel.
• Other medicines used to lower cholesterol levels, called fibrates, which also correct triglyceride levels (for example gemfibrozil or other fibrates). During concomitant use with fibrates, the effect of rosuvastatin is increased.
• Cholestyramine (a medicine also used to lower cholesterol levels), as it alters the functioning of ezetimibe.
• Regorafenib (used to treat tumors).
• Darolutamide (used to treat cancer).
• Each of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see the section “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Remedies for indigestion containing aluminum and magnesium (used to neutralize acids in the stomach; these decrease the levels of rosuvastatin in the blood). This effect may be mitigated by taking this type of medicine 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). Concomitant use of this antibiotic decreases the effects of rosuvastatin.
• Fusidic acid. If you need to take fusidic acid to treat a bacterial infection, you will need to temporarily stop treatment with this medicine. Your doctor will tell you when it is safe to resume treatment with Cholecomb. The combination of Cholecomb and fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Oral contraceptives (the pill). They increase the levels of sex hormones regulated by the pill.
• Capmatinib (used for the treatment of cancer).
• Hormone replacement therapy (increases hormone levels in the blood).
• 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).

If you are hospitalized or treated for another condition, inform the medical staff that you are
taking Cholecomb.

Pregnancy and breastfeeding
Do not take Cholecomb if you are pregnant, suspect you are pregnant or are planning a pregnancy. If you
become pregnant while taking Cholecomb, stop taking it immediately and consult your
doctor. Women must always use contraceptive measures while taking Cholecomb.
Do not take Cholecomb during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
It is not expected that Cholecomb will interfere with the ability to drive vehicles or operate machinery. In
any case, it should be considered that some people may experience dizziness after
taking Cholecomb. If you experience dizziness, consult your doctor before driving vehicles or operating machinery.

Cholecomb contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially
‘sodium-free’.

3. How to take Cholecomb

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts,
consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and engage in physical activity during
the intake of Cholecomb.
The recommended daily dose for adults is one capsule of the prescribed dosage.

Take Cholecomb once a day.
Take the capsule at any time of day, on an empty or full stomach. Swallow the capsule whole with a
glass of water.
Take the medicine at the same time each day.
Cholecomb is not suitable for starting treatment. The initiation of treatment, or, if necessary, an adjustment
of the dosage, must be done only by administering the active ingredients separately, and after establishing the
correct dosage, it is possible to switch to Cholecomb in the appropriate dosage.
The doctor may decide to give you the lowest dose (5 mg/10 mg), if:

• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• you are over 70 years of age.
• you have moderate kidney problems.
• you are at risk of muscle pain (myopathy)

Regular cholesterol checks
It is important to have your cholesterol levels checked regularly by your doctor, to ensure that your cholesterol
reaches and maintains the correct level.

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

If you forget to take Cholecomb
Do not worry, skip the missed dose and take the next scheduled dose (always at the same time).
Do not take a double dose to make up for a missed dose.

If you stop taking Cholecomb
Consult your doctor if you wish to stop treatment with Cholecomb. Keep in mind that in this case
cholesterol levels may rise 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.

Stop taking Cholecomb immediately and seek medical help if you experience any of the following side effects, even if it is only one:
Rare (may affect up to 1 in 1,000 people):

• Allergic reactions such as swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing.
• Unusual muscle pains or pains that last longer than expected. These can rarely develop into a potentially fatal muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney damage.
• Lupus-like syndrome (including skin rashes, joint disorders and effects on blood cells).
• Muscle tearing.

Not known (frequency cannot be estimated from the available data):

• Reddish, non-raised, target-shaped or circular patches on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe 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 reaction with eosinophilia and systemic symptoms).
• Erythema multiforme (life-threatening allergic reactions affecting the skin and mucous membranes).

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

• Headache
• Constipation
• Nausea (feeling unwell)
• Muscle pain
• Feeling of weakness
• Dizziness
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will need to monitor you during treatment.
• Abdominal pain (stomach ache)
• Diarrhoea
• Flatulence (excess gas in the intestines)
• Feeling tired
• Increase in some laboratory blood tests related to liver function (transaminases)

Uncommon (may affect up to 1 in 100 people)

• Skin rash, itching, hives
• An increase in protein in the urine may occur; these normally return to their normal levels without stopping rosuvastatin.
• Increase in some laboratory blood tests of muscle function (CK)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle spasms
• Neck pain
• Loss of appetite
• Pain
• Chest pain
• Hot flushes
• High blood pressure
• Tingling sensation
• Dry mouth
• Inflammation of the stomach
• Back pain
• Muscle weakness
• Pain in the arms and legs
• Swelling, especially in the hands and feet

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

• Inflammation of the pancreas, which causes severe stomach pain that radiates to the back
• Reduced platelets

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

• Jaundice (yellowing of the skin and eyes)
• Inflammation of the liver (hepatitis)
• Traces of blood in the urine
• Damage to the nerves of the legs and arms (such as numbness)
• Memory loss
• Enlargement of the breasts in men (gynaecomastia)

Not known (frequency cannot be estimated from the available data)

• Shortness of breath
• Edema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injuries
• Persistent muscle weakness
• Gallstones or inflammation of the gallbladder (which can cause abdominal 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 or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avvers e .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cholecomb

Store at a temperature below 30°C.
Store in the original package to protect the medicine from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date (EXP) stated on the package. The expiration 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 Cholecomb contains
The active ingredients are rosuvastatin (as rosuvastatin zinc) and ezetimibe. The capsules contain zinc
rosuvastatin equivalent to 5 mg, 10 mg or 20 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.
The other ingredients are:

Core
Silicified Microcrystalline Cellulose [Microcrystalline Cellulose (E460) and Anhydrous Colloidal Silica (E551)], Anhydrous
Colloidal Silica (E551), Magnesium stearate (E572), Povidone (E1201), Sodium croscarmellose (E468), Microcrystalline
Cellulose (E460), Mannitol (E421), Sodium Lauryl Sulfate (E514), Hydroxypropyl Cellulose with low substitution
(E463).

Capsule shell
Cholecomb 5mg/10mg hard capsules
Cap: Titanium dioxide (E171), Yellow Iron Oxide (E172), Gelatin
Body: Titanium dioxide (E171), Gelatin
Cholecomb 10mg/10mg hard capsules
Cap and body: Yellow iron oxide (E172), titanium dioxide (E171), Gelatin
Cholecomb 20mg/10mg hard capsules
Cap: Red iron oxide (E172), titanium dioxide (E171), Yellow iron oxide (E172), Gelatin
Body: Yellow iron oxide (E172), titanium dioxide (E171), Gelatin

Description of the appearance of Cholecomb and contents of the pack
Cholecomb 5 mg/10 mg hard capsules: Hard gelatin capsules, not marked with automatic closing
of the Snap Cone type, with a yellow cap and white body filled with two tablets: one tablet of

Ezetimibe 10 mg, white or almost white, round, flat and with beveled edges, with a stylized E mark on one
side of the tablet and code 612 on the other side; one tablet ofRosuvastatin 5 mg, white or almost
white, round and biconvex, with a „5” mark on one side of the tablet and no mark on the other side. The
length of the capsule is approximately 21.7 mm (± 0.5 mm).
Cholecomb 10mg/10mg hard capsules: Hard gelatin capsule, not marked with automatic closing
of the Snap Cone type, with a yellow cap and yellow body filled with two tablets: one tablet of Ezetimibe

10 mg, white or almost white, round, flat and with beveled edges, with a stylized E mark on one side of the
tablet and code 612 on the other side; one tablet ofRosuvastatin 10 mg, white or almost white,

round, with a mark on one side of the tablet and no mark on the other side. The length of the capsule
is approximately 21.7 mm (± 0.5 mm).
Cholecomb 20mg/10mg hard capsules: Hard gelatin capsule, not marked with automatic closing
of the Snap Cone type, with a caramel cap and yellow body. filled with two tablets: one tablet of

Ezetimibe 10 mg, white or almost white, round, flat and with beveled edges, with a stylized E mark on one
side of the tablet and code 612 on the other side; one tablet ofRosuvastatin 20 mg, white or almost

white, round, with a mark on one side of the tablet and no mark on the other side. The length of the
capsule is approximately 21.7 mm (± 0.5 mm).
5mg/10mg: Packs of 28, 30, 60 and 90 hard capsules in cold blister (OPA/Al/PVC//Al).
10mg/10mg and 20mg/10mg: Packs of 7, 10, 28, 30, 56, 60, 84, and 90 hard capsules in cold blister
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Proterapia Hungary Ltd.
1134 Budapest, Lehel utca 11.
Hungary
Distributor for sales
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Rome
Italy

Manufacturer responsible for batch release
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65.
Hungary

This medicinal product is authorised in the member states of the European Economic Area with the following
names:

Cholecomb 40 mg/10 mg hard capsules

rosuvastatin and ezetimibe

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

1. What Cholecomb is and what it is used for

Cholecomb contains two different active ingredients in one capsule.
One of the active ingredients is rosuvastatin, belonging to the group of medicines called statins, the other active
ingredient is ezetimibe.
Cholecomb is a medicine used to lower levels of total cholesterol in the blood, of the so-called “bad” cholesterol (LDL cholesterol) and of other fatty substances called triglycerides in the blood. It also
increases levels of “good” cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed from the digestive tract, as well as decreasing the
production of cholesterol by the body itself.
For most people, high cholesterol levels do not affect how they feel, as
this does not produce any symptoms. However, if left untreated, it can form a build-up of fat deposits in the
walls of blood vessels, causing them to narrow.
Sometimes, these narrowed blood vessels can become blocked and interrupt the flow of blood to the heart and brain,
causing a heart attack or stroke. By reducing cholesterol levels, it is possible to reduce the risk of having a
heart attack, stroke, or related health problems.
Cholecomb is used in patients whose cholesterol levels can no longer be controlled solely through
a cholesterol-lowering diet. This cholesterol-lowering diet must necessarily be
maintained while using the medicine.
The doctor may prescribe Cholecomb if you are already taking both rosuvastatin and ezetimibe at the same
dosage.
Cholecomb is used in patients with heart disease. Cholecomb reduces the risk of heart attack, stroke, of
surgery to increase blood flow to the heart, or of hospitalization for chest pain.
Cholecomb does not help with weight loss.

2. What you need to know before taking Cholecomb

Do not take Cholecomb if:

• you are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6).
• you have a liver disease.
• you have moderate or severe kidney impairment.
• you have repeated and unexplained muscle pains (myopathy).
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (a medicine used to treat chronic hepatitis C viral infection)
• you have had any repeated and unexplained muscle pain, have a personal or family history of muscle problems, or have previously experienced muscle problems while taking other medicines to lower cholesterol.
• you are taking a medicine called ciclosporin (used, for example, after organ transplants).
• you are pregnant or breastfeeding. If you become pregnant while taking Cholecomb, stop taking the medicine immediately and consult your doctor. Women must avoid becoming pregnant while using Cholecomb by using adequate contraceptive measures.
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking Cholecomb or other medicines containing rosuvastatin
• you have a thyroid gland that is not functioning properly (hypothyroidism).
• you regularly drink large amounts of alcohol.
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• you are taking other medicines called fibrates to lower cholesterol levels (see section “Other medicines and Cholecomb”).

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

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

• you have kidney problems.
• you have liver problems.
• you have had repeated or unexplained muscle pains, or you have a personal or family history of muscle problems, or if you have previously experienced muscle problems while taking other medicines that lower cholesterol. Contact your doctor immediately if you have repeated and unexplained muscle pains, especially if you feel unwell or have a fever. Contact your doctor or pharmacist also if you have constant muscle fatigue.
• 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).
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). In these cases, your doctor may need to choose the right dose of Cholecomb.
• you are taking medicines against infections, including HIV or hepatitis C, for example lopinavir/ritonavir and/or atazanavir. See section “Other medicines and Cholecomb”.
• you have severe respiratory failure.
• you are taking other medicines called fibrates to lower cholesterol. See the section “Other medicines and Cholecomb” for more information.
• you regularly drink large amounts of alcohol.
• you have a thyroid gland that is not functioning properly (Hypothyroidism).
• you are over 70 years of age (your doctor must determine the right dose of Cholecomb that is suitable for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic for bacterial infections) by mouth or by injection. The combination of fusidic acid and Cholecomb can lead to serious muscle problems (rhabdomyolysis).

If any of these circumstances apply to you (or if you are unsure):

Do not take Cholecomb 40 mg/10 mg hard capsules (the highest dose) and consult your doctor or
pharmacist before taking any dose of Cholecomb.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with Cholecomb. Stop using
Cholecomb and seek immediate medical attentionif you notice any of the symptoms described in section 4.
Statins can cause liver problems in a small number of people. This situation can be
easily identified with a simple test that analyzes the levels of liver enzymes in the blood. For this reason
your doctor must perform this blood test (liver function test) regularly during
treatment with Cholecomb. It is important to go to the doctor for the prescribed laboratory tests.
While you are taking the medicine, your doctor will monitor you carefully if you have diabetes or are at risk of
developing diabetes. The risk of developing diabetes is very high if you have high levels of sugar and
fat in your blood, are overweight or have high blood pressure.

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

Other medicines and Cholecomb
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:

• Ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organs). The effect of rosuvastatin is increased if used at the same time as this medicine). Do not take Cholecomb while taking ciclosporin.
• Anticoagulants such as warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken with Cholecomb), ticagrelor or clopidogrel.
• Other medicines used to lower cholesterol levels called fibrates that also correct triglyceride levels (e.g. gemfibrozil or other fibrates). During concomitant use with fibrates, the effect of rosuvastatin is increased. Do not take Cholecomb 40mg/10mg hard capsules inconcomitance with a fibrate.
• Cholestyramine (a medicine used to lower cholesterol levels), as it alters the functioning of ezetimibe.
• Regorafenib (used to treat tumors).
• Darolutamide (used to treat cancer).
• Each of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Antacids containing aluminum and magnesium (used to neutralize stomach acids; these decrease the levels of rosuvastatin in the blood). This effect may be mitigated by taking these types of drugs 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). Concomitant use of this antibiotic decreases the effects of rosuvastatin.
• Fusidic acid. If you need to take fusidic acid to treat a bacterial infection, you will need to temporarily stop treatment with this medicine. Your doctor will tell you when it is safe to resume treatment with Cholecomb. The combination of Cholecomb and fusidic acid can, rarely, cause weakness, pain or tenderness in the muscles (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• Oral contraceptives (the pill). They increase the levels of sex hormones regulated by the pill.
• Capmatinib (used for the treatment of cancer).
• Hormone replacement therapy (increases hormone levels in the blood).
• Fostamatinib (used to treat low platelet counts).
• Febuxostat (used to treat and prevent high blood uric acid levels).
• Teriflunomide (used to treat multiple sclerosis).

If you are hospitalized or treated for another condition, tell the medical staff that you are
taking Cholecomb.

Cholecomb and alcohol
Do not take Cholecomb 40 mg/10 mg in hard capsules (the highest dose) if you regularly drink large
amounts of alcohol.

Pregnancy and breastfeeding
Do not take Cholecomb if you are pregnant, suspect you may be pregnant or are planning a pregnancy.
If you become pregnant while taking Cholecomb, stop taking the medicine immediately and
consult a doctor. Women must always use contraceptive measures during treatment with
Cholecomb.
Do not take Cholecomb during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
It is not expected that Cholecomb will affect your ability to drive or operate machinery. In
any case, you should consider that some people may experience dizziness after
taking Cholecomb.
If you experience dizziness, consult your doctor before driving or operating machinery.

Cholecomb contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially
‘sodium-free’.

3. How to take Cholecomb

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

Take Cholecomb once a day.
Take the capsule at any time of the day, on an empty or full stomach. Swallow each capsule whole with a
glass of water.
Take the medicine at the same time each day.
Cholecomb is not suitable for starting treatment. The start of treatment or, if necessary, a dosage adjustment must be done only by administering the active ingredients separately, and after the correct dosage has been established, you can switch to Cholecomb at the appropriate dosage.
The maximum daily dose of rosuvastatin is 40 mg. This medicine is reserved only for patients with high
cholesterol levels and at high risk of heart attack or stroke whose cholesterol levels have not lowered
enough with 20 mg.

Regular Cholesterol Checks
It is important to have your cholesterol levels checked regularly by your doctor to ensure that your cholesterol
reaches and maintains the correct level.

If you take more Cholecomb than you should
Contact your doctor or the Emergency Room of the nearest hospital as you may need
medical assistance.

If you forget to take Cholecomb
Do not worry, skip the missed dose and take the next scheduled dose (always at the same time).
Do not take a double dose to make up for a missed dose.

If you stop taking Cholecomb
Consult your doctor if you wish to stop treatment with Cholecomb. Keep in mind that in this case
your cholesterol levels may increase again.
If you have any further questions on 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.

Stop taking Cholecomb immediately and seek medical help if you experience any of the following side effects, even if it is only one:
Rare (may affect up to 1 in 1,000 people):

• Allergic reactions such as swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing.
• Unusual muscle pains or pains that last longer than expected. These can rarely develop into a potentially life-threatening muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney damage.
• Lupus-like syndrome (including skin rashes, joint disorders and effects on blood cells).
• Muscle rupture.

Not known (frequency cannot be estimated from available data):

• Reddish, non-raised, target-shaped or circular patches on the trunk, often with blisters in the centre, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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).
• Erythema multiforme. (life-threatening allergic reactions that affect the skin and mucous membranes).

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

• Headache
• Constipation
• Nausea (feeling unwell)
• Muscle pain
• Feeling of weakness
• Dizziness
• An increase in protein in the urine may occur; these usually return to normal levels without stopping rosuvastatin.
• Diabetes. This is more likely if you have high levels of sugar and fat in your blood, if you are overweight and have high blood pressure. Your doctor will need to monitor you during treatment.
• Abdominal pain (stomach ache);
• Diarrhoea;
• Flatulence (excess gas in the intestines);
• Feeling tired
• Increase in some laboratory blood tests related to liver function (transaminases);

Uncommon (may affect up to 1 in 100 people)

• Skin rash, itching, hives
• Increase in some laboratory blood tests of muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure.
• Feeling of pins and needles;
• Dry mouth;
• Inflammation of the stomach,
• Back pain;
• Muscle weakness,
• Pain in the arms and legs;
• Swelling, especially in the hands and feet.

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

• Inflammation of the pancreas, which causes severe stomach pain that spreads to the back
• Reduced platelets

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

• Jaundice (yellowing of the skin and eyes)
• Inflammation of the liver (hepatitis)
• Traces of blood in the urine
• Damage to the nerves of legs and arms (such as numbness)
• Memory loss
• Enlargement of the breast in men (gynecomastia)

Not known (frequency cannot be estimated from available data)

• Shortness of breath
• Edema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injuries
• Persistent muscle weakness
• Gallstones or inflammation of the gallbladder (which can cause abdominal 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, pharmacist or nurse. 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 Cholecomb

Store at a temperature below 30 °C.
Store in the original package to protect the medicine from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the package. 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 Cholecomb contains
The active ingredients are rosuvastatin (as rosuvastatin zinc) and ezetimibe. The capsules contain zinc
rosuvastatin equivalent to 40 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe
The other ingredients are:

Core
Silicified Microcrystalline Cellulose [Microcrystalline Cellulose (E460) and Anhydrous Colloidal Silica (E551)], Colloidal
Anhydrous Silica (E551), Magnesium stearate (E572), Povidone (E1201), Sodium Croscarmellose (E468), Microcrystalline
Cellulose (E460), Mannitol (E421), Sodium Lauryl Sulfate (E514), Hydroxypropyl Cellulose with low
substitution (E463)

Capsule shell
Cap: Red iron oxide (E172), Titanium dioxide (E171), Yellow iron oxide (E172), Gelatin
Body: Gelatin, Yellow iron oxide (E172), Titanium dioxide (E171)

Description of the appearance of Cholecomb and contents of the pack
Hard gelatin capsule, not marked with automatic closure of the Snap Cone type, with a red cap and
yellow body filled with three tablets: one Ezetimibe 10 mg tablet,white or almost white, round,
flat and with beveled edges, with a stylized E mark on one side of the tablet and code 612 on the other side;
two Rosuvastatin 20 mg tablets,white or almost white, round, with a mark on one side of the
tablet and no mark on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Packs of 7, 10, 28, 30, 56, 60, 84, and 90 hard capsules in cold blister (OPA/AL/PVC // Al) inserted into the
folded cardboard box with the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Proterapia Hungary Ltd.
1134 Budapest, Lehel utca 11.
Hungary
Distributor for sales
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Rome
Italy

Manufacturer responsible for batch release
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65.
Hungary

This medicinal product is authorised in the member states of the European Economic Area with the following
names: