ROSUCETIL 5 mg/100 mg Hard Capsule

Зміст інструкції

1. ROSUCETIL 5 mg/100 mg hard capsules, 10 mg/100 mg hard capsules, 20 mg/100 mg hard capsules
   1. What is ROSUCETIL and what is it used for
   2. What you need to know before taking ROSUCETIL
   3. How to take ROSUCETIL
   4. Possible side effects
   5. How to store ROSUCETIL
   6. Package contents and other information

ROSUCETIL 5 mg/100 mg hard capsules, 10 mg/100 mg hard capsules, 20 mg/100 mg hard capsules

Rosuvastatin/Acetylsalicylic acid

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

1. What is ROSUCETIL and what is it used for

ROSUCETIL contains two active ingredients:

• Rosuvastatin belongs to a group of medicines called “statins” which regulate lipids (fats), which are used to reduce levels in the blood of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone have not been effective. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels of the heart causing coronary heart disease. If you are at risk of another heart attack, rosuvastatin can also be used to reduce that risk, even if your cholesterol levels are normal. During treatment you must continue to follow a standard diet to lower cholesterol.
• Acetylsalicylic acid, belonging to a group of medicines called antiplatelet agents. Platelets are tiny blood cells that cause blood clotting and are involved in thrombosis. When a clot forms in an artery, it blocks the flow of blood and interrupts the supply of oxygen. When this happens in the heart, it can cause a heart attack or angina.

These two active substances, taken together, reduce the probability of having another heart attack, if you have
already had one previously or if you suffer from attacks of chest pain (unstable angina pectoris). ROSUCETIL is
indicated in patients who are already taking rosuvastatin and acetylsalicylic acid at these dosages. Instead of
taking rosuvastatin and acetylsalicylic acid separately, you will receive a ROSUCETIL capsule containing
both substances at the same dosages.

2. What you need to know before taking ROSUCETIL

Do not take ROSUCETIL:

• if you are allergic to rosuvastatin, to acetylsalicylic acid, to other salicylates, to non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to peanuts or soy (see below);
• if you are pregnant or breastfeeding. If you become pregnant while taking ROSUCETIL, stop taking it immediately and contact your doctor. Women must avoid pregnancy during treatment with ROSUCETIL by using appropriate contraceptive measures;
• if you have a liver disease;
• if you have moderate or severe kidney failure;
• if you have repeated or unexplained muscle aches or pains;
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines (used for a viral liver infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• if you have had asthma attacks in the past or a severe allergic reaction called “angioedema” after taking salicylates or non-steroidal anti-inflammatory drugs. The signs include itching, hives, red spots on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
• If you have had or have a history of recurrent stomach ulcers and/or gastrointestinal bleeding, or other types of bleeding, such as cerebrovascular hemorrhage;
• if you have ever had a problem with your blood not clotting properly;
• if you suffer from gout;
• if you suffer from uncompensated heart failure;
• if you are taking a medicine called methotrexate (used for cancer or rheumatoid arthritis) at doses greater than 15 mg per week.
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking rosuvastatin or other related medicines.

If you fall into any of the above cases (or if you have any doubts), you should return to your doctor and inform him/her.

Warnings and precautions
Consult your doctor or pharmacist before taking ROSUCETIL:

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or if you have had a previous history of muscle problems while taking other medicines that lower cholesterol. Immediately inform your doctor if you have unexplained muscle aches or pains, especially if you do not feel well or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness;
• If 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 that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4)
• if you regularly consume significant amounts of alcohol;
• if your thyroid is not functioning properly;
• if you are taking other medicines called fibrates to lower cholesterol. Read carefully

cholesterol;

• if you are taking medicines used to fight HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, see section “Other medicines and ROSUCETIL”;
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and ROSUCETIL can lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and ROSUCETIL”;
• if you have severe respiratory failure;
• if you are over 70 years old: your doctor needs to choose the appropriate initial dose for you;
• if you are of Asian origin (i.e. Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor must choose the correct starting dose of ROSUCETIL suitable for you.
• if you have or have had problems with your stomach or small intestine (ulcers or gastrointestinal bleeding);
• if you suffer from high blood pressure;
• if you are asthmatic, suffer from hay fever, have nasal polyps or other chronic respiratory diseases; acetylsalicylic acid can cause an asthma attack;
• in case of hypersensitivity (allergy) to other pain or anti-inflammatory medicines, or other medicines for rheumatism or other factors that can cause allergies;
• if you have other allergies (e.g. with skin reactions, itching);
• if you are taking other medicines called anticoagulants (e.g. coumarin derivatives, heparin - except for treatment with low-dose heparin);
• with impaired kidney function or reduced blood flow to the heart or vessels (e.g. kidney vascular disease, weakened heart muscle, reduced blood volume, major surgery, blood poisoning or increased bleeding): acetylsalicylic acid can further increase the risk of kidney dysfunction and acute renal failure.
• if you have heavy menstrual periods. Consult your doctor if your symptoms worsen or if serious or unexpected side effects occur, e.g. unusual symptoms of bleeding, severe skin reactions or any other sign of a serious allergy (see section “Possible side effects”).

Metamizole (a substance to reduce pain and fever) can reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that adhere to each other and form a blood clot), if taken simultaneously. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection.
In a small number of people, statins can alter liver function. This is detected with a simple test that allows monitoring of increased levels of liver enzymes in the blood. For this reason, your doctor will usually request this blood test (liver function test) before and during treatment with ROSUCETIL.
During treatment with this medicine, your doctor will carefully check that you do not have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure.
You should be careful not to become dehydrated (you may feel thirsty with a dry mouth) because the simultaneous use of acetylsalicylic acid can worsen kidney function.
Inform your doctor if you are planning to undergo surgery (even minor, such as a tooth extraction) as acetylsalicylic acid thins the blood and can lead to an increased tendency to bleed.
Acetylsalicylic acid can cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, ROSUCETIL should not be given to children and adolescents under the age of 18.
In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause destruction or accelerated destruction of red blood cells or a certain type of anemia. This risk may be caused by factors such as high dosage; fever or acute infections.
Acetylsalicylic acid at low doses reduces the excretion of uric acid. This can trigger an attack of gout in patients at risk.
If you cut or produce a lesion, bleeding may take a little longer to stop. This depends on the effect of acetylsalicylic acid. Small cuts or lesions (e.g. during shaving) usually do not matter. If unusual bleeding occurs (in an unusual place or of unusual duration), contact your doctor.
In association with treatment with rosuvastatin, serious skin reactions have been reported, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using ROSUCETIL and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents
ROSUCETIL should not be used in children and adolescents.

Other medicines and ROSUCETIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because ROSUCETIL contains rosuvastatin and acetylsalicylic acid and these substances can affect the mechanism of action of other medicines and some medicines can affect the action of rosuvastatin and acetylsalicylic acid.
Tell your doctor if you are taking any of the following medicines, which may increase the occurrence of side effects:

• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• antacids (used to neutralize stomach acids);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• regorafenib (used to treat tumors);
• darolutamide (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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir,
• dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• ketoconazole, itraconazole (antifungal medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• medicines for thinning the blood/preventing clots (e.g. warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid can increase the risk of bleeding if taken before removing a clot or blood thinning treatment, so if you are to undergo such treatment, you should be careful of signs of external or internal bleeding (e.g. bruising);
• organ rejection after transplantation (cyclosporine, tacrolimus). Do not take this medicine in conjunction with cyclosporine because the effect of rosuvastatin is increased;
• hypertension (e.g. diuretics and ACE inhibitors);
• heartbeat regulation (digoxin);
• treatment of manic-depressive illnesses (lithium);
• pain and inflammation (e.g. NSAIDs such as ibuprofen, naproxen or steroids);
• gout (probenecid, benzbromarone);
• glaucoma (acetazolamide);
• cancer or rheumatoid arthritis (methotrexate at doses less than 15 mg/week);
• medicines to lower blood sugar (antidiabetics) (e.g. glibenclamide) - blood sugar levels may decrease;
• selective serotonin reuptake inhibitors (for the treatment of depression) such as sertraline and paroxetine);
• corticosteroids used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed (with the exception of medicines applied to the skin or in cortisone replacement therapy for Addison's disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects.
• seizures (valproic acid);
• medicines that cause increased urinary excretion (diuretics: so-called aldosterone antagonists, such as spironolactone and canrenonate, loop diuretics, e.g. furosemide);
• alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking ROSUCETIL. Your doctor will tell you when it is safe to start taking ROSUCETIL again. Taking ROSUCETIL with fusidic acid can rarely cause weakness, soreness or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

ROSUCETIL with food, drinks and alcohol
Drinking alcohol may potentially increase the risk of gastrointestinal bleeding and prolong bleeding time. Therefore, it is recommended not to drink alcohol during treatment with ROSUCETIL.

Pregnancy and breastfeeding
Pregnancy
Do not take ROSUCETIL if you are pregnant, suspect you are pregnant or are planning to become pregnant. If you become pregnant while taking ROSUCETIL, stop taking it immediately and inform your doctor.
Women must avoid becoming pregnant during treatment with ROSUCETIL by using adequate contraception.
Breastfeeding
Do not take ROSUCETIL if you are breastfeeding

Driving and using machines
Most people can drive vehicles and use machines during treatment with ROSUCETIL as it does not affect their abilities.
However, some people may experience dizziness during treatment with ROSUCETIL.
If the capsules cause you to feel unwell, dizzy or tired, or give you a headache, do not drive vehicles or use machines and contact your doctor immediately.

ROSUCETIL contains lactose
If your doctor has diagnosed you with intolerance to some sugars (lactose or milk sugar), consult him/her before taking ROSUCETIL.

ROSUCETIL contains soy oil
If you are allergic to peanuts or soy, do not use this medicine.

3. How to take ROSUCETIL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts about the use of this medicine, ask your doctor or pharmacist

Taking the medicine

• Take this medicine after a meal
• Swallow the capsules whole with a glass of water. Do not take ROSUCETIL with grapefruit juice.
• Do not open, crush or chew the capsules
• This medicine must be taken at the same time each day.

Dosage to be taken
The recommended dose is one capsule once a day.
Try to take the capsules at approximately the same time each day; this may help you not to forget to take them.
The doctor will decide the appropriate dosage for you, according to your condition, the ongoing treatment and your personal level of risk.
This medicine is not suitable for initial treatment. The start of treatment must only occur with the administration of the two active substances separately and after defining the appropriate doses, it is possible to switch to the appropriate dosage of ROSUCETIL.
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 the correct levels. The doctor may decide to increase the dose up to the amount of ROSUCETIL that is most suitable for you.

Use in elderly patients
It is not necessary to modify the dose in elderly patients.

Use in children and adolescents
ROSUCETIL should not be used in children and adolescents.

Patients with renal impairment
It is not necessary to modify the dose if you suffer from mild to moderate renal impairment.
The use of ROSUCETIL is contraindicated in patients with severe renal impairment.

Patients with hepatic impairment
It is not necessary to modify the dose if you suffer from mild to moderate hepatic impairment.
The use of ROSUCETIL is contraindicated in patients with severe hepatic impairment.

If you take more ROSUCETIL than you should
Symptoms of severe poisoning may be dizziness and ringing in the ears, especially in elderly patients.
Contact your doctor or go to the emergency room of the nearest hospital immediately. Do not drive to the hospital, but ask someone to accompany you, or call an ambulance. Bring the package of the medicine with you so that the doctor knows what you have taken.

If you forget to take ROSUCETIL
Do not worry. If you forget to take a capsule, completely skip that dose. Take the next dose at the correct time. Do not take a double dose to make up for the forgotten capsule.

If you stop taking ROSUCETIL
The doctor will advise you how long you should take the medicine. Your cholesterol levels may rise again if you stop taking ROSUCETIL.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ROSUCETIL and consult your doctor immediatelyif you experience any of the
following very rare and serious side effects after taking this medicine.

• Sudden shortness of breath, chest pain, wheezing or difficulty breathing;
• Swelling of the eyelids, face or lips;
• Swelling of the tongue and throat which causes great difficulty in breathing and/or swallowing;
• Severe skin reactions including a severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions;
• Unusual bleeding such as coughing up blood, if black stools or vomit containing blood appear (sign of severe bleeding in the stomach), blood in the urine;
• Reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, 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).

Also, stop taking ROSUCETIL and see your doctor immediately

• if you have any unexplained muscle pain or weaknessthat lasts longer than you would expect. As with other statins, a very small number of people have experienced muscle problems that rarely have evolved into a life-threatening muscle damage known as rhabdomyolysis.
• if a muscle rupture occurs;
• if you develop a lupus-like syndrome(including rash, joint disorders and effects on blood cells).

Side effects with rosuvastatin and acetylsalicylic acid when taken separately.
Tell your doctor if any of the following effects worsen or persist for more than a week.
ROSUVASTATIN

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 already have high blood sugar and fat levels, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

• Rash, itching, hives or other skin reactions
• An increase in the amount of protein in your urine - values usually return to normal spontaneously without having to stop taking ROSUCETIL (only 5 mg and 20 mg dosages).

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

• Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps).

If you think you are having an allergic reaction, stop taking ROSUCETILand seek
immediate medical help.

• Muscle damage in adults - as a precaution, stop taking ROSUCETIL and see your doctor immediately if you have unexplained muscle pain or weaknessthat lasts longer than expected
• Severe stomach pain (inflammation of the pancreas)
• Increased liver enzymes in the blood
• Reduced platelets in the blood, which increases the risk of bleeding or bruising (thrombocytopenia)
• Lupus-like syndrome (includes skin reaction, joint disorders and effects on blood cells).

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflamed liver)
• Traces of blood in the urine
• Nerve damage in the legs and arms (such as numbness)
• Joint pain
• Memory loss
• Gynaecomastia (breast enlargement in men)

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

• Diarrhoea (loose stools)
• Cough
• Shortness of breath
• Edema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual problems
• Depression
• Breathing problems, including persistent cough and/or wheezing or fever
• Tendon injury
• A nerve disorder that can cause weakness, tingling or numbness
• Persistent muscle weakness
• 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.
ACETYLSALICYLIC ACID

Common(may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain and diarrhoea.
• Minor blood loss from the gastrointestinal tract (micro-bleeding)
• Bleeding, e.g. nosebleeds, bleeding gums, skin bleeding or bleeding from the urinary and reproductive tracts with possible increased bleeding time. This effect may persist for 4 to 8 days after stopping the medication.

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

• Bleeding from the stomach or intestine. After long-term use of acetylsalicylic acid, anaemia (iron deficiency anaemia) may occur due to occult blood loss from the stomach or intestine.
• Gastric or intestinal ulcers, which very rarely can lead to perforation.
• Intracranial bleeding, blood in the urine.
• Gastrointestinal inflammation
• Skin reactions.

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

• Hypersensitivity reactions of the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following manifestations may occur: low blood pressure, attacks of shortness of breath, inflammation of the nasal mucosa, nasal congestion, anaphylactic shock, swelling of the face, tongue and larynx (Quincke's edema)
• Severe bleeding, such as bleeding in the brain, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants (blood-thinning medications), which in individual cases can be life-threatening
• Confusion
• Headache, dizziness
• Hearing impairment or ringing in the ears (tinnitus), especially in children and the elderly, which may be signs of an overdose (see also "If you take more ROSUCETIL than you should").

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

• Increases in liver function test values
• Kidney dysfunction and acute renal failure
• Decreased blood sugar (hypoglycaemia)
• Acetylsalicylic acid at low doses reduces the excretion of uric acid. This can trigger an attack of gout in patients at risk.
• Skin rash with fever with involvement of the mucous membranes (exudative multiforme erythema).

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

• Accelerated degradation or decay of red blood cells in the blood and a specific form of anaemia (low number of red blood cells) in patients with severe glucose-6-phosphate dehydrogenase deficiency.

If any of these side effects worsen, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 ROSUCETIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Expiry. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What ROSUCETIL contains
The active substances are rosuvastatin (as rosuvastatin calcium salt) and acetylsalicylic acid.
ROSUCETIL hard capsules 5 mg/100 mg contain 5 mg of rosuvastatin (as calcium salt) and 100 mg of
acetylsalicylic acid.
ROSUCETIL hard capsules 10 mg/100 mg contain 10 mg of rosuvastatin (as calcium salt) and 100 mg of
acetylsalicylic acid.
ROSUCETIL hard capsules 20 mg/100 mg contain 20 mg of rosuvastatin (as calcium salt) and 100 mg of
acetylsalicylic acid.
The other ingredients are:

Film-coated tablet containing rosuvastatin:
Tablet core
Lactose monohydrate
Microcrystalline cellulose
Magnesium oxide, heavy
Croscarmellose sodium (type A)
Colloidal anhydrous silica
Magnesium stearate
Film coating
Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Yellow iron oxide (E172)
Lecithin (soy)
Red iron oxide (E 172)
Xanthan gum
Black iron oxide (E 172)

Tablet with acetylsalicylic acid
Microcrystalline cellulose
Corn starch
Colloidal anhydrous silica
Stearic acid

Capsule shell
Gelatin
Titanium dioxide (E171)
Indigo carmine (E132)
Yellow iron oxide (E172)

Black ink:
Shellac
Propylene glycol
Strong ammonia solution
Black iron oxide (E172)
Potassium hydroxide.

Description of the appearance of ROSUCETIL and contents of the pack
ROSUCETIL 5 mg/100 mg hard gelatin capsule, size 2, with an opaque white body and opaque dark green cap.
Each capsule contains a white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and a
brown film-coated, biconvex, round tablet of rosuvastatin 5 mg.
ROSUCETIL 10 mg/100 mg hard gelatin capsule, size 1, with an opaque white body imprinted in black “ASA 100 mg”
and opaque light green cap imprinted in black “RSV 10 mg”. Each capsule contains a white or almost white,
biconvex, oval, uncoated tablet of acetylsalicylic acid and a brown film-coated, biconvex, round tablet of
rosuvastatin 10 mg.
ROSUCETIL 20 mg/100 mg hard gelatin capsule, size 0, with an opaque white body imprinted in black “ASA 100 mg”
and opaque green cap imprinted in black “RSV 20 mg”. Each capsule contains a white or almost white,
biconvex, oval, uncoated tablet of acetylsalicylic acid and two brown film-coated, biconvex, round tablets of
rosuvastatin 10 mg.
The hard capsules are available in PA/AL/PVC/AL blisters in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati, 40

• 20121 – Milan

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