ROSUCETIL

Package leaflet: Information for the patient

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

Rosuvastatin/ Acetylsalicylic acid
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, inform 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 taking 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 ROSUCETIL is and what it is used for

ROSUCETIL contains two active substances:

• Rosuvastatin, which belongs to a group of medicines called "statins" that regulate lipids (fats). These are used to reduce blood levels 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, leading to coronary heart disease. If you are at risk of another heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.
• Acetylsalicylic acid, which belongs 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 blood flow and interrupts the supply of oxygen. When this occurs in the heart, it can cause a heart attack or angina.

These two active substances, taken together, reduce the likelihood of having another heart attack, if you have already had one previously or if you suffer from episodes of chest pain (unstable angina pectoris). ROSUCETIL is indicated for patients who are already taking rosuvastatin and acetylsalicylic acid at these dosages. Instead of taking rosuvastatin and acetylsalicylic acid separately, you will receive one 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, acetylsalicylic acid, other salicylates, 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 liver disease;
• if you have moderate or severe kidney failure;
• if you have repeated or unexplained muscle cramps or muscle pain;
• if you are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (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 previously had asthma attacks or a serious allergic reaction called “angioedema” after taking salicylates or non-steroidal anti-inflammatory drugs. Signs include itching, hives, red spots on hands, feet and 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 ulcer and/or gastrointestinal bleeding, or other types of bleeding, such as cerebrovascular hemorrhage;
• if you have ever had problems with blood clotting;
• 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 exceeding 15 mg per week;
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking rosuvastatin or related medicines.

If any of the above apply to you (or if you have any doubts), you must consult your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking ROSUCETIL:

• if you have kidney problems;
• if you have liver problems;
• if you have experienced repeated or unexplained muscle cramps or pain, personal or family history of muscle disorders, or if you previously had muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you feel unwell 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, sometimes involving respiratory muscles) or ocular myasthenia (a condition causing weakness of eye muscles), as statins may occasionally worsen myasthenia or trigger its onset (see section 4);
• if you regularly consume large amounts of alcohol;
• if your thyroid gland is not functioning properly;
• if you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol levels;
• if you are taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir; see section “Other medicines and ROSUCETIL”;
• if you are currently taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). The combination of fusidic acid and ROSUCETIL may lead to severe muscle problems (rhabdomyolysis). See section “Other medicines and ROSUCETIL”;
• if you have severe respiratory insufficiency;
• if you are over 70 years old: your doctor needs to choose the appropriate starting dose for you;
• if you are of Asian origin (i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must select the correct initial dosage of ROSUCETIL suitable for you;
• if you have or have had stomach or small intestine problems (ulcers or gastrointestinal bleeding);
• if you suffer from high blood pressure;
• if you have asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack;
• if you have hypersensitivity (allergy) to other painkillers or anti-inflammatory medicines, other rheumatism medicines, or other substances that may cause allergies;
• if you have other allergies (e.g., skin reactions, itching);
• if you are taking other medicines known as anticoagulants (e.g., coumarin derivatives, heparin – except low-dose heparin therapy);
• if you have impaired kidney function or reduced cardiac or vascular blood flow (e.g., renal vascular disease, weakened heart muscle, reduced blood volume, major surgery, sepsis, or increased bleeding): acetylsalicylic acid may further increase the risk of kidney dysfunction and acute kidney failure;
• if you have heavy menstrual bleeding. Consult your doctor if your symptoms worsen or if you experience severe or unexpected side effects, such as unusual bleeding symptoms, serious skin reactions, or any other signs of severe allergy (see section “Possible side effects”).

Metamizole (a substance used to relieve pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blood clot) when taken concurrently. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.
In a small number of people, statins may affect liver function. This is detected through a simple blood test monitoring increased levels of liver enzymes. 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 monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.
Be careful not to become dehydrated (you may feel thirsty with a dry mouth), as concurrent use of acetylsalicylic acid may worsen kidney function.
Inform your doctor if you are scheduled for surgery (even minor procedures such as tooth extraction), as acetylsalicylic acid thins the blood and may increase the tendency to bleed.
Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a very rare condition affecting the brain and liver and can be life-threatening. For this reason, ROSUCETIL must not be given to children and adolescents under 18 years of age.
In patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency: acetylsalicylic acid may cause destruction or accelerated destruction of red blood cells or a certain type of anemia. This risk may be increased by factors such as high dosage, fever, or acute infections.
Low-dose acetylsalicylic acid reduces uric acid excretion. This may trigger a gout attack in at-risk patients.
If you cut yourself or sustain an injury, bleeding may take longer to stop. This is due to the effect of acetylsalicylic acid. Minor cuts or injuries (e.g., during shaving) are usually not significant. If you experience unusual bleeding (in an unusual location or of unusual duration), contact your doctor.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin therapy.
Stop using ROSUCETIL and seek immediate medical attention if you notice any of the symptoms described in section 4.
Children and adolescents
ROSUCETIL must not be used in children and adolescents.
Other medicines and ROSUCETIL
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This is because ROSUCETIL contains rosuvastatin and acetylsalicylic acid, and these substances may affect how other medicines work, and some medicines may affect the action of rosuvastatin and acetylsalicylic acid.
Inform your doctor if you are taking any of the following medicines, which may increase the risk 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);
• 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir,
• dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• ketoconazole, itraconazole (antifungal medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• medicines for blood thinning/clot prevention (e.g., warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding when taken before clot removal or anticoagulant therapy; therefore, if undergoing such treatment, be alert for signs of external or internal bleeding (e.g., bruising);
• organ transplant rejection (cyclosporine, tacrolimus). Do not take this medicine with cyclosporine, as the effect of rosuvastatin increases;
• hypertension (e.g., diuretics and ACE inhibitors);
• heart rate regulation (digoxin);
• treatment of manic-depressive disorders (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 below 15 mg/week);
• medicines to lower blood sugar (antidiabetics) (e.g., glibenclamide) – blood sugar levels may decrease;
• selective serotonin reuptake inhibitors (for depression treatment) such as sertraline and paroxetine;
• corticosteroids used as hormone replacement therapy when adrenal glands or pituitary are destroyed or removed (except for topical corticosteroids or cortisone replacement therapy in Addison’s disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects;
• seizures (epilepsy) (valproic acid);
• medicines causing increased urinary excretion (diuretics: so-called aldosterone antagonists such as spironolactone and canrenoate, loop diuretics, e.g., furosemide);
• alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If you need to take oral fusidic acid for the treatment of a bacterial infection, you must temporarily stop taking ROSUCETIL. Your doctor will advise you when it is safe to restart ROSUCETIL. Taking ROSUCETIL with fusidic acid may 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 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 may be pregnant, or are planning a pregnancy. If you become pregnant during treatment with 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 operate machinery while being treated with ROSUCETIL, as it does not affect their abilities.
However, some people may experience dizziness during treatment with ROSUCETIL.
If the capsules make you feel unwell, dizzy, tired, or cause headaches, do not drive or operate machinery and contact your doctor immediately.
ROSUCETIL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), consult them before taking ROSUCETIL.
ROSUCETIL contains soybean oil
If you are allergic to peanuts or soy, do not use this medicine.

3. How to take ROSUCETIL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts about how to use this medicine, consult 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 should be taken at the same time each day.

Dosage
The recommended dose is one capsule once daily.
Try to take the capsules at approximately the same time each day; this may help you remember to take them.
Your doctor will determine the appropriate dose for you based on your condition, ongoing treatment, and individual risk profile.
This medicine is not suitable for initial treatment. Treatment initiation must only occur by administering the two active substances separately. Once the appropriate doses have been established, switching to the suitable dosage of ROSUCETIL may be considered.

Periodic cholesterol checks
It is important to visit your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and maintains the correct levels. Your doctor may decide to increase the dose until the most appropriate amount of ROSUCETIL for you is reached.

Use in elderly patients
Dose adjustment is not required in elderly patients.

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

Patients with renal impairment
Dose adjustment is not required in patients with mild to moderate renal impairment.
The use of ROSUCETIL is contraindicated in patients with severe renal impairment.

Patients with hepatic impairment
Dose adjustment is not required in patients with 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 overdose may include dizziness and ringing in the ears, especially in elderly patients.
Contact your doctor or go immediately to the nearest hospital emergency department. Do not drive yourself to the hospital; ask someone to accompany you or call an ambulance. Take the medicine pack 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, simply skip that dose. Take the next dose at the usual time. Do not take a double dose to make up for the missed capsule.

If you stop taking ROSUCETIL
Your doctor will advise you on how long you should continue taking 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 immediately if you experience any of the following very rare and serious side effects after taking this medicine:

• Sudden shortness of breath, chest pain, difficulty breathing or breathlessness;
• Swelling of the eyelids, face or lips;
• Swelling of the tongue and throat causing severe difficulty in breathing and/or swallowing;
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions;
• Unusual bleeding such as coughing up blood, black stools or vomiting blood (signs of severe stomach bleeding), blood in the urine;
• Reddish, flat, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or 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 hypersensitivity syndrome).

In addition, stop taking ROSUCETIL and contact your doctor immediately

• if you have any unusual muscle tenderness or pain that lasts longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, which rarely progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.
• if muscle rupture occurs;
• if you develop a lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).

Side effects with rosuvastatin and acetylsalicylic acid administered individually.
Inform your doctor if any of the following side effects worsens or persists for more than one week.
ROSUVASTATIN
Common (may affect up to 1 in 10 people):

• Headache
• Stomach pain
• Constipation
• Feeling unwell
• Muscle pain
• Feeling of weakness
• Dizziness
• Diabetes. This is more likely if you already have high levels of sugar and fats in the blood, 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
• Increase in the amount of protein in the urine – values usually return to normal spontaneously without the need to stop taking ROSUCETIL (only with 5 mg and 20 mg doses).

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, intense itching of the skin (with raised lumps).

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

• Muscle damage in adults – as a precaution, stop taking ROSUCETIL and contact your doctor immediately if you have unusual muscle tenderness or pain that lasts longer than expected
• Severe stomach pain (inflammation of the pancreas)
• Increase in liver enzymes in the blood
• Reduction in platelets in the blood, increasing 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)
• Blood traces 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
• Oedema (swelling)
• Sleep disorders, including insomnia and nightmares
• Sexual problems
• Depression
• Respiratory problems, including persistent cough and/or breathlessness or fever
• Tendon injury
• A nerve disorder that may cause weakness, tingling or numbness
• Persistent muscle weakness
• 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 the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.
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 tract and reproductive organs, with possible prolonged bleeding time. This effect may persist for 4 to 8 days after taking the medicine.

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 may 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 affecting the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following may occur: drop in blood pressure, attacks of breathlessness, inflammation of the nasal mucosa, nasal congestion, allergic shock, swelling of the face, tongue and larynx (Quincke's oedema)
• Severe bleeding, such as bleeding in the brain, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants (blood-thinning medicines), which in individual cases may 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 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 kidney failure
• Decrease in blood sugar (hypoglycaemia)
• Low-dose acetylsalicylic acid reduces uric acid excretion. In patients at risk, this may trigger an attack of gout.
• Skin rash with fever involving mucous membranes (exudative multiform erythema).

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

• Accelerated breakdown or destruction of red blood cells in the blood and a specific form of anaemia (low red blood cell count) in patients with severe glucose-6-phosphate-dehydrogenase deficiency.

If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
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 ROSUCETIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
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 ROSUCETIL contains
The active substances are rosuvastatin (as rosuvastatin calcium) 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 components are:
Tablet coated with film containing rosuvastatin:
Tablet core
Monohydrate lactose
Microcrystalline cellulose
Magnesium oxide, heavy
Crospovidone (type A)
Anhydrous colloidal silicon dioxide
Magnesium stearate
Film coating
Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Iron oxide yellow (E172)
Lecithin (soy)
Iron oxide red (E172)
Xanthan gum
Iron oxide black (E172)

Tablet containing acetylsalicylic acid
Microcrystalline cellulose
Corn starch
Anhydrous colloidal silicon dioxide
Stearic acid

Capsule shell
Gelatin
Titanium dioxide (E171)
Indigo carmine (E132)
Iron oxide yellow (E172)

Black ink:
Shellac
Propylene glycol
Strong ammonia solution
Iron oxide black (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 dark green opaque cap. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet of rosuvastatin 5 mg.

ROSUCETIL 10 mg/100 mg hard gelatin capsule, size 1, with an opaque white body printed in black with “ASA 100 mg” and a light green opaque cap printed in black with “RSV 10 mg”. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet of rosuvastatin 10 mg.

ROSUCETIL 20 mg/100 mg hard gelatin capsule, size 0, with an opaque white body printed in black with “ASA 100 mg” and an opaque green cap printed in black with “RSV 20 mg”. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and two brown, biconvex, round, film-coated tablets of rosuvastatin 10 mg each.

The hard capsules are available in PA/AL/PVC/AL blisters, pack size of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati, 40
20121 – Milan, Italy

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