Package Insert: Information for the Patient

Rocilik 5mg/100mg Hard Capsules

Rocilik 10mg/100mg Hard Capsules

Rocilik 20mg/100mg Hard Capsules

rosuvastatina/ácido acetilsalicílico

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Rocilik contains two active substances – rosuvastatina and acetylsalicylic acid.

-Rosuvastatina belongs to a group of substances called statins, which are medications that regulate the level of lipids (fats), reducing the levels of cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes on their own have failed. Cholesterol is a fatty substance (lipid) that can cause the narrowing of blood vessels in the heart, causing coronary heart disease. If you are at risk of having a heart attack, rosuvastatina can also be used to reduce this risk even if your cholesterol levels are normal. You must maintain a low-cholesterol diet during treatment.

-Acetylsalicylic acid in low doses belongs to a group of medications called antiplatelet agents. Platelets are small blood cells that produce blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. When this happens 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 had one previously or if you suffer from unstable chest pain (angina pectoris).

Rocilik is indicated in patients who are already taking rosuvastatina and acetylsalicylic acid at these doses. Instead of taking rosuvastatina and acetylsalicylic acid as separate tablets, you will receive a Rocilik capsulethat contains both components with the same dose as before.

Do not take Rocilik

-If you are allergic to rosuvastatin, acetylsalicylic acid, or any other salicylate or nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other components of this medication (listed in section 6).

-If you are pregnant or breastfeeding or if you become pregnant while taking Rocilik, stop taking this medication immediately and inform your doctor. Women should avoid becoming pregnant while taking Rocilik using appropriate contraceptive methods.

- If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other related medications.

-If you have liver disease.

-If you have severe kidney problems.

-If you have recurring or unexplained muscle pain.

- If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications (used to treat a viral liver infection called hepatitis C).

-If you are taking a medication called ciclosporin (used, for example, after an organ transplant).

-If you have had an asthma attack or inflammation of some parts of the body, such as the face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs.

-If you currently have or have ever had a stomach ulcer or intestinal ulcer or any other type of bleeding, such as a cerebral hemorrhage.

-If you have ever had a problem with your blood not clotting properly.

-If you have gout.

-If you have uncompensated heart failure.

-If you are taking a medication called methotrexate (for example, for cancer or rheumatoid arthritis) in doses above 15 mg per week.

-This medication contains traces of soy lecithin. Do not use it in case of allergy to peanuts or soy.

If you find yourself in any of the situations mentioned above (or are unsure), please consult your doctor again.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

-If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

-If you have kidney problems.

-If you have liver problems.

- If you have heart problems.

-If you have had repeated or unjustified muscle pain, personal or family history of muscle problems, or previous history of muscle problems when taking other cholesterol-lowering medications. Inform your doctor immediately if you have unjustified muscle pain, especially if you feel unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness.

-If you regularly drink large amounts of alcohol.

-If you have a thyroid gland that does not function correctly.

-If you are taking other medications called fibrates to lower cholesterol. Read this leaflet carefully, even if you have already taken other cholesterol-lowering medications.

-If you are taking medications used to treat HIV (human immunodeficiency virus) infection, for example, ritonavir with lopinavir and/or atazanavir (see section: “Other medications and Rocilik”).

-If you are taking or have taken within the last 7 days medications containing fusidic acid (used to treat bacterial infections) administered orally or by injection; taking Rocilik with fusidic acid may cause severe muscle weakness (rhabdomyolysis); (see section: “Other medications and Rocilik”).

-If you have severe respiratory failure.

-If you are over 70 years old.

-If you are of Asian origin, i.e., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must choose the correct initial dose of Rocilik that suits you.

-If you have or have had problems with your stomach or small intestine (ulcers or gastrointestinal bleeding)

-If you have high blood pressure.

-If you are asthmatic, have hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack.

-If you have ever had gout

-In case of hypersensitivity (allergy) to other pain medications and anti-inflammatory drugs, other medications for rheumatism, or other factors that cause allergy.

-If you have other allergies (for example, skin reactions, itching).

-If you have heavy menstrual periods.

- If you have glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency

You must seek immediate medical attention if your symptoms worsen or if you experience severe or unexpected side effects, for example, unusual bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see section "Possible side effects").

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported associated with rosuvastatin treatment. Stop using Rocilik and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This is identified by a simple test that detects elevated levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rocilik.

While taking this medication, your doctor will monitor you for diabetes or risk of developing it. You are likely to be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure.

You must be careful not to become dehydrated (you may feel thirsty with a dry mouth) as the use of acetylsalicylic acid at the same time may cause a deterioration in renal function.

Inform your doctor if you are planning to undergo surgery (even a small one, such as tooth extraction), as acetylsalicylic acid thins the blood, increasing the risk of bleeding.

Acetylsalicylic acid can cause Reye's syndrome when administered to children. Reye's syndrome is a rare disease that affects the brain and liver and can be potentially fatal. This medication should not be administered to children and adolescents under 18 years old.

If you cut or injure yourself, bleeding may take a little longer than usual. This is related to the effect of acetylsalicylic acid. Small cuts and injuries (for example, when shaving) are usually not significant. If you have unusual bleeding (in an unusual place or of unusual duration), contact your doctor.

Children and adolescents

Rocilik should not be used in children or adolescents. Safety and efficacy have not been established.

Other medications and Rocilik

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Rocilik may affect or be affected by other medications, such as:

-fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimibe)

-antacids (used to neutralize acid in the stomach)

-oral contraceptives (the pill)

-regorafenib (used to treat cancer)

- darolutamida (used to treat cancer)

-any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section: “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, gelcaprevir, pibrentasvir

-ketoconazole, itraconazole (antifungal medications)

-antibiotics (rifampicin, erythromycin, clarithromycin)

-blood thinners/anticoagulants (for example, warfarin, heparin, coumarin, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before eliminating the blood clot or before treatment to thin the blood. Therefore, if you are about to undergo such treatment, you should pay attention to signs of external or internal bleeding (for example, hematomas)

-medications to prevent organ rejection after transplant (ciclosporin, tacrolimus)

-medications to treat high blood pressure (for example, diuretics and ACE inhibitors)

-medications to regulate heart rhythm (digoxin)

-medications to treat manic-depressive disorder (lithium)

-medications to treat pain and inflammation (for example, NSAIDs, such as ibuprofen, naproxen, or steroids)

-medications to treat gout (for example, probenecid, benzbromarone)

-medications to treat glaucoma (acetazolamide)

-medications for cancer or rheumatoid arthritis (methotrexate; in doses below 15 mg per week)

-medications to lower blood sugar (antidiabetic medications) (for example, glibenclamide): blood sugar levels may decrease

-medications to treat depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)

-medications such as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed (except for products applied to the skin or corticosteroid 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.

-anticonvulsant medications for the brain (epilepsy) (valproic acid)

-medications that cause an increase in urine excretion (diuretics: the so-called aldosterone antagonists, such as spironolactone and canrenone, diuretics of the loop, for example, furosemide)

-alcohol: the risk of gastrointestinal ulcers and bleeding increases.

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop using this medication. Your doctor will tell you when it is safe to restart the treatment with this medication. Taking Rocilik with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Rocilik may further lower your blood pressure if you are already taking other medications to treat your high blood pressure.

Taking Rocilik with food and drinks

This medication should be taken with food (see section ‘How to take Rocilik’). Do not take grapefruit juice during treatment with this medication. Drinking alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Rocilik if you are pregnant or breastfeeding. If you become pregnant while taking this medication, stop taking it immediately and consult your doctor. Women should avoid becoming pregnant using appropriate contraceptive methods.

Driving and operating machinery

Most people can drive a car and use machines during treatment with Rocilik; this will not affect your ability. However, some people may feel sick, dizzy, or tired, or have a headache during treatment, do not drive or use machines and contact your doctor immediately.

Rocilik contains lactose and soy lecithin

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medication.

This medication contains traces of soy lecithin, which may contain soy oil. Do not use it in case of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Your doctor will determine the suitable dose for you depending on your disease, current treatment, and risk level.

The recommended dose is one capsule per day. You can take it at any time of the day. This medication should be taken with food. You should take your medication at the same time every day. Capsules should be swallowed with plenty of liquid and should not be crushed or chewed. Do not take Rocilik with grapefruit juice.

If you are admitted to a hospital or receive treatment for another disease, inform the medical staff that you are taking this medication.

Use in children and adolescents

Rocilik should not be used in children and adolescents.

If you take more Rocilik than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Rocilik

Do not worry. If you forget to take a capsule, omit that dose completely. Take your next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you stop taking Rocilik

Your doctor will advise you for how long you should take your medication. Your cholesterol levels may increase again if you stop taking Rocilik. Your disease may reappear if you stop using your medication before being told to do so.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Rocilik and seek medical attentionimmediatelyif you experience any of the following rare and serious side effects after taking this medicine:

• Difficulty breathing with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the eyelids, face, or lips.
• Swelling of the face, lips, tongue, and/or throat that may cause difficulty swallowing.
• Intense itching of the skin (with rashes).
• Severe skin reactions, such as intense skin rash, urticaria, skin redness all over the body, intense itching, blisters, peeling, and skin swelling, Stevens-Johnson syndrome, or other allergic reactions.
• If you experience black stools or vomiting with blood (signs of severe stomach bleeding).

Also, stop taking Rocilik and speak with your doctor immediately

• If you have unexplained pains or discomfortsin the muscles that last longer than expected. Like other statins, a very small number of people have experienced unpleasant muscle side effects and rarely have become a potentially fatal muscle damage known asrabdomiólisis.
• If you experience muscle rupture
• If you have a syndrome similar to lupus (including skin rash, joint disorders, and blood cell alterations).

Stop using Rocilik and seek medical attention immediately if you notice any of the following symptoms:

• Reddish patches on the trunk, flat, in the shape of a target or circles, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

The followingside effectshave been reported. If the presence of any of them causes you problems orif they last more than a week, you mustcontact your doctor.

ROSUVASTATINA

Frequent(may affect up to 1 in 10 people):

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• Diabetes. It is more frequent if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while taking this medicine.

Less frequent(may affect up to 1 in 100 people):

• Hives, itching, urticaria, or other skin reactions.
• Increased protein in the urine: this usually returns to normal on its own without having to stop taking this medicine).

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

• Severe allergic reaction: symptoms include swelling of the face, lips, tongue, and/or throat, difficulty breathing, and severe itching of the skin (with raised bumps).If you think you are having an allergic reaction, stop taking this medicineand seek medical help immediately.
• Muscle damage in adults: as a precaution,stop taking this medicine and speak with your doctor immediately if you have unexplained pains or discomfortsin the muscles that last longer than expected.
• Intense stomach pain (pancreatitis).
• Increased liver enzymes in the blood.
• Reduced platelets, increasing the risk of bleeding or bruising (thrombocytopenia).
• A syndrome similar to lupus (including rash, joint disorders, and blood cell alterations)

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

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

Frequency unknown(the frequency cannot be estimated from the available data):

• Diarrhea (soft stools).
• Stevens-Johnson syndrome (severe skin rash in the form of blisters on the skin, mouth, eyes, and genitals).
• Cough.
• Difficulty breathing.
• Swelling.
• Sleep disorders, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon injury.
• A nerve disorder that can cause weakness, tingling, or numbness.
• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

ÁCIDO ACETILSALICÍLICO

Frequent(may affect up to 1 in 10 people):

• Gastrointestinal discomfort such as heartburn, nausea, vomiting, abdominal pain, and diarrhea.
• Increased tendency to bleed
• Minor bleeding from the gastrointestinal tract (micro-bleeding).
• Bleeding such as nosebleeds, bleeding gums, skin bleeding, or bleeding from the urinary tract and genital organs, with a possible extension of the bleeding time. This effect can last from 4 to 8 days after ingestion.

Less frequent(may affect up to 1 in 100 people):

• Stomach or intestinal bleeding. After long-term use of aspirin, anemia (iron deficiency anemia) may occur due to occult bleeding from the stomach or intestines.
• Subdural hematoma, blood in the urine.
• Stomach ulcers or intestinal ulcers, which very rarely may cause perforation.
• Gastrointestinal inflammation.
• Skin reactions such as urticaria
• Nasal discharge

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

• Severe skin hypersensitivity reactions, respiratory tract, gastrointestinal system, and cardiovascular system, especially in asthmatics. The following characteristics of the disease may be present: fall in blood pressure, asthma attacks, nasal mucosa inflammation, nasal congestion, anaphylactic shock, facial swelling, tongue, and laryngeal swelling (Quincke's edema).
• Severe skin reactions such as hives known as erythema multiforme, and may be life-threatening, Stevens-Johnson syndrome, and Lyell syndrome.
• Severe bleeding, such as cerebral hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant anticoagulant treatment that may put life at risk in individual cases.

• Confusion
• Headache, dizziness
• Impaired hearing or tinnitus, especially in children and the elderly, may be signs of an overdose (see also "If you take more Rocilik than you should").
• Abnormal menstrual bleeding or prolonged bleeding.

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

• Liver function test abnormalities.
• Renal dysfunction and acute renal failure.
• Low blood sugar (hypoglycemia).
• Aspirin reduces the excretion of uric acid in low doses. This may trigger a gout attack in at-risk patients.
• Febrile eruptions with mucous membrane involvement (erythema exudativum multiforme).

Frequency unknown(the frequency cannot be estimated from the available data):

• Accelerated hemolysis or hemolysis of red blood cells and a certain form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
• Dizziness

If any of the side effects worsen or if you notice any side effect that is not listed in this prospectus, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging afterCAD. The expiration date is the last day of the month indicated.

Store below 30 °C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rocilik

The active principles are rosuvastatina (as rosuvastatina calcium) and acetylsalicylic acid.

Rocilik 5 mg/100 mg hard capsules: each hard capsule contains 5 mg of rosuvastatina (as rosuvastatina calcium) and 100 mg of acetylsalicylic acid.

Rocilik 10 mg/100 mg hard capsules:each hard capsule contains 10 mg of rosuvastatina (as rosuvastatina calcium) and 100 mg of acetylsalicylic acid.

Rocilik 20 mg/100 mg hard capsules:each hard capsule contains 20 mg of rosuvastatina (as rosuvastatina calcium) and 100 mg of acetylsalicylic acid.

The other components (excipients) are:

Rosuvastatina coated tablet

Tablet core: lactose monohydrate, microcrystalline cellulose, heavy magnesium oxide, crospovidone, anhydrous colloidal silica, magnesium stearate.

Coating system:polyvinyl alcohol, titanium dioxide (E171), talc, yellow iron oxide (E 172), soy lecithin, red iron oxide (E 172), xanthan gum, black iron oxide (E 172).

Acetylsalicylic acid tablet

microcrystalline cellulose, cornstarch, anhydrous colloidal silica, stearic acid.

Capsule coating:

gelatin, titanium dioxide (E 171), indigotin (E 132), yellow iron oxide (E 172)

Black ink:

shellac, propylene glycol, strong ammonia solution, black iron oxide (E 172), potassium hydroxide.

Appearance of the product and contents of the package

Rocilik 5 mg/100 mg hard capsules: hard gelatin capsules of size 2, opaque white body and opaque dark green cap. Each capsule contains a white or almost white, biconvex, oval, acetylsalicylic acid tablet and a brown, biconvex, round rosuvastatina tablet.

Rocilik 10 mg/100 mg hard capsules: hard gelatin capsules of size 1 and with opaque white body with black overprint (ASA 100) and opaque light green cap with overprint “RSV 10”. Each capsule contains a white or almost white, biconvex, oval, acetylsalicylic acid tablet and a brown, biconvex, round rosuvastatina tablet.

Rocilik 20 mg/100 mg hard capsules: hard gelatin capsules of size 0, with opaque white body with black overprint (ASA 100) and opaque green cap with overprint “RSV 20”. Each capsule contains a white or almost white, biconvex, oval, acetylsalicylic acid tablet and two brown, biconvex, round rosuvastatina tablets.

Rocilik is available in a blister pack containing 30 hard capsules.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Last review date of this leaflet: May2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/