ROCILIK 20 MG/100 MG HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Rocilik 5mg/100mg Hard Capsules

Rocilik 10mg/100mg Hard Capsules

Rocilik 20mg/100mg Hard Capsules

rosuvastatin/acetylsalicylic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Rocilik and what is it used for

Rocilik contains two active substances – rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of substances called statins, which are medicines that regulate lipid (fat) levels, reducing cholesterol and triglyceride levels 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 narrowing of the blood vessels in the heart, leading to coronary heart disease. If you are at risk of having a heart attack, rosuvastatin can also be used to reduce this risk even if your cholesterol levels are normal. You should maintain a low-cholesterol diet during treatment.
• Acetylsalicylic acid in low doses belongs to a group of medicines 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 previously had one or if you suffer from chest pain attacks (unstable angina).

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

2. What you need to know before you take Rocilik

Do not take Rocilik

• If you are allergic to rosuvastatin, acetylsalicylic acid, or any other salicylate or non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding or if you become pregnant while taking Rocilik, stop taking this medicine immediately and inform your doctor. Women must avoid becoming pregnant while taking Rocilik using adequate 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 medicines.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains.
• If you take a combination of medicines sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you take a medicine called ciclosporin (used, for example, after organ transplantation).
• If you have had a heart attack or inflammation of some parts of the body, for example, face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs.
• If you currently have or have ever had a stomach or small intestine ulcer or any other type of bleeding such as a stroke.
• 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 (for example, for cancer or rheumatoid arthritis) in doses higher than 15 mg per week.
• This medicine contains traces of soy lecithin. It must not be used in case of peanut or soy allergy.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).
• If you have kidney problems.
• If you have liver problems.
• If you have heart problems.
• If you have had repeated or unexplained muscle pains, personal or family history of muscle problems, or previous history of muscle problems when taking other cholesterol-reducing medicines. Inform your doctor immediately if you have unexplained muscle pains, especially if you do not feel well or have a fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not function properly.
• If you take other medicines called fibrates to reduce cholesterol. Read this leaflet carefully, even if you have already taken other medicines for high cholesterol.
• If you take medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section: "Other medicines and Rocilik"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir
• ketoconazole, itraconazole (antifungal medicines)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• blood-thinning treatments/prevention of blood clots (e.g., warfarin, heparin, coumarin, clopidogrel, ticlopidine): acetylsalicylic acid can increase the risk of bleeding if taken before eliminating the blood clot or before treatment to thin the blood. Therefore, if you are going to undergo such treatment, you should pay attention to signs of external or internal bleeding (e.g., bruising)
• treatments to prevent organ rejection after transplantation (ciclosporin, tacrolimus)
• treatments for high blood pressure (e.g., diuretics and ACE inhibitors)
• treatments to regulate heart rhythm (digoxin)
• treatments for manic-depressive disorder (lithium)
• treatments for pain and inflammation (e.g., NSAIDs, such as ibuprofen, naproxen, or steroids)
• treatments for gout (e.g., probenecid, benzbromarone)
• treatments for glaucoma (acetazolamide)
• medicines for cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week)
• medicines to reduce blood sugar levels (antidiabetic medicines) (e.g., glibenclamide): blood sugar levels may decrease
• treatments for depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)

-treatments such as hormone replacement therapy when the adrenal or pituitary glands have been destroyed or removed (with the exception of products applied to the skin or 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.

• anticonvulsant treatments for the brain [epilepsy] (valproic acid)
• medicines that cause increased urine excretion (diuretics: the so-called aldosterone antagonists, such as spironolactone and canrenone, loop diuretics, e.g., furosemide)
• alcohol: the risk of gastrointestinal ulcers and bleeding is increased.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with this medicine. Taking Rocilik with fusidic acid can cause severe muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

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

Taking Rocilik with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Rocilik if you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking the medicine immediately and consult your doctor. Women must avoid becoming pregnant using adequate contraceptive methods.

Driving and using machines

Most people can drive a car and use machines during treatment with Rocilik; this will not affect their ability. However, some people feel dizzy during treatment with this medicine. If you feel unwell, 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 some sugars, consult them before taking this medicine.

This medicine contains traces of soy lecithin, which may contain soy oil. It must not be used in case of peanut or soy allergy.

3. How to take Rocilik

Follow exactly the administration instructions of this medicine given 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 medicine should be taken with food. You should take your medicine at the same time every day. The 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 hospitalized or receive treatment for another disease, inform the medical staff that you are taking this medicine.

Use in children and adolescents

Rocilik must not be used in children and adolescents.

If you take more Rocilik than you should

Contact your doctor or the nearest hospital for advice.

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

If you forget 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 make up for forgotten doses.

If you stop taking Rocilik

Your doctor will advise you for how long you should take your medicine. Your cholesterol levels may increase again if you stop taking Rocilik. Your disease may recur if you stop using your medicine before you are told to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Rocilik and seek medical attention immediatelyif you experience any of the following very rare and serious adverse 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 can cause difficulty swallowing.
• Severe skin itching (with hives)
• Severe skin reactions, such as intense skin rash, urticaria, 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.
• If you experience black stools or vomiting with blood (signs of severe stomach bleeding).

In addition, stop taking Rocilik and talk to your doctor immediately

• If you have unjustified pain or discomfortin the muscles that lasts longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects and have rarely become potentially life-threatening muscle damage known as rhabdomyolysis.
• If you experience muscle rupture
• If you have a syndrome similar to lupus disease(including skin rash, joint disorders, and alterations in blood cells).

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

• Red, non-raised spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

The following side effectshave been reported. If the presence of any of them causes you problems or if they last more than one week, you should contact your doctor.

ROSUVASTATIN

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

• Headache.
• Stomach pain.
• Constipation.
• Nausea
• Muscle pain.
• Feeling of weakness.
• Dizziness.
• Diabetes. It is more common if you 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, urticaria, or other skin reactions.
• Increased amount of 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: signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe skin itching (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 talk to your doctor immediately if you have unusual pain or discomfortin the muscles that lasts longer than expected.
• Severe stomach pain (inflamed pancreas).
• Increased liver enzymes in the blood.
• Decreased platelets, which increases the risk of bleeding or bruising (thrombocytopenia).
• A syndrome similar to lupus (including rash, joint disorders, and alterations in blood cells).

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (liver inflammation).
• 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 not known(frequency cannot be estimated from the available data):

• Diarrhea (soft stools).
• Stevens-Johnson syndrome (severe skin rash with blisters on the skin, mouth, eyes, and genitals).
• Cough.
• Difficulty breathing.
• Edema (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.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia of the eyes (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, or drooping eyelids, difficulty swallowing, or difficulty breathing.

ACETYLSALICYLIC ACID

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

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

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

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

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

• Hypersensitivity reactions of the skin, respiratory tract, gastrointestinal system, and cardiovascular system, especially in asthmatics. The following characteristics of the disease may occur: drop in blood pressure, dyspnea attacks, nasal mucosa inflammation, nasal congestion, anaphylactic shock, swelling of the face, tongue, and larynx (Quincke's edema).
• Severe skin reactions such as a rash known as erythema multiforme, and it occurs in forms that can 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 treatment with anticoagulants (anticoagulant medications) that can be life-threatening in individual cases.

• Confusion
• Headache, dizziness
• Hearing loss or ringing in the ears (tinnitus), especially in children and the elderly, can be signs of an overdose (see also "If you take more Rocilik than you should").
• Abnormally heavy or prolonged menstrual periods.

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

• Disorder in liver function tests.
• Kidney dysfunction and acute kidney failure.
• Decreased blood sugar (hypoglycemia).
• Acetylsalicylic acid reduces the excretion of uric acid at low doses. This can trigger a gout attack in patients at risk.
• Febrile eruptions with mucous membrane involvement (erythema multiforme exudative).

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

• Accelerated or breakdown 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 not listed in this leaflet, 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 leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Rocilik

Keep this medicine out of sight and reach of children.

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

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rocilik

The active ingredients are rosuvastatin (as rosuvastatin calcium) and acetylsalicylic acid.

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

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

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

The other components (excipients) are:

Coated tablet with rosuvastatin

Core of the tablet: 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).

Tablet with acetylsalicylic acid

Microcrystalline cellulose, corn starch, anhydrous colloidal silica, stearic acid.

Capsule shell:

Gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172)

Black ink:

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

Appearance of the product and package contents

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

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

Rocilik 20 mg/100 mg hard capsules: hard gelatin capsules, size 0, with white opaque body and black printing (ASA 100) and green opaque cap with printing "RSV 20". Each capsule contains a white or almost white, biconvex, oval-shaped tablet of acetylsalicylic acid and two brown, biconvex, round tablets of 10 mg of rosuvastatin.

Rocilik is available in blisters containing 30 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Date of the last revision of this leaflet: May 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/