Rocilik 10 mg/100 mg hard capsules

Package leaflet: Information for the user

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 the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Rocilik is and what it is 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 by lowering cholesterol and triglyceride levels in the blood when a low-fat diet and lifestyle changes alone have failed. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart, leading to heart disease. If you are at risk of having a heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. You should maintain a cholesterol-lowering diet during treatment.
• Acetylsalicylic acid in low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells involved in blood clotting and thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the oxygen supply. 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 previously had one or if you suffer from chest pain attacks (unstable angina).

Rocilik is indicated for 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 one Rocilik capsule containing both components at the same dose as before.

2. What you need to know before starting to 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 components 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 should avoid becoming pregnant while taking Rocilik by using appropriate contraceptive methods.
• If you have ever developed a severe skin rash, peeling of the skin, 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 pain.
• If you are taking a combination of 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 ever had an asthma attack or swelling of certain 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 or small intestine ulcer or any other type of bleeding, such as a cerebral hemorrhage.
• If you have ever had problems with blood clotting.
• If you suffer from gout.
• If you have uncompensated heart failure.
• If you are taking a medicine called methotrexate (for example, for cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.
• This medicine contains traces of soybean lecithin. It should not be used if you are allergic to peanuts or soy.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of 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 unexplained muscle pain, personal or family history of muscle disorders, or previous muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or discomfort, 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 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.
• If you are taking medicines used against HIV infection (AIDS virus), for example, ritonavir with lopinavir and/or atazanavir (see section: "Other medicines and Rocilik").
• If you are taking or have taken in the last 7 days medicines containing fusidic acid (used to treat bacterial infections) administered orally or by injection; taking Rocilik with fusidic acid may cause severe muscle problems (rhabdomyolysis); (see section: "Other medicines and Rocilik").
• If you have severe respiratory insufficiency.
• 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 suitable for you.
• If you have or have had stomach or small intestine problems (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 trigger an asthma attack.
• If you have ever had gout.
• In case of hypersensitivity (allergy) to other painkillers and anti-inflammatory medicines, other medicines for rheumatism, or other allergy-causing agents.
• If you have other allergies (e.g., skin reactions, itching).
• If you have heavy menstrual periods.
• If you have glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency.

You should seek immediate medical attention if your symptoms worsen or if you experience serious or unexpected side effects, such as signs of unusual bleeding, severe skin reactions, or any other signs of a severe allergic reaction (see section "Possible side effects").

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported 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 may affect the liver. This is detected by a simple blood test showing elevated liver enzyme levels (transaminases). For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rocilik.

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

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 lead to worsening of kidney function.

Inform your doctor if you are planning to undergo surgery (even minor procedures such as tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease affecting the brain and liver and can be potentially fatal. This medicine must not be given to children and adolescents under 18 years of age.

If you are cut or injured, bleeding may take longer than normal. This is related to the effect of acetylsalicylic acid. Small cuts and injuries (e.g., while shaving) are usually not significant. If you experience unusual bleeding (in an unusual location or of unusual duration), contact your doctor.

Children and adolescents

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

Other medicines and Rocilik

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

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

• Fibrates (e.g., gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (e.g., ezetimibe)
• Treatments for indigestion (used to neutralize stomach acid)
• Oral contraceptives (the pill)
• Regorafenib (used to treat cancer)
• Darolutamide (used to treat cancer)
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section: “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir
• Ketoconazole, itraconazole (antifungal medicines)
• Rifampicin, erythromycin, clarithromycin (antibiotics)
• Blood-thinning/anticoagulant treatments (e.g., warfarin, heparin, coumarin, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before clot removal or anticoagulant therapy. Therefore, if you are undergoing such treatment, pay attention to signs of external or internal bleeding (e.g., bruising)
• Treatments to prevent organ rejection after transplantation (cyclosporine, 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; at doses below 15 mg per week)
• Medicines to lower blood sugar (antidiabetic medicines) (e.g., glibenclamide): blood sugar levels may decrease
• Treatments for depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• Hormone replacement therapies when adrenal or pituitary glands have been destroyed or removed (except for 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 increase urinary excretion (diuretics: 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 to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with this medicine. Taking Rocilik with fusidic acid may cause 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 for high blood pressure.

Taking Rocilik with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

Most people can drive and operate machinery while being treated with Rocilik; this will not affect your ability. However, some people may feel dizzy during treatment with this medicine. If you feel unwell, dizzy, tired, or have a headache during treatment, do not drive or use machinery and contact your doctor immediately.

Rocilik contains lactose and soybean lecithin

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

This medicine contains traces of soybean lecithin, which may contain soybean oil. It should not be used if you are allergic to peanuts or soy.

3. How to take Rocilik

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults

Your doctor will determine the appropriate dose for you depending on your condition, your current treatment, and your level of risk.

The recommended dose is one capsule per day. You may take it at any time of day. This medicine must be taken with food. Take your medicine at the same time each day. The capsules should be swallowed with plenty of liquid and must not be crushed or chewed. Do not take Rocilik with grapefruit juice.

If you are admitted to hospital or receive treatment for another illness, 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 nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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, skip that dose completely. Take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Rocilik

Your doctor will advise you how long you should take this medicine. Your cholesterol levels may rise again if you stop taking Rocilik. Your condition may return if you stop taking your medicine before you are told to do so.

If you have any further questions about 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 everyone will experience them.

Stop taking Rocilik and seek medical attention immediately if 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 may cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Severe skin reactions, such as severe rash, urticaria, 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.
• If you have black stools or vomit blood (signs of significant stomach bleeding).

Also, stop taking Rocilik and speak to your doctor immediately

• If you have unexplained muscle pain or discomfort lasting longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, and rarely these have progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.
• If you experience muscle rupture
• If you develop a lupus-like syndrome (including skin rash, joint disorders and changes in blood cells).

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

• Reddish, non-elevated spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The following side effects have been reported. If any of them cause you problems or last longer than one week, you should contact your doctor.

ROSUVASTATIN

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

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Feeling of weakness.
• Dizziness.
• Diabetes. This is more likely to occur if you have high levels of sugar and fats in your blood, are overweight, or 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.
• Increase in the amount of protein in the urine: this usually returns to normal on its own without needing 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 itching of the skin (with raised lumps). If you think you are having an allergic reaction, stop taking this medicine and seek medical help immediately.
• Muscle damage in adults: as a precaution, stop taking this medicine and speak to your doctor immediately if you have unusual muscle pain or discomfort lasting longer than expected.
• Severe stomach pain (inflamed pancreas).
• Increased liver enzymes in blood.
• Reduction in platelets, increasing the risk of bleeding or bruising (thrombocytopenia).
• A lupus-like syndrome (includes rash, joint disorders and changes in blood cells).

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

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

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

• Diarrhoea (loose stools).
• Stevens-Johnson syndrome (severe blistering rash on the skin, mouth, eyes and genitals).
• Cough.
• Difficulty breathing.
• Oedema (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 may cause weakness, tingling or numbness.
• Constant muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

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

ACETYLSALICYLIC ACID

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

• Gastrointestinal discomfort such as heartburn, nausea, vomiting, abdominal pain and diarrhoea.
• 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, possibly with prolonged bleeding time. This effect may last from 4 to 8 days after ingestion.

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

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

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

• Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal system and cardiovascular system, especially in asthmatics. The following symptoms may occur: drop in blood pressure, shortness of breath attacks, inflammation of nasal mucosa, nasal congestion, anaphylactic shock, swelling of the face, tongue and larynx (Quincke's oedema).

• Severe skin reactions such as a rash known as erythema multiforme, and life-threatening forms such as Stevens-Johnson syndrome and Lyell's syndrome.

• Severe bleeding, such as cerebral haemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants (blood thinners), which may be life-threatening in individual cases.

• Confusion.

• Headache, dizziness.

• Hearing impairment or ringing in the ears (tinnitus), especially in children and elderly people, which may be signs of 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):

• Abnormalities in liver function tests.
• Kidney dysfunction and acute renal failure.
• Decreased blood sugar (hypoglycaemia).
• Acetylsalicylic acid reduces uric acid excretion at low doses. This may trigger a gout attack in at-risk patients.
• Febrile rashes with involvement of mucous membranes (erythema multiforme).

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

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

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

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocilik

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 EXP. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rocilik

The active substances 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:

Rosuvastatin 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 (E172), soybean lecithin, red iron oxide (E172), xanthan gum, black iron oxide (E172).

Acetylsalicylic acid tablet

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

Capsule shell:

Gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172)

Black ink:

Shellac, propylene glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide.

Appearance of the product and contents of the package

Rocilik 5 mg/100 mg hard capsules: hard gelatin capsules of size 2, with an opaque white body and an opaque dark green cap. Each capsule contains one uncoated, white or almost white, biconvex, oval tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet containing 5 mg of rosuvastatin.

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

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

Rocilik is available in blister packs 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 most recent revision of this leaflet: May 2023

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