ASPIFOX 5 MG/100 MG HARD CAPSULES

Introduction

Patient Information Leaflet

Aspifox 5 mg/100 mg hard capsules

Aspifox 10 mg/100 mg hard capsules

Aspifox 20 mg/100 mg 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 Aspifox and what is it used for
2. What you need to know before you take Aspifox
3. How to take Aspifox
4. Possible side effects
5. Storage of Aspifox
6. Contents of the pack and other information

1. What is Aspifox and what is it used for

Aspifox contains two active substances – rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of substances called statins, which are medicines that regulate lipid levels (fats), 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).

Aspifox 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 an Aspifox capsule that contains both components with the same dose as before.

2. What you need to know before you take Aspifox

Do not take Aspifox

• 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 Aspifox, stop taking this medicine immediately and inform your doctor. Women must avoid becoming pregnant while taking Aspifox using adequate contraceptive methods.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain.
• If you take a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used for the viral infection of the liver called hepatitis C).
• If you take a medicine called ciclosporin (used, for example, after an organ transplant).
• If you have had an asthma attack or inflammation of some parts of the body, for example, face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs.
• If you have ever developed a severe skin rash or skin peeling and/or blisters in the mouth after taking rosuvastatin or other related medicines.
• 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.
• If you are allergic to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aspifox

• If you have kidney problems.
• If you have liver problems.
• If you have had repeated or unexplained muscle pain, personal or family history of muscle problems, or previous history of muscle problems when taking other medicines to reduce cholesterol. Inform your doctor immediately if you have unexplained muscle pain, 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 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 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 against HIV infection, for example, ritonavir with lopinavir and/or atazanavir, see "Other medicines and Aspifox".
• If you are taking or have taken in the last 7 days medicines that contain fusidic acid (used to treat bacterial infections) administered orally or by injection; taking Aspifox with fusidic acid can cause severe muscle damage (rhabdomyolysis); see "Other medicines and Aspifox".
• 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, and Indian. Your doctor must choose the correct initial dose of Aspifox that suits 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 can induce an asthma attack.
• In case of hypersensitivity (allergy) to other painkillers and anti-inflammatory drugs, other medicines for rheumatism, or other factors that cause allergy.
• If you have other allergies (for example, skin reactions, itching).
• If you take other medicines called anticoagulants (for example, coumarin derivatives, heparin, with the exception of treatment with low-dose heparin).
• With renal insufficiency or reduced cardiac and vascular blood flow (for example, vascular disease of the kidneys, cardiac muscle weakness, reduced blood volume, major surgery, blood poisoning, or increased bleeding): acetylsalicylic acid can further increase the risk of renal dysfunction and acute renal failure.
• If you have heavy menstrual periods.

You should seek medical attention immediately if your symptoms worsen or if you experience serious 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 in association with rosuvastatin treatment. Stop using Aspifox and seek medical attention immediately 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 identifies elevated liver enzyme levels in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Aspifox.

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

You should be careful not to become dehydrated (you may feel thirsty with a dry mouth) as the use of acetylsalicylic acid at the same time can cause a deterioration of kidney 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, which can increase the risk of bleeding.

Acetylsalicylic acid can cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease that affects the brain and liver and can be potentially fatal. For this reason, Aspifox should not be given to children and adolescents under 18 years of age.

In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated breakdown, breakdown of red blood cells, or a certain form of anemia. This risk can be caused by factors such as high doses, fever, or acute infections.

Acetylsalicylic acid reduces the excretion of uric acid at low doses. This can trigger a gout attack in patients at risk.

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 important. If you have unusual bleeding (in an unusual location or of unusual duration), contact your doctor.

Children and adolescents

Aspifox should not be used in children or adolescents.

Other medicines and Aspifox

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

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

• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to reduce cholesterol (such as ezetimibe)
• treatments for indigestion (used to neutralize stomach acid)
• oral contraceptives (the pill)
• hormone replacement therapy.
• Regorafenib, darolutamida, capmatinib (used to treat cancer)
• Fostamatinib (used to treat low platelet counts)
• Febuxostat (used to treat and prevent high levels of uric acid in the blood)
• Teriflunomida (used to treat multiple sclerosis)
• 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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir

ketoconazole, itraconazole (antifungal medicines)

• rifampicin, erythromycin, clarithromycin (antibiotics)
• blood-thinning treatments/prevention of blood clots (for example, warfarin, heparin, coumarin, clopidogrel, ticlopidine, ticagrelor): acetylsalicylic acid can increase the risk of bleeding if taken before removing 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 (for example, bruising)
• treatments to prevent organ rejection after transplantation (ciclosporin, tacrolimus)
• treatments for high blood pressure (for example, diuretics and ACE inhibitors)
• treatments to regulate heart rhythm (digoxin)
• treatments for manic-depressive disorder (lithium)
• treatments for pain and inflammation (for example, NSAIDs, such as ibuprofen, naproxen, or steroids)
• treatments for gout (for example, probenecid, benzbromarone)
• treatments for glaucoma (acetazolamide)
• medicines against cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week)
• medicines to reduce sugar in the blood (antidiabetic medicines) (for example, 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, for example, furosemide)
• metamizol (substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together and form a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.
• alcohol: the risk of gastrointestinal ulcers and bleeding is increased.

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

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

Taking Aspifox with food and drinks

You should take Aspifox with food. Do not take grapefruit juice during treatment with Aspifox.

Alcohol consumption may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

Do not take Aspifox if you are pregnant or breastfeeding. If you become pregnant while taking Aspifox, 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 Aspifox; this will not affect their ability. However, some people feel dizzy during treatment with Aspifox. If you feel sick, dizzy, or tired, or have a headache during treatment, do not drive or use machines and contact your doctor immediately.

Aspifox contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Aspifox contains soy lecithin

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

3. How to take Aspifox

Follow the administration instructions for this medication exactly 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 illness, current treatment, and risk level.

This medication is not suitable for starting treatment. The initiation of treatment should only be done by administering the active ingredients separately, and after establishing the appropriate doses, it is possible to switch to Aspifox with the suitable concentration.

The recommended dose is one capsule per day.

This medication should be taken with food. You should take your medication 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 Aspifox with grapefruit juice.

If you are hospitalized or receive treatment for another illness, inform the medical staff that you are taking Aspifox.

Use in elderly patients

No dose modification is necessary in elderly patients.

Use in children and adolescents

Aspifox should not be used in children and adolescents.

Patients with renal insufficiency

Dose change is not necessary if you have mild or moderate renal insufficiency.

The use of Aspifox in patients with severe renal insufficiency is contraindicated.

Patients with hepatic insufficiency

Dose change is not necessary if you have mild or moderate hepatic insufficiency.

The use of Aspifox in patients with severe hepatic insufficiency is contraindicated.

If you take more Aspifox 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Aspifox

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 Aspifox

Your doctor will advise you how long you should take your medication. Your cholesterol levels may increase again if you stop taking Aspifox. Your illness may reappear if you stop using your medication before being indicated.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

Stop taking Aspifox and seek medical attention immediatelyif you experience any of the following very rare and serious side effects after taking this medication:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.

• Swelling of the tongue and throat that causes great difficulty breathing and/or swallowing.
• Severe itching of the skin (with raised bumps)
• Red spots on the trunk, non-raised, 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).
• If you experience black stools or vomiting with blood (signs of heavy stomach bleeding).

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

• in the muscles that last 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 breakdown
• If you have a syndrome similar to lupus disease(including skin rash, joint disorders, and alterations in blood cells).

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

ROSUVASTATIN

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

• Headache.
• Stomach pain.

• Constipation.

• Feeling sick.
• Muscle pain.
• Feeling of weakness.
• Dizziness.
• Diabetes. It is more frequent if you have high sugar and fat levels in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

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

• Rash, itching, hives, or other skin reactions.
• Increased protein in the urine: this usually returns to normal on its own without having to stop taking your Aspifox capsules (only in the 5-20 mg dose).

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

• Severe allergic reaction: signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps). If you think you are having an allergic reaction, stop taking Aspifoxand seek medical attention immediately.
• Muscle damage in adults: as a precaution, stop taking Aspifox and talk to your doctor immediately if you have unusual pains or discomfortin the muscles that last 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 skin 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).
• Blood in the urine.
• Nerve damage in the legs and arms (such as numbness).
• Joint pain.
• Memory loss.
• Gynecomastia (breast growth in men).

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

• Diarrhea (soft stools).
• 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, numbness, or tingling.
• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia gravis (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.
• 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 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.

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 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 Aspifox than you should").

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

• Liver function test disorder.
• Kidney dysfunction and acute kidney failure.
• Low 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 (multiform exudative erythema).

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

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

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 side effects

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

5. Conservation of Aspifox

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD/EXP. 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt (does not apply to Hospital Use), ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofAspifox

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

Aspifox 5 mg/100 mg hard capsules

Each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Aspifox 10 mg/100 mg hard capsules

Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Aspifox 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 are:

Coated tablet with rosuvastatin

Core of the tablet

Lactose monohydrate (see section 2 "Aspifox contains lactose")

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type IA)

Anhydrous colloidal silica

Magnesium stearate

Coating system

Polyvinyl alcohol

Titanium dioxide (E171)

Talc

Yellow iron oxide (E172)

Soy lecithin (see section 2 "Aspifox contains soy 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 (E 171)

Indigotine (E 132)

Yellow iron oxide (E 172)

Black ink:

Lacquer shellac

Propylene glycol

Strong ammonia solution

Black iron oxide (E172)

Potassium hydroxide

Appearance of the product and package contents

Aspifox 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 acetylsalicylic acid tablet and a brown, biconvex, round 5 mg rosuvastatin coated tablet.

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

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

Aspifox is available in blisters containing 20, 28, 30, 56, 60, 90, and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Adamed Pharma S.A.

Pienków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Poland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this leaflet: February 2025

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