Package Insert: Information for the User

Acid Acetylsalicylic Cinfamed 100 mg Enteric-Coated Tablets EFG

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 you should not give it to others who may 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.

Acetylsalicylic acid, at the present dose in this medication, belongs to a group of medications called antiplatelet agents. Platelets are blood components, smaller than red and white blood cells, that aggregate when blood coagulates. By preventing this aggregation, antiplatelet agents reduce the likelihood of blood clots (thrombi) forming. Your doctor has prescribed acetylsalicylic acid to prevent thrombi formation and reduce therisk of artery obstruction, as:

• You have previously experienced a myocardial infarction or angina pectoris.
• You have experienced a non-hemorrhagic transient or permanent transient ischemic attack.
• You have undergone a surgical intervention, such as coronary angioplasty or coronary bypass surgery.

Do not take Cinfamed Acetylsalicylic Acid

• If you are allergic to acetylsalicylic acid or any of the other components of this medication (listed in section 6).
• If you have or have had asthma, with or without nasal polyps, after taking acetylsalicylic acid.
• If you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases coughing or ringing in the ears) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as tartrazine dye.
• If you have or have had acute gastric ulcers or repeated stomach discomfort.
• If you have a history of bleeding or perforation of the stomach after treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• If you have hemophilia or other bleeding disorders that predispose you to internal bleeding.
• If you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).

• If you are taking medications for blood clotting (oral anticoagulants).
• If you have severe heart disease.
• If you are taking methotrexate.
• If you are under 16 years old, unless a doctor's explicit indication, as the use of acetylsalicylic acid is related to the appearance of Reye's syndrome, a rare but serious disease.
• If you are in your third trimester of pregnancy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take acetylsalicylic acid.

Inform your doctor before taking acetylsalicylic acid if you are in any of the following situations:

• You have recently undergone surgery, including dental surgery.
• If you are about to undergo surgery, including dental surgery in the next seven days.
• If you are taking nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen, or other medications, as certain medications may interact with acetylsalicylic acid and produce undesirable effects (see "Other Medications and Cinfamed Acetylsalicylic Acid").
• If you are taking corticosteroids.
• If you are taking antidepressants.
• If you are taking antiplatelet agents.
• If you have hypertension or have severe kidney, heart, or liver problems, have coagulation disorders, or are taking anticoagulants.
• If you are allergic to other anti-inflammatory or antirheumatic medications.
• If you have glucose-6-phosphate dehydrogenase deficiency.
• If you have rhinitis and/or urticaria.
• If you have suffered or suffer from gout attacks.

Acetylsalicylic acid may cause bronchospasm, asthma attacks, or other hypersensitivity reactions. Risk factors include pre-existing asthma, hay fever, nasal polyps, or chronic respiratory insufficiency, as well as patients with other allergic manifestations, such as skin reactions, itching, or urticaria.

Other Medications and Cinfamed Acetylsalicylic Acid

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

Certain medications may interact with acetylsalicylic acid, so they should not be used without consulting a doctor. This is especially important in the case of:

• Analgesics and nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen, used to treat muscle pain and/or inflammation.
• Corticosteroids, except for hydrocortisone used in Addison's disease, as it may increase the risk of gastrointestinal bleeding and ulcers.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Blood clotting medications (oral anticoagulants) as they increase the risk of bleeding.
• Some medications for controlling hypertension.
• Medications for lowering blood sugar levels.
• Ciclosporin, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alfa.
• Lithium, used in some psychiatric diseases.
• Methotrexate, used to treat cancer and rheumatoid arthritis; it increases the hepatotoxicity of methotrexate.
• Medications used to treat gout.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat seizures.
• Zidovudine, used to treat HIV infections.
• Phenobarbital and valproic acid, medications for epilepsy.
• When taken together, metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.

Taking Cinfamed Acetylsalicylic Acid with Food, Drinks, and Alcohol

Take this medication with a glass of water, preferably on an empty stomach, and at least 1 hour before meals.

If you habitually consume alcohol (three or more alcoholic beverages – beer, wine, liquor, etc. per day), taking acetylsalicylic acid may cause stomach bleeding.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

IMPORTANT FOR WOMEN

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

Last trimester of pregnancy

Do not take this medication if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

First and second trimester of pregnancy

Do not take this medication during the first 6 months of pregnancy unless absolutely necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, if taken for more than a few days, this medication may cause kidney problems in your fetus, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should consult their doctor before using this medication, as acetylsalicylic acid passes into breast milk.

Fertility

Based on the limited available data, human studies have not shown a consistent effect of acetylsalicylic acid on fertility deterioration, and there is no conclusive evidence in animal studies.

Driving and Operating Machines

No effects have been described.

Interference with Diagnostic Tests

If you are to undergo any diagnostic test (including blood and urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Cinfamed Acetylsalicylic Acid contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

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

Take this medication with a glass of water, preferably on an empty stomach and at least 1 hour before meals. Do not crush, break, or chew the tablets.

The normal dose is one 100 mg acetylsalicylic acid tablet once a day.

Make sure to take the medication regularly, every day at the same time.

Your doctor will indicate the duration of treatment with acetylsalicylic acid. Do not stop treatment before.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist. Due to its delayed-release formulation, 100 mg acetylsalicylic acid is not indicated in acute myocardial infarction. However, if in an emergency you must use it, it is recommended to crush the first tablet or chew and swallow it to accelerate the absorption of acetylsalicylic acid.

If you take more Cinfamed Acetylsalicylic Acid than you should

Consult your doctor or pharmacist immediately.

Given the nature of the preparation, the possibility of accidental overdose is very low.

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and occasionally diarrhea.

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 Cinfamed Acetylsalicylic Acid

Do not take a double dose to compensate for the missed doses.

Take it as soon as possible and continue taking it according to the usual schedule.

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

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding and cause acute or chronic anemia, or iron deficiency anemia, with the corresponding clinical symptoms, such as fatigue and pallor.

In patients with severe glucose-6-phosphate dehydrogenase deficiency, cases of hemolysis and hemolytic anemia have been reported.

General list of possible side effects

Frequent side effects(may affect up to 1 in 10 people)

• At high doses: hypotrombinemia (decreased levels of a blood protein necessary for coagulation)
• dizziness
• tinnitus (ringing in the ears)
• epistaxis (nosebleed), rhinitis
• gastrointestinal disorders such as indigestion, abdominal pain and inflammation
• gastrointestinal bleeding
• skin rash, itching
• urinary and genital bleeding

Infrequent side effects(may affect up to 1 in 100 people)

• anemia due to low iron levels in the blood
• hypersensitivity, drug-induced hypersensitivity, allergic edema and angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing) intracranial and intracranial bleeding
• hematoma
• nasal congestion
• gum bleeding, gastrointestinal erosion and ulcer
• hepatic insufficiency and liver disorders (especially in patients with juvenile arthritis)
• urticaria
• Reye's syndrome (a rare and serious disease characterized by inflammation of the brain and liver) in children under 16 years old with fever, flu, or chickenpox (see "What you need to know before starting to take Acetylsalicylic acid cinfamed)

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

• hemorrhagic anemia
• anaphylactic reaction (severe and generalized allergic reaction)
• bleeding, muscle bleeding
• gastrointestinal ulcer perforation
• increase in liver enzyme levels (transaminases)
• renal insufficiency, acute renal failure

Unknown frequency(frequency cannot be estimated from available data)

• hemolysis (destruction of red blood cells), hemolytic anemia
• anaphylactic shock (severe allergic reaction)
• cardiorespiratory distress (acute syndrome caused by severe respiratory insufficiency that also alters heart rhythm)
• procedural bleeding
• respiratory disease exacerbated by acetylsalicylic acid (respiratory syndrome characterized by nasal polyps, asthma, and sensitivity to acetylsalicylic acid)
• intestinal diaphragmatic disease (intestinal tract narrowing)

In long-term treatments and at high doses, the following may occur: dizziness, ringing in the ears, hearing loss, sweating, headache, confusion, and kidney problems, with cases of renal insufficiency and acute renal failure reported.

Treatment should be stopped immediately if the patient notices any episode of hearing loss, ringing in the ears, or dizziness.

In patients who have had an allergic reaction to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions (severe and generalized allergic reactions) may occur. This could also happen in patients who have not previously shown hypersensitivity to these drugs.

Reporting side effects

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

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

Store below 30°C. Do not refrigerate.

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

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

Composition of Cinfa Acetylsalicylic Acid

• The active ingredient is acetylsalicylic acid

The other components are: powdered cellulose, pregelatinized cornstarch , Acryl-EZE Clear (93F19255) ( polycarboxylate type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate, and lauryl sulfate of sodium). See section 2 Cinfa Acetylsalicylic Acid contains sodium.

Appearance of the product and contents of the package

Cinfa Acetylsalicylic Acid 100 mg tablets are round, biconvex, and white. They are coated with a gastro-resistant coating that prevents the acetylsalicylic acid from being released immediately in the stomach, but rather in a delayed manner in the duodenum. They are packaged in PVC-Al/PVC-PVDC blisters of 30 and 500 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

TOLL MANUFACTURING SERVICES S.L.

c/ Aragoneses 2-

28108 – Alcobendas - Madrid

Spain

or

FARMALIDER S.A.

c/ Aragoneses, 2,

28108 – Alcobendas – Madrid

Spain

or

LABORATORIOS MEDICAMENTOS INTERNACIONALES, S.A.

C/ Solana, 26,

Torrejón de Ardoz 28850 (Madrid)

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: December 2024

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76287/P_76287.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76287/P_76287.html