ACETYLSALICYLIC ACID CINFAMED 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Acetylsalicylic Acid Cinfamed 100 mg Gastro-Resistant Tablets EFG

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 Package Leaflet:

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

1. What is Acetylsalicylic Acid Cinfamed and what is it used for

Acetylsalicylic acid, at the dose present in this medicine, belongs to a group of medicines called antiplatelet agents. Platelets are components of blood, smaller than red and white blood cells, that clump together when blood clots. By preventing this clumping, antiplatelet agents reduce the likelihood of blood clots (thrombi) forming. Your doctor has prescribed acetylsalicylic acid to prevent the formation of thrombi and reduce the risk of obstruction of your arteries, since:

• You have previously suffered a heart attack or angina pectoris.
• You have suffered a non-hemorrhagic transient or permanent stroke.
• You have undergone surgical intervention, such as coronary angioplasty or coronary bypass.

2. What you need to know before you take Acetylsalicylic Acid Cinfamed

Do not take Acetylsalicylic Acid Cinfamed

• if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had asthma, with or without nasal polyps, after taking acetylsalicylic acid.
• if you have presented allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, as well as the dye tartrazine.
• if you have or have had acute gastroduodenal ulcer or recurring gastric discomfort.
• if you have a history of hemorrhage or gastric perforation after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• if you have hemophilia or other blood coagulation problems that predispose you to internal bleeding.
• if you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).

• if you are being treated with medicines for blood coagulation (oral anticoagulants).
• if you have severe heart disease.
• if you are being treated with methotrexate.
• if you are under 16 years old, unless explicitly indicated by a doctor, since 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 surgical intervention, including dental surgery.
• you are going to undergo surgical intervention, including dental surgery, in the next seven days.
• you are taking non-steroidal anti-inflammatory drugs, such as ibuprofen or naproxen, or other types of medicines, since certain medicines can interact with acetylsalicylic acid and produce unwanted effects (see "Other medicines and Acetylsalicylic Acid Cinfamed").
• you are being treated with corticosteroids.
• you are being treated with antidepressants.
• you are being treated with antiplatelet agents.
• you have hypertension or have serious kidney, heart, or liver problems, present blood coagulation disorders, or are being treated with anticoagulants.
• you are allergic to other anti-inflammatory or anti-rheumatic drugs.
• you have a deficiency of glucose-6-phosphate dehydrogenase.
• you have rhinitis and/or urticaria.
• you have suffered or suffer from gout attacks.

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

Other medicines and Acetylsalicylic Acid Cinfamed

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

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

• Pain relievers and non-steroidal anti-inflammatory drugs, such as ibuprofen or naproxen, used to treat muscle pain and/or inflammation.
• Corticosteroids, except hydrocortisone used in Addison's disease, as it may increase the risk of gastrointestinal bleeding and ulcers.
• Diuretics.
• Certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Medicines for blood coagulation (oral anticoagulants), as they increase the risk of bleeding.
• Certain medicines for controlling hypertension.
• Medicines to lower blood sugar levels.
• Cyclosporin, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alpha.
• Lithium, used in some psychiatric diseases.
• Methotrexate, used to treat cancer and rheumatoid arthritis; it increases the hepatotoxicity of methotrexate.
• Medicines used to treat gout.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medicines used as sedatives for sleep problems and to treat convulsions.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medicines for epilepsy.
• If administered together, metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping and forming a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.

Taking Acetylsalicylic Acid Cinfamed with food, drinks, and alcohol

Take this medicine 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, Breast-feeding, and Fertility

Pregnancy

IMPORTANT FOR WOMEN

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

Pregnancy - last trimester

Do not take this medicine 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 and your baby's tendency to bleed and delay or prolong delivery more than expected.

Pregnancy - first and second trimester

Do not take this medicine during the first 6 months of pregnancy unless absolutely necessary and as indicated 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 the 20th week of pregnancy, if taken for more than a few days, this medicine may cause kidney problems in your fetus, which may lead to 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 more than a few days, your doctor may recommend additional checks.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Women who are breast-feeding should consult their doctor before taking this medicine, as acetylsalicylic acid passes into breast milk.

Fertility

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

Driving and using machines

No effects have been described in this regard.

Interference with diagnostic tests

If you are going to have any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Acetylsalicylic Acid Cinfamed contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Acetylsalicylic Acid Cinfamed

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

Take this medicine with a glass of water, preferably on an empty stomach and at least 1 hour before meals. The tablets should not be crushed, broken, or chewed.

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

Try to take the medicine 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 think the action of this medicine is too strong or too weak, tell your doctor or pharmacist. Due to its delayed-release galenic form, 100 mg acetylsalicylic acid is not indicated in the event of acute myocardial infarction. However, if it is necessary to use it in an emergency, it is recommended to crush the first tablet or chew it and swallow it in order to accelerate the absorption of acetylsalicylic acid.

If you take more Acetylsalicylic Acid Cinfamed 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 medicine and the amount ingested.

If you forget to take Acetylsalicylic Acid Cinfamed

Do not take a double dose to make up for forgotten doses.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell 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 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

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

• With high doses: hypoprothrombinemia (decreased value of a blood protein necessary for coagulation)
• dizziness
• tinnitus (ringing in the ears)
• epistaxis (nasal bleeding), rhinitis
• gastrointestinal disorders such as indigestion, gastrointestinal and abdominal pain, inflammation
• gastrointestinal, gastrointestinal bleeding
• skin rash, itching
• bleeding from the urinary and genital tracts

Uncommon 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 can cause difficulty swallowing or breathing) bleeding in the brain and inside the skull
• hematoma
• nasal congestion
• gum bleeding, gastrointestinal erosion, and ulcer
• liver failure 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 with febrile processes, flu, or chickenpox (see "What you need to know before you 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, bleeding in the muscles
• perforation of gastrointestinal ulcers
• increase in liver enzyme levels (transaminases)
• renal failure, acute renal failure

Frequency not known(frequency cannot be estimated from the 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 (narrowing of the intestinal tract)

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

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

In patients who have presented an allergic reaction to acetylsalicylic acid and other non-steroidal 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 of side effects

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

5. Storage of Acetylsalicylic Acid Cinfamed

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

Store below 30°C. Do not refrigerate.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Acetylsalicylic Acid Cinfamed

• The active ingredient is acetylsalicylic acid

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

Appearance of the Product and Packaging Contents

The Acetylsalicylic Acid Cinfamed 100 mg tablets are round, biconvex, and white in color. They are coated with a gastro-resistant coating that makes the acetylsalicylic acid not released immediately in the stomach, but in a delayed manner in the duodenum. They are available in packages of 30 and 500 tablets in PVC-Al/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Park

31620 Huarte (Navarre) – Spain

Manufacturer

TOLL MANUFACTURING SERVICES S.L.

Aragoneses Street, 2-

28108 – Alcobendas - Madrid

Spain

or

FARMALIDER S.A.

Aragoneses Street, 2,

28108 – Alcobendas – Madrid

Spain

or

INTERNATIONAL MEDICINES LABORATORIES, S.A.

Solana Street, 26,

Torrejón de Ardoz 28850 (Madrid)

Spain

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Park

31620 Huarte (Navarre) – Spain

Date of the Last Revision of this Prospectus: December 2024

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

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

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