Acetylsalicylic acid Cinfamed 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylsalicylic acid cinfamed 100 mg gastro-resistant tablets EFG

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ácido acetilsalicílico cinfamed is and what it is used for

Acetylsalicylic acid, at the dose present in this medicine, belongs to a group of medicines called platelet aggregation inhibitors. Platelets are components of the blood, smaller than red and white blood cells, which aggregate when blood clots. By preventing this aggregation, platelet aggregation inhibitors reduce the likelihood of blood clots (thrombi) forming. Your doctor has prescribed acetylsalicylic acid to prevent the formation of blood clots and to reduce the risk of blockage of your arteries, because:

• You have previously had a myocardial infarction or angina pectoris.
• You have had a non-haemorrhagic stroke, either transient or permanent.
• You have undergone a surgical procedure such as coronary angioplasty or coronary bypass.

2. What you need to know before starting to take acetylsalicylic acid cinfamed

Do not take Acetylsalicylic acid cinfamed

• if you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6).

• if you suffer or have suffered from asthma, with or without nasal polyps, after taking acetylsalicylic acid.

• if you have experienced allergic reactions of an asthmatic type (difficulty breathing, suffocation, bronchospasm and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other painkillers, or the tartrazine dye.

• if you suffer or have suffered from acute gastroduodenal ulcer or recurrent stomach discomfort.

• if you have a history of gastrointestinal bleeding or perforation following treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

• if you suffer from hemophilia or other blood coagulation disorders that predispose you to internal bleeding.

• if you suffer from severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).

• if you are being treated with anticoagulant medicines (oral anticoagulants).

• if you suffer from a serious heart condition.

• if you are being treated with methotrexate.

• if you are under 16 years of age, unless specifically directed by a doctor, as the use of acetylsalicylic acid is associated with Reye's syndrome, a rare but serious illness.

• 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.
• you are scheduled to undergo surgery, including dental surgery, within the next seven days.
• you are taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, or other types of medicines, as certain medicines may interact with acetylsalicylic acid and cause 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 suffer from hypertension or have serious kidney, heart, or liver problems, have blood coagulation disorders, or are being treated with anticoagulants.
• you are allergic to other anti-inflammatory or antirheumatic drugs.
• you have glucose-6-phosphate dehydrogenase deficiency.
• you suffer from rhinitis and/or urticaria.
• you have had or currently 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 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 might need to take any other medicine.

Certain medicines may interact with acetylsalicylic acid and therefore should not be used without consulting your doctor. This is especially important in the case of:

• Analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, used to treat pain and/or muscle inflammation.
• Corticosteroids, except hydrocortisone used in Addison's disease, as they may increase the risk of gastrointestinal bleeding and ulcers.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), as they increase the risk of bleeding.
• Medicines for blood coagulation (oral anticoagulants), as they increase the risk of bleeding.
• Some medicines used to control hypertension.
• Medicines used to lower blood sugar levels.
• Cyclosporine, used in transplant patients.
• Vancomycin, an antibiotic used for certain infections.
• Interferon alfa.
• Lithium, used in certain psychiatric conditions.
• Methotrexate, used for the treatment of cancer and rheumatoid arthritis; increases the hepatotoxicity of methotrexate.
• Medicines used to treat gout.
• Antacids.
• Digoxin, used for heart problems.
• Barbiturates, medicines used as sedatives for sleep disorders and to treat seizures.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medicines used for epilepsy.
• If administered together, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid as a cardioprotective agent.

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 regularly consume alcohol (three or more alcoholic drinks – beer, wine, spirits, 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 medicine.

Pregnancy – third trimester

Do not take this medicine if you are in the last three months of pregnancy, as it could harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and may delay or prolong labor beyond the expected duration.

Pregnancy – first and second trimesters

You should not take this medicine during the first six months of pregnancy unless absolutely necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 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 treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Fertility

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

Driving and using machines

No effects have been reported in this regard.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test 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 instructions for use of this medicine as given by your doctor or pharmacist. If in 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 must not be crushed, broken, or chewed.

The usual dose is one 100 mg acetylsalicylic acid tablet once daily.

Try to take the medicine regularly, at the same time each day.

Your doctor will determine the duration of treatment with acetylsalicylic acid. Do not stop treatment prematurely.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist. Due to its modified-release formulation, acetylsalicylic acid 100 mg is not indicated at the time of acute myocardial infarction. However, in an emergency situation where its use is required, it is recommended to crush the first tablet or chew it and swallow it to accelerate the absorption of acetylsalicylic acid.

If you take more Acetylsalicylic acid cinfamed than you should

Contact your doctor or pharmacist immediately.

Due to the nature of the preparation, the likelihood of accidental poisoning is very low.

The main symptoms of overdose are: headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, rapid breathing, confusion, nausea, vomiting, and occasionally diarrhea.

In case of overdose or accidental ingestion, contact 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 Acetylsalicylic acid cinfamed

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

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

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 experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects 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 may lead to 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 haemolysis and haemolytic anaemia have been reported.

General list of possible adverse effects

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

• At high doses: hypoprothrombinaemia (decreased levels of a blood protein essential for clotting)
• dizziness
• tinnitus (ringing in the ears)
• epistaxis (nosebleeds), rhinitis
• gastrointestinal disorders such as indigestion, gastrointestinal and abdominal pain, gastrointestinal inflammation
• gastrointestinal bleeding
• skin rash, itching
• bleeding from the urinary tract and genital organs

Uncommon adverse effects (may affect up to 1 in 100 people)

• anaemia due to low iron levels in the blood
• hypersensitivity, drug-induced hypersensitivity, allergic oedema and angioedema (swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing)
• bleeding in the brain and within the skull
• bruising
• nasal congestion
• bleeding from the gums, gastrointestinal erosion and ulcer
• liver failure and liver disorders (especially in patients with juvenile arthritis)
• urticaria
• Reye's syndrome (a rare and serious illness characterised by inflammation of the brain and liver) in children under 16 years of age with fever, influenza or varicella (see “What you need to know before taking acetylsalicylic acid cinfamed”)

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

• haemorrhagic anaemia
• anaphylactic reaction (severe, generalized allergic reaction)
• bleeding, bleeding into muscles
• perforation of gastrointestinal ulcer
• increased levels of liver enzymes (transaminases)
• renal impairment, acute renal failure

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

• haemolysis (destruction of red blood cells), haemolytic anaemia
• anaphylactic shock (severe allergic reaction)
• cardiorespiratory distress (acute syndrome caused by severe respiratory failure affecting also cardiac rhythm)
• procedural bleeding
• aspirin-exacerbated respiratory disease (respiratory disorder characterised by nasal polyps (soft growths inside the nose), asthma, and sensitivity to acetylsalicylic acid)
• intestinal diaphragm disease (narrowing of the intestinal tract)

With long-term treatment and high doses, the following may occur: dizziness, ringing in the ears, deafness, sweating, headache, confusion, and kidney problems; cases of renal impairment and acute renal failure have been reported.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylsalicylic acid cinfamed

• The active substance is acetylsalicylic acid.

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

Appearance of the product and contents of the pack

Acetylsalicylic acid cinfamed 100 mg tablets are round, biconvex and white in colour. They are coated with a gastro-resistant coating that delays the release of acetylsalicylic acid until the duodenum, rather than releasing it immediately in the stomach. The tablets are supplied in packs of 30 and 500 tablets in PVC-Al/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

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

Date of the most recent revision of this leaflet: December 2024

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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76287/P_76287.html

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