Acetylsalicylic acid Pensa 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid PENSA 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, as 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ácido Acetilsalicílico PENSA is and what it is used for

This medicine contains acetylsalicylic acid, which at low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the supply of oxygen. When this occurs in the heart, it may cause a heart attack or angina; in the brain, it may cause a stroke.

Ácido Acetilsalicílico PENSA is taken to reduce the risk of blood clot formation and thereby prevent:

• heart attacks
• strokes
• cardiovascular problems in patients who have stable or unstable angina (a type of chest pain).

Ácido Acetilsalicílico PENSA is also used to prevent blood clot formation after certain types of cardiac surgery intended to widen or unblock blood vessels.

This medicine is not recommended for emergency use. It may only be used as a preventive treatment.

2. What you need to know before taking Acetylsalicylic Acid PENSA

Do not take Acetylsalicilic Acid PENSA:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).
• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs are commonly used for arthritis or rheumatism and pain

• if you have previously experienced an asthma attack or swelling of certain body parts, e.g. 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 haemorrhage
• if you have ever had a problem with your blood not clotting properly
• if you have severe liver or kidney problems
• if you are in the last 3 months of pregnancy; you must not use doses higher than 100 mg per day (see section “Pregnancy, lactation and fertility”)
• if you are taking a medicine called methotrexate (e.g. to treat cancer or rheumatoid arthritis) at doses higher than 15 mg per week

Warnings and precautions

Before starting treatment with Acetylsalicylic Acid PENSA, inform your doctor:

• if you have kidney, liver or heart problems
• if you have or have ever had stomach or small intestine problems
• 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
• if you have heavy menstrual periods

You should consult a doctor immediately if your symptoms worsen or if you experience serious or unexpected adverse effects, e.g. unusual bleeding symptoms, serious skin reactions or any other signs of a severe allergic reaction (see section “Possible side effects”).

Inform your doctor if you have planned surgery (including minor procedures such as dental extraction), as acetylsalicylic acid is an anticoagulant and may increase the risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a very rare condition affecting the brain and liver and may be life-threatening. For this reason, Acetylsalicylic Acid PENSA must not be given to children under 16 years of age unless directed by a doctor.

You should take care not to become dehydrated (you may feel thirsty and have a dry mouth), as using acetylsalicylic acid at the same time may lead to impaired kidney function.

This medicine is not suitable for relieving pain or reducing fever.

If you are in any of the above situations, or if you are unsure, consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take Acetylsalicylic Acid PENSA 100 mg.

Taking Acetylsalicylic Acid PENSA with other medicines

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

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as other medicines used for:

• preventing blood clots (e.g. warfarin, heparin, clopidogrel)
• preventing rejection of a transplanted organ (cyclosporine, tacrolimus)
• treating high blood pressure (e.g. diuretics and ACE inhibitors)
• regulating heart rhythm (digoxin)
• bipolar disorder (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)
• gout (e.g. probenecid)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; at doses less than 15 mg per week)
• diabetes (e.g. glibenclamide)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or

paroxetine)

• used as hormone replacement therapy when adrenal glands or the pituitary gland have been destroyed or removed, or medicines used to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)
• if administered together, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping 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 PENSA with food and drink

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and lactation

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

Pregnancy

Pregnant women must not take acetylsalicylic acid during pregnancy unless instructed by their doctor.

If you continue or start treatment with this medicine during pregnancy as directed by your doctor, use acetylsalicylic acid exactly as directed and do not exceed the recommended dose.

Pregnancy – third trimester

Do not take this medicine in doses exceeding 100 mg per day if you are in the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour beyond expected duration.

If you take this medicine at low doses (up to and including 100 mg per day), you will require strict obstetric monitoring as directed by your doctor.

Pregnancy – first and second trimesters

You must not take this medicine during the first 6 months of pregnancy unless absolutely necessary and directed by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days beyond 20 weeks of pregnancy, 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 more than a few days, your doctor may recommend additional monitoring.

You must not take Acetylsalicylic Acid PENSA during the last 3 months of pregnancy unless directed by your doctor, and in that case the daily dose must not exceed 100 mg (see section “Do not take Acetylsalicylic Acid PENSA”). Normal or high doses of this medicine during the final stage of pregnancy may cause serious complications in the mother or baby.

Lactation

Women who are breastfeeding should not take acetylsalicylic acid unless directed by their doctor.

Fertility

Acetylsalicylic acid may affect female fertility through its effect on ovulation. This effect is reversible upon discontinuation of treatment.

Driving and using machines

Acetylsalicylic Acid PENSA is not expected to affect your ability to drive or use machines.

Acetylsalicylic Acid PENSA contains sodium

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

3. How to take Acetylsalicylic Acid PENSA

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

Adults

Prevention of heart attacks:

• The recommended dose is 75–160 mg once daily.

Prevention of strokes:

• The recommended dose is 75–325 mg once daily.

Prevention of cardiovascular problems in patients with stable or unstable angina (a type of chest pain):

• The recommended dose is 75–160 mg once daily.

Prevention of blood clot formation after certain types of cardiac surgery:

• The recommended dose is 75–160 mg once daily.

Elderly patients

Dosage is the same as for adults. In general, acetylsalicylic acid should be used with caution in elderly patients, who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Children

Acetylsalicylic acid must not be given to children and adolescents under 16 years of age, unless specifically prescribed by a doctor (see section "Take special care with Acetylsalicylic Acid PENSA").

Method of administration

For oral use.

The tablets should be swallowed whole with sufficient liquid (half a glass of water). The tablets have an enteric coating that prevents irritating effects in the intestine; therefore, they must not be crushed, broken, or chewed.

If you take more Acetylsalicylic Acid PENSA than you should

If you (or someone else) accidentally take too many tablets, inform your doctor immediately, contact the nearest emergency service right away, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

Show the medicine or empty packaging to your doctor.

Symptoms of overdose may include tinnitus (ringing in the ears), hearing disturbances, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A large overdose may lead to abnormally rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar levels, coma, and shock.

If you forget to take Acetylsalicylic Acid PENSA

If you forget to take a dose, wait until it is time to take the next dose and continue treatment as usual.

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

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 notice any of the following serious adverse effects, stop taking Acetylsalicylic Acid PENSA and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face or body, rash, fainting or difficulty swallowing (serious allergic reaction).
• Red skin rash with blisters or peeling, which may be associated with high fever and joint pain. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell syndrome.
• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

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

• Indigestion.
• Increased tendency to bleed.

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

• Urticaria.
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, cerebral haemorrhage; altered blood cell count.
• Nausea and vomiting.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous bleeding).
• Serious skin reactions such as a rash known as erythema multiforme, and life-threatening forms such as Stevens-Johnson syndrome and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, e.g., lips, face or body, or shock.
• Abnormally heavy or prolonged menstrual periods.

Adverse effects of unknown frequency:

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Stomach or small intestine ulcers and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• Hepatic function disorder.
• High levels of uric acid in the blood.

Reporting of adverse effects

If you experience any type 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, Website: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid PENSA

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

Store below 30°C. Do not refrigerate. Keep in the original packaging.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid PENSA

• The active substance is acetylsalicylic acid.
• The other components are: powdered cellulose, pregelatinized corn starch without gluten, Acryl-EZE Clear (93F19255) (methacrylic acid copolymer type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate and sodium lauryl sulfate).

Appearance of the medicinal product and contents of the container

Acetylsalicylic Acid PENSA 100 mg tablets are round, biconvex and white in colour. They are coated with a gastro-resistant coating that prevents the immediate release of acetylsalicylic acid in the stomach, allowing delayed release in the duodenum. The product is supplied in packs of 30 tablets in PVC-Al/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
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,
28850 Torrejón de Ardoz, Madrid
Spain

Date of the most recent review of this leaflet: September 2025

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