Acetylsalicylic acid Pensa Pharma 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylsalicylic acid pensa pharma 100 mg gastro-resistant tablets

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, pharmacist or nurse.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is Ácido acetilsalicílico pensa pharma and what is it used for?

Ácido acetilsalicílico pensa pharma contains acetylsalicylic acid, which, at low doses, belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood to clot 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.

Acetylsalicylic acid is taken to reduce the risk of thrombus formation and thus prevent:

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

This medicine is also used to prevent thrombus formation after certain types of cardiac surgery intended to widen or unblock blood vessels.

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

2. What you need to know before taking acetylsalicylic acid pensa pharma

Do not take acetylsalicylic acid pensa pharma

• if you are allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are commonly used for arthritis or rheumatism and pain), or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had 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
• if you have a history of bleeding or perforation (gastric or intestinal) caused by previous treatment with NSAIDs
• if you have a history of recurrent gastroduodenal ulcer/bleeding with episodes of ulceration or bleeding, 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 have severe liver or kidney problems
• if you have severe heart problems, which may cause difficulty breathing and swelling of the ankles
• if you are in the last 3 months of pregnancy; you must not use doses higher than 100 mg per day (see section “Pregnancy, breastfeeding 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

Talk to your doctor, pharmacist or nurse before taking this medicine:

• if you have kidney, liver or heart problems
• if you have or have ever had ulcers or bleeding (e.g. in the stomach or small intestine)
• 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
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)

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

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

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.

Children and adolescents

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

Other medicines and acetylsalicylic acid pensa pharma

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, alteplase)
• preventing organ transplant rejection (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)
• 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
• 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, insulin)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or medicines to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

Taking acetylsalicylic acid pensa pharma with alcohol

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

Pregnancy, breastfeeding and fertility

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 should not take acetylsalicylic acid during pregnancy unless directed by their doctor.

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

Pregnancy – third trimester

Do not take this medicine at 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 more than expected.

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 trimester

You should 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 this medicine during the last 3 months of pregnancy unless directed by your doctor, and in such cases the daily dose must not exceed 100 mg (see section “Do not take acetylsalicylic acid pensa pharma”). Normal or high doses of this medicine during the final stage of pregnancy may cause serious complications in the mother or baby.

Breastfeeding

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

This medicine is not expected to affect your ability to drive or use machines.

Acetylsalicylic acid pensa pharma contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Acetylsalicylic acid pensa pharma

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

Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once daily.

Prevention of strokes:

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

Prevention of blood clots after certain types of heart surgery:

• The recommended dose is 100 mg once daily.

This medicine should not be used at higher doses unless advised by a doctor. The dose should not exceed 300 mg per day.

Elderly patients

Doses are 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 and adolescents

Acetylsalicylic acid must not be given to children and adolescents under 16 years of age unless prescribed by a doctor (see section “Warnings and precautions”).

Method of administration: 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 pharma than you should

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

Show the medicine or the empty packaging to your doctor.

Symptoms of overdose may include ringing in the ears, hearing problems, 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, pulmonary edema, coma, and shock.

If you forget to take acetylsalicylic acid pensa pharma

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

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

If you stop taking acetylsalicylic acid pensa pharma

Do not stop taking this medicine without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop taking this medicine and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering 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.

Other adverse effects are:

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

• Nausea, vomiting, diarrhoea.
• Indigestion.
• Increased tendency to bleed.

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

• Hives (urticaria).
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, cerebral haemorrhage.
• Altered number of blood cells.
• Constriction in the lower respiratory tract (bronchospasm), asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous bleeding).
• Severe 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.
• Reye's syndrome (a very rare illness in children affecting the brain and liver (see section 2 "Children and adolescents")).
• Abnormally heavy or prolonged menstrual periods.

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

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder, acute kidney failure.
• Hepatic function disorder.
• Increased liver enzymes in blood.
• High levels of uric acid in blood.
• Low blood sugar levels.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 pharma

Keep this medicine out of the sight and reach of children. Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the 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 Ácido acetilsalicílico pensa pharma

• The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, potato starch, talc, triacetin and copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion.

Appearance of the product and contents of the pack

White, round, biconvex gastro-resistant tablets without a score mark.

Available in PVC/Al blisters containing 30 and 60 gastro-resistant tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Manufacturer

G.L. Pharma GmbH

Industriestrasse 1, Lannach, Steiermark

8502 Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy: Acido Acetilsalicilico Pensa

Portugal: Acido Acetilsalicilico Lumec

Spain: Acido Acetilsalicilico pensa pharma 100 mg gastro-resistant tablets

Date of the most recent review of this leaflet: February 2026

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