Acetylsalicylic acid PensA

Package leaflet: Information for the user

Acido Acetilsalicilico Pensa 100 mg gastro-resistant tablets

acetylsalicylic acid
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Acido Acetilsalicilico Pensa is and what it is used for

Acido Acetilsalicilico Pensa 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, blood flow becomes blocked and oxygen
supply is interrupted. When this occurs in the heart, it may cause a heart attack or angina; in the brain, it
may cause a stroke.
Acido Acetilsalicilico Pensa is taken to reduce the risk of blood clot formation and thus prevent further:

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

Acido Acetilsalicilico Pensa is also used to prevent the formation of blood clots after certain types of
heart surgery performed 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 Acido Acetilsalicilico Pensa

Do not take Acido Acetilsalicilico Pensa:

• if you are allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are often used for arthritis, rheumatism, or pain) or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced an asthma attack or swelling of certain body parts, such as face, lips, throat, or
  tongue (angioedema) after taking salicylates or NSAIDs.
• if you have a history of gastrointestinal bleeding or perforation (stomach or intestinal failure) caused by previous treatment with NSAIDs.
• if you currently have or have ever had a stomach or duodenal ulcer.
• if you have a history of recurrent gastric or duodenal ulcers or bleeding, or any other type of bleeding such as stroke.
• if you have ever had blood clotting disorders.
• if you have severe liver or kidney problems.
• if you have severe heart problems that may cause shortness of breath and ankle swelling.
• if you are in the last three months of pregnancy; you must not use doses exceeding 100 mg per day (see section “Pregnancy, breastfeeding and fertility”).
• if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses exceeding 15 mg per week.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Acido Acetilsalicilico Pensa:

• 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 suffer from glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency.

You must contact your doctor immediately if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions, or any other signs of severe allergy (see section “Possible side effects”).
Inform your doctor if you are planning a surgical procedure (even minor, such as tooth extraction), as acetylsalicylic acid makes the blood thinner and may increase the risk of bleeding.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as concomitant use of acetylsalicylic acid in this condition may lead to impaired kidney function.
This medicine is not suitable for use as an anti-inflammatory, painkiller, or antipyretic.
If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist.

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

Other medicines and Acido Acetilsalicilico Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be altered if acetylsalicylic acid is taken at the same time as other medicines for:

• blood thinning/preventing blood clot formation or dissolving clots (e.g. warfarin, heparin, clopidogrel, alteplase, ticlopidine, cilostazol, and dipyridamole)
• prevention of organ transplant rejection (e.g. cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics and ACE inhibitors)
• regulation of heart rhythm (e.g. digoxin)
• bipolar disorder (e.g. lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids)
• gout (e.g. probenecid, sulfinpyrazone)
• epilepsy (e.g. valproate, phenytoin)
• glaucoma (e.g. acetazolamide)
• cancer or rheumatoid arthritis (e.g. methotrexate; at doses below 15 mg per week)
• diabetes (e.g. sulfonylureas, insulin)
• depression (e.g. selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• hormone replacement therapy when adrenal glands or pituitary gland have been destroyed or removed, or for treating inflammation, including rheumatic diseases and intestinal inflammation (e.g. corticosteroids)

Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blood clot) when taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

Acido Acetilsalicilico Pensa and alcohol
Consumption of alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

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

Pregnancy
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by a doctor.
If you continue or start treatment with Acido Acetilsalicilico Pensa during pregnancy as directed by your doctor, take Acido Acetilsalicilico Pensa exactly as recommended and do not exceed the recommended dose.

Pregnancy – third trimester
Do not take Acido Acetilsalicilico Pensa at doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect your and your baby’s tendency to bleed and may lead to delayed or prolonged labour.
If you take low-dose Acido Acetilsalicilico Pensa (up to 100 mg per day), strict obstetric monitoring as advised by your doctor is required.

Pregnancy – first and second trimesters
You should not take Acido Acetilsalicilico Pensa during the first six months of pregnancy unless absolutely necessary and recommended by your doctor. If treatment is needed during this period or while trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, if taken for more than a few days, Acido Acetilsalicilico Pensa may cause kidney problems in the fetus, leading 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 require treatment for more than a few days, your doctor may recommend additional monitoring.

You must not take Acido Acetilsalicilico Pensa during the last three months of pregnancy unless advised by your doctor, and in such cases the daily dose must not exceed 100 mg (see section “Do not take Acido Acetilsalicilico Pensa”). Regular or high doses of this medicine during late pregnancy may cause serious complications in mother or baby.

Breastfeeding
Breastfeeding women should not take acetylsalicylic acid unless advised by a doctor.

Fertility
Acetylsalicylic acid may affect female fertility by influencing ovulation. This effect is reversible upon discontinuation of treatment.

Driving and using machines
Acido Acetilsalicilico Pensa is unlikely to affect the ability to drive or operate machinery.

Acido Acetilsalicilico Pensa contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ACETYLSALICYLIC ACID PENSA

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
Prevention of heart attacks:

• The recommended dose is 100 mg once daily.

Prevention of stroke:

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

This medicine must not be used at higher doses unless advised by your doctor, and in such
cases the dose must not exceed 300 mg per day.
Elderly patients
Acetylsalicylic Acid Pensa should be used with caution in elderly patients, who are more susceptible to
adverse effects. Treatment should be regularly re-evaluated at regular intervals.
Use in children and adolescents
Acetylsalicylic Acid Pensa 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
For oral use.
Swallow the tablets whole with sufficient water (half a glass of water). The tablets have a
gastro-resistant coating that prevents intestinal irritation; 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 or
contact the nearest emergency department right away. Show the doctor any remaining tablets or the
empty packaging.
Symptoms of overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting, and abdominal pain. A significant overdose may lead to
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
If you miss a dose, wait until it is time to take your next dose, then continue as usual.
Do not take a double dose to make up for the missed tablet.
If you stop taking Acetylsalicylic Acid Pensa
Consult your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following serious side effects, stop taking Acido Acetilsalicilico Pensa and inform your doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction)
• Skin redness with blisters or peeling, possibly 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 vomit or urine, or dark stools

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

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

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

• Urticaria (hives)
• Runny nose
• Breathing difficulties

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

• Severe bleeding of the stomach or intestine, cerebral haemorrhage; changes in blood cell count
• Contraction of muscles in the lower respiratory tract (bronchospasm), asthma attack
• Inflammation of blood vessels
• Bruising with purple spots (cutaneous haemorrhage)
• Severe skin reactions such as a rash known as erythema multiforme and its life-threatening forms, Stevens-Johnson syndrome and Lyell syndrome
• Hypersensitivity reactions, such as swelling, for example of the lips, face or body, or anaphylactic shock
• Reye's syndrome (a very rare condition in children affecting the brain and liver (see section 2 “Children and adolescents”)
• Abnormal, heavy or prolonged menstrual bleeding

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

• Ringing in the ears (tinnitus) or reduced hearing
• Headache
• Dizziness
• Stomach or small intestine ulcers and perforation
• Prolonged bleeding time
• Impaired kidney function, acute kidney failure
• Impaired liver function
• Increased liver enzymes in blood tests
• High level of uric acid in the blood
• Low blood sugar levels

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acido Acetilsalicilico Pensa

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 label and on the carton after "Exp:". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Acetilsalicilico Pensa contains

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

Description of the appearance of Acido Acetilsalicilico Pensa and pack contents

White, round, biconvex gastro-resistant tablets without a break line.
Acido Acetilsalicilico Pensa 100 mg gastro-resistant tablets are available in PVC/aluminum blisters in packs of 30 and 60 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 - Milano
Italy

Manufacturer:
GL Pharma GmbH
Industriestrasse 1, A-8502 Lannach
Austria

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Acido Acetilsalicilico Pensa
Portugal: Ácido Acetilsalicilico Lumec
Spain: Acido Acetilsalicilico Pensa Pharma 100 mg Comprimidos gastroresistentes