ACIDO 100 mg Enteric-Coated Tablet

Зміст інструкції

1. Acido Acetilsalicilico Pensa 100 mg gastro-resistant tablets
   1. What is Acido Acetilsalicilico Pensa and what is it 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

Acido Acetilsalicilico Pensa 100 mg gastro-resistant tablets

acido acetilsalicilico

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Acido Acetilsalicilico Pensa and what is it 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 is blocked and oxygen supply is interrupted. When this occurs
in the heart, it can cause a heart attack or angina; in the brain it can cause a stroke.
Acido Acetilsalicilico Pensa is taken to reduce the risk of blood clot formation and
therefore prevent further:

• heart attacks
• stroke 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 some types of heart surgery performed to widen or unblock blood vessels. This medicine is not recommended in emergency situations. It can 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 or rheumatism and pain) or to any of the other ingredients of this medicine (listed in section 6).
• if you have had asthma or swelling of some parts of the body, such as the face, lips, throat or

tongue (angioedema) after taking salicylates or NSAIDs.

• if you have a history of gastrointestinal bleeding or perforation (gastric or intestinal insufficiency) caused by previous therapy with NSAIDs.
• if you currently have or have ever had a stomach or small intestine ulcer.
• if you have a history of recurrent gastric and duodenal ulcer/bleeding with episodes of ulceration or bleeding, or any other type of bleeding such as a stroke.
• if you have ever had problems with blood clotting.
• if you have severe liver or kidney problems.
• if you have serious heart problems that can cause shortness of breath and swelling of the ankles.
• if you are in the last 3 months of pregnancy; you should not use doses higher than 100 mg per day (see section “Pregnancy and breastfeeding”).
• if you are taking a medicine called methotrexate (for example for cancer or rheumatoid arthritis) in doses higher than 15 mg per week. Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking Acido Acetilsalicilico Pensa:
• if you have problems with your kidneys, liver or heart.
• if you have or have ever had ulcers or bleeding (for example 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 can trigger an asthma attack.
• if you have ever had gout.
• if you have heavy menstrual periods.
• if you suffer from a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme.

You should immediately contact your doctor if the symptoms worsen or if serious or unexpected side effects occur, such as unusual bleeding symptoms, severe skin reactions or any other sign of a serious allergy (see section “Possible side effects”).
Tell your doctor if you are planning surgery (even minor, such as a tooth extraction), as acetylsalicylic acid thins the blood and this could increase the risk of bleeding.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as in this case the concomitant use of acetylsalicylic acid can lead to a deterioration of kidney function.
This medicine is not suitable as an anti-inflammatory, pain reliever 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, if given to children, can cause Reye's syndrome. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, Acido Acetilsalicilico Pensa should not be given to children and adolescents under the age of 16 unless advised by a doctor.

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

• thinning the blood/preventing the formation of blood clots or their dissolution (e.g. coumarin, warfarin, heparin, clopidogrel, alteplase, ticlopidine, cilostazol and dipyridamole)
• organ rejection after transplantation (e.g. cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics and ACE inhibitors)
• regulating the heartbeat (e.g. digoxin)
• manic-depressive illness (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; in doses less than 15 mg per week)
• diabetes (e.g. sulfonylureas, insulin)
• depression (e.g. selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• use as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation of the intestine (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 join together and form a blood clot) if taken at the same time. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection. Acido Acetilsalicilico Pensa with alcoholTaking alcohol can increase the risk of gastrointestinal bleeding and prolong bleeding time. Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by a doctor. You should not take Acido Acetilsalicilico Pensa if you are in the last 3 months of pregnancy, unless advised by your doctor and in this case the daily dose should not exceed 100 mg (see section “Do not take Acido Acetilsalicilico Pensa”). Regular or high doses of this medicine during the later stages of pregnancy can cause serious complications in the mother or the baby. Breastfeeding Women who are breastfeeding should not take acetylsalicylic acid unless advised by a doctor. Fertility Acetylsalicylic acid can affect female fertility through an effect on ovulation. This effect is reversible after stopping treatment. Driving and using machinesAcido Acetilsalicilico Pensa should not alter your ability to drive or operate machinery. Acido Acetilsalicilico Pensa contains lactoseIf you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ACIDO ACETILSALICILICO PENSA

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once a day.

Prevention of stroke:

• The recommended dose is 100 mg once a day.

Prevention of cardiovascular problems in patients suffering from stable or unstable angina (a type

of chest pain):

• The recommended dose is 100 mg once a day.

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

• The recommended dose is 100 mg once a day.

This medicine should not be used at higher doses unless advised by your doctor and in such
cases the dose should not exceed 300 mg per day.
Elderly
Acido Acetilsalicilico Pensa should be used with caution in elderly patients who are more prone to
adverse effects. Treatment should be re-evaluated at regular intervals.

Use in children and adolescents
Acido Acetilsalicilico Pensa should 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 (1/2 glass of water). The tablets have a
gastro-resistant coating that prevents irritating effects on the intestine and therefore they should not be
crushed, broken or chewed.

If you take more Acido Acetilsalicilico Pensa than you should
If you (or someone else) accidentally take too many tablets, inform your doctor immediately or
contact the nearest emergency room immediately. 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 considerable overdose can lead to
faster breathing (hyperventilation), fever, excessive sweating, restlessness,
convulsions, hallucinations, low blood sugar levels, pulmonary edema, coma and shock.

If you forget to take Acido Acetilsalicilico Pensa
If you forget a dose, wait until the time to take the next dose, then continue as usual.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Acido Acetilsalicilico Pensa
Talk to your doctor before stopping taking this medicine.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Acido Acetilsalicilico Pensa and tell your doctor immediately:

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

• Hives
• Runny nose
• Difficulty breathing

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

• Severe bleeding of the stomach or intestines, cerebral haemorrhage; altered number of blood cells
• Contraction of the muscles of the lower respiratory tract (bronchospasm), asthma attack
• Inflammation in blood vessels
• Bruising with purple spots (skin haemorrhage)
• Severe skin reactions such as a rash known as erythema multiforme and its life-threatening forms, Stevens-Johnson syndrome and Lyell’s syndrome
• Hypersensitivity reactions, such as swelling, for example of the lips, face or body, or anaphylactic shock
• Reye’s syndrome (a very rare disease in children that affects 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 ability
• Headache
• Dizziness
• Ulcers in the stomach or small intestine and perforation
• Prolonged bleeding time
• Impaired kidney function, acute renal 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the label and on the package after
“Exp:”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Acetilsalicilico Pensa contains

• The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The excipients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch, talc, triacetin and acrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%. Description of the appearance of Acido Acetilsalicilico Pensa and contents of the packGastro-resistant tablets of white colour, round and biconvex, without fracture. Acido Acetilsalicilico Pensa 100 mg gastro-resistant tablets are available in PVC/ aluminium blisters in packs of 30 and 60 gastro-resistant tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and ManufacturerMarketing Authorisation Holder:Towa Pharmaceutical S.p.A. Via Enrico Tazzoli, 6
• 20154 - Milan Italy Manufacturer:GL Pharma GmbH Industriestrasse 1, A-8502 Lannach Austria This medicinal product is authorised in the Member States of the European Economic Area with the followingnames:Italy: Acido Acetilsalicilico Pensa

Portugal: Ácido Acetilsalicilico Lumec
Spain: Acido Acetilsalicilico Pensa Pharma 100 mg gastro-resistant tablets