Acetylsalicylic acid Zentiva Italia

Patient Information Leaflet

Acetylsalicylic Acid Zentiva Italia 100 mg enteric-coated tablets

Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms appear to be the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Acido acetilsalicilico Zentiva Italia is and what it is used for

Acido acetilsalicilico Zentiva Italia contains acetylsalicylic acid, which at low doses belongs to a group of medicines called antiplatelet agents. Platelets are tiny blood cells that cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it interrupts 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.
Acido acetilsalicilico Zentiva Italia is taken to reduce the risk of blood clot formation and thus further prevent:

• heart attacks.
• strokes.
• cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain). Acido acetilsalicilico Zentiva Italia is also used to prevent blood clot formation after certain types of heart surgery intended to widen or unblock blood vessels. This medicine is not recommended for emergencies.

2. What you need to know before taking Acido acetilsalicilico Zentiva Italia

Do not take Acido acetilsalicilico Zentiva Italia if you

• are allergic to acetylsalicylic acid, other salicylates, or other non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are often used for arthritis, rheumatism, and pain) or any of the other ingredients of this medicine (listed in section 6).
• have had an asthma attack after taking salicylates or NSAIDs.
• currently have or have ever had a stomach or small intestine ulcer.
• have a history of gastrointestinal bleeding or perforation (gastric or intestinal failure) caused by previous treatment with NSAIDs.
• have a history of recurrent gastric or duodenal ulceration/bleeding, or any other type of bleeding such as stroke.
• have ever had problems with blood not clotting properly.
• have severe liver or kidney problems.
• are in the last three months of pregnancy; you must not use doses higher than 100 mg per day (see section “Pregnancy, breastfeeding and fertility”).
• are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses exceeding 15 mg per week.

Warnings and precautions
Talk to your doctor before taking Acido acetilsalicilico Zentiva Italia if you

• have kidney, liver, or heart problems.
• have or have ever had ulcers or bleeding (e.g. in the stomach or small intestine).
• have uncontrolled high blood pressure.
• are asthmatic, have hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
• have ever had gout.
• have heavy or prolonged menstrual periods.
• suffer from glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency.

You must consult a doctor immediately if symptoms worsen or if serious or unexpected side effects occur, such as unusual bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see section 4 “Possible side effects”).
Inform your doctor if you are planning to undergo surgery (even minor procedures such as tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.
Be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as concomitant use of acetylsalicylic acid may cause deterioration of kidney function.
This medicine is not suitable for use as a 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 may cause Reye's syndrome when given to children. Reye's syndrome is a very rare condition affecting the brain and liver, which can be life-threatening. For this reason, Acido acetilsalicilico Zentiva Italia must not be given to children under 16 years of age, unless advised by a doctor.
Other medicines and Acido acetilsalicilico Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if acetylsalicylic acid is taken at the same time as other medicines for:

• Cancer or rheumatoid arthritis (methotrexate). Do not take Acido acetilsalicilico Zentiva Italia if you are taking methotrexate at doses exceeding 15 mg per week. Consult your doctor if you are taking methotrexate at doses below 15 mg per week.
• Blood thinning/prevention of blood clots or clot dissolution (e.g. warfarin, heparin, clopidogrel, alteplase).
• Prevention of organ rejection after transplantation (cyclosporine, tacrolimus).
• Hypertension (e.g. diuretics and ACE inhibitors).
• Regulation of 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) when taken concomitantly. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardiovascular protection.
• Gout (e.g. probenecid).
• Epilepsy (valproate, phenytoin).
• Glaucoma (acetazolamide).
• Diabetes (e.g. glibenclamide, insulin).
• Depression (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 intestinal inflammation (corticosteroids).

Acido acetilsalicilico Zentiva Italia with food, drinks and alcohol
Drinking 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 breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you need to continue or start treatment with Acido acetilsalicilico Zentiva Italia during pregnancy as advised by your doctor, use Acido acetilsalicilico Zentiva Italia as directed by your doctor and do not exceed the recommended dose.
Pregnancy – third (last) trimester
Do not take Acido acetilsalicilico Zentiva Italia 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 fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond normal duration.
If you take Acido acetilsalicilico Zentiva Italia at low doses (up to 100 mg per day inclusive), close obstetric monitoring is required as advised by your doctor.
Pregnancy – first and second trimesters
You should not take Acido acetilsalicilico Zentiva Italia during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used.
From week 20 of pregnancy, Acido acetilsalicilico Zentiva Italia may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Women who are breastfeeding should not take acetylsalicylic acid unless advised by a doctor.
Driving and using machines
Acido acetilsalicilico Zentiva Italia should not affect your ability to drive or use machinery.
Acido acetilsalicilico Zentiva Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Acido acetilsalicilico Zentiva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
Acido acetilsalicilico Zentiva Italia is not suitable for all dosages described below. For these dosages,
other medicinal products containing acetylsalicylic acid should be used.
Prevention of heart attacks:

• The recommended dose is 75–150 mg once daily, for example one tablet (100 mg) of this medicine per day.

Prevention of stroke:

• The recommended dose is 75–300 mg once daily, for example one tablet (100 mg) up to three tablets (300 mg) per day.

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

• The recommended dose is 75–150 mg once daily, for example one tablet (100 mg) of this medicine per day.

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

• The recommended dose is 75–150 mg once daily, for example one tablet (100 mg) of this medicine per day.

This medicine must not be used at higher doses unless advised by a doctor. The dose must not exceed
300 mg per day.
Elderly
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
For oral use.
The tablets should be swallowed whole with sufficient liquid (half a glass of water). The
tablets have an enteric coating which prevents irritating effects on the intestine and therefore must not be crushed, broken, or chewed.
If you take more Acido acetilsalicilico Zentiva Italia than you should
If you (or someone else) accidentally take too many tablets, contact your doctor or go to the nearest
emergency department immediately. Show the doctor any remaining medicines or the empty pack.
Symptoms of overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting, and abdominal pain. A severe overdose may lead to
rapid breathing (hyperventilation), fever, excessive sweating, restlessness,
seizures, hallucinations, hypoglycaemia, pulmonary oedema, coma, and shock.
If you forget to take Acido acetilsalicilico Zentiva Italia
If you miss a dose, wait until the next scheduled dose, then continue as normal.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Acido acetilsalicilico Zentiva Italia
Do not stop taking Acido acetilsalicilico Zentiva Italia without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Acetylsalicylic acid Zentiva Italia and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling, possibly accompanied by 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 vomit or urine, or black stools.
• Changes in behaviour with nausea and vomiting could be an early sign of Reye's syndrome, a potentially life-threatening condition requiring immediate medical treatment (see also section 2 "Children and adolescents").

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

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

Uncommon (may affect up to 1 in 100 people):

• Hives (urticaria).
• Runny nose (rhinorrhoea).
• Breathing difficulties.

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

• Severe bleeding in the stomach or intestines, cerebral haemorrhage; altered blood cell count.
• Cramps in the lower airways, asthma attack.
• Inflammation of blood vessels (vasculitis).
• Bruising with purple spots (skin bleeding).
• Hypersensitivity reactions, such as swelling, e.g. of lips, face or body, or shock.
• Abnormally heavy or prolonged menstrual periods.

Not known (frequency cannot be estimated from available data):

• Ringing in the ears (tinnitus) or reduced hearing.
• Headache.
• Dizziness.
• Stomach or duodenal ulcers and perforation.
• Prolonged bleeding time.
• Impaired kidney function, acute renal failure.
• Liver failure, increased liver enzymes.
• High levels of uric acid or low blood sugar levels.

Reporting of side effects
If you experience any side effect, 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Acetylsalicylic Acid Zentiva Italia

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 or blister 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 Zentiva Italia contains

• 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; methacrylic acid-ethyl acrylate copolymer.

Description of the appearance of Acido acetilsalicilico Zentiva Italia and package contents
White, round, biconvex film-coated tablet with a diameter of approximately 8.1 mm.
Packaging:
30, 90 or 100 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy
Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
This medicinal product is authorized in the European Economic Area member states with the following names:
Denmark: Anopyrin
Czech Republic: Zanosa
Italy: Acido acetilsalicilico Zentiva Italia
France: Asared