ACIDO 100 mg Enteric-Coated Tablet

Зміст інструкції

1. Acido acetilsalicilico Zentiva Italia 100 mg gastro-resistant tablets
   1. What is Acido acetilsalicilico Zentiva Italia and what is it used for
   2. What you need to know before taking Acido acetilsalicilico Zentiva Italia
   3. How to take Acido acetilsalicilico Zentiva Italia
   4. Possible side effects
   5. How to store Acido acetilsalicilico Zentiva Italia
   6. Contents of the pack and other information

Acido acetilsalicilico Zentiva Italia 100 mg gastro-resistant tablets

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Acido acetilsalicilico Zentiva Italia and what is it 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 to clot and are involved in thrombosis. When a blood clot occurs in an
artery, it interrupts blood flow and disrupts oxygen supply. When this
happens in the heart it can cause a heart attack or angina; in the brain it can cause a stroke.
Acido acetilsalicilico Zentiva Italia is taken to reduce the risk of blood clot formation
and therefore prevent further

• 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 some types of heart surgery in order 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 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 insufficiency) caused by previous therapy with NSAIDs.
• 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.
• have ever had a problem with impaired blood clotting.
• have serious problems with your liver or kidneys.
• are in the last three months of pregnancy; you should 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 greater than 15 mg per week.

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

• have problems with your kidneys, liver or heart.
• 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 can induce an asthma attack.
• have ever had gout.
• have heavy or prolonged menstrual periods.
• suffer from a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme.

You must immediately consult a doctor if the symptoms worsen or if serious or unexpected side effects occur, e.g. unusual bleeding symptoms, severe skin reactions or any other sign of a serious allergic reaction (see section 4 “Possible side effects”).
Tell your doctor if you are planning to undergo surgery (even minor, such as a tooth extraction) because acetylsalicylic acid thins the blood and there may be an increased risk of bleeding.
Be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as the simultaneous use of acetylsalicylic acid can cause a deterioration of kidney function.
This medicine is not suitable as a pain reliever or antipyretic.
If any of the above conditions apply to you, or if you have any doubts, ask your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid can cause Reye's syndrome if given to children. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, Acido acetilsalicilico Zentiva Italia should 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 the 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 higher than 15 mg per week. Talk to your doctor if you are taking methotrexate at doses lower than 15 mg per week.
• Blood thinning/prevention of clot formation or dissolution (e.g. warfarin, heparin, clopidogrel, alteplase).
• Organ rejection after transplantation (cyclosporine, tacrolimus).
• High blood pressure (e.g. diuretics and ACE inhibitors).
• Regulation of heart rate (digoxin).
• Manic-depressive illness (lithium).
• Pain and inflammation (e.g. NSAIDs (such as ibuprofen) or steroids).
• Metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells join together and form a blood clot) if taken concurrently. Therefore, this combination should be used with caution in patients taking low doses of 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 inflammation of the intestine (corticosteroids).

Acido acetilsalicilico Zentiva Italia with food, beverages and alcohol
Drinking alcohol can increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you need to continue or start treatment with Acido acetilsalicilico Zentiva Italia during pregnancy as directed by your doctor, use Acido acetilsalicilico Zentiva Italia as recommended by your doctor and do not use doses higher than recommended.
Pregnancy – third (last) trimester
Do not take Acido acetilsalicilico Zentiva Italia at doses higher than 100 mg per day in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It can cause problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.
If you take Acido acetilsalicilico Zentiva Italia at low doses (up to 100 mg per day inclusive), close obstetric monitoring is necessary as recommended by your doctor.
Pregnancy – first and second trimester
You should not take Acido acetilsalicilico Zentiva Italia in the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If you need treatment during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, Acido acetilsalicilico Zentiva Italia can cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligo-hydramnios) or causing the 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.
Breastfeeding
Breastfeeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and operating machinery
Acido acetilsalicilico Zentiva Italia should not affect your ability to drive and use machines.

Acido acetilsalicilico Zentiva Italia contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Acido acetilsalicilico Zentiva Italia

Take this medicine following exactly the instructions of 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 medicines containing acetylsalicylic acid must be used.
Prevention of heart attacks:

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

Prevention of strokes:

• The recommended dose is 75 - 300 mg once a day, for example from one tablet (100 mg) 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 a day, for example one tablet (100 mg) of this medicine per day.

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

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

This medicine should not be used at higher doses unless advised by a doctor. The dose
should 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 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.
The tablets should be swallowed whole with sufficient liquid (1/2 glass of water). The
tablets have an enteric coating that prevents irritating effects on the intestine and therefore
should 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, you should inform your
doctor immediately or contact the nearest emergency room immediately. Show the doctor any
remaining medicine or the empty package.
Symptoms of overdose may include ringing in the ears, hearing problems, headache,
dizziness, confusion, nausea, vomiting, and abdominal pain. A high overdose can lead to
faster breathing than normal (hyperventilation), fever, excessive sweating, restlessness,
convulsions, hallucinations, hypoglycemia, pulmonary edema, coma and shock.

If you forget to take Acido acetilsalicilico Zentiva Italia
If you forget a dose, wait until the time of the next dose, then continue as normal.
Do not take a double dose to make up for a missed dose.

If you stop taking Acido acetilsalicilico Zentiva Italia
Do not stop taking Acido acetilsalicilico Zentiva Italia without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 Zentiva Italia and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling and 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.
• Changes in behaviour with nausea and vomiting may be an early sign of Reye's syndrome, a potentially fatal illness that requires immediate medical attention (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.
• Runny nose.
• Difficulty breathing.

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

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

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.
• Impaired kidney function, acute renal failure.
• Liver failure, increased liver enzymes.
• High uric acid level or low blood sugar levels.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 to provide more information on the safety of
this medicine.

5. How to store Acido acetilsalicilico Zentiva Italia

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 package or blister after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido acetilsalicilico Zentiva Italia contains

• The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid. The other ingredients are: lactose monohydrate; microcrystalline cellulose; anhydrous colloidal silica; potato starch; talc; triacetin; acrylic acid-ethyl acrylate copolymer.

Description of the appearance of Acido acetilsalicilico Zentiva Italia and contents of the pack
White, round, biconvex film-coated tablet with a diameter of approximately 8.1 mm.
Packs:
30, 90 or 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano

Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

This medicinal product is authorised in the member states of the European Economic Area under the following denominations:
Denmark: Anopyrin
Czech Republic: Zanosa
Italy: Acido acetilsalicilico Zentiva Italia
France: Asared