Acetylsalicylic acid Doc Generici

Package leaflet: Information for the patient

ACETYLSALICYLIC ACID DOC Generici 100 mg gastro-resistant tablets

Generic medicine
Please read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO ACETILSALICILICO DOC Generici is and what it is used for

ACIDO ACETILSALICILICO DOC Generici 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 DOC Generici is taken to reduce the risk of blood clot formation and thus prevent the following:

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

ACIDO ACETILSALICILICO DOC Generici is also used to prevent the formation of blood clots after certain heart procedures 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 DOC Generici

Do not take ACIDO ACETILSALICILICO DOC Generici if

• you are allergic to the active substance, to other salicylates, or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced an asthma attack or swelling of certain body parts (e.g. face, lips, throat, or tongue) (angioedema) after taking salicylates or other non-steroidal anti-inflammatory analgesics (NSAIDs).
• you suffer from mastocytosis (a blood tumor), because the use of acetylsalicylic acid may cause you severe allergic reactions (including circulatory shock with hot flushes, hypotension, tachycardia, and vomiting).
• you currently have or have ever had a stomach or small intestine ulcer or any other type of bleeding, such as a stroke.
• you have experienced blood clotting disorders.
• you suffer from severe liver or kidney problems.
• you suffer from cirrhosis.
• you have severe heart problems that may cause shortness of breath and swelling of the ankles (severe heart failure).
• you are in the last 3 months of pregnancy; you must not take doses exceeding 100 mg per day (see section “Pregnancy and breastfeeding”).
• you are taking a medicine called methotrexate (e.g. for the treatment of cancer or rheumatoid arthritis) at doses equal to or greater than 15 mg per week.

Warnings and precautions
Before taking ACIDO ACETILSALICILICO DOC Generici, inform your doctor if:

• you have kidney, liver, or heart problems
• you have or have previously had stomach or small intestine problems
• you have high blood pressure
• you suffer from seasonal allergies, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack
• you have ever had gout
• you have heavy menstrual periods
• you are prone to nosebleeds
• you are anemic or suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may cause episodes of anemia after eating certain foods, such as fava beans (favism).

You must immediately contact your doctor if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions, or any other sign of a serious allergic reaction (see section “Possible side effects”).
Stop taking ACIDO ACETILSALICILICO DOC Generici if you experience prolonged vomiting, loss of consciousness, or abnormal behavior during treatment.
Inform your doctor if you are scheduled for surgery (even minor procedures such as tooth extraction), as acetylsalicylic acid makes the blood thinner and may therefore increase the risk of bleeding.
Be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as concurrent use of acetylsalicylic acid may lead to impaired kidney function.
This medicine is not suitable for use as a painkiller or to reduce fever.

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, which can be life-threatening. For this reason, ACIDO ACETILSALICILICO DOC Generici must not be given to children under 16 years of age, unless advised by a doctor.
If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist.

Other medicines and ACIDO ACETILSALICILICO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effectiveness of treatment may be affected if acetylsalicylic acid is taken simultaneously with other medicines used for:

• thinning the blood/preventing clots (e.g. warfarin, heparin, coumarins, clopidogrel, ticlopidine, dipyridamole)
• prevention of organ transplant rejection (cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics, ACE inhibitors, antihypertensives)
• regulation of heart rhythm (digoxin)
• manic-depressive illness (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids)
• gout (e.g. probenecid)
• epilepsy (valproate, valproic acid, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate at doses below 15 mg per week). Do not take ACIDO ACETILSALICILICO DOC Generici if you are taking methotrexate at doses exceeding 15 mg per week.
• diabetes (e.g. insulin, sulfonylureas)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
• use as hormone replacement therapy after destruction or removal of adrenal glands or pituitary gland, or to treat inflammation, including rheumatic diseases and intestinal inflammation (glucocorticoids, except hydrocortisone for Addison's disease)

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 concurrently. Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.

ACIDO ACETILSALICILICO DOC Generici and alcohol
Consumption of alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by a doctor.
You must not take ACIDO ACETILSALICILICO DOC Generici during the last 3 months of pregnancy, except on medical prescription, and in such cases the daily dose must not exceed 100 mg (see section “Do not take ACIDO ACETILSALICILICO DOC Generici”). Regular or high doses of this medicine during the later stages of pregnancy may cause serious complications in the mother or baby.
Breastfeeding women should not take acetylsalicylic acid unless advised by a doctor.

Driving and using machines
ACIDO ACETILSALICILICO DOC Generici does not affect the ability to drive or use machinery.

Excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ACETYLSALICYLIC ACID DOC Generici

Take this medicine exactly as directed by your doctor. 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.

The usual dose for long-term treatment is 100 mg (one tablet) once daily. ACETYLSALICYLIC ACID DOC Generici must not be taken at higher doses unless advised by your doctor, and the dose must not exceed 300 mg per day.
Elderly
As in adults. In general, acetylsalicylic acid should be used with caution in elderly patients, who are more sensitive to adverse events. Treatment should be regularly re-evaluated.
Use in 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 “Take special care with ACETYLSALICYLIC ACID DOC Generici”).
Method of administration
For oral use.
The tablets must be swallowed whole with an adequate amount of liquid (half a glass of water). The tablets have a gastro-resistant coating which prevents irritating effects on the intestine, and therefore must not be crushed, broken, or chewed.
If you take more ACETYLSALICYLIC ACID DOC Generici than you should
If you (or anyone else) accidentally take too many tablets, seek immediate medical advice from your doctor or contact the nearest emergency department. Show the doctor what medicine is left 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, coma, and shock.
If you suspect an overdose, contact your doctor immediately. The doctor will decide whether further measures are necessary, depending on the severity of the overdose.
If you forget to take ACETYLSALICYLIC ACID DOC Generici
If you forget a dose, wait until it is time to take the next dose, then continue as usual.
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any of the following serious adverse reactions, stop taking ACIDO ACETILSALICILICO DOC Generici and contact your 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 associated with high fever and joint pain. These may be signs of erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome.
• Unusual bleeding, such as coughing up blood, blood in vomit or urine, or dark stools.

Common adverse reactions (may occur in 1 to 10 out of 100 patients):

• Indigestion, nausea, vomiting, abdominal pain, heartburn, diarrhoea.
• Increased tendency to bleed.

Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):

• Urticaria.
• Runny nose.
• Difficulty breathing.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):

• Severe bleeding from the stomach or intestine, cerebral haemorrhage; altered blood cell counts.
• Bronchospasm, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous haemorrhage).
• Severe skin reactions such as rashes known as erythema multiforme and its life-threatening variants, Stevens-Johnson syndrome and Lyell's syndrome.
• Hypersensitivity reactions, such as swelling of, for example, lips, face or body, or shock.
• Very heavy or prolonged menstrual periods.

Adverse reactions with unknown frequency:

• Rapid destruction of red blood cells and a form of anaemia in patients with a severe form of glucose-6-phosphate dehydrogenase deficiency.
• Ringing in the ears (tinnitus), reduced hearing ability or deafness.
• Headache, dizziness, vertigo, sweating and confusion. These may be symptoms of overdose.
• Stomach or small intestine ulcers and perforation.
• Sudden, life-threatening allergic reactions.
• Prolonged bleeding time.
• Impaired kidney function and acute renal failure.
• Impaired liver function, increased liver enzyme levels.
• High levels of uric acid in the blood.
• Elevated blood sugar levels.
• Severe skin reactions.
• Reye's syndrome.
• Delayed delivery.

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

5. How to store ACIDO ACETILSALICILICO DOC Generici

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What ACIDO ACETILSALICILICO DOC Generici contains
The active substance is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of
acetylsalicylic acid.
The excipients are: tablet core: microcrystalline cellulose, maize starch, anhydrous colloidal silicon dioxide, stearic acid; coating: methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Description of the appearance of ACIDO ACETILSALICILICO DOC Generici and pack contents
ACIDO ACETILSALICILICO DOC Generici 100 mg gastro-resistant tablets are white, round, biconvex, film-coated tablets with a diameter of 7.2 mm.
Pack sizes:
30 gastro-resistant tablets.
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy
Manufacturer
Actavis Limited
BLB 016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate (BG)
Italy
This summary of product characteristics was last approved in