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1. ACIDO ACETILSALICILICO DOC Generici 100 mg gastro-resistant tablets
   1. What is ACIDO ACETILSALICILICO DOC Generici and what is it used for
   2. What you need to know before taking ACIDO ACETILSALICILICO DOC Generici
   3. How to take ACIDO ACETILSALICILICO DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. How to store ACIDO ACETILSALICILICO DOC Generici
   6. Contents of the pack and other information

ACIDO ACETILSALICILICO DOC Generici 100 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before taking this medicine.

• 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 they have the same symptoms as you, as it may 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 DOC Generici is and what it is used for
• 2. What you need to know before you take ACIDO ACETILSALICILICO DOC Generici
• 3. How to take ACIDO ACETILSALICILICO DOC Generici
• 4. Possible side effects
• 5. How to store ACIDO ACETILSALICILICO DOC Generici
• 6. Contents of the pack and other information

1. What is ACIDO ACETILSALICILICO DOC Generici and what is it 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 cells in the blood that cause coagulation and are involved in thrombosis. When
a blood clot forms in an artery, blood flow is blocked and the supply of
oxygen 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 DOC Generici is taken to reduce the risk of blood clot formation and therefore 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 some heart surgeries, performed to widen or unblock blood vessels.
This medicine is not recommended in emergency cases. It can only be used as
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 ingredient or to other salicylates or to any of the other components of this medicine (listed in section 6).
• you have had an asthma attack or some parts of your body, e.g. face, lips, throat or tongue (angioedema) have swollen after taking salicylates or other analgesic anti-inflammatory drugs (NSAIDs).
• if you suffer from mastocytosis (a blood tumor), because the use of acetylsalicylic acid may cause you severe allergic reactions (including circulatory shock with hot flashes, 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 had problems with blood coagulation.
• you suffer from severe liver or kidney problems.
• you suffer from cirrhosis.
• if you have serious heart problems that can cause shortness of breath and swelling of the ankles (severe heart failure).
• you are in the last 3 months of pregnancy; you should not take doses higher than 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 tell your doctor if:

• you have problems with your kidneys, liver or heart
• you have or have had problems with your stomach or small intestine
• 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 bleeding
• you are prone to nosebleeds
• if you are anemic or suffer from a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme which can cause episodes of anemia after eating certain foods, such as broad beans (favism).

You should immediately see your doctor if your symptoms worsen or if you experience serious or unexpected side effects, e.g. unusual bleeding symptoms, severe skin reactions or any other sign of a severe allergic reaction (see section “Possible side effects”).
Stop taking ACIDO ACETILSALICILICO DOC Generici if prolonged vomiting, loss of consciousness or abnormal behavior occur during treatment.
Tell your doctor if you are going to have surgery (even a minor one, such as a tooth extraction), as acetylsalicylic acid makes the blood more fluid and therefore there may be an increased risk of bleeding.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) because the simultaneous use of acetylsalicylic acid can cause deterioration of kidney function.
This medicine is not suitable as a pain reliever or to reduce fever.

Children and adolescents
Acetylsalicylic acid, if administered 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 DOC Generici should not be given to children under the age of 16, 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effectiveness of the treatment may be affected if acetylsalicylic acid is taken at the same time as other medicines for:

• thinning the blood/preventing blood clots (e.g. warfarin, heparin, coumarins, clopidogrel, ticlopidine, dipyridamole)
• organ transplant rejection (cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics, ACE inhibitors and antihypertensives)
• regulating the heartbeat (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 less than 15 mg per week). Do not take ACIDO ACETILSALICILICO DOC Generici if you are taking methotrexate at doses greater than 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 the adrenal glands or pituitary gland, or to treat inflammation, including rheumatic diseases and inflammation of the intestine (glucocorticoids, with the exception of hydrocortisone for Addison's disease)

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor.
You should not take ACIDO ACETILSALICILICO DOC Generici in the last 3 months of pregnancy unless prescribed by your doctor and in this case the daily dose should not exceed 100 mg (see section “Do not take ACIDO ACETILSALICILICO DOC Generici”). Regular or high doses of this medicine during the last part of pregnancy can cause serious complications in the mother or baby.
Breastfeeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and operating machinery
ACIDO ACETILSALICILICO DOC Generici does not affect the ability to drive and operate machinery.

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

3. How to take ACIDO ACETILSALICILICO DOC Generici

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once a day. Prevention of strokes:
• The recommended dose is 100 mg once a day. Prevention of cardiovascular problems in patients suffering from stable or unstable angina (atype of chest pain):
• The recommended dose is 100 mg once a day. Prevention of blood clot formation after certain types of heart surgery:
• The recommended dose is 100 mg once a day.

The usual dose for prolonged treatment is 100 mg (one tablet) once a day. ACIDO
ACETILSALICILICO DOC Generici should not be taken at doses higher than recommended by your doctor
and the dose should 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 re-evaluated at regular intervals.
Use in 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 “Special care with ACIDO
ACETILSALICILICO DOC Generici”).
Method of administration
Oral use.
The tablets should be swallowed whole with a sufficient amount of 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 DOC Generici than you should
If you (or anyone else) accidentally take too many tablets, you should immediately contact
your doctor or go to the nearest emergency room. Show the doctor what is left of the
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 considerable overdose can
lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness,
convulsions, hallucinations, low blood sugar levels, coma and shock.
If you suspect a drug overdose, contact your doctor immediately who will decide if
further measures are necessary, depending on the severity of the overdose.

If you forget to take ACIDO ACETILSALICILICO DOC Generici
If you forget a dose, wait until the time to take the next dose, then proceed as
usual.
Do not take a double dose to make up for a missed tablet.
If you have any doubts about the use of this product, 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 notice any of the following serious side effects, stop taking
ACIDO ACETILSALICILICO DOC Generici 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 may 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.

Common side effects (may affect between 1 and 10 in 100 patients):

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

Uncommon side effects (may affect between 1 and 10 in 1000 patients):

• Hives.
• Runny nose.
• Difficulty breathing.

Rare side effects (may affect between 1 and 10 in 10,000 patients):

• Severe bleeding from the stomach or intestines, cerebral haemorrhage; altered number of blood cells.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purplish spots (skin 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.

Side effects 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 enzyme deficiency.
• Ringing in the ears (tinnitus), reduced hearing ability or deafness.
• Headache, dizziness, lightheadedness, sweating and confusion. These may be symptoms of overdose.
• Ulcers in the stomach or small intestine and perforation.
• Sudden, life-threatening allergic reactions
• Prolonged bleeding time.
• Impaired kidney function and acute renal failure.
• Impaired liver function, increased levels of liver enzymes.
• High levels of uric acid in the blood.
• Elevated blood sugar level
• Severe skin reactions.
• Reye's syndrome
• Delayed labour.

Reporting of side effects
If you get any side effects, talk to 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
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 at a temperature below 25°C.
Store in the original package to protect the medicine from humidity.
Do not use this medicine after the expiry date which is stated on the box 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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACIDO ACETILSALICILICO DOC Generici contains
The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of
acetylsalicylic acid.
The excipients are: tablet core:microcrystalline cellulose, corn starch, anhydrous colloidal silica, 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 contents of the
pack
ACIDO ACETILSALICILICO DOC Generici 100 mg gastro-resistant tablets are
round, white, biconvex, film-coated tablets with a diameter of 7.2 mm.

Packs:
30 gastro-resistant tablets.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
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