ACIDO 100 mg Enteric-Coated Tablet

Зміст інструкції

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

Acido Acetilsalicilico Mylan 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. Do not give it to other people, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Acido Acetilsalicilico Mylan and what is it used for

Acido Acetilsalicilico Mylan 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 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 Mylan is taken to reduce the risk of blood clot formation and therefore
prevent the following:

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

Acido Acetilsalicilico Mylan is also used to prevent the formation of blood clots after some
heart interventions made to widen or unblock blood vessels.
This medicine is not recommended in emergency cases. It can only be used as a preventive
treatment.

2. What you need to know before taking Acido Acetilsalicilico Mylan

Do not take Acido Acetilsalicilico Mylan

• if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis, rheumatism and pain.
• if you have suffered from asthma in the past or if some parts of your body, e.g. face, lips, throat or tongue (angioedema) have swollen after taking salicylates or non-steroidal anti-inflammatory drugs (NSAIDs).
• if you currently have or have ever had an ulcer in the stomach or small intestine or any other type of bleeding, such as a stroke
• if you have ever had problems with blood clotting
• if you suffer from severe liver or kidney problems
• if you suffer from severe 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 take doses higher than 100 mg per day
• (see section “Pregnancy and breastfeeding”)
• if you are taking a medicine called methotrexate (e.g. for the treatment of cancer or rheumatoid arthritis) at doses higher than 15 mg per week.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Acetilsalicilico Mylan:

• if you have problems with your kidneys, liver or heart.
• if you have or have ever had ulcers in the stomach or small intestine that can cause bleeding. This type of ulcer are open wounds that develop on the inner lining of the stomach and small intestine.
• if you are taking anticoagulant medicines (used to prevent blood clots).
• if you have uncontrolled high blood pressure.
• if you are asthmatic, have hay fever, growths in the nasal mucosa (nasal polyps) or other chronic respiratory diseases; acetylsalicylic acid can trigger an asthma attack.
• if you are elderly. Elderly people are particularly sensitive to the side effects of NSAIDs, including acetylsalicylic acid.
• if you have ever had gout.
• if you have heavy menstrual periods;
• if you are taking medicines that can alter the process that allows bleeding to stop, i.e. to retain blood in a damaged vessel (hemostasis) (see section 2 “Other medicines and Acido Acetilsalicilico Mylan”).
• if you are taking medicines that can increase the risk of developing ulcers such as oral corticosteroids (often used to relieve inflammation), selective serotonin reuptake inhibitors (usually used as antidepressants) and deferasirox (used to remove excess iron from the body) (see section 2 “Other medicines and Acido Acetilsalicilico Mylan”).
• if you suffer from a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme.

You should immediately contact 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 serious allergic reaction (see section “Possible side effects”).
Tell your doctor if you are about to undergo 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 a deterioration in kidney function.
This medicine is not suitable as an anti-inflammatory, pain reliever or to reduce fever.
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, which can be life-threatening. For this reason, Acido Acetilsalicilico Mylan should not be given to children under 16 years of age, unless advised by a doctor.

Other medicines and Acido Acetilsalicilico Mylan
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. coumarin, warfarin, heparin, clopidogrel, alteplase, ticlopidine, cilostazol and dipyridamole).
• organ transplant rejection (cyclosporine, tacrolimus)
• high blood pressure (e.g. diuretics and ACE inhibitors)
• regulating heartbeat (digoxin)
• manic-depressive illness (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids)
• gout (e.g. probenecid, sulfinpyrazone)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate at doses less than 15 mg per week)
• diabetes (e.g. sulfonylureas, insulin)
• 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 (corticosteroids).

Metamizole (a substance used to reduce pain and fever) can decrease the effect of acetylsalicylic acid on platelet aggregation (blood cells that attach 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 Mylan with alcohol
Drinking alcohol can increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
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.
Pregnancy
If you continue or start treatment with acetylsalicylic acid during pregnancy as directed by your doctor, use acetylsalicylic acid as directed by your doctor and do not take a higher dose than recommended.

Pregnancy – last trimester
Do not take more than 100 mg per day of acetylsalicylic acid if you are in the last 3 months of pregnancy as it can harm the baby or cause complications during childbirth. It can cause problems with the baby's kidneys and heart. It can affect your and the baby's tendency to bleed and delay or prolong labor.
If you are taking acetylsalicylic acid at low doses (up to 100 mg per day, inclusive), strict obstetric monitoring as recommended by your doctor is necessary.

Pregnancy – first and second trimester
You should not take acetylsalicylic acid during the first 6 months of pregnancy unless strictly 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. If taken for more than a few days from the twentieth week onwards, acetylsalicylic acid can cause kidney problems in the baby which can lead to a reduction in the levels of amniotic fluid surrounding the baby (oligohydramnios) or a narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment 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 using machines
Acido Acetilsalicilico Mylan does not affect the ability to drive and use machines.

Acido Acetilsalicilico Mylan contains lactose
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Acido Acetilsalicilico Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. 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 (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 taken at doses higher than unless your doctor advises you to and the
dose should not exceed 100 mg per day.
Elderly
As in adults. Acido Acetilsalicilico Mylan should be used with caution in elderly patients who
are more likely to develop 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 the age of 16 years, unless
prescribed by a doctor (see section “Warnings and precautions”).
Route 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 they should not be crushed, broken or chewed.

If you take more Acido Acetilsalicilico Mylan than you should
If you (or anyone else) accidentally take too many tablets, you should immediately contact your
doctor or contact the nearest emergency room. Show the doctor what is left of the medicine or
the empty package.
Symptoms of moderate 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 which can cause
dehydration, (you may feel restless, suffer from seizures (epilepsy), hallucinations, low blood sugar), coma and shock.

If you forget to take Acido Acetilsalicilico Mylan
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 the missed tablet.

If you stop taking Acido Acetilsalicilico Mylan
Talk to your doctor before stopping taking this medicine.
If you have any further questions on 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 Mylan and tell your doctor immediately:
Rare adverse effects (may affect up to 1 in 1000 people)

• Serious allergic reactions which may present with the following symptoms: swelling of the face, tongue, larynx, abdomen or arms and legs, itchy rash, shortness of breath, vomiting, dizziness and low blood pressure.
• Skin redness with blisters or peeling and which may be associated with high fever and joint pain. This may be erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome.
• Cerebral haemorrhage (acute bleeding inside the skull or brain). Symptoms may include sudden severe headache and stroke-like symptoms - such as difficulty speaking and weakness of one side of the body, feeling or being unwell, altered vision, convulsions or loss of consciousness.

Frequency not known (cannot be estimated from the available data)

• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.
• Acute kidney failure (rapid reduction in kidney function). Symptoms may include feeling or being unwell, dehydration, confusion, high blood pressure, stomach pain, mild back pain and fluid build-up in the body.

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 from the stomach or intestines.
• Changes in blood cell counts.
• Bronchospasm (contraction of the muscles lining the airways (bronchi) in the lungs: feeling of chest tightness with difficulty breathing).
• Asthma attack.
• Inflammation of blood vessels.
• Bruising with purplish spots (skin haemorrhage).
• Erythema nodosum (swelling of fat under the skin causing red plaques and nodules).
• Reye’s syndrome (a very rare disease in children that affects the brain and liver (see section 2 “Children and adolescents”).
• Very heavy or prolonged menstrual periods.

Side effects with unknown frequency (frequency cannot be established on the basis of the available data)

• Tinnitus (ringing in the ears) or impaired hearing.
• Headache.
• Dizziness (a sensation of spinning or lightheadedness).
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time such as nosebleeds and bleeding gums
• Impaired kidney function
• Impaired liver function
• Increased liver enzymes in blood tests
• High levels 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. 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 Mylan

Keep this medicine out of the sight and reach of children.
Store at a temperature below 30 °C.
Do not use this medicine after the expiry date which is stated on the carton or blister after “Exp.”.
The expiry date refers to the last day of the month.
Do not dispose of any medicine in waste water 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 Mylan contains

• The active ingredient is acetylsalicylic acid. Each tablet contains 100 mg of acetylsalicylic acid.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch, talc, triacetin and methacrylic acid - ethyl acrylate copolymer (1:1).

Description of the appearance of Acido Acetilsalicilico Mylan and contents of the pack
Acido Acetilsalicilico Mylan are gastro-resistant tablets, round, white, biconvex, coated with
diameter of approximately 8.1 and thickness of approximately 3.5 mm.
Each pack contains 30 tablets in blisters.

Marketing authorisation holder and manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano

Manufacturer
G.L. Pharma GmbH
Schloßplatz 1
Lannach, A-8502
Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
France Acide acétylsalicylique Viatris 100 mg, comprimé gastro-résistant
Italy Acido acetilsalicilico Mylan 100 mg gastro-resistant tablets
Portugal Ácido Acetilsalicílico Mylan
Spain Ácido Acetilsalisílico Viatris 100 mg comprimidos gastrorresistentes