Acetylsalicylic acid Mylan

Package leaflet: Information for the patient

Acetylsalicylic Acid Mylan 100 mg gastro-resistant tablets

Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Acido Acetilsalicilico Mylan is and what it is 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 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 Mylan is taken to reduce the risk of blood clots forming, and thus to prevent the
following:

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

Acido Acetilsalicilico Mylan is also used to prevent 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 Acetylsalicylic Acid Mylan

Do not take Acetylsalicylic Acid Mylan

• if you are allergic to acetylsalicylic acid or to 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 previously experienced asthma or swelling of certain body parts, e.g. face, lips, throat, or tongue (angioedema), after taking salicylates or non-steroidal anti-inflammatory drugs (NSAIDs).
• if you currently have or have ever had a stomach or small intestine ulcer or any other type of bleeding, such as a stroke.
• if you have ever had blood clotting problems.
• if you suffer from severe liver or kidney problems.
• if you suffer from severe heart problems that may cause shortness of breath and swelling of the ankles.
• if you are in the last 3 months of pregnancy; you must not take doses exceeding 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 exceeding 15 mg per week.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylsalicylic Acid Mylan:

• if you have kidney, liver, or heart problems.
• if you have or have ever had ulcers in the stomach or small intestine that may cause bleeding. These types of ulcers are open sores 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 have asthma, hay fever, nasal polyps (growths on the nasal mucosa), or other chronic respiratory diseases; acetylsalicylic acid may 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 may affect the process that stops bleeding, i.e. the ability to retain blood in a damaged vessel (hemostasis) (see section 2 “Other medicines and Acetylsalicylic Acid Mylan”).
• if you are taking medicines that may increase the risk of developing ulcers, such as oral corticosteroids (often used to reduce inflammation), selective serotonin reuptake inhibitors (SSRIs, usually used as antidepressants), or deferasirox (used to remove excess iron from the body) (see section 2 “Other medicines and Acetylsalicylic Acid Mylan”).
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

You must immediately contact your doctor if your symptoms worsen or if you experience serious or unexpected side effects, e.g. signs of unusual bleeding, severe skin reactions, or any other sign of a severe allergic reaction (see section “Possible side effects”).
Inform your doctor if you are about to undergo surgery (even minor procedures, such as tooth extraction), as acetylsalicylic acid makes the blood thinner and may therefore increase the risk of bleeding.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as taking acetylsalicylic acid at the same time may lead to deterioration of kidney function.
This medicine is not suitable for use as an anti-inflammatory, painkiller, or to reduce fever.
If any of the above conditions apply to you, or if you have any doubts about them, consult your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid, if 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, Acetylsalicylic Acid Mylan must not be given to children under 16 years of age, unless advised by a doctor.

Other medicines and Acetylsalicylic Acid Mylan
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 at the same time as other medicines for:

• thinning the blood/preventing clots (e.g. coumarin, warfarin, heparin, clopidogrel, alteplase, ticlopidine, cilostazol, and dipyridamole).
• preventing organ transplant rejection (cyclosporine, tacrolimus).
• high blood pressure (e.g. diuretics and ACE inhibitors).
• regulating heart rhythm (digoxin).
• bipolar disorder (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 below 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 intestinal inflammation (corticosteroids).

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 simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

Acetylsalicylic Acid Mylan and alcohol
Consumption of alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

Pregnancy – third 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 may harm the baby or cause complications during delivery. It may cause kidney and heart problems in the baby. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond expectations.
If you take low-dose acetylsalicylic acid (up to 100 mg per day, inclusive), strict obstetric monitoring is required as advised by your doctor.

Pregnancy – first and second trimesters
You must not take acetylsalicylic acid during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days from the 20th week onwards, acetylsalicylic acid may cause kidney problems in the baby, which may lead to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or 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
Women who are breastfeeding must not take acetylsalicylic acid unless advised by a doctor.

Driving and using machines
Acetylsalicylic Acid Mylan does not affect the ability to drive or use machinery.

Acetylsalicylic Acid Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Acetylsalicylic Acid Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 clots after certain types of heart surgery:

• The recommended dose is 100 mg once daily.

This medicine should not be taken at higher doses unless your doctor specifically advises you to do so,
and the dose must not exceed 100 mg per day.
Elderly
As in adults. Acetylsalicylic Acid Mylan should be used with caution in elderly patients, who are more
prone to developing adverse events. Treatment should be regularly reassessed.
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 “Warnings and precautions”).
Method of administration
For oral use.
The tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water).
The tablets have a gastro-resistant coating that prevents irritating effects on the intestine and therefore
must not be crushed, split or chewed.
If you take more Acetylsalicylic Acid Mylan than you should
If you (or anyone else) accidentally take too many tablets, contact your doctor or go to the nearest
emergency department immediately. Show the doctor what is left of the medicine or the empty pack.
Symptoms of moderate 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 which may cause dehydration (you may feel restless, suffer
seizures (epilepsy), hallucinations, low blood sugar), coma and shock.
If you forget to take Acetylsalicylic Acid Mylan
If you miss a dose, wait until it is time to take your next dose, then continue as normal.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Acetylsalicylic Acid Mylan
Talk to your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following serious side effects, stop taking
Acetylsalicylic Acid Mylan and contact your doctor immediately:
Rare adverse reactions (may affect up to 1 in 1,000 people)

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

Frequency not known (cannot be estimated from available data)

• Unusual bleeding, such as coughing up blood, blood in vomit or urine, or dark stools.
• Acute renal failure (rapid reduction in kidney function). Symptoms may include feeling unwell, dehydration, confusion, high blood pressure, stomach pain, mild backache and fluid accumulation 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):

• Urticaria.
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding from the stomach or intestine.
• Changes in blood cell count.
• Bronchospasm (contraction of the muscle lining the airways (bronchi) in the lungs: sensation of chest tightness with breathing difficulty).
• Asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous haemorrhage).
• Erythema nodosum (inflammation of fat under the skin causing red plaques and nodules).
• Reye's syndrome (a very rare condition in children affecting the brain and liver (see section 2 “Children and adolescents”)).
• Very heavy or prolonged menstrual periods.

Side effects with frequency not known (frequency cannot be estimated from available data):

• Ringing in the ears (tinnitus) or impaired hearing.
• Headache.
• Dizziness (a sensation of dizziness or spinning of the head).
• Stomach or small intestine ulcers 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 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acetylsalicylic Acid Mylan

Keep this medicine out of the sight and reach of children.
Store below 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 the month.
Do not dispose of medicines 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 Mylan contains

• The active substance is acetylsalicylic acid. Each tablet contains 100 mg of acetylsalicylic acid.
• The other components are: monohydrate lactose, 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 package contents
Acido Acetilsalicilico Mylan are gastro-resistant, round, white, biconvex coated tablets with a diameter of approximately 8.1 mm and a thickness of approximately 3.5 mm.
Each pack contains 30 tablets in blister packs.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

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

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