Package Insert:Patient Information

Acid Acetilsalicilic Alter 100 mg Gastric Resistant Tablets EFG

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication contains acetylsalicylic acid, which at low doses belongs to a group of medications called antiplatelet agents. Platelets are small blood cells that produce blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. When this occurs in the heart, it can cause a heart attack or angina; in the brain, it can cause a stroke.

Aspirin Alter is taken to reduce the risk of blood clot formation and consequently prevent:

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

Aspirin Alter is also used to prevent blood clot formation after certain types of cardiac surgery to widen or unblock blood vessels.

This medication is not recommended for emergency cases. It can only be used as a preventive treatment.

Do not take Acetilsalicilico Alter:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medication (listed in section 6).
• if you are allergic to other salicylates or to nonsteroidal anti-inflammatory drugs (NSAIDs).

• NSAIDs are often used for arthritis or rheumatism and pain
• if you have had an asthma attack or swelling of some parts of the body, e.g. face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs
• if you currently have or have ever had an ulcer in your stomach or small intestine or any other type of bleeding such as a cerebral hemorrhage
• if you have ever had a problem with your blood not clotting properly
• if you have severe liver or kidney problems
• if you are in the last 3 months of pregnancy; do not use doses greater than 100 mg per day (see section “Pregnancy and breastfeeding”)
• if you are taking a medication called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses greater than 15 mg per week

Warnings and precautions

Before starting treatment with Acetilsalicilico Alter, inform your doctor:

• if you have kidney, liver, or heart problems
• if you have or have ever had any problems with your stomach or small intestine
• if you have high blood pressure
• if you are asthmatic, have hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack
• if you have ever had gout
• if you have heavy menstrual bleeding

Consult a doctor immediately if your symptoms worsen or if you experience severe or unexpected side effects, e.g. abnormal bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see section “Possible side effects”).

Inform your doctor if you are planning a surgical procedure (including minor procedures, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, there may be an increased risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a rare disease that affects the brain and liver and can be life-threatening. For this reason, Acetilsalicilico Alter should not be administered to children under 16 years of age, unless a doctor indicates otherwise.

Be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as the use of acetylsalicylic acid at the same time may cause deterioration of renal function.

This medication is not suitable for relieving pain or reducing fever.

If you are in any of the above cases, or if you are unsure, consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take Acetilsalicilico Alter 100 mg.

Taking Acetilsalicilico Alter with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

If taken together, metamizol (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as other medications used to:

• prevent blood clot formation (e.g. warfarin, heparin, clopidogrel)
• prevent organ transplant rejection (ciclosporin, tacrolimus)
• control high blood pressure (e.g. diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• manic-depressive disorder (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids)
• gout (e.g. probenecid)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week)
• diabetes (e.g. glibenclamide)
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or

• paroxetine)
• used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or medications to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

Taking Acetilsalicilico Alter with food and drinks

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnant women should not take acetylsalicylic acid during pregnancy unless a doctor indicates otherwise. Do not take Acetilsalicilico Alter if you are in the last 3 months of pregnancy, unless your doctor indicates and in that case the daily dose should not exceed 100 mg (see section “Do not take Acetilsalicilico Alter”). Normal or high doses of this medication during the last phase of pregnancy may cause serious complications in the mother or baby.

Women who are breastfeeding should not take acetylsalicylic acid unless a doctor indicates otherwise.

Driving and operating machinery

Acetilsalicilico Alter should not affect your ability to drive and operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

Prevention of heart attacks:

• The recommended dose is 75-160 mg once a day.

Prevention of strokes:

• The recommended dose is 75-325 mg once a day.

Prevention of cardiovascular problems in patients with stable or unstable angina (a type of chest pain):

• The recommended dose is 75-160 mg once a day.

Prevention of thrombus formation after certain types of cardiac surgery:

• The recommended dose is 75-160 mg once a day.

Older patients

The same doses as adults. In general, acetylsalicylic acid should be used with caution in older patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Children

Acetylsalicylic acid should not be administered to children and adolescents under 16 years of age, unless prescribed by a doctor (see section “Be especially careful with Acetylsalicylic Acid Alter”).

Administration form

Oral.

The tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water). The tablets have a gastric-resistant coating that prevents irritating effects on the intestine, and therefore should not be crushed, broken, or chewed.

If you take more Acetylsalicylic Acid Alter than you should

If you (or someone else) accidentally take too many tablets, you should inform your doctor immediately, contact the nearest emergency service or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Show your doctor the medication or the empty packaging.

The symptoms of overdose may include ringing in the ears, hearing problems, headaches, dizziness, confusion, nausea, vomiting, and abdominal pain. A large overdose can lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar levels, coma, and shock.

If you forgot to take Acetylsalicylic Acid Alter

If you forget to take a dose, wait until the time to take the next dose and continue treatment as usual.

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Acetilsalicílico Alter and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face, or body, hives, fainting, or difficulty swallowing (severe allergic reaction).
• Redness 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 syndrome.
• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

Frequent side effects (may affect up to 1 in 10 patients):

• Indigestion.
• Increased tendency to bleed.

Less common side effects (may affect up to 1 in 100 patients):

• Urticaria.
• Nasal discharge.
• Difficulty breathing.

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

• Intense bleeding in the stomach or intestines, cerebral hemorrhage; altered number of blood cells.
• Nausea and vomiting.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruises with purple patches (cutaneous bleeding).
• Severe skin reactions such as hives known as erythema multiforme, and may present in forms that can put your life at risk, Stevens-Johnson syndrome, and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, for example, lips, face, or body, or shock.
• Abnormally heavy or prolonged menstrual bleeding.

Side effects of unknown frequency:

• Tinnitus or reduced hearing capacity.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• Hepatic function disorder.
• High levels of uric acid in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 30°C. Do not refrigerate. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Acetilsalicylic Acid Alter

• The active ingredient is acetilsalicylic acid
• The other components are: powdered cellulose, pregelatinized cornstarch without gluten, Acryl-EZE Clear (93F19255) (polycarboxylate type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate, and laurilsulfate of sodium).

Appearance of the product and content of the packaging

The Acetilsalicylic Acid Alter 100 mg tablets are round, biconvex, and white in color. They are coated with a gastroresistant coating that prevents the immediate release of acetilsalicylic acid in the stomach, but rather a delayed release in the duodenum. They are presented in packs of 30 tablets in PVC-Al blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Alter, S.A. Laboratories

Mateo Inurria 30 Street

28036 Madrid, Spain

Responsible for manufacturing

TOLL MANUFACTURING SERVICES S.L.

Aragoneses 2 Street

28108 – Alcobendas – Madrid, Spain

or

FARMALIDER S.A.

Aragoneses 2 Street

28108 – Alcobendas – Madrid, Spain

or

Laboratorios Medicamentos Internacionales, S.A.

Solana 26 Street

28850 Torrejón de Ardoz, Madrid

Last review date of this leaflet: June 2018

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/