Acetylsalicylic Acid ALTER 100 mg Gastro-Resistant Tablets

2. What you need to know before taking Acetylsalicylic Acid Alter

Do not take Acetylsalicylic Acid Alter:

• if you are allergic (hypersensitive) 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 medicines (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 a stomach or intestinal ulcer or any other type of bleeding, such as a stroke
• 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; you should not take more than 100 mg per day (see section "Pregnancy and breastfeeding")
• if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses greater than 15 mg per week

Warnings and precautions

Before starting treatment with Acetylsalicylic Acid Alter, inform your doctor:

• if you have kidney, liver or heart problems
• if you have or have ever had stomach or intestinal problems
• 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 periods

You should consult a doctor immediately 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 severe allergy (see section "Possible side effects").

Inform your doctor if you are planning to have surgery (even minor surgery, such as tooth extraction) as acetylsalicylic acid is an anticoagulant and may increase the risk of bleeding.

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

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 cause kidney function to deteriorate.

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

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist.

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

Taking Acetylsalicylic Acid Alter with other medicines

Inform your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.

If taken together, metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together 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 medicines used to:

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

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

Taking Acetylsalicylic Acid 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless their doctor advises them to do so. You should not take Acetylsalicylic Acid Alter if you are in the last 3 months of pregnancy, unless your doctor advises you to do so and in that case the daily dose should not exceed 100 mg (see section "Do not take Acetylsalicylic Acid Alter"). Normal or high doses of this medicine during the last phase of pregnancy can cause serious complications in the mother or baby.

Breastfeeding women should not take acetylsalicylic acid unless their doctor advises them to do so.

Driving and using machines

Acetylsalicylic Acid Alter is unlikely to affect your ability to drive or use machines.

3. How to take Acetylsalicylic Acid Alter

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 heart surgery:

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

Elderly patients

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

Children

Acetylsalicylic acid should not be given to children and adolescents under 16 years of age, unless prescribed by a doctor (see section "Special warnings and precautions for use").

Method of administration

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 should not be crushed, broken or chewed.

If you take more Acetylsalicylic Acid Alter than you should

If you (or someone else) have taken too many tablets, contact your doctor immediately, contact the nearest emergency department or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Show your doctor 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 large overdose can lead to faster than normal breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, low blood sugar, coma and shock.

If you forget to take Acetylsalicylic Acid Alter

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

Do not take a double dose to make up for forgotten doses.

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 Acetylsalicylic Acid Alter and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face or body, rash, 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.

Common side effects (may affect up to 1 in 10 people):

• 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 in the stomach or intestines, cerebral hemorrhage; altered blood cell count.
• Nausea and vomiting.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruises with purple spots (cutaneous bleeding).
• Severe skin reactions such as rash known as erythema multiforme, and can be life-threatening, Stevens-Johnson syndrome and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, e.g. lips, face or body, or shock.
• Abnormally heavy or prolonged menstrual periods.

Side effects of unknown frequency:

• Ringing in your ears (tinnitus) or reduced hearing.
• Headache.
• Dizziness.
• Ulcers in the stomach or intestine and perforation.
• Prolonged bleeding time.
• Disorder of kidney function.
• Disorder of liver function.
• High levels of uric acid in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid Alter

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

Do not store above 30°C. Do not refrigerate. Keep in the original package.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and further information

Composition of Acetylsalicylic Acid Alter

• The active ingredient is acetylsalicylic acid
• The other ingredients are: powdered cellulose, pregelatinized corn starch without gluten, Acryl-EZE Clear (93F19255) (methacrylic acid copolymer type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate and sodium lauryl sulfate).

Appearance of the product and package contents

Acetylsalicylic Acid Alter 100 mg tablets are round, biconvex and white. They are coated with a gastro-resistant coating that makes acetylsalicylic acid not released immediately in the stomach, but delayed in the duodenum. They are available in packs of 30 tablets in PVC-Al blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid, Spain

Manufacturer

TOLL MANUFACTURING SERVICES S.L.

c/ Aragoneses 2-

28108 – Alcobendas – Madrid, Spain

or

FARMALIDER S.A.

c/ Aragoneses 2

28108 – Alcobendas – Madrid, Spain

or

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana 26

28850 Torrejón de Ardoz, Madrid

Date of last revision of this package leaflet: June 2018

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/