Acetylsalicylic acid Alter 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid Alter 100 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is Acetylsalicylic Acid Alter and what is it used for?

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

Acetylsalicylic Acid Alter is taken to reduce the risk of thrombus formation and thereby prevent:

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

Acetylsalicylic Acid Alter is also used to prevent thrombus formation after certain types of cardiac surgery intended to widen or unblock blood vessels.

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

2. What you need to know before starting to take Acetylsalicylic Acid Alter

Do not take Acetylsalicylic Acid Alter:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).

• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs).

• NSAIDs are commonly used for arthritis, rheumatism, or pain

• if you have previously experienced an asthma attack or swelling of certain body parts, e.g., face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs

• if you currently have or have ever had a stomach or small intestine ulcer, or any other type of bleeding such as cerebral hemorrhage

• if you have ever had problems with blood clotting

• if you have severe liver or kidney problems

• if you are in the last 3 months of pregnancy; you must not use doses exceeding 100 mg per day (see section “Pregnancy and breastfeeding”)

• if you are taking a medicine called methotrexate (e.g., to treat cancer or rheumatoid arthritis) at doses exceeding 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 small intestine problems
• if you have high blood pressure
• if you suffer from asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger 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 a serious allergic reaction (see section “Possible side effects”).

Inform your doctor if you have planned any surgical procedure (including minor procedures such as dental extraction), as acetylsalicylic acid is an anticoagulant and may increase the risk of bleeding.

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

You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as using acetylsalicylic acid at the same time may lead to impaired kidney function.

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

If you are in any of the above situations, or if you are unsure, 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 if you are taking, have recently taken, or might need to take any other medicines.

When used concomitantly, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (the process by which blood cells clump together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid as a cardioprotective agent.

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

• preventing blood clots (e.g., warfarin, heparin, clopidogrel)
• preventing rejection of a transplanted organ (cyclosporine, tacrolimus)
• treating 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)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; at 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 medicines used 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor. You must not take Acetylsalicylic Acid Alter during the last 3 months of pregnancy unless directed by your doctor, and in such cases the daily dose must not exceed 100 mg (see section “Do not take Acetylsalicylic Acid Alter”). Normal or high doses of this medicine during the final stage of pregnancy may cause serious complications in the mother or baby.

Breastfeeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

Acetylsalicylic Acid Alter is not expected to affect your ability to drive or use machines.

3. How to take Acetylsalicylic Acid Alter

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

Prevention of heart attacks:

• The recommended dose is 75–160 mg once daily.

Prevention of strokes:

• The recommended dose is 75–325 mg once daily.

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

• The recommended dose is 75–160 mg once daily.

Prevention of blood clot formation after certain types of cardiac surgery:

• The recommended dose is 75–160 mg once daily.

Elderly patients

Dosage is 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 must not be given to children and adolescents under 16 years of age unless prescribed by a doctor (see section "Take special care with Acetylsalicylic Acid Alter").

Method of administration

Oral use.

The tablets must be swallowed whole with sufficient liquid (half a glass of water). The tablets have a gastro-resistant coating that prevents irritating effects in the intestine; therefore, they must 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 must inform your doctor immediately, contact the nearest emergency service, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Show the medicine or empty packaging to your doctor.

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

If you forget to take Acetylsalicylic Acid Alter

If you forget to take a dose, wait until it is time for your 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Sudden difficulty breathing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling, which may be associated with high fever and joint pain. This could 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.

Frequent adverse effects (may affect up to 1 in 10 people):

• Indigestion.
• Increased tendency to bleed.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Urticaria.
• Runny nose.
• Difficulty breathing.

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

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

Adverse effects of unknown frequency:

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Stomach or small intestine ulcers and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• Hepatic function disorder.
• High levels of uric acid in the blood.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Acetylsalicylic Acid Alter

• The active substance is acetylsalicylic acid.
• The other components are: powdered cellulose, pregelatinized gluten-free corn starch, 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 contents of the pack

Acetylsalicylic Acid Alter 100 mg tablets are round, biconvex and white in colour. They are coated with an enteric coating that prevents the immediate release of acetylsalicylic acid in the stomach, allowing delayed release in the duodenum. Packaged in PVC-Al blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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, Spain

Date of the most recent revision of this leaflet: June 2018

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