Acetylsalicylic acid Liderfen 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid Liderfen 100 mg gastro-resistant tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is Acetylsalicylic Acid Liderfen and what is it used for

This medicine contains acetylsalicylic acid, which at low doses belongs to a group of medicines known as 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 Liderfen is taken to reduce the risk of thrombus formation and thus prevent:

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

Acetylsalicylic Acid Liderfen 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 situations. It can only be used as a preventive treatment.

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

Do not take Acetylsalicylic Acid Liderfen:

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

• NSAIDs are frequently used for arthritis or rheumatism and 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 infarction

• 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 higher than 100 mg per day (see section “Pregnancy and lactation”)

• 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 Liderfen, 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 are asthmatic, have 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 must consult a doctor immediately if your symptoms worsen or if you experience serious or unexpected adverse effects, e.g. unusual bleeding symptoms, severe skin reactions, or any other signs of a serious allergic reaction (see section “Possible adverse effects”).

Inform your doctor if you have a surgical procedure planned (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 disease affecting the brain and liver, which can be life-threatening. For this reason, Acetylsalicylic Acid Liderfen must not be given to children under 16 years of age, unless 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 renal 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 Liderfen 100 mg.

Taking Acetylsalicylic Acid Liderfen with other medicines

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

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 adrenal glands or the pituitary gland have been destroyed or removed, or medicines to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)

If administered together, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.

Taking Acetylsalicylic Acid Liderfen with food and drink

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

Pregnancy, lactation 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 Liderfen during the last 3 months of pregnancy unless directed by your doctor, and in such case the daily dose must not exceed 100 mg (see section “Do not take Acetylsalicylic Acid Liderfen”). 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 Liderfen is not expected to affect your ability to drive or operate machinery.

3. How to take Acetylsalicylic Acid Liderfen

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 heart surgery:

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

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 must not be administered to children and adolescents under 16 years of age, unless prescribed by a physician (see section "Take special care with Acetylsalicylic Acid Liderfen").

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 in the intestine; therefore, they must not be crushed, broken, or chewed.

If you take more Acetylsalicylic Acid Liderfen 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Show the medicine or the empty packaging to your doctor.

Symptoms of overdose may include ringing in the ears, hearing disturbances, 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 Liderfen

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 missed 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 Acetylsalicylic Acid Liderfen and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your 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):

• Hives.
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, brain hemorrhage; 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 your ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Stomach or small intestine ulcers and perforation.
• Prolonged bleeding time.
• Kidney function disorder.
• Liver 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 Medicinal Products, Website: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid Liderfen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

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

6. Package contents and additional information

Composition of Acetylsalicylic Acid Liderfen

• The active substance is acetylsalicylic acid.
• The other components 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 medicinal product and contents of the pack

Acetylsalicylic Acid Liderfen 100 mg tablets are round, biconvex and white in colour. They are coated with a gastro-resistant coating that delays the release of acetylsalicylic acid, preventing its immediate release in the stomach and allowing delayed release in the duodenum. The product is supplied in packs of 30 tablets in PVC-Al blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

FARMALIDER S.A.
C/ Aragoneses 15
28108 – Alcobendas – Madrid
Spain

Manufacturer:

TOLL MANUFACTURING SERVICES S.L.
C/ Aragoneses 2
28108 – Alcobendas – Madrid
Spain

or

FARMALIDER S.A.
C/ Aragoneses 15
28108 – Alcobendas – Madrid
Spain

Date of the most recent review of this leaflet: January 2020

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