ACETYLSALICYLIC ACID KERN PHARMA 100 MG GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Acetylsalicylic Acid Kern Pharma 100 mg Gastro-Resistant Tablets EFG

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Acetylsalicylic Acid Kern Pharma and what is it used for
2. What you need to know before taking Acetylsalicylic Acid Kern Pharma
3. How to take Acetylsalicylic Acid Kern Pharma
4. Possible side effects

5 Storage of Acetylsalicylic Acid Kern Pharma

1. Contents of the pack and further information

1. What is Acetylsalicylic Acid Kern Pharma 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 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.

Acetylsalicylic Acid Kern Pharma is taken to reduce the risk of thrombus formation and thus prevent:

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

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

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

2. What you need to know before taking Acetylsalicylic Acid Kern Pharma

Do not take Acetylsalicylic Acid Kern Pharma

• 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 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 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 “Do not take Acetylsalicylic Acid Kern Pharma”)
• if you are taking a medicine called methotrexate (e.g. to treat cancer or rheumatoid arthritis) in doses greater than 15 mg per week.

Warnings and precautions

Before starting treatment with Acetylsalicylic Acid Kern Pharma, 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 scheduled 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 administered 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 Kern Pharma 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 the use of 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 Kern Pharma 100 mg.

Taking Acetylsalicylic Acid Kern Pharma with other medicines

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

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

• prevent blood clots (e.g. warfarin, heparin, clopidogrel)
• prevent organ rejection after transplantation (cyclosporin, tacrolimus)
• treat high blood pressure (e.g. diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• treat manic-depressive disorder (lithium)
• relieve pain and inflammation (e.g. NSAIDs such as ibuprofen, steroids or metamizole)
• 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 the adrenal or pituitary glands have been destroyed or removed, or medicines to treat inflammation, including rheumatic and intestinal diseases (corticosteroids)

If administered 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.

Taking Acetylsalicylic Acid Kern Pharma with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using 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 Kern Pharma 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 Kern Pharma”). Normal or high doses of this medicine during the last phase of pregnancy may 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 Kern Pharma should not affect your ability to drive and use machines.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Acetylsalicylic Acid Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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.

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 administered 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 Kern Pharma 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 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 may 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 Kern Pharma

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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Acetylsalicylic Acid Kern Pharma can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Acetylsalicylic Acid Kern Pharma 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 occur in 1 to 10 of every 100 patients):

• Indigestion.
• Increased tendency to bleed.

Uncommon side effects (may occur in 1 to 10 of every 1,000 patients):

• Hives.
• Runny nose.
• Difficulty breathing.

Rare side effects (may occur in 1 to 10 of every 10,000 patients):

• 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.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Acetylsalicylic Acid Kern Pharma

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

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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

6. Contents of the pack and further information

Composition of Acetylsalicylic Acid Kern Pharma

• The active substance 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 contents of the pack

Acetylsalicylic Acid Kern Pharma 100 mg tablets are round, biconvex and white. They are coated with a gastro-resistant coating that makes the acetylsalicylic acid not released immediately in the stomach, but delayed in the duodenum. They are available in packs of 30 or 60 tablets in PVC-Al/PVC-PVDC blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

TOLL MANUFACTURING SERVICES S.L.

c/ Aragoneses 2-

28108 – Alcobendas - Madrid

Spain

or

FARMALIDER S.A.

c/ Aragoneses 15-

28108 – Alcobendas – Madrid

Spain

or

Laboratorios Medicamentos Internacionales, S.A.

c/ Solana, 26,

28850 Torrejón de Ardoz – Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain - Acetylsalicylic Acid Kern Pharma 100 mg gastro-resistant tablets EFG

Portugal - Acetylsalicylic Acid Phaseoxer 100 mg gastro-resistant tablets

Date of last revision of this package leaflet: February 2020.

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