Acetylsalicylic acid Kern Pharma 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Acetylsalicylic Acid Kern Pharma 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet:

1. What Acetylsalicylic Acid Kern Pharma is and what it is 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. How to store Acetylsalicylic Acid Kern Pharma
6. Contents of the pack and other 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 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 Kern Pharma 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 Kern Pharma 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 Kern Pharma

Do not take Acetylsalicylic Acid Kern Pharma

• 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 commonly used for arthritis, rheumatism, and pain.
• if you have ever had 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 a 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 higher than 100 mg per day (see section “Pregnancy and breastfeeding”).
• if you are taking a medicine called methotrexate (e.g. for treating cancer or rheumatoid arthritis) at doses higher 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 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 should 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 side 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 condition affecting the brain and liver and can be life-threatening. For this reason, Acetylsalicylic Acid Kern Pharma must not be given to children under 16 years of age, unless directed by a doctor.

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 Kern Pharma 100 mg.

Taking Acetylsalicylic Acid Kern Pharma with other medicines

Tell 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 organ transplant rejection (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, steroids, or metamizole)

• 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 used 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 to form a clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid as a cardioprotective agent.

Taking Acetylsalicylic Acid Kern Pharma with food and drink

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

Women who are breastfeeding should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

Acetylsalicylic Acid Kern Pharma is not expected to affect your ability to drive or use machinery.

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

3. How to take Acetylsalicylic Acid Kern Pharma

Follow exactly the instructions for use of this medicine as given 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 given to children and adolescents under 16 years of age, unless prescribed by a doctor (see section “Take special care with Acetylsalicylic Acid Kern Pharma”).

Method of administration

Oral use.

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

Show the medication 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 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 adverse effects

Like all medicines, Acetylsalicylic Acid Kern Pharma may produce adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse 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 (serious allergic reaction).
• Skin redness with blisters 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 occur in 1 to 10 out of 100 patients):

• Indigestion.
• Increased tendency to bleed.

Uncommon adverse effects (may occur in 1 to 10 out of 1,000 patients):

• Urticaria.
• Runny nose.
• Difficulty breathing.

Rare adverse effects (may occur in 1 to 10 out of 10,000 patients):

• Severe 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.
• Bruising with purple spots (cutaneous bleeding).
• Severe skin reactions such as rash known as erythema multiforme, and forms which may be life-threatening, including 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 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.

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

5. Storage of Acetylsalicylic Acid Kern Pharma

Keep this medicine out of sight and reach of children.

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 containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

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

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Kern Pharma

• 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 Kern Pharma 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 available in packs of 30 or 60 tablets in PVC-Al/PVC-PVDC blisters.

Only certain 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

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

Spain - Ácido Acetilsalicílico Kern Pharma 100 mg gastro-resistant tablets EFG

Portugal - Ácido Acetilsalicílico Pharmakern 100 mg gastro-resistant tablets

Date of the most recent review of this leaflet: February 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/