Acetylsalicylic acid TARBIS 100 mg GASTRO-RESISTANT TABLETS

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

Do not take Acetylsalicylic Acid Tarbis:

• if you are allergic (hypersensitive) to acetylsalicylic acid or any of the other components of this medication (listed in section 6).
• if you are allergic to other salicylates or non-steroidal anti-inflammatory medications (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 had a stomach or small intestine ulcer or any other type of bleeding, such as a stroke
• if you have 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 medication 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 Tarbis, inform your doctor:

• if you have kidney, liver, or heart problems
• if you have or have 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 induce an asthma attack
• if you have 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 a tooth extraction) as acetylsalicylic acid is an anticoagulant, and there may be an increased 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 Tarbis 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 using acetylsalicylic acid at the same time may cause kidney function to deteriorate.

This medication 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 Tarbis 100 mg.

Taking Acetylsalicylic Acid Tarbis with other medications

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

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

• prevent blood clot formation (e.g. warfarin, heparin, clopidogrel)
• prevent organ transplant rejection (cyclosporine, 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 like 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) like sertraline or paroxetine)
• are used as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medications 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 Tarbis 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnant women should not take acetylsalicylic acid during pregnancy unless their doctor prescribes it. You should not take Acetylsalicylic Acid Tarbis if you are in the last 3 months of pregnancy, unless your doctor prescribes it, and in that case, the daily dose should not exceed 100 mg (see section "Do not take Acetylsalicylic Acid Tarbis"). Normal or high doses of this medication 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 prescribes it.

Driving and using machines

Acetylsalicylic Acid Tarbis should not affect your ability to drive and use machines.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Acetylsalicylic Acid Tarbis

Follow the administration instructions of this medication exactly 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 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 given to children and adolescents under 16 years of age, unless prescribed by a doctor (see section "Be careful with Acetylsalicylic Acid Tarbis").

Method of administration

Oral.

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 Tarbis 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, phone 91 562 04 20, indicating the medication and the amount taken.

Show your doctor the medication 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 rapid breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, low blood sugar, coma, and shock.

If you forget to take Acetylsalicylic Acid Tarbis

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 other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Acetylsalicylic Acid Tarbis 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.

Frequent side effects (may affect up to 1 in 10 patients):

• Indigestion.
• Increased tendency to bleed.

Uncommon side effects (may affect up to 1 in 100 patients):

• Hives.
• Runny nose.
• Difficulty breathing.

Rare side effects (may affect up to 1 in 1,000 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 a rash known as erythema multiforme, and life-threatening forms, 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 small intestine and perforation.
• Prolonged bleeding time.
• Disorder of kidney function.
• Disorder of liver function.
• High levels of uric acid in the blood.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es

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

5. Storage of Acetylsalicylic Acid Tarbis

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

Store below 25°C. Do not refrigerate. Keep in the original packaging.

6. Package contents and additional information

Composition of Acetylsalicylic Acid Tarbis

• The active ingredient is acetylsalicylic acid
• The other components are: powdered cellulose, pregelatinized cornstarch 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 Tarbis 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 in a delayed manner in the duodenum. They are available in packages of 30, 100, and 500 tablets in PVC-Al blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

Netherlands

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate

Paola, PLA3000

Malta

Date of the last revision of this leaflet: February 2020

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