Prospecto:Information for the Patient

Acid Acetilsalicilic Tarbis 100 mg gastro-resistant tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must 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 do not appear in this prospect. See section 4.

1. What isAcid Acetilsalicilic Tarbisand for what it is used

2. What you need to know before starting to takeAcid Acetilsalicilic Tarbis

3. How to takeAcid Acetilsalicilic Tarbis

4. Possible adverse effects

5. Storage ofAcid Acetilsalicilic Tarbis

6. Contents of the package and additional information

This medication contains acetylsalicylic acid, which at low doses belongs to a group of medications called antiplatelet agents. Platelets are small blood cells that produce blood coagulation and are involved in thrombosis. When a blood clot originates 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 cerebral infarction.

Tarbis Acetylsalicylic Acid is taken to reduce the risk of blood clot formation and consequently prevent:

- heart attacks

- cerebral infarctions

- cardiovascular problems in patients who have stable or unstable angina (a type of chest pain).

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

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

Do not take Tarbis Acetilsalicílico:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medication (listed in section 6).
• if you are allergic to other salicylates or nonsteroidal 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 an ulcer in your stomach or small intestine 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; do not use doses greater than 100 mg per day (see section “Pregnancy and breastfeeding”)
• if you are taking a medication called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses greater than 15 mg per week

Warnings and precautions

Before starting treatment with Tarbis Acetilsalicílico, inform your doctor:

• if you have kidney, liver or heart problems
• if you have or have ever had any problems with your stomach or small intestine
• 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 bleeding

You must consult a doctor immediately if your symptoms worsen or if you experience severe or unexpected side effects, e.g. abnormal bleeding symptoms, severe skin reactions or any other sign of severe allergy (see section “Possible side effects”).

Inform your doctor if you are planning a surgical procedure (including minor procedures, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, which may increase the risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a rare disease that affects the brain and liver and can be life-threatening. For this reason, Tarbis Acetilsalicílico should not be administered to children under 16 years of age, unless a doctor indicates otherwise.

You must 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 deterioration of renal function.

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

If you are in any of the above cases, or if you are unsure, consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take Tarbis Acetilsalicílico 100 mg.

Taking Tarbis Acetilsalicílico with other medications

Inform your doctor or pharmacist that you are taking, have taken recently 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 for:

• preventing blood clot formation (e.g. warfarin, heparin, clopidogrel)
• preventing organ transplant rejection (ciclosporin, tacrolimus)
• treating high blood pressure (e.g. diuretics and ACE inhibitors)
• regulating heart rhythm (digoxin)
• manic-depressive disorder (lithium)
• pain and inflammation (e.g. NSAIDs such as ibuprofen, steroids or metamizol)
• gout (e.g. probenecid)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; in 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 medications to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)
• if administered together, metamizol (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump 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 Tarbis Acetilsalicílico 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnant women should not take acetylsalicylic acid during pregnancy unless a doctor indicates otherwise. Do not take Tarbis Acetilsalicílico if you are in the last 3 months of pregnancy, unless your doctor indicates and in that case the daily dose should not exceed 100 mg (see section “Do not take Tarbis Acetilsalicílico”). Normal or high doses of this medication during the last phase of pregnancy may cause serious complications in the mother or baby.

Women who are breastfeeding should not take acetylsalicylic acid unless a doctor indicates otherwise.

Driving and operating machinery

Tarbis Acetilsalicílico should not affect your ability to drive and operate machinery.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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.

Older patients

The same doses as adults. In general, aspirin should be used with caution in older patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Children

Aspirin should not be administered to children and adolescents under 16 years of age, unless prescribed by a doctor (see section “Be especially careful with Aspirin Tarbis”).

Administration form

Oral administration.

The tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water). The tablets have a gastric-resistant coating that prevents irritating effects on the intestine, and therefore should not be crushed, broken, or chewed.

If you take more Aspirin Tarbis than you should

If you (or someone else) accidentally take too many tablets, you should immediately inform your doctor, contact the nearest emergency service or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Show your doctor the medication or the empty packaging.

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

If you forgot to take Aspirin Tarbis

If you forget to take a dose, wait until the time to take the next dose and continue treatment as usual.

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Acetilsalicilic Acid Tarbis and contact your doctor immediately:

- Sudden difficulty breathing, swelling of your lips, face, or body, hives, fainting, or difficulty swallowing (severe allergic reaction).

- Skin redness 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 affect up to 1 in 10 patients):

- Indigestion.

- Increased tendency to bleed.

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

- Urticaria.

- Nasal discharge.

- Difficulty breathing.

Rare side effects (may affect up to 1 in 1,000 patients):

- Severe bleeding in the stomach or intestines, cerebral hemorrhage; altered number of blood cells.

- Nausea and vomiting.

- Coughing up mucus, asthma attack.

- Inflammation of blood vessels.

- Bruises with purple spots (cutaneous bleeding).

- Severe skin reactions such as hives known as erythema multiforme, and may present in forms that can put your life at risk, Stevens-Johnson syndrome, and Lyell syndrome.

- Hypersensitivity reactions, such as swelling of, for example, lips, face, or body, or shock.

- Abnormally heavy or prolonged menstrual bleeding.

Side effects of unknown frequency:

- Ringing in your ears (tinnitus) or reduced hearing ability.

- 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.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughSpanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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

Composition of Acetilsalicylic Acid Tarbis

• The active ingredient is acetilsalicylic acid
• The other components are: powdered cellulose, pregelatinized cornstarch without gluten, Acryl-EZE Clear (93F19255) (copolymer of C-type metacrylic acid, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate, and laurilsulfate of sodium).

Appearance of the product and content of the packaging

The Acetilsalicylic Acid Tarbis 100 mg tablets are round, biconvex, and white in color. They are coated with a gastroresistant coating that prevents the immediate release of acetilsalicylic acid in the stomach, but rather a delayed release in the duodenum. They are presented in PVC-Al blisters of 30, 100, and 500 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Responsible for manufacturing

TOLL MANUFACTURING SERVICES S.L.

c/ Aragoneses 2-

28108 – Alcobendas - Madrid

or

FARMALIDER S.A.

c/ Aragoneses 15-

28108 – Alcobendas – Madrid

or

LABORATORIOS MEDICAMENTOS INTERNACIONALES S.A

C/ Solana 26

28850 – Torrejón de Ardoz - Madrid

Last review date of this leaflet: February 2020

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