Package Insert: Information for the Patient

Acid Acetilsalicilic RATIO 100 mg Gastric Resistant Tablets EFG

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others who may 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 are not listed in this package insert. See section 4.

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 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.

Aspirin RATIO is taken to reduce the risk of blood clots forming and consequently prevent:

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

Aspirin RATIO is also used to prevent blood clots from forming 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 RATIO Acetylsalicylic Acid:

• 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 to 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 cerebral hemorrhage
• 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. to treat cancer or rheumatoid arthritis) in doses greater than 15 mg per week

Warnings and precautions

Before starting treatment with RATIO Acetylsalicylic Acid, inform your doctor:

• if you have problems with your kidneys, liver or heart
• 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 induce 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 intervention (including minor procedures, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, there may be an increased 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, RATIO Acetylsalicylic Acid should not be administered to children under 16 years of age, unless a doctor indicates it.

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 RATIO Acetylsalicylic Acid 100 mg.

Taking RATIO Acetylsalicylic Acid 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 to:

• prevent blood clotting (e.g. warfarin, heparin, clopidogrel)
• prevent organ transplant rejection (ciclosporin, tacrolimus)
• treating high blood pressure (e.g. diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• manic-depressive 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; 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 with metamizol, it may reduce the effect of acetylsalicylic acid to decrease platelet aggregation (antiplaquetary) and therefore should be used with caution in patients taking it to protect the heart (cardioprotector).

Taking RATIO Acetylsalicylic Acid 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, or 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 it. Do not take RATIO Acetylsalicylic Acid if you are in the last 3 months of pregnancy, unless your doctor indicates it and in that case the daily dose should not exceed 100 mg (see section “Do not take RATIO Acetylsalicylic Acid”). 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 it.

Driving and operating machinery

RATIO Acetylsalicylic Acid should not affect your ability to drive and operate machinery.

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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 RATIO”).

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 RATIO 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 may lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar levels, coma, and shock.

If you forgot to take Aspirin RATIO

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 can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Acetilsalicílico RATIO and contact your doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face, or body, hives, 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.

Less frequent 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):

• Intense 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.
• 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:

• Tinnitus or reduced hearing capacity.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• Liver 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 prospectus. You can also report them directly throughSistema Español de Farmacovigilancia de Medicamentos de Uso Humano, 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 usethis medication after the expiration date that appearson the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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

Composition of Acetilsalicilic Acid RATIO

• The active ingredient is acetilsalicilic 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 contents of the packaging

The Acetilsalicilic Acid RATIO 100 mg tablets are round, biconvex, and white in color. They are coated with a gastroresistant coating that prevents the acetilsalicilic acid from being released immediately in the stomach, but rather in a delayed manner in the duodenum. They are presented in blister packs of 30 tablets made of PVC-Al/PVC-PVDC.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st Floor, Alcobendas

28108– Madrid

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, Torrejón de Ardoz 28850 (Madrid)

Spain

Last review date of this leaflet: July 2019

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