Acetylsalicylic acid Tarbis 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid Tarbis 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 you must not pass it on 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Acetylsalicylic Acid Tarbis is and what it is used for
2. What you need to know before taking Acetylsalicylic Acid Tarbis
3. How to take Acetylsalicylic Acid Tarbis
4. Possible side effects
5. How to store Acetylsalicylic Acid Tarbis
6. Contents of the pack and other information

1. What is Acetylsalicylic Acid Tarbis 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 Tarbis is taken to reduce the risk of blood clot formation and thus prevent:

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

Acetylsalicylic Acid Tarbis is also used to prevent blood clot 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 Tarbis

Do not take Acetylsalicylic Acid Tarbis:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components 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 or rheumatism and pain

• if you have previously experienced 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 cerebral haemorrhage

• 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 must not use doses exceeding 100 mg per day (see section “Pregnancy and breastfeeding”)

• if you are taking a medicine called methotrexate (e.g. to treat cancer or rheumatoid arthritis) in doses exceeding 15 mg per week

Warnings and precautions

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

• if you have problems with your kidneys, liver or heart
• if you have or have ever had problems with your stomach or small intestine
• if you have high blood pressure
• if you have asthma, 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 must 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 sign of a serious allergic reaction (see section “Possible adverse effects”).

Inform your doctor if you have planned a surgical procedure (even a minor one, such as a 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 may be life-threatening. For this reason, Acetylsalicylic Acid Tarbis must not be given to children under 16 years of age, unless directed 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 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 Tarbis 100 mg.

Taking Acetylsalicylic Acid Tarbis with other medicines

Inform 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 affected if acetylsalicylic acid is taken at the same time as other medicines used for:

• preventing blood clots (e.g. warfarin, heparin, clopidogrel)
• preventing rejection of a transplanted organ (cyclosporine, 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 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 to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids)
• when administered together, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.

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 are planning 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 Tarbis during the last 3 months of pregnancy unless instructed by your doctor, and in such case the daily dose must not exceed 100 mg (see section “Do not take Acetylsalicylic Acid Tarbis”). 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 Tarbis is not expected to affect your ability to drive or use machines.

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

3. How to take Acetylsalicylic Acid Tarbis

Follow exactly the administration instructions for this medicine 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 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 cardiac 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 Tarbis").

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 intestinal irritative effects; therefore, they must 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 must inform your doctor immediately, contact the nearest emergency service, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse 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 (serious allergic reaction).
• Red skin with blisters or peeling, which 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 adverse effects (may affect up to 1 in 10 patients):

• Indigestion.
• Increased tendency to bleed.

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

• Hives.
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, brain hemorrhage; altered blood cell count.
• Nausea and vomiting.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (skin bleeding).
• Serious skin reactions such as rash known as erythema multiforme, and life-threatening forms such as 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.

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.
• Kidney function disorder.
• Liver function disorder.
• High levels of uric acid in the blood.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es

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

5. Storage of Acetylsalicylic Acid Tarbis

Keep this medicine out of the 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

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

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Tarbis

• The active substance is acetylsalicylic acid.
• The other components are: powdered cellulose, pregelatinized corn starch (gluten-free), Acryl-EZE Clear (93F19255) (methacrylic acid copolymer type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate and sodium lauryl sulfate).

Appearance of the medicinal product and contents of the pack

Acetylsalicylic Acid Tarbis 100 mg tablets are round, biconvex and white in colour. They are coated with a gastro-resistant coating that prevents the immediate release of acetylsalicylic acid in the stomach, instead allowing delayed release in the duodenum. The tablets are available in PVC-Al blister packs containing 30, 100 or 500 tablets.

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

The Netherlands

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate

Paola, PLA3000

Malta

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

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