Aspirin protect 100 mg gastro-resistant tablets (acetylsalicylic acid) – prevention of repeat heart attack and stroke

Aspirin protect is a medicine containing acetylsalicylic acid at a dose of 100 mg, in the form of gastro-resistant tablets. It belongs to the group of antithrombotic medicines – platelet aggregation inhibitors. It prevents blood platelets (thrombocytes) from sticking and clumping together and thereby reduces the chance of a blood clot (thrombus) forming.

Unlike classic aspirin for pain and fever, Aspirin protect is taken long-term, once a day, at a low dose – by people who have already had a heart attack or stroke or who recently had heart bypass surgery. The gastro-resistant coating means that the tablet does not dissolve in the stomach but in the intestine. In Serbia the medicine is available without a prescription, but the leaflet expressly states that a doctor must be consulted before first use for these indications.

What is Aspirin protect 100 mg used for and how should it be taken?

Key facts about the medicine

What is Aspirin protect used for?

According to the current package leaflet and summary of product characteristics (secondary prophylaxis of cerebrovascular and cardiovascular thrombotic diseases), Aspirin protect is used:

• to prevent blood clots after a heart attack or stroke, i.e. to prevent a repeat heart attack or stroke in patients who have already had these conditions;
• after bypass surgery – an operation that bypasses the heart's blood vessels so that the heart receives enough blood.

The medicine works by inhibiting platelet aggregation – it stops platelets from sticking and clumping together. At this dose Aspirin protect is not a medicine for pain, headache or fever and is not taken as needed, but regularly, as advised by a doctor. An older version of the leaflet listed other indications as well; these are no longer part of the valid documentation for this medicine in Serbia.

How is it used and dosed?

• Swallow the tablet whole with enough liquid, preferably at least 30 minutes before a meal.
• The medicine is for oral use; treatment should be checked at regular intervals.
• The usual adult dose applies to patients without severe kidney or liver impairment.
• This is the general dosage from the leaflet; the actual dose and duration of treatment are decided by the doctor.

Special patient groups

• Older patients: acetylsalicylic acid should be used with caution because they are more prone to adverse events.
• Children and adolescents under 16: the medicine must not be used unless a doctor prescribes it (e.g. in Kawasaki disease or to prevent thrombosis during heart surgery). With viral infections (influenza A and B, chickenpox) there is a risk of Reye's syndrome – a rare, life-threatening disease of the brain and liver; persistent vomiting may be a sign of it.
• Kidney or liver impairment: the medicine must not be used in severe impairment; milder forms require caution and medical supervision.
• G6PD enzyme deficiency: acetylsalicylic acid may cause haemolysis or haemolytic anaemia.

Contraindications – when the medicine must not be used

Do not take Aspirin protect:

• if you are allergic to acetylsalicylic acid or to any of the excipients;
• if you have previously had an asthma attack or another hypersensitivity reaction when using salicylates or other non-steroidal anti-inflammatory drugs;
• if you have a stomach or duodenal ulcer;
• if you have an abnormally increased tendency to bleed (haemorrhagic diathesis);
• if you have severe kidney or liver impairment;
• if you have severe heart failure;
• if you are taking methotrexate at doses of 15 mg per week or more at the same time;
• in the last trimester of pregnancy at doses above 100 mg per day;
• in children under 16, unless a doctor prescribes treatment (e.g. to prevent thrombosis during heart surgery).

Precautions and warnings

Tell your doctor before use if any of the following applies to you:

• allergy to other painkillers, anti-inflammatory or antirheumatic medicines;
• bronchial asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease or other allergies (rash, itching);
• impaired liver or kidney function, or cardiovascular conditions (e.g. heart failure, dehydration, major surgery, sepsis, major blood loss) – acetylsalicylic acid may further increase the risk of acute kidney failure;
• previous ulcer or bleeding in the stomach or intestine (signs may be blood in the stool or black stool);
• you are also using anticoagulants or non-steroidal anti-inflammatory drugs;
• you have gout;
• you are due to have surgery, including minor procedures such as a tooth extraction – the tendency to bleed is increased.

Small cuts (e.g. when shaving) are usually of no significance, but if you notice unusual bleeding – in an unusual place or lasting unusually long – seek medical help.

Interactions with other medicines, alcohol and food

Aspirin protect can strengthen the effect of some medicines. Tell your doctor if you are taking:

• methotrexate (a medicine for cancer and rheumatoid arthritis);
• non-steroidal anti-inflammatory drugs and other anti-inflammatory medicines – higher risk of ulcers and bleeding in the digestive tract;
• anticoagulants, thrombolytics or other medicines that affect platelet function – increased risk of bleeding (watch for bruising);
• SSRI antidepressants – higher risk of ulcers and bleeding in the digestive tract;
• digoxin (a medicine for heart failure);
• insulin and sulfonylurea derivatives – blood sugar may fall more than usual;
• systemic glucocorticoids (except hydrocortisone as replacement therapy) – risk of ulcers and bleeding, and of salicylate overdose after corticosteroid treatment ends;
• valproic acid (a medicine for epilepsy).

Aspirin protect may weaken the effect of medicines that lower blood pressure (diuretics, ACE inhibitors) and of gout medicines that increase uric acid excretion (probenecid, benzbromarone).

Ibuprofen and naproxen may reduce the effect of Aspirin protect on platelets and thus limit protection against heart attack and stroke. Metamizole may also reduce the antiplatelet effect, so this combination should be used with caution.

Alcohol: do not drink alcohol while taking Aspirin protect, as it increases the risk of bleeding in the digestive tract.

Pregnancy and breastfeeding

Third trimester: in the last 3 months of pregnancy you must not take doses higher than 100 mg per day – the medicine may cause kidney and heart problems in the unborn baby, affect the tendency to bleed in mother and baby and delay or prolong labour. With lower doses (100 mg per day or less) strict obstetric monitoring is required.

First and second trimester: the medicine should not be taken during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor, at the lowest dose for the shortest possible time. Use for more than a few days from week 20 of pregnancy may cause kidney problems in the unborn baby (oligohydramnios) or narrowing of the ductus arteriosus.

Breastfeeding: small amounts of the medicine pass into breast milk; the doctor decides on its use.

Fertility: the medicine may affect female fertility; this effect disappears after stopping the medicine.

Driving and using machines

According to the leaflet, Aspirin protect has no effect on the ability to drive or use machines.

Possible side effects

• Common (up to 1 in 10 patients): dizziness, ringing in the ears, nosebleeds, inflammation of the nasal lining, indigestion, abdominal pain, inflammation and bleeding in the digestive tract, rash, itching, bleeding from the urinary and genital organs.
• Uncommon (up to 1 in 100): iron-deficiency anaemia, hypersensitivity reactions, allergic swelling and angioedema, bleeding in the brain, haematoma, blocked nose, bleeding gums, ulcers and damage to the lining of the digestive tract, impaired liver function, hives.
• Rare (up to 1 in 1,000): anaemia due to bleeding, anaphylactic reaction, bleeding into muscles, ulcer perforation, raised liver enzymes, impaired kidney function and acute kidney failure.
• Not known: haemolysis and haemolytic anaemia, anaphylactic shock, cardiorespiratory distress syndrome, bleeding during surgery, respiratory disease worsened by acetylsalicylic acid, narrowing of the small intestine (intestinal diaphragm disease).

Report any suspected side effects to your doctor, pharmacist or the Medicines and Medical Devices Agency of Serbia (ALIMS).

Overdose, missed dose and stopping treatment

• Overdose: tell a doctor immediately or go to the nearest emergency department. Moderate poisoning may cause light-headedness, dizziness, ringing in the ears, hearing impairment, sweating, nausea and vomiting, headache and confusion. Severe overdose can lead to rapid breathing, fever, dehydration, restlessness, seizures, hallucinations, low blood sugar, coma, shock and respiratory arrest.
• Missed dose: do not take a double dose; continue taking the medicine as described in the leaflet or as prescribed by your doctor.
• Stopping treatment: do not stop Aspirin protect without first talking to your doctor.

Related information

• How to lower high blood pressure without drugs?
• How to measure your pulse and why it matters

For additional care and support with high blood pressure and heart conditions (regular blood pressure checks), see also the Blood pressure monitors category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: acetylsalicylic acid, 100 mg in one gastro-resistant tablet.
• Tablet core: maize starch; cellulose powder.
• Gastro-resistant coating: methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30% (contains polysorbate 80 and sodium lauryl sulfate); talc; triethyl citrate.
• The medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially "sodium-free".
• Appearance: white coated tablets. Pack: PP/aluminium blister; box of 28 tablets (2 × 14) or 98 tablets (7 × 14).
• Marketing authorisation holder: BAYER D.O.O. BEOGRAD, Omladinskih brigada 88b, Belgrade.
• Manufacturer: BAYER BITTERFELD GMBH, Bitterfeld-Wolfen, Germany.
• Authorisation numbers: 000457209 2023 (28 tablets) and 000457211 2023 (98 tablets), dated 09.10.2024.

Storage

• Store below 25 °C.
• Keep out of the sight and reach of children.
• Do not use after the expiry date stated on the box and blister.
• Return unused medicine to a pharmacy that collects unused medicines from the public.

Frequently asked questions

Is Aspirin protect the same as ordinary aspirin?

No. Aspirin protect contains 100 mg of acetylsalicylic acid in a gastro-resistant tablet and is taken long-term, once a day, to prevent blood clots after a heart attack or stroke and after bypass surgery. It is not intended to relieve pain or fever.

Can I start taking Aspirin protect on my own as prevention?

Not without a doctor. Although it is available without a prescription, the leaflet states that a doctor must be consulted before first use for these indications, because the medicine increases the risk of bleeding and is not suitable for everyone.

When is the best time to take the tablet?

Swallow the tablet whole with enough liquid, preferably at least 30 minutes before a meal, at roughly the same time every day.

Can I take ibuprofen for pain while on Aspirin protect?

Ask your doctor or pharmacist. Ibuprofen and naproxen can reduce the effect of Aspirin protect on platelets, and taking them together increases the risk of ulcers and bleeding in the digestive tract.

Do I need to stop Aspirin protect before a tooth extraction?

Tell your dentist or surgeon that you are taking the medicine. Do not stop treatment yourself – the doctor decides whether a break is needed.

Sources

• ALIMS – Package leaflet Aspirin® protect, 100 mg, gastro-resistant tablets (October 2024)
• ALIMS – Summary of product characteristics Aspirin® protect, 100 mg, gastro-resistant tablets

Sources checked on: 23 October 2026.