Aspirin Protect contains the active pharmaceutical ingredient acetylsalicylic acid. It inhibits the coagulation of the blood platelets even in small concentrations. Due to an enteric coating, the tablet dissolves in the small intestine. Therefore, Aspirin Protect is gentle on the stomach lining. Aspirin Protect may only be taken if prescribed by a physician.
Aspirin Protect serves as:
• Prevention of arterial thromboses after surgeries involving the coronary vessels (bypass and elimination of a constriction of the coronary vessels).
• Prevention of strokes after preliminary stages have occurred (transient ischaemic attacks, TIA).
• Prevention of arterial thromboses (blood clots in coronary vessels) and after a myocardial infarction (reinfarction prophylaxis).
• Prevention of myocardial infarctions in patients after a high risk was determined by a physician. Comorbidities such as high blood pressure, diabetes, elevated blood lipids must be treated at the same time. Smoking should also be stopped.
• Treatment of unstable angina pectoris.
• Treatment of an acute myocardial infarction.
• Prevention of arterial thromboses after surgeries on blood vessels.

Aspirin Protect must not be taken for an extended
period of time or in higher doses without consulting a physician.
When must Aspirin Protect not be taken?
You must not take Aspirin Protect in the following cases:
• If you are suffering from a gastric or duodenal
ulcer;
• If you have a pathological increased tendency to
bleed;
• If you are hypersensitive to the active
pharmaceutical ingredient acetylsalicylic acid or other anti-inflammatory drugs (antirheumatic agents) or pain and fever medication. Such a hypersensitivity manifests e.g. in the form of asthma, shortness of breath, circulatory problems, swelling of the skin and mucus membranes or skin rashes (urticaria).
• In the event of serious heart, kidney and liver diseases.
• If you have to take methotrexate concomitantly in a dose of more than 15 mg per week.
• In the last three months of pregnancy
When is caution indicated during the use of Aspirin Protect?
• During treatment with Aspirin Protect, ulcers
can occur in the upper gastrointestinal tract. Bleeding can occur in rare cases or perforations (gastric or intestinal perforation) can occur in individual cases. These complications can occur at any time during treatment without any warning symptoms. Contact your physician if you have stomach pain and suspect a connection to the administration of medication.
• Careful monitoring is indicated in the event of a limited renal or cardiovascular function such as volume deficiencies, major surgeries, blood poisoning or major bleeding.
• Thedrugshouldbetakenonlyinaccordancewith strict instructions of the physician in the event of chronic or recurring gastrointestinal disorders and asthma, urticaria, nasal polyps, hay fever or other allergies, a rare disease of the red blood cells, the so-called “glucose-6 phosphate dehydrogenase deficiency” as well as a treatment with anticoagulants (“blood thinners”) or blood pressure reducing agents (antihypertensives).
• Aspirin Protect is not recommended for children and adolescents under the age of 18.
• Children and adolescents with fever, flu, chickenpox or other viral diseases may use Aspirin Protect only as instructed by the physician and only as a second choice agent. Consult the physician immediately if disturbances of consciousness with vomiting occur during these illnesses or after they subsided.
• Taking Aspirin Protect and antidiabetic drugs (e.g. insulin, sulphonylureas) at the same time may lower the blood sugar level.
• You should talk to your physician if you are
taking Aspirin Protect concurrently with any pain or anti-inflammatory medication (such as, for example, the active pharmaceutical ingredients ibuprofen or naproxen), as these may weaken the effect of Aspirin Protect.
• The effect of gout medications (probenecid and sulfinpyrazone), diuretics and medications against high blood pressure may be reduced. If antirheumatic agents or methotrexate (which is e.g. taken to treat chronic polyarthritis; see also section “When must Aspirin Protect not be used?”) are used, then the adverse effects may intensified.
• In the event of the concomitant and prolonged use of Aspirin Protect, the effect of cortisone products, anticonvulsants (anti-epileptics), blood thinners, digoxin and lithium preparations against depression may be increased. The adverse effect of these medicinal products may be increased.
• If taken concomitantly with cortisone products, alcohol or medicinal products from the group of the so-called serotonin reuptake inhibitors against depression, Aspirin Protect may increase the risk for bleeding. The concomitant use of Aspirin Protect and cortisone products or alcohol may increase the risk for gastrointestinal ulcers.
• The tendency to bleed may be increased even after minor interventions such as tooth extractions.
• Acetylsalicylic acid reduces the excretion of uric acid even in small dosages. This can induce gout in patients who already exhibit a low uric acid excretion.
Inform your physician or pharmacist if
• you are suffering from other diseases,
• have allergies or
• are using other medicinal products (even over-
the-counter medications!).
Ask or inform the physician or dentist about the use of the medication prior to surgical interventions.
May Aspirin Protect be taken during pregnancy and lactation?
You should not use medicinal products during pregnancy and lactation as a precaution. If you continue or start treatment with Aspirin Protect during pregnancy per instruction of the physician, then this may occur only under strict compliance with his or her instructions and only during the first six months of pregnancy. Aspirin Protect must not be taken during the last three months of pregnancy due to a possible risk to the unborn child, the risk for bleeding and a possible delay of the date of the birth.
If higher doses are taken regularly during lactation, then the infant should be weaned.

• Prevention of arterial thromboses without bypass
surgery on the coronary vessels and after dilation
(balloon dilation) of constricted coronary vessels:
100 mg/day.
• Prevention of arterial thromboses after bypass
surgery on the coronary vessels and after dilation
(balloon dilation) of constricted coronary vessels:
100–300 mg/day.

• Prevention of strokes:
3 × 100 mg/day.
• Prevention of thromboses after myocardial
infarction and treatment of unstable angina
pectoris:
1 × 100 mg/day.
• Prevention of heart attacks in patients after a
high risk was determined by a physician:
1 × 100 mg/day.
It is recommended to take the tablets with a bit
of fluid at least half an hour before a meal. Drink
approximately 1⁄2 -1 glass of liquid afterward. The
tablets should not be crushed, broken or chewed.
• In the event of acute myocardial infarction:
If you suffer of an acute myocardial infarction, at
hospital, you will be administered 200-300 mg of
acetylsalicylic acid intravenously. Alternatively,
you may be administered a rapidly absorbed

acetylsalicylic acid preparation (non-enteric-
coated form), which you may take by mouth,

either crushed or chewed, in order for the active
pharmaceutical ingredient to be absorbed more
quickly. From the second day onwards, the dose
is 100 mg of Aspirin Protect daily.
The treating physician decides on the dosage and
the duration of use.
Do not change the prescribed dose by yourself. Talk
to your physician or pharmacist if you believe that
the medicine acts too mildly or too strongly.
Consult a physician immediately in the event of an
uncontrolled administration (overdose). Tinnitus
and/or sweating may indicate an overdose.
Aspirin Protect should not be used in children and
adolescents under the age of 18.

Stomach problems are a common side effect. Asthma, digestive problems, nausea, vomiting and diarrhoea were reported occasionally. Hypersensitivity reactions (such as swelling of the skin and mucous membranes (e.g. stuffy nose), skin rashes, shortness of breath, drop in blood pressure up to shock) as well as gastrointestinal bleeding and gastrointestinal ulcers, which very rarely may lead to perforations may occur in rare cases. Headaches, dizziness, tinnitus, visual impairment, hearing impairment, states of confusion, anaemia due to iron deficiency as well as renal and hepatic dysfunctions rarely occur.
In rare to very rare cases, serious bleeding, especially in patients with unbalanced hypertension and/ or treated concomitantly with “blood thinners” (anticoagulants) were reported, and these can in single cases be potentially life-threatening.
Very rare side effects may include severe skin reactions, low blood sugar, disturbances of the acid base balance as well as Reye’s syndrome in children.
Contusions, nose bleeds, bleeding gums, urogenital bleeding and bleeding after surgical interventions were observed. A prolongation of the bleeding time is possible.
Sudden renal failure was reported.
The medicinal product must be discontinued and the physician must be consulted if signs of a hypersensitivity reaction occur.
If black stool or bloody vomiting occur during the treatment, then the medicinal product should be discontinued and the physician should be consulted immediately.
You should inform your physician or pharmacist if you notice side effects that are not described here.
To report any side effect(s):
National Pharmacovigilance and Drug Safety Center (NPC).
Fax: + 966 - 11 - 205 - 7662.
Call NPC at +966 - 11 - 2038222,
Ext.: 2317 - 2356 - 2353 - 2354 - 2334 - 2340. Toll - free: 8002490000.
E - mail: npc.drug@sfda.gov.sa.
Website: www.sfda.gov.sa/npc

Keep out of the reach and sight of children.
Not to be stored above 25°C.
Do not use this medicine after the expiry date which is stated on the container after “EXP”.
Your doctor or pharmacist will provide you with more detailed information. They have the detailed information for healthcare professionals.