Aspirin Protect 100 mg 60 film-coated tablets

Heart attacks and strokes are usually the result of a sudden reduction in blood flow to the heart or brain. A common cause is blood clots (thrombi), which block important blood vessels in the heart or brain. As a result, there is a lack of oxygen and the heart and brain are damaged.
Aspirin Protect contains the active ingredient acetylsalicylic acid (ASA). Even in low doses, this inhibits the sticking together of platelets (platelet aggregation) and thus counteracts the formation of thrombi.

Application

Aspirin Protect 100 mg film-coated tablets are used in adults

• for the prevention of strokes after recovering from stroke and when precursor stages have occurred (transient ischemic attacks, TIA),
• for the prevention of blood clot formation (thrombosis) in the coronary arteries after surviving a heart attack (re-infarction prophylaxis),
• For the prevention of arterial thrombosis after vascular surgery (e.g. after procedures to dilate narrowed coronary arteries such as percutaneous transluminal coronary angioplasty, PTCA),
• For the prevention of cardio-vascular events (affecting the heart and vascular system) such as angina pectoris or myocardial infarction in patients with diabetes mellitus and high cardiovascular risk.

Contraindications

Do not take Aspirin Protect 100 mg film-coated tablets,

• if you are allergic to acetylsalicylic acid, other salicylates or any of the other ingredients of this medicine (listed in section 6),
• if you have had asthma attacks or are otherwise hypersensitive to certain analgesic medicines - acetylsalicylic acid or substances with a similar mechanism of action (non-steroidal anti-inflammatory drugs) - in the past,
• if you suffer from acute gastrointestinal ulcers,
• if you have a history of bleeding, ulcers or breakthrough in the gastrointestinal tract due to previous therapy with NSAIDs (non-steroidal anti-inflammatory drugs);
• if you have active gastrointestinal ulcers/bleeding or if you have a history of bleeding, ulcers or a breakthrough in the gastrointestinal area;
• if you suffer from an increased tendency to bleed (haemorrhagic diathesis),
• if you suffer from severe liver failure;
• if you suffer from severe kidney failure;
• if you suffer from severe heart failure (heart failure);
• if you are taking 15 mg or more of methotrexate (medicines used to treat cancer or certain rheumatic diseases) per week at the same time
• if you are taking anticoagulants (medicines to "thin the blood") at the same time, if high doses of salicylates are used;
• in the last 3 months of pregnancy
• if you suffer from hyperoxaluria (a certain condition with a tendency to form kidney stones).

Interactions

The effect of the following drugs or groups of preparations can be influenced by simultaneous treatment with Aspirin Protect 100 mg film-coated tablets.
If you are taking methotrexate (medicines used to treat cancer or certain rheumatic diseases) at doses of 15 mg/week or more, do not take Aspirin Protect 100 mg film-coated tablets.
If you are taking anticoagulants (medicines used to "thin the blood"), do not take Aspirin Protect 100 mg film-coated tablets in high doses.

Combinations that require special care:

• Methotrexate at doses below 15 mg/week (medicines used to treat cancer or certain rheumatic diseases) - there is a risk of increased (side) effects of methotrexate.
• Anticoagulant medicines, blood clot-dissolving medicines/other medicines that inhibit platelets sticking together and clumping together (antiplatelet agents) / medicines to inhibit hemostasis (haemostasis inhibitors) - bleeding can occur due to increased action. Aspirin Protect 100 mg film-coated tablets may increase the risk of bleeding if taken before a treatment designed to dissolve blood clots. Therefore, you need to pay close attention to signs of external or internal bleeding (for example, bruising) if you are to undergo such treatment. A medical check-up is absolutely necessary.
• Other analgesic and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs) at high doses of acetylsalicylic acid: increased risk of ulcers and bleeding in the gastrointestinal tract, an overdose is also possible.
• Certain medicines used to treat depression (selective serotonin reuptake inhibitors): the risk of bleeding in the upper gastrointestinal tract increases.
• Certain medicines for the treatment of cardiac insufficiency and for the treatment of certain cardiac arrhythmias (digoxin): Enhancement of the effect up to increased risk of side effects. Appropriate monitoring and, if necessary, dose adjustment by the doctor is recommended.
• Certain medicines for gout (eg, probenecid, benzbromarone). Weakening of the effect of gout remedies possible.
• Medicines for diabetes (e.g. insulin, sulfonylureas): hypoglycaemia can occur due to increased effect. More frequent blood glucose self-checks are recommended.
• Certain medicines for dehydration and lowering blood pressure (diuretics): there is a risk of severe renal dysfunction. When taken at the same time, it is important to ensure sufficient fluid intake. Certain dehydrating agents (e.g. furosemide) may weaken the antihypertensive effect, so blood pressure checks are recommended.
• Medicines containing cortisone or cortisone-like substances (with the exception of products applied to the skin or hydrocortisone in cortisone replacement therapy for Addison's disease): increased risk of gastrointestinal side effects.
• Certain medicines for high blood pressure (antihypertensives) and/or cardiac insufficiency ("ACE inhibitors", aldosterone antagonists): there is a risk of severe renal dysfunction and the antihypertensive effect may also be reduced. When taken at the same time, it is important to ensure sufficient fluid intake. Blood pressure checks are recommended.
• Certain medicines for epilepsy (valproic acid): There is a risk of increased (side) effects of valproic acid.
• Some non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen, may reduce the effect of low-dose acetylsalicylic acid on platelet clumping and may thus limit the protective effect of Aspirin Protect 100 mg film-coated tablets on the heart

Please also note that:
Aspirin Protect 100 mg film-coated tablets in higher doses may alter the results of laboratory tests, so inform your doctor about taking Aspirin Protect 100 mg film-coated tablets.

Taking Aspirin Protect 100 mg film-coated tablets together with alcohol
Please avoid drinking alcohol during the treatment period with Aspirin Protect 100 mg film-coated tablets, as the side effects of the drug may be increased (risk of bleeding in the gastrointestinal tract, prolonged bleeding time).

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Pregnancy: First and second trimester of pregnancy: During the first six months of pregnancy and if you wish to have children,
you should only take Aspirin Protect 100 mg film-coated tablets after consulting your doctor. The aim is to keep the dose as low as possible and the treatment as short as possible. Third trimester of pregnancy: Do not take Aspirin Protect 100 mg film-coated tablets in the last three months of pregnancy due to an increased risk of complications for mother and baby. Due to the acetylsalicylic acid component, there is a risk of developmental disorders in the unborn child (malformations in the circulatory system and/or renal dysfunction up to kidney failure). During childbirth, there may be increased bleeding in mother and child and delay/prolongation of the birth process.

Lactation:
The active ingredient acetylsalicylic acid and its degradation products are excreted in breast milk in small quantities. With short-term use of Aspirin Protect 100 mg film-coated tablets and low dose, interruption of breastfeeding will not be necessary. However, if you use or take high doses for a longer period of time, you should stop weaning.

Reproductive capacity:
Aspirin Protect 100 mg film-coated tablets belong to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible after discontinuation of the drug.

Application

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Please check with your doctor or pharmacist if you are not sure.

Dosage:
Unless otherwise prescribed by the doctor, the usual dose is for

• Adults:
  1 x daily 100 mg (1 film-coated tablet of Aspirin Protect 100 mg)
• Children and adolescents:
  There is no indication for the use of Aspirin Protect 100 mg film-coated tablets in children and adolescents.

Method of administration:
For oral use.
The enteric-coated tablets should be swallowed whole, preferably at least 30 minutes before the meal, with plenty of water.
The enteric-coated tablets must not be crushed, broken or chewed to ensure release in the intestine.
Usually, Aspirin Protect 100mg film-coated tablets are used as a long-term precaution.

Note:
Higher doses are available for the use of acetylsalicylic acid for pain and/or fever.

Special patient groups: Elderly persons (65 years of age and older) and underweight persons:
In elderly patients,
special caution is advised due to possible comorbidities or underweight (see sections "Do not take Aspirin Protect 100 mg film-coated tablets" and "Warnings and precautions"). In particular, it is recommended to use the lowest effective dose in the elderly and underweight.
Patients with liver dysfunction:
If you suffer from liver dysfunction, it is recommended to increase the time interval between two doses. In case of severe liver dysfunction, do not take Aspirin Protect 100 mg film-coated tablets. Aspirin Protect 100 mg film-coated tablets should be used with special caution if you have impaired liver function.
Patients with renal dysfunction:
If you suffer from renal dysfunction, it is recommended to extend the time interval between two doses. In case of severe renal impairment, do not take Aspirin Protect 100 mg film-coated tablets. Aspirin Protect 100 mg film-coated tablets should be used with special caution if you have impaired kidney function.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are possible and listed according to their frequency: Common (may affect up to 1 in 10 people):

Gastrointestinal symptoms such as heartburn, nausea, vomiting, abdominal pain.

Uncommon (may affect up to 1 in 100 people):
Hypersensitivity reactions, such as skin reactions.
Redness of the skin, hives (urticaria), itching.

Rare (may affect up to 1 in 1,000 people):
Hypersensitivity reactions of the respiratory, gastrointestinal and cardiovascular systems, especially in asthma patients. Signs of a hypersensitivity reaction may include: drop in blood pressure, bouts of shortness of breath, life-threatening shock or swelling of the skin and mucous membrane.
Severe skin reactions such as rash with redness, blistering and peeling of the skin.
Gastrointestinal inflammation, gastrointestinal ulcers, gastrointestinal bleeding, which very rarely can lead to anemia due to iron deficiency.
Breakthrough of a gastrointestinal ulcer, especially in elderly patients.
In case of abdominal pain, blackening of the stool, vomiting blood or vomiting like coffee grounds, discontinue Aspirin Protect 100 mg film-coated tablets and inform the doctor immediately.

Rare to very rare:
Serious haemorrhages such as cerebral haemorrhage, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants, have been reported, which in individual cases can be life-threatening.

Very rare (may affect up to 1 in 10,000 people):
drop in blood sugar.
Acetylsalicylic acid reduces uric acid excretion in low doses. In patients at risk for this, this can trigger a gout attack under certain circumstances.

Not known (frequency cannot be estimated from the available data):
Anemia due to blood loss or decay, decay of red blood cells,.
Drug hypersensitivity, allergic swelling and swelling of the skin and mucous membrane, severe allergic reaction up to life-threatening shock.
Cerebral hemorrhage and cranial hemorrhage.
Dizziness, headaches, impaired hearing, ringing in the ears and mental confusion can already be signs of an overdose.
Shortness of breath caused by heart disease. Bleeding with prolonged bleeding time such as nosebleeds, bleeding gums, skin bleeding, bleeding of the urinary and genital organs (genitourinary tract), surgical bleeding, bruising or muscle bleeding. This effect may last for 4 to 8 days after stopping taking the Aspirin Protect 100 mg film-coated tablets.
Asthma, runny nose, nasal congestion.
Indigestion, pain in the gastrointestinal tract, pain in the upper abdomen.
Liver dysfunction, increases in liver function tests. Sudden, regressive severe hepato-damaging episodes have been reported, particularly in patients with a history of liver damage and in rheumatism patients, such as those with juvenile arthritis, rheumatic fever or systemic lupus erythematosus. (In these patients, the doctor will check liver function regularly).
Restriction of renal function, acute renal failure.
Swelling due to water retention in tissues, hypertension and heart failure have been reported in association with nonsteroidal anti-inflammatory drugs (NSAIDs) treatment.

Composition

The active ingredient is: acetylsalicylic acid One film-coated tablet contains 100 mg of acetylsalicylic acid.

The other ingredients are:tablet core:
cellulose powder, corn starch. Tablet coating: metacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate.

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