Adverse reactions : תופעות לוואי

4.8. Undesirable effects
The following incidence rating is used to evaluate the frequency of side effects: 
Very common: ≥ 1/10
Common:      ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1,000 to < 1/100
Rare:       ≥ 1/10,000 to < 1/1,000
Very rare:  < 10,000
Not known: frequency cannot be estimated from the available data

Blood and lymphatic system disorders:
Rare to very rare serious bleedings, such as cerebral bleeding, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants, which in isolated cases may be potentially life-threatening, have been reported.
Haemolysis and haemolytic anaemia in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency have been reported.
Bleeding, e.g. nosebleeds, bleeding gums, cutaneous bleeding or urogenital bleeding, possibly with prolongation of the bleeding time. This effect can persist for 4 to 8 days after use.
Immune system disorders:
Rare:
- Hypersensitivity reactions of the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. Symptoms may include hypotension, attacks of dyspnoea, rhinitis, nasal congestion, anaphylactic shock and angioneurotic oedema.

Metabolism:
Very rare:
- Hypoglycaemia.
- At low dosages, acetylsalicylic acid reduces the excretion of uric acid. This may cause a gout attack in predisposed patients.


Nervous system disorders:
Headache, dizziness, impaired hearing ability, tinnitus and mental confusion can be signs of an overdose (see also section 4.9).

Gastrointestinal disorders:
Common:
- Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain and diarrhoea.
- Minor gastrointestinal bleeding (microhaemorrhaging).

Uncommon:
- Gastrointestinal ulcers which in very rare cases can lead to perforation.
- Gastrointestinal bleeding.
Prolonged use of Aspirin Cardio may cause iron deficiency anaemia due to occult blood loss from the gastrointestinal tract.
- Gastrointestinal inflammation.

Not known:
- If there is pre-existing damage to the intestinal mucosa, formation of multiple membranes may occur in the intestinal cavity, possibly with subsequent stenosis.

If you pass black stools (tarry stools) or vomit blood, both of which are a sign of serious bleeding in the stomach, inform a doctor immediately.

Hepatobiliary disorders:
Very rare:
- Increase of liver enzyme values.

Skin and subcutaneous tissue disorders:
Uncommon:
- Skin reactions (very rare cases ranging up to erythema exsudativum multiforme).
Renal and urinary disorders:
Very rare:
- Renal impairment and acute renal failure.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il