Adverse reactions : תופעות לוואי

4.8. Undesirable effects

The information below lists reported adverse reactions, ranked using the following frequency classification: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100) ; very rare (<1/10,000) and not known (cannot be estimated from the available data).
System organ class           Frequency           Adverse effects
Blood and lymphatic          Not known           Thrombocytopenia,
system disorders                                 Agranulocytosis*

Immune system disorder       Not                 Hypersensitivity (including skin known               rash)

Psychiatric disorders        Not                 Dysphoria Euphoria known               Drug dependence (see section 4.4),

Nervous system disorders     Common             Dizzinessc
Light-headednessc
Not                Sedationc known              Headache
Eye Disorder                 Not known          Miosis visual disturbances

Cardiac disorders            Not known           Bradycardia

Cod Acamol 15/325 tablets MW Feb 2024
           Ear and labyrinth disorders Not known            Hearing loss

Respiratory, thoracic and       Common           Shortness of breathc mediastinal disorders
Not known        Respiratory depressiona

Gastrointestinal disorders      Common           Nauseac
Vomitingc

Not known        Constipationc ,
Abdominal pain,
Hepatobiliary disorders         Not known        Liver damageb

Skin and subcutaneous           Not known        Pruritus tissue disorders

Renal and urinary               Not known        Difficult micturition disorders                                        Urinary retention

General disorders and        Uncommon             Drug withdrawal syndrome administration site conditions a
Codeine can cause respiratory depression particularly in overdosage and in patients with compromised respiratory function.
b
Liver damage in association with therapeutic use of paracetamol has been documented; most cases have occurred in conjunction with chronic alcohol abuse.
c
Some of these side effects appear more common in ambulatory: rather than non- ambulatory patients.
Lying down may alleviate these effects they occur.
* There have been some reports of blood dyscrasias- Thrombocytopenia and argranulocytosis, with the use of paracetamol- containing products, but the causal relationship has not been established.9 Prolonged use of a pain killer for headaches can make them worse.

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