Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The frequency and severity of depression-related symptoms such as blurred vision, dry mouth and constipation do not usually increase during treatment with mianserin; in fact an actual decrease has been observed in many cases.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) very rare (<1/10,000) and not known (cannot be estimated from available data).

Blood and lymphatic disorders
Not known: Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis has been reported during treatment with mianserin1. Leucopenia and aplastic anaemia.

Metabolism and nutrition disorders
Not known: Hyponatraemia2

Psychiatric disorders
Not known: Suicidal ideation, suicidal behaviour3. Psychotic manifestations, including mania and paranoid delusions, may be exacerbated during antidepressant therapy. Interference with sexual function in adults4, withdrawal symptoms in adults4, withdrawal symptoms (e.g. neuro-muscular irritability) in neonates whose mothers received tricyclic or bridged tricyclic antidepressants during pregnancy4. Hypomania has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.

Nervous system disorders
Not known: Dizziness, drowsiness, tremor. Convulsions have also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.

Vascular disorders
Not known: Postural hypotension

Hepatobiliary disorders
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Not known: Disturbances of liver function. Jaundice, usually mild, has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.

Skin and subcutaneous tissue disorders
Not known: Skin rash, sweating

Musculoskeletal and connective tissue disorders
Not known: Arthralgia, polyarthropathy, arthritis
Reproductive system and breast disorders
Not known: Breast disorders (gynaecomastia, nipple tenderness and nonpuerperal lactation).

General disorders and administration site conditions
Not known: Oedema
1
These reactions have occurred most commonly after 4-6 weeks and were generally reversible on stopping treatment. A full blood count is recommended every four weeks during the first three months of treatment. In addition, monitoring of the patient’s clinical condition should continue and if a patient develops fever, sore throat, stomatitis or other signs of infection, treatment should be stopped and a full blood count obtained (see section 4.4). These adverse reactions have been observed in all age groups but appear to be more common in the elderly.
2
Usually in the elderly, and possibly due to inappropriate secretion of antidiuretic hormone, hyponatraemia has been associated with all types of antidepressants and should be considered in all patients who develop drowsiness, confusion or convulsions whilst taking an antidepressant.
3
Cases of suicidal ideation and suicidal behaviours have been reported during mianserin therapy or early after treatment discontinuation (see section 4.4).
4
Although not reported with mianserin, these adverse events can occur with tricyclics and bridged tricyclics

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/