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MIANSERIN is a brand name for Mianserin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mianserin Tablets are indicated for symptoms of depressive illness.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The daily dose can be taken either in divided doses or as a single dose at night (due to the favourable effect on sleep). It is often advantageous to maintain antidepressant treatment for several months after clinical improvement has occurred.
In order to ensure an optimal antidepressant effect the dosage of mianserin should not be reduced. Adults Treatment should usually commence with 30 mg or 40 mg mianserin per day increasing gradually as necessary. The effective dosage usually lies between 30 mg and 90 mg.
Divided doses of up to 200 mg are well tolerated. Older people The use of mianserin is restricted to patients over 65 who: • do not respond to other antidepressant drugs • have glaucoma • have prostatic hypertrophy Not more than 30 mg a day initially.
A lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response. Pharmacokinetic studies of mianserin in the elderly patient suggest a longer half-life and slower metabolic clearance. This information implies that a single night time dose of mianserin should be preferable to the divided dose in older people; in addition a lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response.
4). Method of administration For oral use. The tablets should be swallowed whole without chewing.
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. 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, 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 Not known: Disturbances of liver function. Jaundice, usually mild, has also been reported at therapeutic dosage and under such circumstances treatment should be withdrawn.
Paediatric population Mianserin should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
1. Mania. Severe liver disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 non- puerperal lactation).
General disorders and administration site conditions Not known:
Oedema 1These 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. 4). These adverse reactions have been observed in all age groups but appear to be more common in the elderly.
2Usually 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.
4). 4Although 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. uk/yellowcard.
As an improvement in the patient’s depression may not occur during the first 2-4 weeks of treatment with mianserin, patients should be closely monitored during this period. Haematological and hepatic reactions Mianserin has been associated with haematological and hepatic reactions and patients require careful supervision.
A full blood count is recommended every 4 weeks during the first 3 months of treatment; subsequent clinical monitoring should continue and treatment should be stopped and a full blood count obtained if fever, sore throat, stomatitis or other signs of infection develop.
Cardiac effects Care should always be taken in patients with recent myocardial infarction, heart block or arrhythmia. Serious cardiotoxic effects appear to be rare at therapeutic dosage, even in patients with pre-existing cardiac disease, recent myocardial infarction or cardiac insufficiency.
Use in older people Older people are less liable to experience adverse reactions such as agitation, confusion and postural hypotension with mianserin than with tricyclics or bridged tricyclics, but all anti-depressant therapy should be used with caution in this group of patients.
g. g. 8). Diabetes, hepatic or liver impairment When treating patients with diabetes, hepatic or renal insufficiency, normal precautions should be exercised and the dosages of any concurrent therapy kept under review. Anticholinergic side effects Patients with narrow angle glaucoma or symptoms suggestive of prostatic hypertrophy should also be monitored even though anticholinergic side effects are not anticipated with mianserin therapy.
Hypomaina There are indications that mianserin, like other anti-depressants, may precipitate hypomania in susceptible subjects with bipolar affective illness. In such a case treatment with mianserin should be withdrawn. Surgery If surgery is necessary during mianserin therapy the anaesthetist should be informed of the treatment being given.
Phaeochromocytoma Care should always be taken in patients with phaeochromocytoma.