1. Name Of The Medicinal Product
Surmontil 50mg Capsules
2. Qualitative And Quantitative Composition
Each capsule contains 69.75mg of Trimipramine Maleate, equivalent to 50mg Trimipramine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Capsule
Opaque hard gelatine capsules, the body white, the cap green. Both the body and the cap are printed longitudinally “SU50” in black.
The capsules contain an off white or slightly cream powder or plug of powder.
4. Clinical Particulars
4.1 Therapeutic Indications
Surmontil has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days.
4.2 Posology And Method Of Administration
Adults
For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day.
Elderly
10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.
Children
Not recommended.
Route of administration is oral.
4.3 Contraindications
• Recent myocardial infarction
• Any degree of heart block or other cardiac arrhythmias
• Mania
• Severe liver disease
• During breast feeding
• Hypersensitivity to trimipramine maleate or to any of the excipients
4.4 Special Warnings And Precautions For Use
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide
Other psychiatric conditions for which Surmontil is prescribed can also be associated with an increased risk of suicide
Patients with a history of suicide
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.
The elderly are particularly liable to experience adverse reactions, especially agitation, confusion and postural hypotension.
Avoid if possible in patients with narrow angle glaucoma, symptoms suggestive of prostatic hypertrophy and a history of epilepsy.
Patients posing a high suicidal risk require close initial supervision. Tricyclic antidepressants potentiate the central nervous depressant action of alcohol.
Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If surgery is necessary, the anaesthetist should be informed that a patient is being so treated.
It may be advisable to monitor liver function in patients on long term treatment with Surmontil.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Trimipramine should not be given concurrently with, or within 2 weeks of cessation of, therapy with monoamine oxidase inhibitors. Trimipramine may decrease the antihypertensive effect of guanethidine, debrisoquine, betanidine and possibly clonidine. It would be advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants.
Trimipramine should not be given with sympathomimetic agents such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine.
Barbiturates may increase the rate of metabolism.
Surmontil should be administered with care in patients receiving therapy for hyperthyrodism.
4.6 Pregnancy And Lactation
Do not use in pregnancy especially during the first and last trimesters unless there are compelling reasons. There is no evidence from animal work that it is free from hazard.
Trimipramine is contraindicated during lactation.
4.7 Effects On Ability To Drive And Use Machines
Trimipramine may initially impair alertness. Patients should be warned of the possible hazard when driving or operating machinery.
4.8 Undesirable Effects
Cases of suicidal ideation and suicidal behaviours have been reported during trimipramine therapy or early after treatment discontinuation (see section 4.4).
Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage. They may also occur in patients with pre-existing heart disease taking normal dosage.
The following adverse effects, although not necessarily all reported with trimipramine, have occurred with other tricyclic antidepressants.
Atropine-like side effects including dry mouth, disturbance of accommodation, tachycardia, constipation and hesitancy of micturation are common early in treatment but usually lessen.
Other common adverse effects include drowsiness, sweating, postural hypotension, tremor and skin rashes. Interference with sexual function may occur.
Serious adverse effects are rare. The following have been reported: depression of the bone marrow, including agranulocytosis, cholestatic jaundice, hypomania, convulsions and peripheral neuropathy. Psychotic manifestations including mania and paranoid delusions, may be excacerbated during treatment with tricyclic antidepressants.
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.
Withdrawal symptoms may occur on abrupt cessation of therapy and include insomnia, irritability and excessive perspiration.
Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken trimipramine during the last trimester of pregnancy.
4.9 Overdose
Acute overdosage may be accompanied by hypotensive collapse, convulsions and coma. Provided coma is not present, gastric lavage should be carried out without delay even though some time may have passed since the drug was ingested. Patients in a coma should have an endotracheal tube passed before gastric lavage is started. Absorption of trimipramine is slow but, as cardiac effects may appear soon after the drug is absorbed, a saline purge should be given. Electrocardiography monitoring is essential.
It is important to treat acidosis as soon as it appears with, for example, 20 ml per kg of M/6 sodium lactate injection by slow intravenous injection. Intubation is necessary and the patient should be ventilated before convulsions develop. Convulsions should be treated with diazepam administered intravenously.
Ventricular tachycardia or fibrillation should be treated by electrical defibrillation. If supraventricular tachycardia develops, pyridostigmine bromide 1 mg (adults) intravenously or propranolol 1mg (adults) should be administered at intervals as required.
Treatment should be continued for at least three days even if the patient appears to have recovered.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Psychoanaleptics; Non-selective monoamine reuptake inhibitors, ATC code: N06AA06.
Trimipramine is a tricyclic antidepressant. It has marked sedative properties.
5.2 Pharmacokinetic Properties
Trimipramine undergoes high first-pass hepatic clearance, with a mean value for bioavailability of about 41% after oral administration.
The absolute volume of distribution is 31 litres/kg.
The metabolic clearance is 16 ml/min/kg.
Plasma protein binding of trimipramine is about 95%. The plasma elimination half-life is around 23 hours. Trimipramine is largely metabolised by demethylation prior to conjugation yielding a glucuronide.
5.3 Preclinical Safety Data
No additional pre-clinical data of relevance to the prescriber.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Excipients:
Maize Starch
Microcrystalline cellulose (E460)
Magnesium stearate
Colloidal anhydrous silica
Capsule shell Body:
Titanium dioxide (E171)
Gelatin
Capsule shell Cap:
Titanium dioxide (E171)
Indigo Carmine (E132)
Iron Oxide Yellow (E172)
Gelatin
Printing Ink:
Iron Oxide Black (E172)
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
Store below 25ºC. Keep the blister in the outer carton in order to protect from light.
6.5 Nature And Contents Of Container
Cartons containing PVC/aluminium blisters of 28.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8. Marketing Authorisation Number(S)
PL 04425/0265
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 6 April 1973
Date of latest renewal: 3 May 2002
10. Date Of Revision Of The Text
7 June 2011
Legal category
POM
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