1. Name Of The Medicinal Product
Surmontil 10mg tablets or Trimipramine 10mg Tablets
Surmontil 25mg tablets or Trimipramine 25mg Tablets
2. Qualitative And Quantitative Composition
Each 10mg tablet contains 14mg of trimipramine maleate equivalent to 10mg of trimipramine.
Each 25mg tablet contains 34.9mg of trimipramine maleate, equivalent to 25mg of trimipramine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film-coated tablet
Surmontil 10mg Tablets
White to pale yellow, circular, biconvex, film coated tablet, one face impressed 'SURMONTIL' just inside the perimeter around a centrally impressed '10', scoreline on reverse.
Trimipramine 10mg Tablets
White to pale yellow, circular, biconvex, film coated tablet embossed 'TM' above '10' on one side, scoreline on reverse.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide the dose.
Surmontil 25mg Tablets
White to pale yellow, circular, biconvex, film coated tablet, one face impressed 'SURMONTIL' just inside the perimeter around a centrally impressed '25', reverse face plain.
Trimipramine 25mg Tablet
White to pale yellow, circular, biconvex, film coated tablet, embossed 'TM' above ''25' on one side, reverse side plain.
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-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.
Other psychiatric conditions for which Surmontil is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
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.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 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
Trimiparamine 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 and total 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
Tablet Core:
Calcium Hydrogen Phosphate
Starch Potato
Magnesium Stearate
Talc
Tablet Coat (Opadry OY-L-28900):
Lactose Monohydrate
Hypromellose
Titanium Dioxide
Macrogol 4000
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
5 years
6.4 Special Precautions For Storage
Keep the blister in the outer carton in order to protect from light.
6.5 Nature And Contents Of Container
10mg: Cartons containing PVDC/coated UPVC/aluminium foil blister packs of 84 or 28 tablets.
25mg: Cardboard cartons containing PVDC/coated UPVC/aluminium foil blister packs of 84 or 28 tablets.
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)
Surmontil 10mg tablets: PL 04425/0266
Surmontil 25mg tablets: PL 04425/0267
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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