Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Trimipramine 50mg Capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Trimipramine maleate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Trimipramine 50mg Capsules contain trimipramine, which belongs to a group of medicines called antidepressants. Trimipramine Capsules can be used to treat depression. They are especially useful for treating depression in people who also have problems sleeping, stress (anxiety) or feel irritable and restless (agitated). 2.
What you need to know before you take it
e Trimipramine Capsules
Do not take Trimipramine Capsules if you: are allergic to trimipramine or any of the other ingredients of the capsules (listed in Section 6 Further Information). See section 4 for the signs of an allergic reaction have had a heart attack have had any other heart problems including slow or uneven heart beat have severe liver problems have mania (signs include very high mood, energy and unusual behaviour) are breast-feeding If you are not sure, talk to your doctor or pharmacist before taking trimipramine. Warnings and precautions Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: If you have previously had thoughts about killing or harming yourself. If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. If you have diabetes or are at risk of getting diabetes, your doctor may do blood tests to monitor your blood sugar levels. Check with your doctor or pharmacist before taking this medicine if you: are elderly have an enlarged prostate gland have glaucoma (painful eyes with blurred vision) have or have ever had fits or seizures have thyroid problems The use of Buprenorphine together with trimipramine can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Trimipramine). If you are not sure, talk to your doctor or pharmacist before taking trimipramine. Other medicines and Trimipramine Capsules Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because trimipramine can affect the way some other medicines work and some medicines can affect the way trimipramine works. In particular, tell your doctor if you are taking any of the following medicines: MAOI (MonoAmine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for Parkinson's disease), or you have taken them in the last 2 weeks Sedatives (such as tranquilizers or sleeping pills) Medicines used to treat high blood pressure Adrenaline, noradrenaline, ephedrine or isoprenaline – used in an emergency Phenylephrine or phenylpropanolamine – found in cold and flu medicines Medicines used for chest pain (angina) or high blood pressure such as diltiazem, verapamil, clonidine, digitalis Medicines used for depression (SSRIs such a citalopram, paroxetine, fluoxetine) tricyclic antidepressants and triptan derivatives, lithium and St John's Wort (a herbal remedy) Painkillers such as tramadol Buprenorphine/opioids. These medicines may interact with trimipramine and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms. Macrolide antibiotics, antifungals or fluoroquinolones. Anaesthetics If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trimipramine. Taking trimipramine with alcohol You should avoid drinking alcohol while taking trimipramine.
Pregnancy and breast-feeding Pregnancy Trimipramine should not be used during pregnancy especially during the first and last trimesters unless there are compelling reasons. Breast-feeding Trimipramine should not be used during breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines Trimipramine may make you feel sleepy or less alert. If this happens, do not drive or use any tools or machines. Trimipramine Capsules contain sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially 'sodium-free'. 3.
How to take it
Trimipramine Capsules
Always take trimipramine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth Swallow the capsules whole with a drink of water If you have been told to take trimipramine only once each day then you should take it before going to bed It may take 7 to 10 days before you feel the full benefit of the medicine If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor How much to take Adults The usual starting dose is 50mg to 75mg each day. Your doctor may then increase the dose to 150mg or 300mg each day depending on your condition Once you start to feel better, the usual daily dose then stays the same at 75mg to 150mg each day Elderly The usual starting dose is 10mg to 25mg three times each day Your doctor will then increase this slowly Once you start to feel better, the usual daily dose stays the same at 35mg to 75mg each day Children This medicine should not be used in children as the safety and efficacy of Trimipramine in children have not yet been established. If you take more Trimipramine than you should Tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen if you take too many capsules: fits (seizures), collapse and falling into a coma.
If you forget to take Trimipramine If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Trimipramine Keep taking trimipramine until your doctor tells you to stop. Do not stop taking trimipramine just because you feel better. This is because your illness may come back. When your doctor tells you to stop taking these capsules, he/she will help you stop taking them gradually. Stopping your medicine too quickly could cause sleep problems, feeling irritable and sweating more than usual. 4.
Possible side effects
Like all medicines, trimipramine can cause side effects, although not everybody gets them. Stop taking trimipramine and see a doctor or go to a hospital straight away if: You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to trimipramine. Talk to your doctor straight away if you notice any of the following side-effects: Common (may affect up to 1 in 10 people) Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism) Feeling drowsy or sleepy
Constipation Dry mouth
Tremor (shaking) Blurred vision Rapid heartbeat Sweating more than usual Feeling dizzy or light-headed on standing or sitting up quickly (postural hypotension) Sexual problems Delay when starting to pass water (urine) Skin rash
Rare (may affect up to 1 in 1,000 people) Yellowing of the eyes or skin. This could be a liver problem (such as jaundice) Overactive behaviour or thoughts (mania or hypomania) Numbness or weakness in the arms and legs (peripheral neuropathy) Feeling that someone is 'out to get you' Getting infections more easily than usual. This could be because of a blood disorder (agranulocytosis) Convulsions/fits Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
Not known (frequency cannot be estimated from the available data)
Increased thirst and passing water (urine) more often than normal. You may also feel tired and hungry. This could be due to high blood sugar levels or a condition called
diabetes An uneven or fast heartbeat An increased risk of bone fractures has been observed in patients taking this kind of medicine. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Trimipramine Capsules
Keep this medicine out of the sight and reach of children. Do not use Trimipramine Capsules after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Trimipramine Capsules contains Each Trimipramine 50mg Capsules contains 69.75mg of the active substance, trimipramine maleate, equivalent to 50mg of trimipramine The other ingredients are microcrystalline cellulose (E460), colloidal anhydrous silica, croscarmellose Sodium, pre-gelatinised Starch and magnesium Stearate The capsule shell contains titanium dioxide (E171), indigotine (E132), iron oxide yellow (E172) and gelatin The printing ink contains shellac, iron oxide black (E172) and potassium hydroxide What Trimipramine Capsules look like and contents of the pack Trimipramine 50mg Capsules are hard gelatin capsule approximately 19.20 x 6.93 mm in size with white opaque body imprinted with "301" in black ink and green cap imprinted with Glenmark logo "G" in black ink, filled with white to pale yellow powder. They are supplied in blister packs of 28 capsules. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue, Kenton, Middlesex HA3 0BU United Kingdom
Manufacturer Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire WD18 8YA, United Kingdom Glenmark Pharmaceuticals s.r.o. Fibichova 143 56617 Vysoke Myto Czech Republic This leaflet was last revised in 05/2021.
Frequently asked questions about Trimipramine 50mg Capsules
How do I take Trimipramine 50mg Capsules?
Trimipramine 50mg Capsules comes as capsule containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Trimipramine 50mg Capsules?
The active substance in Trimipramine 50mg Capsules is trimipramine maleate.
Are there equivalent medicines to Trimipramine 50mg Capsules?
Medicines with the same active substance, strength and form include: Trimipramine 50 mg capsules hard, Trimipramine 50mg Capsules. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Trimipramine 50mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Trimipramine 50mg Capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: trimipramine maleate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Trimipramine 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
Posology
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.
Paediatric population
Not recommended.
Method of administration
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 Trimipramine 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.
Hyperglycaemia/Diabetes:
Epidemiologic studies have identified an increased risk of diabetes mellitus in depressed patients receiving tricyclic antidepressants. Therefore, patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on trimipramine, should get appropriate glycaemic monitoring (see section 4.8).
Serotonin Syndrome:
Concomitant administration of Trimipramine and buprenorphine/opioids may result in serotonin syndrome, a potentially life-threatening condition (see section 4.5).
If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
QT interval prolongation:
Like other tricyclic antidepressants, trimipramine may dose-dependently prolong QT interval (see section 4.8).
Caution should be taken in patients with known risk factors for prolongation of QT interval such as:
• congenital long QT syndrome, bradycardia
• concomitant use of drugs that are known to prolong the QT interval, induce bradycardia or hypokalemia (see section 4.5)
• uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia).
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 Trimipramine.
Trimipramine Capsules contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially 'sodium-free'.
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.
Trimipramine should be administered with care in patients receiving therapy for hyperthyroidism.
Co-administration with other serotonergic active substances (such as SSRIs, SNRIs, MAOIs, lithium, triptans, tramadol, linezolid, L-tryptophan, and St John's Wort –Hypericum perforatum-preparations) may lead to serotonin syndrome (see section 4.4). Close clinical monitoring is required when these substances are co-administered with trimipramine.
Trimipramine should be used cautiously when co-administered with:
• Buprenorphine/opioids as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).
Trimipramine should be used with caution in patients receiving drugs known to prolong QT interval (e.g. Class IA and III antiarrhythmics, macrolides, floroquinolones, some antifungals, some antipsychotics), induce hypokalemia (e.g. hypokalemic diuretics, stimulant laxatives, glucocorticoids, tetracosactides) or bradycardia (e.g. beta-blockers, diltiazem, verapamil, clonidine, digitalis) (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
Trimipramine should not be used during pregnancy especially during the first and last trimesters of pregnancy unless there are compelling reasons.
There is no evidence from animal studies that it is free from hazard.
Breast-feeding
Trimipramine is contraindicated during breast-feeding (see section 4.3).
Fertility
No data on the effects of trimipramine on human fertility are available.
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. Other cardiac disorders include QT interval prolongation, torsade de pointes (see section 4.4)
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 exacerbated 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.
Hyperglycaemia. Epidemiologic studies have identified an increased risk of diabetes mellitus in depressed patients receiving tricyclic antidepressants (see section 4.4).
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.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Acute overdosage may be accompanied by hypotensive collapse, convulsions, coma, QT interval prolongation, torsades de pointes. Overdose may result in a fatal outcome.
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.
💬 Ask about this leaflet
Ask anything about Trimipramine 50mg Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.