• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What Trimipramine Capsules are and what they are used for
2. What you need to know before you take Trimipramine Capsules
3. How to take Trimipramine Capsules
4. Possible side effects
5. How to store Trimipramine Capsules
6. Contents of the pack and other information

• 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.

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.

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.

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trimipramine.

You should avoid drinking alcohol while taking trimipramine.

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.

Trimipramine may make you feel sleepy or less alert. If this happens, do not drive or use any tools or machines.

This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially ‘sodium-free’.

• 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

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.

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 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.

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.

• 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.

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.

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.

• 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

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.

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