Patient leaflet - Trimipramine 50 mg hard capsules
What Trimipramine is and what it is used for
The name of your medicine is Trimipramine 50mg Capsules, Hard (called trimipramine in this leafl
et). Your Capsules contain a medicine
called trimipramine. This belongs to a group of medicines called antidepressants. Trimipramine 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 (agitation).
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What you need to know before you take Trimipramine
Do not take this medicine and tell your doctor if:
•
You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Trimipramine Capsules (listed in Section 6 Further Information). Signs of an allergic reaction include: a rash, swelling or breathing problems, swelling of your lips, face, throat or tongue
•
You have had a heart attack
•
You have had any other heart problems including slow or uneven
heart beat
•
You have severe liver problems
•
You have mania (signs include very high mood, energy and unusual
behaviour)
•
You are breast-feeding
Do not take this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking trimipramine.
Take special care with 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 leafl
et. 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
•
You have an enlarged prostate gland
•
You have glaucoma (painful eyes with blurred vision)
•
You have or have ever had fits or seizures
•
You 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 if any of the above apply to you, talk to your doctor or pharmacist before taking trimipramine.
Other medicines and 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. Also some medicines can affect the way trimipramine works.
Tell your doctor if you are taking any of the following medicines:
•
MAOI (MonoAmine Oxidase Inhibitors) medicine such as tranylcypromine, phenelzine and isocarboxazid (for Parkinson’s disease), or 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
•
Phenylelphrine or phenylpropanolamine – found in cold and flu preparations
•
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) tricyclics and triptan derivatives, lithium, St
John’s Wort
•
Pain Killers 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 flu oroquinolones.
Anaesthetics
If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking trimipramine.
Trimipramine and alcohol
You should avoid drinking alcohol while taking trimipramine.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not breast-feed if you are taking trimipramine.
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.
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How to take Trimipramine
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:
Depression
•
Adults usually start by taking 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
Package leaflet: Information for the user
Trimipramine 50mg Capsules, Hard
trimipramine
Version: 07
Date & Time: 19.05.2023 & 2:40 PM
Submission: N12330-u15c
Trimipramine 50 mg
Capsules, Hard
P15xxxxx
T r i m i p r a m i n e 5 0 m g
C a p s u l e s , H a r d
P 1 5 x x x x x
Elderly:
•
Elderly usually start by taking 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:
Children should not take trimipramine
If you take more trimipramine than you should
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: 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.
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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 the following side-effects:
•
Painful erection of the penis, unrelated to sexual activity, that will not
go away (priapism)
•
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)
•
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.
Below is a list of other side effects that have been reported:
•
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
An increased risk of bone fractures has been observed in patients taking this kind of medicine.
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse. 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.
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How to store Trimipramine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date refers to the last date of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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Contents of the pack and other information
What Trimipramine contains
The active substance is Trimipramine
Each Capsule, Hard contains 50 mg Trimipramine
The other ingredients are:
Cellulose, Microcrystalline (E460), Maize starch, Silica colloidal anhydrous, Magnesium Stearate, Titanium Dioxide (E171), Brilliant blue FCF (E133) and Gelatin.
What Trimipramine looks like and contents of the pack
Trimipramine Capsule, Hard is blue opaque cap/white opaque body, size “1” hard gelatin capsule shells, imprinted with “TRM” on cap and “50” on body with black ink, filled with white to off-white powder.
Pack sizes:
HDPE bottles or Securitainers of 50 capsules, hard.
Cartons containing opaque PVdC coated PVC/aluminium blisters of 28 capsules, hard.
Marketing Authorisation Holder
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000, Malta
Or
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip, HA4 6QD, United Kingdom
This leaflet was last revised in 05/2023.
P15XXXXX