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TRIMIPRAMINE 50 MG CAPSULES

Active substance(s): TRIMIPRAMINE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Trimipramine 50mg Capsules/
Surmontil 50mg Capsules
(trimipramine maleate)
This product is available in the above names, but will
be referred to as Trimipramine Capsules throughout
this leaflet.
Read all of this leaflet carefully before you start
taking this medicine
 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
 If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Trimipramine Capsules are and what they are
used for
2. Before you take Trimipramine Capsules
3. How to take Trimipramine Capsules
4. Possible side effects
5. How to store Trimipramine Capsules
6. Further information
1. What Trimipramine Capsules are and what they
are used for
Trimipramine Capsules contain a medicine called
trimipramine. This 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
(agitation).
2. Before you take Trimipramine Capsules
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,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
✕ You have had a heart attack
✕ You have 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 Capsules
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.
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
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking
trimipramine.
Taking other medicines
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 Capsules can affect the
way some other medicines work.
Also some medicines can affect the way Trimipramine
Capsules work.
Tell your doctor if you are taking any of the
following medicines:
 MAOI (MonoAmine Oxidase Inhibitors) medicine
such as tranylcypromine, phenelzine and
isocarboxazid (for depression) or selegiline (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
 Phenylephrine or phenylpropanolamine – found in
cold and flu preparations
Anaesthetics
If you are going to have an anaesthetic (for an
operation), tell your doctor or dentist that you are
taking Trimipramine Capsules.
Taking Trimipramine Capsules with food and drink
You should avoid drinking alcohol while taking
Trimipramine Capsules.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, might become pregnant, or think you
may be pregnant.
Do not breast-feed if you are taking Trimipramine
Capsules.
Driving and using machines
Trimipramine Capsules may make you feel sleepy or
less alert. If this happens do not drive or use any tools
or machines.
3. How to take Trimipramine Capsules
Always take Trimipramine Capsules 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
Capsules 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
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
then stays the same at 35mg to 75mg each day
Children:
Children should not take Trimipramine Capsules.
If you take more Trimipramine Capsules than you
should
If you take more Trimipramine Capsules 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 Capsules
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








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 type of medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or
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 Tel: Freephone
0808 100 3352. By reporting side effects you can help
provide more information on the safety of this
medicine.
5. How to store Trimipramine Capsules
KEEP 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.
Do not store above 25°C. Store in the original
package to protect from light.
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. Further information

If you stop taking Trimipramine Capsules
Keep taking Trimipramine Capsules until your doctor
tells you to stop. Do not stop taking Trimipramine
Capsules 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 Capsules can cause
side effects, although not everybody gets them.
Stop taking Trimipramine Capsules 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 Capsules.
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)
Below is a list of other side effects that have been
reported:
 Feeling drowsy or sleepy
 Constipation
 Dry mouth
 Tremor (shaking)
 Blurred vision

What Trimipramine Capsules contain
• Each Trimipramine Capsule contains 50mg
trimipramine (as maleate).
• Other ingredients include maize starch,
microcrystalline cellulose (E460), colloidal
anhydrous silica, magnesium stearate, indigo
carmine (E132), yellow iron oxide (E172), titanium
dioxide (E171) and gelatin.
• The printing ink contains opacode-S/I/8100 black:
shellac, soya lecithin (E322), antifoam DC1510
and black iron oxide (E172).

What Trimipramine Capsules look like and
contents of the pack
Trimipramine Capsules have a white body with SU50
printed in black ink and a green cap with SU50 printed
in black ink.
The capsules contain an off white or slightly cream
powder or plug of powder.
They are supplied in blister packs of 28 capsules.
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganes, 62, 28923 Alcorcon, Madrid, Spain.
Procured from within the EU by the Product Licence
Holder: Millsdale Pharmaceuticals, John Street,
Warrington, Cheshire, WA2 7UB. UK.
PL No. 08811/ 0053

This leaflet was prepared 11th August 2016

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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