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Active substance(s): TRIMIPRAMINE MALEATE

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Patient Information Leaflet

Trimipramine 10mg Film-coated Tablets
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.
 The name of your medicine is Trimipramine 10mg Film-coated Tablets
but it will be referred to as Trimipramine Tablets throughout the
remainder of this leaflet.
 Trimipramine Tablets are also available in other strengths.
In this leaflet:
1) What Trimipramine Tablets are and what they are used for
2) Before you take Trimipramine Tablets
3) How to take Trimipramine Tablets
4) Possible side effects
5) How to store Trimipramine Tablets
6) Further information
Your tablets contain a medicine called trimipramine. This belongs to a
group of medicines called antidepressants.
Trimipramine Tablets 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
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to trimipramine or any of the other
ingredients of Trimipramine Tablets (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
 You have severe liver problems
 You have mania (signs include very high mood, energy and unusual
 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 Tablets.
Take special care with Trimipramine Tablets
Thoughts of suicide and worsening of your depression or anxiety
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
 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 Tablets.
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
Tablets can affect the way some other medicines work. Also some
medicines can affect the way Trimipramine Tablets 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 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
 Phenylephrine or phenylpropanolamine – found in cold and flu
 Medicines used for chest pain (angina) or high blood pressure such as
diltiazem, verapamil, clonidine, digitalis
 Medicines used for depression (SSRIs such as citalopram, paroxetine,
fluoxetine) tricyclics and triptan derivatives, lithium, St John’s Wort
 Pain killers such as tramadol
 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 Tablets.
Taking Trimipramine Tablets and drink
You should avoid drinking alcohol while taking Trimipramine Tablets.
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 Tablets.
Driving and using machines
Trimipramine Tablets may make you feel sleepy or less alert. If this
happens, do not drive or use any tools or machines.
Important information about some of the ingredients of
Trimipramine Tablets
Trimipramine Tablets contain lactose. If you have been told that you
cannot digest or tolerate some sugars, talk to your doctor before taking
Trimipramine Tablets.
Always take Trimipramine Tablets 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 tablets whole with a drink of water
 If you have been told to take Trimipramine Tablets 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 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 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 should not take Trimipramine Tablets
If you take more Trimipramine Tablets than you should
If you take more Trimipramine Tablets 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 Tablets
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 Tablets
Keep taking Trimipramine Tablets until your doctor tells you to stop. Do
not stop taking Trimipramine Tablets just because you feel better. This is
because your illness may come back. When your doctor tells you to stop
taking these tablets 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.
Like all medicines, Trimipramine Tablets can cause side effects, although
not everybody gets them.
Stop taking Trimipramine Tablets 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
Talk to your doctor straight away if you notice the following
 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
 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
 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 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:
By reporting side effects you can help provide more information on the
safety of this medicine.

Keep out of the sight and reach of children.
Do not store above 25oC.
Keep the blister pack in the carton to protect from light.
Do not use Trimipramine Tablets 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.
 If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
 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.
What Trimipramine Tablets contain
Each tablet contains 10mg of trimipramine as maleate.
The other ingredients are potato starch, calcium hydrogen phosphate
dihydrate, talc, magnesium stearate, lactose monohydrate, hypromellose,
titanium dioxide (E171) and macrogol.
What Trimipramine 10mg Film-coated Tablets look like and contents
of the pack
Trimipramine 10mg Tablets are white to pale yellow, circular, biconvex,
film-coated tablets. On one face they have ‘SURMONTIL’ impressed just
inside the perimeter around a centrally impressed ‘10’ and an incomplete
scoreline on the reverse face.
Trimipramine 10mg Film-coated Tablets come in packs containing
50 or 100 tablets.
Manufactured by
Famar Health Care Services Madrid S.A.U., Alcorcon, Spain.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0808


This leaflet does not contain all the information about your medicine. If
you have any questions or are not sure about anything, ask your doctor
or pharmacist.
Leaflet dated 5th May 2017
Leaflet coded XXXXXXXXXXX
Surmontil® is a registered trademark of SANOFI.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.