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Patient Information Leaflet

Surmontil® 50mg Hard Capsules / Trimipramine 50mg Hard Capsules
(trimipramine maleate)
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.
 Surmontil® 50mg Hard Capsules / Trimipramine 50mg Hard Capsules
are also available in other strengths.

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

In this leaflet:
1) What Surmontil Capsules are and what they are used for
2) Before you take Surmontil Capsules
3) How to take Surmontil Capsules
4) Possible side effects
5) How to store Surmontil Capsules
6) Further information

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 Surmontil
Capsules can affect the way some other medicines work. Also some
medicines can affect the way Surmontil Capsules work.

The name of your medicine is Surmontil 50mg Hard Capsules /
Trimipramine 50mg Hard Capsules (called Surmontil Capsules in this
leaflet). Surmontil Capsules contain a medicine called trimipramine. This
belongs to a group of medicines called antidepressants.
Surmontil 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).
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to trimipramine or any of the other
ingredients of Surmontil 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
 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 Surmontil Capsules.
Take special care with Surmontil Capsules
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 are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Surmontil Capsules.

Tell your doctor if you are taking any of the following medicines:
 MAOI (MonoAmine Oxidase Inhibitors) medicines 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
 Phenylephrine or phenylpropanolamine – found in cold and flu
If you are going to have an anaesthetic (for an operation), tell your doctor
or dentist that you are taking Surmontil Capsules.
Taking Surmontil Capsules with food and drink
You should avoid drinking alcohol while taking Surmontil 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 Surmontil Capsules.
Driving and using machines
Surmontil Capsules may make you feel sleepy or less alert. If this
happens do not drive or use any tools or machines.
Always take Surmontil 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 Surmontil 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 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 then stays the same
at 35mg to 75mg each day
Children should not take Surmontil Capsules.
If you take more Surmontil Capsules than you should
If you take more Surmontil 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 Surmontil 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.
If you stop taking Surmontil Capsules
Keep taking Surmontil Capsules until your doctor tells you to stop. Do not
stop taking Surmontil 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.
Like all medicines, Surmontil Capsules can cause side effects, although
not everybody gets them.
Stop taking Surmontil 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
Surmontil Capsules.

Reporting of side effects
If you get 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: By reporting side effects, you can help
provide more information on the safety of this medicine.
 Keep this medicine in a safe place where children cannot see or reach
 Do not use Surmontil 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. Keep the blister in the outer carton in order
to protect from light.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it 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 Surmontil Capsules contain
Each capsule contains 50mg of trimipramine as maleate.
The other ingredients are:
Maize starch, Microcrystalline cellulose (E460), Magnesium stearate,
Colloidal anhydrous silica, Titanium dioxide (E171), Gelatin, Indigo
carmine (E132), Iron Oxide Yellow (E172), Iron Oxide Black (E172),
Shellac, Soya lecithin (E322), Antifoam DC1510
What Surmontil Capsules look like and contents of the pack
Surmontil Capsules are opaque, hard gelatin capsules. The capsule body
is white and the cap is green with “SU50” printed in black on both the cap
and the body. They come in uPVC/PVdC/aluminium blister strips in a
printed carton.
Each pack contains 28 capsules.

Talk to your doctor straight away if you notice the following sideeffects:
 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)

sanofi-aventis S.A.
Avenida de Leganés 62,
28925 Alcorcón,
Madrid, Spain

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

PL: 33532/0421

An increased risk of bone fractures has been observed in patients taking
this type of medicine.
If any of the side effects get serious or lasts longer than a few days,
please tell your doctor or pharmacist. Also do this if you notice any
side effects not listed in the leaflet.

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, UK
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 date: 15th November 2013
Leaflet code: XXXXXXXXXX
Surmontil® is a registered trademark of XXXXXXXXXXXXXXXXXXXX.

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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.