SURMONTIL 50MG CAPSULES

Active substance: TRIMIPRAMINE MALEATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Surmontil 50mg Capsules
Trimipramine

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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 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
1. What Surmontil Capsules are
and what they are used for
The name of your medicine is Surmontil
50mg 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).

2. Before you take Surmontil Capsules
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 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
Surmontil Capsules.
Take special care with Surmontil
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.
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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 Surmontil
Capsules.
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.
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 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.
3. How to take Surmontil Capsules
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
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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 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.
4. Possible side effects
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.
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’
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• 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
• 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.
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.
5. How to store Surmontil Capsules
Keep this medicine in a safe place where
children cannot see or reach it.
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.
50mg Capsules: Store below 25°C. Keep
the blister in the outer carton in order 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
What Surmontil Capsules contain
• Each Surmontil 50mg Capsule contains
69.75mg of the active substance,
trimipramine maleate, equivalent to
50mg of trimipramine
• Other ingredients include maize
starch, microcrystalline cellulose
(E460), colloidal anhydrous silica,
magnesium stearate, indigo carmine
(E132), yellow iron oxide (E172),
titanium dioxide (E171), gelatin, and
black iron oxide (E172)
What Surmontil Capsules look like
and contents of the pack
Surmontil 50mg capsules are white and
green with SU50 printed in black. They
are supplied in blister packs of 28
capsules.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62,
Alcorcón 28923 (Madrid) Spain
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.
This leaflet was last revised in 06/2012
© Zentiva, 1973 - 2012

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• 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

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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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