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TRIMIPRAMINE 50MG HARD CAPSULES

Active substance(s): TRIMIPRAMINE / TRIMIPRAMINE MALEATE

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PACKAGE LEAFLET: INFORMATION
FOR THE USER

Surmontil® 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.

The name of your medicine is Surmontil®
50mg hard capsules but it will be referred to
as Surmontil throughout in this leaflet.
In this leaflet:
1.
What Surmontil is and what it is
used for
2.
Before you take Surmontil
3.
How to take Surmontil
4.
Possible side effects
5.
How to store Surmontil
6.
Further information
1. What Surmontil is and what
it is used for
Your capsules contain a medicine called
trimipramine. This belongs to a group of
medicines called antidepressants.
Surmontil 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
Do not take this medicine
and tell your doctor if:
× You are allergic (hypersensitive) to
trimipramine or any of the other
ingredients of Surmontil (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 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 Surmontil.
Take special care with Surmontil
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.

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 Surmontil.

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 can
affect the way some other medicines work.
Also some medicines can affect the way
Surmontil 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
• Phenylephrine 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)
tryciclics and triptan derivatives, lithium,
St John’s Wort
• Pain Killers such as tramadol
• Macrolide antibiotics, antifungals or
floroquinolones.
Anaesthetics
If you are going to have an anaesthetic
(for an operation), tell your doctor or
dentist that you are taking Surmontil.
Taking Surmontil and drink
You should avoid drinking alcohol while
taking Surmontil
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.

Driving and using machines
Surmontil 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
Always take Surmontil 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
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 stays the same at
35mg to 75mg each day
Children:
Children should not take Surmontil.
If you take more Surmontil than you
should
If you take more Surmontil 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
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
Keep taking Surmontil until your doctor tells
you to stop. Do not stop taking Surmontil
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 can cause side
effects, although not everybody gets them.
Stop taking Surmontil 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.
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 heart beat.
Below is a list of other side effects
that have been reported:
• Feeling drowsy or sleepy
• Constipation
• Dry mouth
• Tremor (shaking)
• Blurred vision
• Rapid heart beat
• 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 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety of
this medicine.
5. How to store Surmontil
Keep out of the sight and reach of children.
Do not take your capsules after the expiry
date which is stated on the carton/ blister
label after ‘Exp’. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Store in the original package 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 contains
• The active ingredient is trimipramine as
maleate. Each hard capsule contains
50mg trimipramine (as maleate)
• Other ingredients include maize starch,
microcrystalline cellulose (E460),
colloidal anhydrous silica, magnesium
stearate, gelatin, titanium dioxide (E171),
indigo carmine (E132), yellow iron oxide
(E172). The printing ink contains
Opacode-S/1/8100 black: (shellac, soya
lecithin (E322), antifoam DC1510 and
black iron oxide (E172)).
What Surmontil look like and contents of
the pack
Surmontil are opaque hard capsules with a
white body and green cap printed with
‘SU50’ in black ink on both cap and body.
The capsule contains an off-white or cream
powder.
They are supplied in blister packs of 28
capsules.
Manufactured by:
Famar Healthcare Services Madrid
S.A.U., Avenida de Leganes 62, 28923
Alcorcon, Madrid, Spain.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA40NU,UK.
Surmontil® 50mg hard capsules,
PL 18799/2331
POM
Leaflet date: 09.06.2016
Surmontil is a registered trademark of
Sanofi-aventis.

PACKAGE LEAFLET: INFORMATION
FOR THE USER

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.

The name of your medicine is
Trimipramine® 50mg hard capsules but it
will be referred to as Trimipramine
throughout in this leaflet.
In this leaflet:
1.
What Trimipramine is and what it is
used for
2.
Before you take Trimipramine
3.
How to take Trimipramine
4.
Possible side effects
5.
How to store Trimipramine
6.
Further information
1. What Trimipramine is and
what it is used for
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).
2. 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 (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 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 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.

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
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
• Phenylephrine 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)
tryciclics and triptan derivatives, lithium,
St John’s Wort
• Pain Killers such as tramadol
• Macrolide antibiotics, antifungals or
floroquinolones.
Anaesthetics
If you are going to have an anaesthetic
(for an operation), tell your doctor or
dentist that you are taking
Trimipramine.
Taking Trimipramine and drink
You should avoid drinking alcohol while
taking Trimipramine
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.

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.
3. 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
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.
4. 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 heart beat.
Below is a list of other side effects
that have been reported:
• Feeling drowsy or sleepy
• Constipation
• Dry mouth
• Tremor (shaking)









Blurred vision
Rapid heart beat
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 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety of
this medicine.
5. How to store Trimipramine
Keep out of the sight and reach of children.
Do not take your capsules after the expiry
date which is stated on the carton/ blister
label after ‘Exp’. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Store in the original package 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 Trimipramine contains
• The active ingredient is trimipramine as
maleate. Each hard capsule contains
50mg trimipramine (as maleate)
• Other ingredients include maize starch,
microcrystalline cellulose (E460),
colloidal anhydrous silica, magnesium
stearate, gelatin, titanium dioxide (E171),
indigo carmine (E132), yellow iron oxide
(E172). The printing ink contains
Opacode-S/1/8100 black: (shellac, soya
lecithin (E322), antifoam DC1510 and
black iron oxide (E172)).
What Trimipramine look like and
contents of the pack
Trimipramine are opaque hard capsules with
a white body and green cap printed with
‘SU50’ in black ink on both cap and body.
The capsule contains an off-white or cream
powder.
They are supplied in blister packs of 28
capsules.
Manufactured by:
Famar Healthcare Services Madrid
S.A.U., Avenida de Leganes 62, 28923
Alcorcon, Madrid, Spain.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA40NU,UK.
Trimipramine 50mg hard capsules,
PL 18799/2331
POM
Leaflet date: 09.06.2016

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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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