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SURMONTIL 25MG FILM-COATED TABLETS

Active substance(s): TRIMIPRAMINE MALEATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Surmontil 25mg FilmCoated Tablets
(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
25mg Film-Coated Tablets but it will be
referred to as Surmontil throughout the
leaflet. Please note that the leaflet also
contains information about other strength
Surmontil 10mg Film-Coated Tablets.
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 tablets 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, 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 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 as 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.
Important information about some of
the ingredients of Surmontil
Surmontil contain lactose. If you have
been told that you cannot digest or
tolerate some sugars, talk to your doctor
before taking Surmontil.
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 tablets 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 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.
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 sight and reach of children.
Do not use after the expiry date which is
stated on the carton and bottle label after
‘Exp’. The expiry date refers to the last
day of that month.
Do not store above 25°C.

Keep container tightly closed in order to
protect from light.
If the tablets become discoloured or show
any signs of deterioration, you should
seek the advice of 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.
6. Further information
What Surmontil contains
The active ingredient is trimipramine
maleate.
Each tablet contains 25mg trimipramine
(as maleate).
Other ingredients are: starch potato,
calcium hydrogen phosphate, talc,
magnesium stearate, lactose
monohydrate, hypromellose, titanium
dioxide (E171) and macrogol 400.
What Surmontil looks like and contents
of the pack
Surmontil are white to pale yellow,
circular, biconvex, film-coated tablets
with ‘SURMONTIL’ impressed just
inside the perimeter around a
centrally impressed ‘25’. The tablets
are plain on the other side.
The tablets are available in bottles
containing 50 tablets.
Manufactured by: Famar Health
Care 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,
HA4 0NU, UK.
®

Surmontil 25mg Film-Coated Tablets,
PL 18799/2373
POM
Leaflet date: 16.06.2016
Surmontil is registered trademark of
Sanofi.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Trimipramine 25mg FilmCoated Tablets
(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 25mg Film-Coated Tablets
but it will be referred to as Trimipramine
throughout the leaflet. Please note that
the leaflet also contains information about
other strength Trimipramine 10mg
Film-Coated Tablets.
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 tablets 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, 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 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 as 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.
Important information about some of
the ingredients of Trimipramine
Trimipramine contain lactose. If you have
been told that you cannot digest or
tolerate some sugars, talk to your doctor
before taking trimipramine.
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 tablets 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

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 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.
4. Possible side effects
Like all medicines, Trimipramine can
cause side effects, although not
everybody gets them.

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

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.

Children:
Children should not take 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)

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.







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 sight and reach of children.
Do not use after the expiry date which is
stated on the carton and bottle label after
‘Exp’. The expiry date refers to the last
day of that month.
Do not store above 25°C.

Keep container tightly closed in order to
protect from light.
If the tablets become discoloured or show
any signs of deterioration, you should
seek the advice of 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.
6. Further information
What Trimipramine contains
The active ingredient is trimipramine
maleate.
Each tablet contains 25mg trimipramine
(as maleate).
Other ingredients are: starch potato,
calcium hydrogen phosphate, talc,
magnesium stearate, lactose
monohydrate, hypromellose, titanium
dioxide (E171) and macrogol 400.
What Trimipramine looks like and
contents of the pack
Trimipramine are white to pale
yellow, circular, biconvex, filmcoated tablets with ‘SURMONTIL’
impressed just inside the perimeter
around a centrally impressed ‘25’.
The tablets are plain on the other
side.
The tablets are available in bottles
containing 50 tablets.
Manufactured by: Famar Health
Care 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,
HA4 0NU, UK.
Trimipramine 25mg Film-Coated
Tablets,
PL 18799/2373
POM
Leaflet date: 16.06.2016

Expand view ⇕

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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