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TRIMIPRAMINE 10 MG TABLETS

Active substance(s): TRIMIPRAMINE / TRIMIPRAMINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Surmontil 10 mg
Tablets, Surmontil®
25 mg Tablets
(trimipramine maleate)

To request a copy of this
leaflet in large print, audio
CD or Braille please call
0121 565 3101.

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 Tablets are and what
they are used for.
2. Before you take Surmontil Tablets
3. How to take Surmontil Tablets
4. Possible side effects
5. How to store Surmontil Tablets
6. Further information
1. What Surmontil Tablets are
and what they are used for
The name of your medicine is Surmontil 10
mg or 25 mg Tablets (called Surmontil in
this leaflet). 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).

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.

2. Before you take Surmontil
Tablets
Do not take this medicine and
tell your doctor if:
 You are allergic (hypersensitive) to
trimipramine or any of the other
ingredients of Surmontil Tablets (listed
in Section 5 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.

1

Turn
Over

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)

3

Turn
Over

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

• Phenylelphrine 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 Tablets 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 Tablets
Always take Surmontil exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.

2

Ref: 758

• 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 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 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:
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
Tablets
Keep out of the sight and reach of children.
Do not use after the expiry date which is
stated on the blister or bottle label 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, or store the tablets in the original
container in order to protect from light.
Should your tablets become discoloured
or show any other signs of deterioration,
contact your pharmacist for advice.
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 Tablets contain
• 10 mg: Each film-coated tablet contains
10 mg of trimipramine as maleate.
• 25 mg: Each film-coated tablet contains
25 mg of trimipramine as maleate.
• Other ingredients include potato
starch, calcium hydrogen phosphate
dihydrate, magnesium stearate, talc,
lactose, hypromellose, macrogol and
titanium dioxide (E171).
What Surmontil Tablets look like and
contents of the pack
Surmontil 10 mg Tablets are film-coated,
white to pale yellow, circular and
biconvex. On one face they have
‘SURMONTIL’ impressed just inside the
perimeter around a centrally impressed
‘10’, with a scoreline on reverse face.
Tablets are available in blister packs of
25, 50, or 100 Tablets.
Surmontil 25 mg Tablets are film-coated,
white to pale yellow, circular and biconvex.
On one face they have ‘SURMONTIL’
impressed just inside the perimeter around
a centrally impressed ‘25’. The reverse
face is plain.
Tablets are available in sealed grey
containers with a white lid containing 100
Tablets.
Manufactured by:
Famar Health Care Services Madrid
S.A.U., Alcorcon, 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.
Procured from within the EU by the
Product Licence Holder:
Expono Ltd, Cornwall Road, Smethwick,
B66 2JT, UK.
Repackaged by:
N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0180 - Surmontil® 10 mg Tablets
PL 22961/0181 - Surmontil® 25 mg Tablets
Revision Date: 06.01.2017

POM

Surmontil is a registered trademark of
May & Baker Limited.
®

Ref: 758

4

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Trimipramine 10 mg
Tablets, Trimipramine
25 mg Tablets
(trimipramine maleate)

To request a copy of this
leaflet in large print, audio
CD or Braille please call
0121 565 3101.

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 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
1. What Trimipramine Tablets
are and what they are used
for
The name of your medicine is Trimipramine
10 mg or 25 mg Tablets (called
trimipramine in this leaflet). 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).

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
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.

2. Before you take Trimipramine
Tablets
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 5 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.

1

Turn
Over

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.
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)

3

Turn
Over

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

• Phenylelphrine 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 Tablets 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
Tablets
Always take trimipramine exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.

Ref: 757

• 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 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 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:
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
Tablets
Keep out of the sight and reach of children.
Do not use after the expiry date which is
stated on the blister or bottle label 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, or store the tablets in the original
container in order to protect from light.
Should your tablets become discoloured
or show any other signs of deterioration,
contact your pharmacist for advice.
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.

2

6. Further information
What Trimipramine Tablets contain
• 10 mg: Each film-coated tablet contains
10 mg of trimipramine as maleate.
• 25 mg: Each film-coated tablet contains
25 mg of trimipramine as maleate.
• Other ingredients include potato
starch, calcium hydrogen phosphate
dihydrate, magnesium stearate, talc,
lactose, hypromellose, macrogol and
titanium dioxide (E171).
What Trimipramine Tablets look like
and contents of the pack
Trimipramine 10 mg Tablets are
film-coated, white to pale yellow, circular
and biconvex. On one face they have
‘SURMONTIL’ impressed just inside the
perimeter around a centrally impressed
‘10’, with a scoreline on reverse face.
Tablets are available in blister packs of
25, 50, or 100 Tablets.
Trimipramine 25 mg Tablets are
film-coated white to pale yellow, circular
and biconvex. On one face they have
‘SURMONTIL’ impressed just inside the
perimeter around a centrally impressed
‘25’. The reverse face is plain.
Tablets are available in sealed grey
containers with a white lid containing 100
Tablets.
Manufactured by:
Famar Health Care Services Madrid
S.A.U., Alcorcon, 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.
Procured from within the EU by the
Product Licence Holder:
Expono Ltd, Cornwall Road, Smethwick,
B66 2JT, UK.
Repackaged by:
N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0180 - Trimipramine 10 mg
Tablets
PL 22961/0181 - Trimipramine 25 mg
Tablets
POM
Revision Date: 06.01.2017
Ref: 757

4

Expand Transcript

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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