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SURMONTIL 25MG TABLETS

Active substance(s): TRIMIPRAMINE / TRIMIPRAMINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Surmontil® 25mg Tablets
(trimipramine maleate)

Revision date: 29.09.2015
Leaflet Reference: SURM25

Although your medicine is called Surmontil® 25mg Tablets, it will be
called Surmontil® Tablets throughout this leaflet.

Check with your doctor or pharmacist before taking this medicine
if:

Surmontil® is also available as Surmontil® 10mg Tablets.







Read all of this leaflet carefully before you start taking this
medicine






Keep this leaflet. You may need to read it again.

If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before taking Surmontil® Tablets.

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.

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®
Tablets can affect the way some other medicines work. Also some
medicines can affect the way Surmontil® Tablets work.

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.
2.
3.
4.
5.
6.

Tell your doctor if you are taking any of the following medicines:

What Surmontil® Tablets are and what they are used for.
Before you take Surmontil® Tablets
How to take Surmontil® Tablets
Possible side effects
How to store Surmontil® Tablets
Further Information

1. What Surmontil® Tablets are and what they are used for
Your tablets contain a medicine called trimipramine. This belongs to a
group of medicines called antidepressants.
Surmontil® Tablets 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).



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)



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

2. Before you take Surmontil® Tablets
Do not take this medicine and tell your doctor 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

You are allergic (hypersensitive) to trimipramine or any of the other
ingredients of Surmontil® Tablets (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

Medicines used to treat high blood pressure
Adrenaline, noradrenaline, ephedrine or isoprenaline – used in an
emergency

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® Tablets.
Taking Surmontil® Tablets and drink
You should avoid drinking alcohol while taking Surmontil® Tablets.
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 take this medicine if this applies to you. If you are not sure, talk
to your doctor or pharmacist before taking Surmontil® Tablets.

Do not breast-feed if you are taking Surmontil® Tablets.

Take special care with Surmontil® Tablets

Driving and using machines

Thoughts of suicide and worsening of your depression or anxiety
disorder

Surmontil® Tablets may make you feel sleepy or less alert. If this
happens, do not drive or use any tools or machines.

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:

Important information about some of the ingredients of
Surmontil® Tablets
Surmontil® Tablets contain lactose. If you have been told that you
cannot digest or tolerate some sugars, talk to your doctor before taking
Surmontil® Tablets.

 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.

3. How to take Surmontil® Tablets
Always take Surmontil® Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Taking this medicine

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.
1





Take this medicine by mouth



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

Swallow the Tablets whole with a drink of water
If you have been told to take Surmontil® Tablets only once each
day then you should take it before going to bed

How much to take
Adults:
Depression




Adults usually start by taking 50mg to 75mg each day.



Once you start to feel better, the usual daily dose stays the same
at 75mg to 150mg each day

Your doctor may then increase the dose to 150mg or 300mg each
day depending on your condition

Blurred vision





Sexual problems

Rapid heartbeat
Sweating more than usual
Feeling dizzy or light-headed on standing or sitting up quickly
(postural hypotension)
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.

Elderly:










Elderly usually start by taking 10mg to 25mg three times each day
Your doctor will then increase this slowly

Reporting of side effects:

Once you start to feel better, the usual daily dose then stays the
same at 35mg to 75mg each day

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.

Children:
Children should not take Surmontil® Tablets.
If you take more Surmontil® Tablets than you should
If you take more Surmontil® Tablets 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.

5. How to store Surmontil® Tablets

If you forget to take Surmontil® Tablets








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® Tablets
Keep taking Surmontil® Tablets until your doctor tells you to stop. Do
not stop taking Surmontil® Tablets 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.

6. Further information
What Surmontil® Tablets contain




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

Each tablet contains 25mg of trimipramine as maleate
Other ingredients include starch potato, calcium hydrogen
phosphate, talc, magnesium stearate, Opadry OY-L-28900 (which
contains lactose monohydrate, hypromellose, titanium dioxide
(E171) and macrogol 400)

What Surmontil® Tablets look like and contents of the pack

Stop taking Surmontil® Tablets and see a doctor or go to a
hospital straight away if:



Keep this medicine out of the sight and reach of children.
Do not use Surmontil® Tablets after the expiry date which is stated
on the bottle and carton after EXP. The expiry date refers to the
last day of that month.
Keep the container tightly closed in order to protect from light.
Do not store above 25°C.
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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.

Surmontil® 25mg Tablets are 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 packs of 50

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® Tablets.

Who manufactured your medicine
Manufactured by FAMAR HEALTH CARE SERVICES MADRID S.A.U,
Av. de Leganes 62, 28923 Alcorcon, Madrid, Spain. Procured from
within the EU and repackaged by Product Licence holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3
0RB.

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 jaundice) • Overactive behaviour or thoughts (mania or
hypomania)

PL 16378/0559



Numbness or weakness in the arms and legs (peripheral
neuropathy)

Revision date: 29.09.2015




Feeling that someone is ‘out to get you’




Convulsions/fits



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.

Leaflet Reference: SURM25

Getting infections more easily than usual. This could be because
of a blood disorder (agranulocytosis)

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.

Unusual skin sensations such as numbness, tingling, pricking,
burning or creeping on the skin (paraesthesia)

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

Below is a list of other side effects that have been reported:






POM

Feeling drowsy or sleepy
Constipation
Dry mouth
Tremor (shaking)
2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Trimipramine 25mg Tablets
(trimipramine maleate)

Revision date: 29.09.2015
Leaflet Reference: TRIMI25

Although your medicine is called Trimipramine 25mg Tablets, it will be
called Trimipramine Tablets throughout this leaflet.

Check with your doctor or pharmacist before taking this medicine
if:

Trimipramine is also available as Trimipramine 10mg Tablets.







Read all of this leaflet carefully before you start taking this
medicine






Keep this leaflet. You may need to read it again.

If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before taking Trimipramine Tablets.

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.

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 Tablets can affect the way some other medicines work.
Also some medicines can affect the way Trimipramine Tablets work.

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.
2.
3.
4.
5.
6.

Tell your doctor if you are taking any of the following medicines:

What Trimipramine Tablets are and what they are used for.
Before you take Trimipramine Tablets
How to take Trimipramine Tablets
Possible side effects
How to store Trimipramine Tablets
Further information

1. What Trimipramine Tablets are and what they are used for
Your tablets contain a medicine called trimipramine. This belongs to a
group of medicines called antidepressants.
Trimipramine Tablets 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).



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)



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

2. Before you take Trimipramine Tablets
Do not take this medicine and tell your doctor 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

You are allergic (hypersensitive) to trimipramine or any of the other
ingredients of Trimipramine Tablets (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

Medicines used to treat high blood pressure
Adrenaline, noradrenaline, ephedrine or isoprenaline – used in an
emergency

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 Tablets.
Taking Trimipramine Tablets and drink
You should avoid drinking alcohol while taking Trimipramine Tablets.
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 take this medicine if this applies to you. If you are not sure, talk
to your doctor or pharmacist before taking Trimipramine Tablets.

Do not breast-feed if you are taking Trimipramine Tablets.

Take special care with Trimipramine Tablets

Driving and using machines

Thoughts of suicide and worsening of your depression or anxiety
disorder

Trimipramine Tablets may make you feel sleepy or less alert. If this
happens, do not drive or use any tools or machines.

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:

Important information about some of the ingredients of
Trimipramine Tablets
Trimipramine Tablets contain lactose. If you have been told that you
cannot digest or tolerate some sugars, talk to your doctor before taking
Trimipramine Tablets.

 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.

3. How to take Trimipramine Tablets
Always take Trimipramine Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Taking this medicine

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.
1





Take this medicine by mouth



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

Swallow the Tablets whole with a drink of water
If you have been told to take Trimipramine Tablets only once each
day then you should take it before going to bed

How much to take
Adults:
Depression




Adults usually start by taking 50mg to 75mg each day.



Once you start to feel better, the usual daily dose then stays the
same at 75mg to 150mg each day

Your doctor may then increase the dose to 150mg or 300mg each
day depending on your condition

Blurred vision





Sexual problems

Rapid heartbeat
Sweating more than usual
Feeling dizzy or light-headed on standing or sitting up quickly
(postural hypotension)
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.

Elderly:










Elderly usually start by taking 10mg to 25mg three times each day
Your doctor will then increase this slowly

Reporting of side effects:

Once you start to feel better, the usual daily dose stays the same
at 35mg to 75mg each day

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.

Children:
Children should not take Trimipramine Tablets.
If you take more Trimipramine Tablets than you should
If you take more Trimipramine Tablets 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.

5. How to store Trimipramine Tablets

If you forget to take Trimipramine Tablets








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 Tablets
Keep taking Trimipramine Tablets until your doctor tells you to stop. Do
not stop taking Trimipramine Tablets 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.

6. Further information
What Trimipramine Tablets contain




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

Each tablet contains 25mg of trimipramine as maleate
Other ingredients include starch potato, calcium hydrogen
phosphate, talc, magnesium stearate, Opadry OY-L-28900 (which
contains lactose monohydrate, hypromellose, titanium dioxide
(E171) and macrogol 400)

What Trimipramine Tablets look like and contents of the pack

Stop taking Trimipramine Tablets and see a doctor or go to a
hospital straight away if:



Keep this medicine out of the sight and reach of children.
Do not use Trimipramine Tablets after the expiry date which is
stated on the bottle and carton after EXP. The expiry date refers to
the last day of that month.
Keep the container tightly closed in order to protect from light.
Do not store above 25°C.
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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.

Trimipramine 25mg Tablets are 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 packs of 50

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 Tablets.

Who manufactured your medicine
Manufactured by FAMAR HEALTH CARE SERVICES MADRID S.A.U,
Av. de Leganes 62, 28923 Alcorcon, Madrid, Spain. Procured from
within the EU and repackaged by Product Licence holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3
0RB.

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 jaundice) • Overactive behaviour or thoughts (mania or
hypomania)

PL 16378/0559



Numbness or weakness in the arms and legs (peripheral
neuropathy)

Revision date: 29.09.2015




Feeling that someone is ‘out to get you’




Convulsions/fits



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.

Leaflet Reference: TRIMI25

Getting infections more easily than usual. This could be because
of a blood disorder (agranulocytosis)

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.

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:






POM

Feeling drowsy or sleepy
Constipation
Dry mouth
Tremor (shaking)
2

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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