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SURMONTIL 25MG TABLETS

Active substance(s): TRIMIPRAMINE / TRIMIPRAMINE MALEATE / TRIMIPRAMINE / TRIMIPRAMINE MALEATE

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Surmontil® 25mg Tablets
(trimipramine maleate)
Your medicine is known by the above name but will be referred to as
Surmontil Tablets throughout this leaflet. This medicine is also available in
10mg strength.
Patient Information Leaflet
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
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).

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 Tablets.
Take special care with Surmontil Tablets
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 Tablets.

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.
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 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 breast-feed if you are taking Surmontil Tablets.
Driving and using machines
Surmontil Tablets 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
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.

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
• Take this medicine by mouth
• 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
• 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 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.
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.

4) Possible side effects
Like all medicines, Surmontil Tablets can cause side effects, although not
everybody gets them.
Stop taking Surmontil Tablets 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 Tablets.
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)
• 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 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, 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 Tablets
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and bottle. The expiry date refers to the last day of the month.
• Do not store above 25˚C.
• Store the tablets in the original container in order to protect from light.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Further information
What Surmontil contains:
The active substance is trimipramine maleate. Each film-coated tablet
contains 25mg trimipramine maleate.
The other ingredients are: potato starch, calcium hydrogen phosphate
dihydrate, magnesium stearate, talc, lactose, hypromellose, titanium
dioxide (E171) and macrogol.
What Surmontil look like and the contents of the pack
Surmontil 25mg Tablets are white, round and biconvex. They are marked
on one side with ‘SURMONTIL’ just inside the perimeter around a centrally
marked ‘25’, and plain on the other.
Surmontil Tablets come in bottles containing 100 tablets.
PL 10383/2182 Surmontil 25mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Famar Health Care Services Madrid,
S.A.U. Alcorcón, Madrid, Spain.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 13.12.2016
Surmontil® is a registered trademark of SANOFI.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the leaflet in a format suitable
for you.

Trimipramine 25mg Tablets
(trimipramine maleate)
Your medicine is known by the above name but will be referred to as
Trimipramine Tablets throughout this leaflet. This medicine is also
available in 10mg strength.
Patient Information Leaflet
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
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).

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 Tablets.
Take special care with Trimipramine Tablets
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 Tablets.

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.
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 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 breast-feed if you are taking Trimipramine Tablets.
Driving and using machines
Trimipramine Tablets 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
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.

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
• Take this medicine by mouth
• 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
• 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 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.
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.

4) Possible side effects
Like all medicines, Trimipramine Tablets can cause side effects, although
not everybody gets them.
Stop taking Trimipramine Tablets 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 Tablets.
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)
• 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 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, 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 Tablets
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and bottle. The expiry date refers to the last day of the month.
• Do not store above 25˚C.
• Store the tablets in the original container in order to protect from light.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Further information
What Trimipramine contains:
The active substance is trimipramine maleate. Each film-coated tablet
contains 25mg trimipramine maleate.
The other ingredients are: potato starch, calcium hydrogen phosphate
dihydrate, magnesium stearate, talc, lactose, hypromellose, titanium
dioxide (E171) and macrogol.
What Trimipramine look like and the contents of the pack
Trimipramine 25mg Tablets are white, round and biconvex. They are
marked on one side with ‘SURMONTIL’ just inside the perimeter around a
centrally marked ‘25’, and plain on the other.
Trimipramine Tablets come in bottles containing 100 tablets.
PL 10383/2182 Trimipramine 25mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Famar Health Care Services Madrid,
S.A.U. Alcorcón, Madrid, Spain.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 13.12.2016

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the leaflet in a format suitable
for you.

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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