SURMONTIL 10MG TABLETS

Active substance: TRIMIPRAMINE

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Surmontil 10mg Tablets

2501
02.08.13[2]

(trimipramine maleate)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as Surmontil Tablets throughout the
following leaflet. Surmontil Tablets are also available in other strengths.
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
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
Surmontil 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 6 Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
- You have had a heart attack
- You have 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.

Tell your doctor if you are taking any of the following medicines:
- MAOI (MonoAmine Oxidase Inhibitors) medicine such as
tranylcypromine, phenelzine and isocarboxazid (for depression) or
selegiline (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
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 with food 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
trimipramine.
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 then stays the same at
35mg to 75mg each day

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.

Children:
Children should not take Surmontil Tablets.

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 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.

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.

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)
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 type of medicine.
If any of the side effects get serious or lasts longer than a few days,
please tell your doctor or pharmacist. Also do this if you notice any
side effects not listed in the leaflet.
5. HOW TO STORE SURMONTIL TABLETS
Keep out of the sight and reach of children.
Check the "expiry" date, which is printed on the carton label and bottle
label. If it is out of date do not use it and contact your pharmacist.
o

Do not store above 25 C.
Store in the original container to protect from light.
If your doctor decides to stop the treatment return any left over medicine to
the pharmacist. Only keep them if your doctor tells you.
If your tablets become discoloured or shown any other signs of
deterioration, please contact your pharmacist before taking your medicine.
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
Each tablet contains 10 mg of trimipramine (as maleate).
Other ingredients include calcium hydrogen phosphate dihydrate, potato
starch, magnesium stearate, talc, lactose monohydrate, hypromellose,
titanium dioxide (E171) and macrogol.
What Surmontil Tablets look like and contents of the pack
Surmontil Tablets are white, circular and biconvex. On one face they have
‘SURMONTIL’ impressed just inside the perimeter around a centrally
impressed ‘10’, scoreline on reverse face.
Tablets are available in blister packs of 25, 50 and 100.

Manufacturer and Product Licence Holder
Manufactured by
Aventis Pharma, Dagenham, Essex RM10 7XS, UK.
Sanofi- Aventis S.A., Alcorcon, Spain.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2501

Leaflet revision and issue date (Ref) 02.08.13[2]
Surmontil is a trademark of May & Baker Limited.

Trimipramine 10mg Tablets

2501
02.08.13[2]

(trimipramine maleate)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as Trimipramine Tablets throughout the
following leaflet. Trimipramine Tablets are also available in other strengths.
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
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
Trimipramine 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 6 Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
- You have had a heart attack
- You have 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.
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.
T ell your doctor if you are taking any of the following medicines:
- MAOI (MonoAmine Oxidase Inhibitors) medicine such as
tranylcypromine, phenelzine and isocarboxazid (for depression) or
selegiline (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
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 with food 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.
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 then 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)
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 type of medicine.
If any of the side effects get serious or lasts longer than a few days,
please tell your doctor or pharmacist. Also do this if you notice any
side effects not listed in the leaflet.
5. HOW TO STORE TRIMIPRAMINE TABLETS
Keep out of the sight and reach of children.
Check the "expiry" date, which is printed on the carton label and bottle
label. If it is out of date do not use it and contact your pharmacist.
o

Do not store above 25 C.
Store in the original container to protect from light.
If your doctor decides to stop the treatment return any left over medicine to
the pharmacist. Only keep them if your doctor tells you.
If your tablets become discoloured or shown any other signs of
deterioration, please contact your pharmacist before taking your medicine.
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 Tablets contain
Each tablet contains 10 mg of trimipramine (as maleate).
Other ingredients include calcium hydrogen phosphate dihydrate, potato
starch, magnesium stearate, talc, lactose monohydrate, hypromellose,
titanium dioxide (E171) and macrogol.
What Trimipramine Tablets look like and contents of the pack
Trimipramine Tablets are white, circular and biconvex. On one face they
have ‘SURMONTIL’ impressed just inside the perimeter around a centrally
impressed ‘10’, scoreline on reverse face.
Tablets are available in blister packs of 25, 50 and 100.

Manufacturer and Product Licence Holder
Manufactured by
Aventis Pharma, Dagenham, Essex RM10 7XS, UK.
Sanofi- Aventis S.A., Alcorcon, Spain.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2501

Leaflet revision and issue date (Ref) 02.08.13[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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