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TRIMIPRAMINE 50MG HARD CAPSULES

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SURMONTIL® 50mg HARD CAPSULES
(trimipramine maleate)
This product is available using the above name but will be referred to as Surmontil Capsules
throughout the following 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 Capsules are and what they are used for
2. Before you take Surmontil Capsules
3. How to take Surmontil Capsules
4. Possible side effects
5. How to store Surmontil Capsules
6. Further information
1. WHAT SURMONTIL CAPSULES ARE AND WHAT THEY ARE USED FOR
Surmontil Capsules contain a medicine called trimipramine. This belongs to a group of medicines
called antidepressants.
Surmontil Capsules 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 CAPSULES
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Surmontil
Capsules (listed in Section 6 Further information). Signs of an allergic reaction include: a rash,
swelling or breathing problems, swelling of your lips, face, throat or tongue
• You have had a heart attack
• You have had any other heart problems including slow or uneven heart beat
• You have severe liver problems
• You have mania (signs include very high mood, energy and unusual behaviour)
• You are breast-feeding
Do not take this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist
before taking Surmontil Capsules.
Take special care with Surmontil Capsules
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 Capsules.
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 Capsules can affect the way some other medicines work. Also some medicines can affect
the way Surmontil Capsules 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 a 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 Capsules.
Taking Surmontil Capsules with food and drink
You should avoid drinking alcohol while taking Surmontil Capsules.
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 Capsules.
Driving and using machines
Surmontil Capsules may make you feel sleepy or less alert. If this happens do not drive or use any
tools or machines.
3. HOW TO TAKE SURMONTIL CAPSULES
Always take Surmontil Capsules 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 capsules whole with a drink of water
• If you have been told to take Surmontil Capsules 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 Capsules.
If you take more Surmontil Capsules than you should
If you take more Surmontil Capsules 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 Capsules
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 Capsules
Keep taking Surmontil Capsules until your doctor tells you to stop. Do not stop taking Surmontil
Capsules just because you feel better. This is because your illness may come back. When your doctor
tells you to stop taking these capsules 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 Capsules can cause side effects, although not everybody gets them.
Stop taking Surmontil Capsules 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 Capsules.
Talk to your doctor straight away if you notice the following side-effects:
• Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
• Overactive behaviour or thoughts (mania or hypomania)
• Numbness or weakness in the arms and legs (peripheral neuropathy)
• Feeling that someone is ‘out to get you’
• Getting infections more easily than usual. This could be because of a blood disorder
(agranulocytosis)
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin
(paraesthesia)
• Increased thirst and passing water (urine) more often than normal. You may also feel tired and
hungry. This could be due to high blood sugar levels or a condition called diabetes
• An uneven or fast 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 CAPSULES
• Keep out of the sight and reach of children.
• Do not use Surmontil Capsules after the expiry date. The expiry date refers to the last day of that
month.
• Do not store above 25°C.
• Keep the blister in the original package in order to protect from light.
• If the capsules become discoloured or show any other signs of deterioration, you should seek the
advice of your doctor or 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.
6. FURTHER INFORMATION
What Surmontil Capsules contain
• Each capsule contains 50mg of trimipramine as maleate.
• Other ingredients include maize starch, microcrystalline cellulose (E460), anhydrous colloidal silica,
magnesium stearate, gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide
(E172). The printing ink contains Opacode-S/l/8100 Black: (shellac, soya lecithin (E322), antifoam
DC1510 and black iron oxide (E172)).
What Surmontil Capsules look like and contents of the pack
Surmontil Capsules are hard capsules with a white body and green cap with “SU50” printed in black
on both cap and body. The capsule contains an off-white or cream powder. They are supplied in
blister packs of 28 capsules.
PL: 15814/1292

POM

Manufactured by FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avenida de Leganes 62,
28923 Alcorcon, Madrid, Spain. Procured from within the EU and repackaged by the Product Licence
holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
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.
Leaflet revision and issue date (Ref.): 22.11.2016.
Surmontil is a registered trademark of sanofi.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRIMIPRAMINE 50mg HARD CAPSULES
(trimipramine maleate)
This product is available using the above name but will be referred to as Trimipramine Capsules
throughout the following 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 Capsules are and what they are used for
2. Before you take Trimipramine Capsules
3. How to take Trimipramine Capsules
4. Possible side effects
5. How to store Trimipramine Capsules
6. Further information
1. WHAT TRIMIPRAMINE CAPSULES ARE AND WHAT THEY ARE USED FOR
Trimipramine Capsules contain a medicine called trimipramine. This belongs to a group of medicines
called antidepressants.
Trimipramine Capsules 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 CAPSULES
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Trimipramine
Capsules (listed in Section 6 Further information). Signs of an allergic reaction include: a rash,
swelling or breathing problems, swelling of your lips, face, throat or tongue
• You have had a heart attack
• You have had any other heart problems including slow or uneven heart beat
• You have severe liver problems
• You have mania (signs include very high mood, energy and unusual behaviour)
• You are breast-feeding
Do not take this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist
before taking Trimipramine Capsules.
Take special care with Trimipramine Capsules
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 Capsules.
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 Capsules can affect the way some other medicines work. Also some medicines can
affect the way Trimipramine Capsules 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 a 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 Capsules.
Taking Trimipramine Capsules with food and drink
You should avoid drinking alcohol while taking Trimipramine Capsules.
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 Capsules.
Driving and using machines
Trimipramine Capsules may make you feel sleepy or less alert. If this happens do not drive or use any
tools or machines.
3. HOW TO TAKE TRIMIPRAMINE CAPSULES
Always take Trimipramine Capsules 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 capsules whole with a drink of water
• If you have been told to take Trimipramine Capsules 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 Capsules.
If you take more Trimipramine Capsules than you should
If you take more Trimipramine Capsules 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 Capsules
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 Capsules
Keep taking Trimipramine Capsules until your doctor tells you to stop. Do not stop taking Trimipramine
Capsules just because you feel better. This is because your illness may come back. When your doctor
tells you to stop taking these capsules 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 Capsules can cause side effects, although not everybody gets them.
Stop taking Trimipramine Capsules 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 Capsules.
Talk to your doctor straight away if you notice the following side-effects:
• Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
• Overactive behaviour or thoughts (mania or hypomania)
• Numbness or weakness in the arms and legs (peripheral neuropathy)
• Feeling that someone is ‘out to get you’
• Getting infections more easily than usual. This could be because of a blood disorder
(agranulocytosis)
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin
(paraesthesia)
• Increased thirst and passing water (urine) more often than normal. You may also feel tired and
hungry. This could be due to high blood sugar levels or a condition called diabetes
• An uneven or fast 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 CAPSULES
• Keep out of the sight and reach of children.
• Do not use Trimipramine Capsules after the expiry date. The expiry date refers to the last day of
that month.
• Do not store above 25°C.
• Keep the blister in the original package in order to protect from light.
• If the capsules become discoloured or show any other signs of deterioration, you should seek the
advice of your doctor or 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.
6. FURTHER INFORMATION
What Trimipramine Capsules contain
• Each capsule contains 50mg of trimipramine as maleate.
• Other ingredients include maize starch, microcrystalline cellulose (E460), anhydrous colloidal silica,
magnesium stearate, gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide
(E172). The printing ink contains Opacode-S/l/8100 Black: (shellac, soya lecithin (E322), antifoam
DC1510 and black iron oxide (E172)).
What Trimipramine Capsules look like and contents of the pack
Trimipramine Capsules are hard capsules with a white body and green cap with “SU50” printed in
black on both cap and body. The capsule contains an off-white or cream powder. They are supplied in
blister packs of 28 capsules.
PL: 15814/1292

POM

Manufactured by FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avenida de Leganes 62,
28923 Alcorcon, Madrid, Spain. Procured from within the EU and repackaged by the Product Licence
holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
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.
Leaflet revision and issue date (Ref.): 22.11.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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