Trimipramine 25mg Tablets
Ref: LTT132/250416/1 /F
Surmontil 25mg Tablets
(Trimipramine maleate)
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.
Your medicine is called Surmontil 25mg Tablets, throughout the rest of this leaflet your medicine will be referred to as Surmontil Tablets
In this leaflet:
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
^ What Surmontil Tablets are and what they are used for
The name of your medicine is Surmontil 25mg Tablets (called Surmontil Tablets in this leaflet). 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).
Before you take Surmontil Tablets
Do not take this medicine and tell your doctor if:
x 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 x You have had a heart attack
x You have had any other heart problems including slow or uneven heart beat
x You have severe liver problems
x You have mania (signs include very high mood, energy and unusual behaviour)
x 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 works.
Tell your doctor if you are taking any of the following medicines:
* MAOI (MonoAmine Oxidase Inhibitors) medicine such as tranylcypromine, phenelzine and isocarboxazid (for Parkinson's disease), or have taken them in the last 2 weeks
* Sedatives (such as tranquilizers or sleeping pills)
* Medicines used to treat high blood pressure
* Adrenaline, noradrenaline, ephedrine or isoprenaline - used in an emergency
* 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 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.
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
Surmontil ® 25mg Tablets
(trimipramine maleate)
Patient Information Leaflet (continued)
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.
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 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.
[5) How to store Surmontil Tablets
* 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.
* 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.
Further information
What this medicine contains:
Each tablet contains 25mg of trimipramine as maleate.
Also contains potato starch, calcium hydrogen phosphate, talc, magnesium stearate and opadry OY-L-28900 consisting of lactose monohydrate, hypromellose, titanium dioxide and macrogol 400.
What this medicine looks like and contents of the pack
Surmontil are white, circular, biconvex, film-coated tablets, one face impressed ‘SURMONTIL' just inside the perimeter around a centrally impressed ‘25', reverse face plain.
They come in a bottle, pack size 50.
Manufacturer and Licence Holder
This medicine is manufactured by Famar Health Care Services Madrid S.A.U., Avenida de Leganes 62, 28923 Alcorcon, Madrid, Spain and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE and repackaged by Lexon (UK) Limited, B98 0rE.
POM PL 33723/0132
Surmontil is a registered trademark of Sanofi-aventis S.A.
Revision date: 25/04/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
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.
Trimipramine 25mg Tablets
(trimipramine maleate)
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.
Your medicine is called Trimipramine 25mg Tablets, throughout the rest of this leaflet your medicine will be referred to as Trimipramine Tablets
In this leaflet:
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
^ What Trimipramine Tablets are and what they are used for
The name of your medicine is Trimipramine 25mg Tablets (called Trimipramine Tablets in this leaflet). 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).
Before you take Trimipramine Tablets
Do not take this medicine and tell your doctor if:
x 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 x You have had a heart attack
x You have had any other heart problems including slow or uneven heart beat
x You have severe liver problems
x You have mania (signs include very high mood, energy and unusual behaviour)
x 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 works.
Tell your doctor if you are taking any of the following medicines:
* mAoI (MonoAmine Oxidase Inhibitors) medicine such as tranylcypromine, phenelzine and isocarboxazid (for Parkinson's disease), or have taken them in the last 2 weeks
* Sedatives (such as tranquilizers or sleeping pills)
* Medicines used to treat high blood pressure
* Adrenaline, noradrenaline, ephedrine or isoprenaline - used in an emergency
* 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 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 stays the same at 35mg to 75mg each day
Trimipramine 25mg Tablets
(trimipramine maleate)
Patient Information Leaflet (continued)
* 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.
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 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.
How to store Trimipramine Tablets
* 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.
* 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.
Further information
What this medicine contains:
Each tablet contains 25mg of trimipramine.
Also contains potato starch, calcium hydrogen phosphate, talc, magnesium stearate and opadry OY-L-28900 consisting of lactose monohydrate, hypromellose, titanium dioxide and macrogol 400.
What this medicine looks like and contents of the pack
Trimipramine are white, circular, biconvex, film-coated tablets, one face impressed ‘SURMONTIL' just inside the perimeter around a centrally impressed ‘25', reverse face plain.
They come in a bottle, pack size 50.
Manufacturer and Licence Holder
This medicine is manufactured by Famar Health Care Services Madrid S.A.U., Avenida de Leganes 62, 28923 Alcorcon, Madrid, Spain and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
POM PL 33723/0132
Revision date: 25/04/16