SURMONTIL 25 MG TABLETS/ TRIMIPRAMINE 25 MG TABLETS - patient leaflet, side effects, dosage

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.

• 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

• 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 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 breastfeeding
• 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
• You are taking this medicine together with buprenorphine (strong pain killer). This combination can lead to serotonin syndrome, a potentially life threatening condition (see section Taking other medicines)

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
• Buprenorphine (strong pain killer). This combination may cause serotonin syndrome and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• 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 breastfeeding

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 by your doctor that you have an intolerance to some sugars, contact 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
• 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 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.
• 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.
• 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: or search for MHRA Yellow Card in the Google play or Apple App Store.

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.
• If the tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do
• 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 46420/0299 Surmontil 25mg Tablets |POM|

Who makes and repackages your medicine?

Your medicine is manufactured by Famar Health Care Services Madrid, S.A.U. Alcorcon, Madrid, Spain.

Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 19.10.2021

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.

• 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

• 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 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 breastfeeding
• 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
• You are taking this medicine together with buprenorphine (strong pain killer). This combination can lead to serotonin syndrome, a potentially life threatening condition (see section Taking other medicines)

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
• Buprenorphine (strong pain killer). This combination may cause serotonin syndrome and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• 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 breastfeeding

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 by your doctor that you have an intolerance to some sugars, contact 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
• 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 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.
• 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.
• 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: or search for MHRA Yellow Card in the Google play or Apple App Store.

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.
• If the tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do
• 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 look like and the contents of the pack

Trimipramine 25mg Tablets are white, round and biconvex. They are marked on one side with ‘TRIMIPRAMINE’ just inside the perimeter around a centrally marked ‘25’, and plain on the other.

Trimipramine Tablets come in bottles containing 100 tablets.

PL 46420/0299 Trimipramine 25mg Tablets |POM|

Who makes and repackages your medicine?

Your medicine is manufactured by Famar Health Care Services Madrid, S.A.U. Alcorcon, Madrid, Spain.

Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 19.10.2021

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.