Document: leaflet MAH BRAND_PLPI 20636-2501 change

• leaflet MAH BRAND_PL 17780-0636
• leaflet MAH BRAND_PLPI 10383-2103
• leaflet MAH BRAND_PLPI 18799-2856
• leaflet MAH BRAND_PLPI 19488-1803
• leaflet MAH BRAND_PLPI 20636-2501
• leaflet MAH GENERIC_PL 17780-0636
• leaflet MAH GENERIC_PL 20046-0292

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Surmontil® 10mg Tablets    ^{2504 16[6]}

(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.

This medicine is available using above name but will be referred as Surmontil Tablets throughout the following leaflet. Surmontil Tablets are also available in other strengths

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

The name of your medicine is Surmontil 10 mg Tablets. Your tablets contain a medicine called trimipramine. This belongs to a group of medicines called antidepressants.

Surmontil Tablets can be used to treat depression. They are especially useful for treating depression in people who also have problems sleeping, stress (anxiety) or feel irritable and restless (agitation).

2.    BEFORE YOU TAKE SURMONTIL TABLETS Do not take this medicine and tell your doctor if:

-    You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Surmontil Tablets (listed in Section 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 Tablets.

Take special care with Surmontil Tablets

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

-    If you have previously had thoughts about killing or harming yourself.

-    If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.

You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

If you have diabetes or are at risk of getting diabetes, your doctor may do blood tests to monitor your blood sugar levels.

Check with your doctor or pharmacist before taking this medicine if:

-    You are elderly

-    You have an enlarged prostate gland

-    You have glaucoma (painful eyes with blurred vision)

-    You have or have ever had fits or seizures

-    You have thyroid problems

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Surmontil Tablets.

Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Surmontil Tablets can affect the way some other medicines work. Also some medicines can affect the way Surmontil Tablets work.

Tell your doctor if you are taking any of the following medicines:

-    mAoI (MonoAmine Oxidase Inhibitors) medicine such as tranylcypromine, phenelzine and isocarboxazid (for Parkinson's disease), or have taken them in the last 2 weeks

-    Sedatives (such as tranquilizers or sleeping pills)

-    Medicines used to treat high blood pressure

-    Adrenaline, noradrenaline, ephedrine or isoprenaline - used in an Emergency

-    Phenylephrine or phenylpropanolamine - found in cold and flu preparations

-    Medicines used for chest pain (angina) or high blood pressure such as diltiazem, verapamil, clonidine, digitalis

-    Medicines used for depression (SSRIs such as citalopram, paroxetine, fluoxetine) tryciclics and triptan derivatives, lithium, St John's Wort

-    Pain killers such as tramadol

-    Macrolide antibiotics, antifungals or floroquinolones.

Anaesthetics

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Surmontil Tablets.

Taking Surmontil Tablets and drink

You should avoid drinking alcohol while taking Surmontil Tablets.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Do not breast-feed if you are taking Surmontil Tablets.

Driving and using machines

Surmontil Tablets may make you feel sleepy or less alert. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Surmontil Tablets

Surmontil Tablets contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Surmontil Tablets.

3. HOW TO TAKE SURMONTIL TABLETS

Always take Surmontil Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

-    Take this medicine by mouth

-    Swallow the Tablets whole with a drink of water

-    If you have been told to take Surmontil Tablets only once each day then you should take it before going to bed

-    It may take 7 to 10 days before you feel the full benefit of the medicine

-    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor

How much to take Adults:

Depression

-    Adults usually start by taking 50mg to 75mg each day

-    Your doctor may then increase the dose to 150mg or 300mg each day depending on your condition

-    Once you start to feel better, the usual daily dose then stays the same at 75mg to 150mg each day

Elderly:

-    Elderly usually start by taking 10mg to 25mg three times each day

-    Your doctor will then increase this slowly

-    Once you start to feel better, the usual daily dose then stays the same at 35mg to 75mg each day

Children:

Children should not take Surmontil Tablets.

If you take more Surmontil Tablets than you should

If you take more Surmontil Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen: fits (seizures), collapse and falling into a coma.

If you forget to take Surmontil Tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Surmontil Tablets

Keep taking Surmontil Tablets until your doctor tells you to stop. Do not stop taking Surmontil Tablets just because you feel better. This is because your illness may come back. When your doctor tells you to stop taking these Tablets he/she will help you stop taking them gradually. Stopping your medicine too quickly could cause sleep problems, feeling irritable and sweating more than usual.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Surmontil Tablets can cause side effects, although not

everybody gets them.

Stop taking Surmontil Tablets and see a doctor or go to a hospital

straight away if:

-    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to Surmontil Tablets.

Talk to your doctor straight away if you notice the following 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.

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 Famar Health Care Services Madrid S.A.U., 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.

PL 20636/2501

Leaflet revision and issue date (Ref) 25.04.16[6] Surmontil is a trademark of May & Baker Limited.

Trimipramine 10mg Tablets    ^{2504 16[6]}

(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.

This medicine is available using above name but will be referred as Trimipramine Tablets throughout the following leaflet. Trimipramine Tablets are also available in other strengths

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

The name of your medicine is Trimipramine 10 mg Tablets. Your tablets contain a medicine called trimipramine. This belongs to a group of medicines called antidepressants.

Trimipramine Tablets can be used to treat depression. They are especially useful for treating depression in people who also have problems sleeping, stress (anxiety) or feel irritable and restless (agitation).

2.    BEFORE YOU TAKE TRIMIPRAMINE TABLETS Do not take this medicine and tell your doctor if:

-    You are allergic (hypersensitive) to trimipramine or any of the other ingredients of Trimipramine Tablets (listed in Section 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 Tablets.

Take special care with Trimipramine Tablets

Thoughts of suicide and worsening of your depression or anxiety

disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

-    If you have previously had thoughts about killing or harming yourself.

-    If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

If you have diabetes or are at risk of getting diabetes, your doctor may do blood tests to monitor your blood sugar levels.

Check with your doctor or pharmacist before taking this medicine if:

-    You are elderly

-    You have an enlarged prostate gland

-    You have glaucoma (painful eyes with blurred vision)

-    You have or have ever had fits or seizures

-    You have thyroid problems

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Trimipramine Tablets.

Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Trimipramine Tablets can affect the way some other medicines work. Also some medicines can affect the way Trimipramine Tablets work.

Tell your doctor if you are taking any of the following medicines:

-    mAoI (MonoAmine Oxidase Inhibitors) medicine such as tranylcypromine, phenelzine and isocarboxazid (for Parkinson's disease), or have taken them in the last 2 weeks

-    Sedatives (such as tranquilizers or sleeping pills)

-    Medicines used to treat high blood pressure

-    Adrenaline, noradrenaline, ephedrine or isoprenaline - used in an Emergency

-    Phenylephrine or phenylpropanolamine - found in cold and flu preparations

-    Medicines used for chest pain (angina) or high blood pressure such as diltiazem, verapamil, clonidine, digitalis

-    Medicines used for depression (SSRIs such as citalopram, paroxetine, fluoxetine) tryciclics and triptan derivatives, lithium, St John's Wort

-    Pain killers such as tramadol

-    Macrolide antibiotics, antifungals or floroquinolones.

Anaesthetics

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Trimipramine Tablets.

Taking Trimipramine Tablets and drink

You should avoid drinking alcohol while taking Trimipramine Tablets. Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Do not breast-feed if you are taking Trimipramine Tablets.

Driving and using machines

Trimipramine Tablets may make you feel sleepy or less alert. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients of Trimipramine Tablets

Trimipramine Tablets contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Trimipramine Tablets.

3. HOW TO TAKE TRIMIPRAMINE TABLETS

Always take Trimipramine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

-    Take this medicine by mouth

-    Swallow the Tablets whole with a drink of water

-    If you have been told to take Trimipramine Tablets only once each day then you should take it before going to bed

-    It may take 7 to 10 days before you feel the full benefit of the medicine

-    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor

How much to take Adults:

Depression

-    Adults usually start by taking 50mg to 75mg each day

-    Your doctor may then increase the dose to 150mg or 300mg each day depending on your condition

-    Once you start to feel better, the usual daily dose then stays the same at 75mg to 150mg each day

Elderly:

-    Elderly usually start by taking 10mg to 25mg three times each day

-    Your doctor will then increase this slowly

-    Once you start to feel better, the usual daily dose 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 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 type of medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE TRIMIPRAMINE TABLETS

Keep out of the sight and reach of children.

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.

Do not store above 25^oC.

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 Famar Health Care Services Madrid S.A.U., 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.

Leaflet revision and issue date (Ref) 25.04.16[6]