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NORTRIPTYLINE HYDROCHLORIDE 25MG TABLETS

Active substance(s): NORTRIPTYLINE HYDROCHLORIDE

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Ref: 0505/031017/2/F

Allegron ® 25mg Tablets
(nortriptyline hydrochloride)
Patient Information Leaflet

If any of the above apply to you, tell your doctor or pharmacist.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

Taking other medicines and Allegron tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take, any other medicines, including medicines obtained without a
prescription.

In this leaflet:
1 What Allegron tablets are and what they are used for
2

What you need to know before you take Allegron tablets

3

How to take Allegron tablets

4

Possible side effects

5

How to store Allegron tablets

6

Contents of the pack and other information

The following medicines may interact with your Allegron tablets:
* guanethidine, debrisoquine, bethanidine, clonidine (used to treat high
blood pressure);
* barbiturates (used for anxiety or to make you feel sleepy);
* alcohol (you should not drink alcohol);
* fluoxetine (another antidepressant);
* cimetidine (for heartburn and ulcers);
* phenothiazines (for mental illness);
* carbamazepine (for epilepsy);
* propafenone, flecainide, encainide, quinidine (for heartbeat disorders).
It may still be all right for you to be given Allegron tablets. Your doctor will be
able to decide what is suitable for you.
Pregnancy and breast-feeding
Do not take Allegron tablets if you are breast-feeding.

1

What Allegron tablets are and what they are used for

Allegron tablets contain the active ingredient nortriptyline hydrochloride,
which is a tricyclic antidepressant. Allegron tablets relieve the symptoms of
depression.
Allegron tablets may also be used for the treatment of bed-wetting in
children 6 years and older.

2

What you need to know before you take Allegron
tablets

Do not take Allegron tablets:
* If you are allergic to nortriptyline hydrochloride or any of the other
ingredients of this medicine (listed in section 6). An allergic reaction may
include rash, itching, difficulty breathing or swelling of the face, lips, throat
or tongue;
* If you have had a recent heart attack or heartbeat disorder;
* If you have severe liver disease;
* If you suffer from mania (abnormally raised mood);
* If you are breast-feeding;
* If the child is under 6 years of age;
* If you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
* If you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Warnings and precautions
Talk to your doctor or pharmacist before taking Allegron tablets
* If you feel suicidal or aggressive - tell your doctor;
* If you are agitated, overactive, or suffer from schizophrenia;
* If you have heart disease;
* If you have a thyroid condition;
* If you have a history of epilepsy;
* If you have high pressure in the eyes (glaucoma);
* If you have an enlarged prostate;
* If your child taking Allegron tablets has a change in behaviour;
* If you are going to have electroconvulsive therapy (electric shock);
* If you are diabetic;
* If you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
* If you have had an allergic reaction to another tricyclic antidepressant in
the past;
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 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.

The safety of nortriptyline for use during pregnancy has not been
established. If you are pregnant, think you may be pregnant or are planning
to have a baby, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Nortriptyline hydrochloride may affect alertness. Use caution when driving or
operating heavy machinery until you’re aware of how this drug affects you. If
you feel Allegron tablets affect your ability to drive or use machines, tell your
doctor immediately.
Allegron tablets 10mg and 25mg contain lactose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Allegron tablets 25mg contain sunset yellow (E110)
Sunset yellow (E110) may cause allergic reactions.

3

How to take Allegron tablets

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be
given once a day, usually at night. The dose should begin at a low level,
10mg, 3-4 times daily, for example and be increased gradually as required.
The maximum dose is 150mg per day.
The elderly:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start
with 10mg three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start
with 10mg three times a day.
Lower dosages are recommended for outpatients than for patients in
hospital who will be under close supervision.
Following remission maintenance treatment may be needed longer term.
This should be at the lowest dose that stops the symptoms of depression
coming back.
Use in children (for bed-wetting only)
Age (years)

Weight
kg

lb

Dose (mg)

6-7

20-25

44-55

10

8-11

25-35

55-77

10-20

Over 11

35-54

77-119

25-35

The dose should be given thirty minutes before bedtime. The maximum
length of treatment should be three months. Another course of treatment
should not be started until a full physical examination has been made.

Allegron ® 25mg Tablets

Ref: 0505/031017/2/B

(nortriptyline hydrochloride)
Patient Information Leaflet (continued)
Allegron tablets are for oral use.
The score line on the 25mg tablet is only there to help you break the tablet if
you have difficulty swallowing it whole.
If you take more Allegron tablets than you should
Go to the nearest casualty department or contact your doctor immediately.
Take the tablet carton with you.
If you forget to take Allegron tablets
If you miss a dose, take one as soon as you can. If you have missed several
doses, tell your doctor. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Allegron tablets
Do not stop taking the tablets or reduce the dose without telling your doctor
first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a
headache or feel generally unwell.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

* altered liver function
* inflamed liver (hepatitis) and liver damage
* weight gain or loss
* sweating
* flushing
* urinating often and at night
* sleepiness
* dizziness
* weakness
* tiredness
* headache
* swollen glands
* hair loss (alopecia)
* 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 on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them. 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.
All medicines can cause allergic reactions, although serious allergic
reactions are very rare. Tell your doctor straight away if you get any
sudden wheeziness, difficulty in breathing, swelling of the eyelids, face
or lips, rash or itching, especially affecting your whole body.
The following side effects have been reported:
* fast or irregular heartbeat
* palpitations
* heart attack (myocardial infarction)
* stroke
* oedema (swelling of the ankles)
* confusion (especially in the elderly) with seeing or hearing things
(hallucinations)
* not knowing where you are (disorientation)
* false beliefs (delusions)
* anxiety, restlessness, agitation
* not sleeping (insomnia)
* nightmares
* panic
* long-lasting abnormal mood
* worsening of mental illness
* numbness, tingling, pins and needles in the hands or feet
* coordination problems
* tremors
* abnormal movements
* fits (seizures)
* altered brainwave (EEG) patterns
* ringing in the ears (tinnitus)
* dry mouth
* rarely, inflamed glands under the tongue or inflammation of the gums
(gingivitis)
* blurred vision, difficulty in focusing, dilated pupils
* constipation, blockage of the digestive tract
* unable to urinate or delayed urination
* rash
* itching
* light sensitivity
* swelling (oedema)
* fever
* reaction to other similar drugs
* blood disorders which may cause you to bruise easily, become anaemic or
be unable to fight off infections
* feeling sick (nausea) and vomiting
* not eating (anorexia)
* indigestion
* diarrhoea
* constipation
* peculiar taste
* inflamed mouth
* abdominal cramps
* black tongue
* development of breasts in men, breast enlargement and milk production in
women
* increased or decreased sex drive
* failure to have an erection (impotence)
* swollen testicles
* altered blood sugar levels
* yellow eyes and skin (jaundice)

How to store Allegron tablets

Expiry date
Do not use this medicine after the expiry date shown on the blister label or
carton label. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine
if your doctor tells you to. If your tablets becomes discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.
Storing your medicine

* Keep out of the sight and reach of children
* Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer needed.
These measures will help to protect the environment.

Important
Remember this medicine is for you. It can only be prescribed by a doctor.
Never give your medicine to other people.
It may harm them, even if their symptoms are the same as yours. This leaflet
does not tell you everything about your medicine. If you have any questions
or are not sure about anything, ask your doctor or pharmacist. He/she will
have addtional information about this medicine and will be able to advise
you.

6

Contents of the pack and other information

What Allegron tablets contain:
Each film-coated tablet contains the active ingredient Nortriptyline
Hydrochloride equivalent to 25mg nortriptyline base.
The inactive ingredients are magnesium stearate, lactose, calcium
phosphate, Sunset yellow lake E110, maize starch, ethylcellulose,
hypromellose, glycerol.
What Allegron tablets looks like and contents of the pack
Your medicine is called Allegron 25mg Tablets but will be referred to as
Allegron throughout this leaflet. They are round orange film-coated tablets
with a scoreline on one side and plain on the other.
Allegron tablets comes in blister packs of 25 and 100 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Laboratorios BIOMED S.L. C/Licorers,
169-170 Nave 14, Poligon Ca'n Robiols, E-07141 Marratxi, Spain and
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL Number: 15184/0505

Allegron is a registered trademark of King Pharmaceuticals Ltd.
Revision date: 03/10/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

®

Ref: 0505/031017/2/F

Paxtibi 25mg Tablets
(nortriptyline hydrochloride)
Patient Information Leaflet

If any of the above apply to you, tell your doctor or pharmacist.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

Taking other medicines and Paxtibi tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take, any other medicines, including medicines obtained without a
prescription.

In this leaflet:
1 What Paxtibi tablets are and what they are used for
2

What you need to know before you take Paxtibi tablets

3

How to take Paxtibi tablets

4

Possible side effects

5

How to store Paxtibi tablets

6

Contents of the pack and other information

The following medicines may interact with your Paxtibi tablets:
* guanethidine, debrisoquine, bethanidine, clonidine (used to treat high
blood pressure);
* barbiturates (used for anxiety or to make you feel sleepy);
* alcohol (you should not drink alcohol);
* fluoxetine (another antidepressant);
* cimetidine (for heartburn and ulcers);
* phenothiazines (for mental illness);
* carbamazepine (for epilepsy);
* propafenone, flecainide, encainide, quinidine (for heartbeat disorders).
It may still be all right for you to be given Paxtibi tablets. Your doctor will be
able to decide what is suitable for you.
Pregnancy and breast-feeding
Do not take Paxtibi tablets if you are breast-feeding.

1

What Paxtibi tablets are and what they are used for

Paxtibi tablets contain the active ingredient nortriptyline hydrochloride, which
is a tricyclic antidepressant. Paxtibi tablets relieve the symptoms of depression.
Paxtibi tablets may also be used for the treatment of bed-wetting in children
6 years and older.

2

What you need to know before you take Paxtibi
tablets

Do not take Paxtibi tablets:
* If you are allergic to nortriptyline hydrochloride or any of the other
ingredients of this medicine (listed in section 6). An allergic reaction may
include rash, itching, difficulty breathing or swelling of the face, lips, throat
or tongue;
* If you have had a recent heart attack or heartbeat disorder;
* If you have severe liver disease;
* If you suffer from mania (abnormally raised mood);
* If you are breast-feeding;
* If the child is under 6 years of age;
* If you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
* If you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paxtibi tablets
* If you feel suicidal or aggressive - tell your doctor;
* If you are agitated, overactive, or suffer from schizophrenia;
* If you have heart disease;
* If you have a thyroid condition;
* If you have a history of epilepsy;
* If you have high pressure in the eyes (glaucoma);
* If you have an enlarged prostate;
* If your child taking Paxtibi tablets has a change in behaviour;
* If you are going to have electroconvulsive therapy (electric shock);
* If you are diabetic;
* If you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
* If you have had an allergic reaction to another tricyclic antidepressant in
the past;
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 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.

The safety of nortriptyline for use during pregnancy has not been established. If you are pregnant, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Nortriptyline hydrochloride may affect alertness. Use caution when driving or
operating heavy machinery until you’re aware of how this drug affects you. If
you feel Paxtibi tablets affect your ability to drive or use machines, tell your
doctor immediately.
Paxtibi tablets 10mg and 25mg contain lactose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Paxtibi tablets 25mg contain sunset yellow (E110)
Sunset yellow (E110) may cause allergic reactions.

3

How to take Paxtibi tablets

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be
given once a day, usually at night. The dose should begin at a low level,
10mg, 3-4 times daily, for example and be increased gradually as required.
The maximum dose is 150mg per day.
The elderly:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start
with 10mg three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start
with 10mg three times a day.
Lower dosages are recommended for outpatients than for patients in
hospital who will be under close supervision.
Following remission maintenance treatment may be needed longer term.
This should be at the lowest dose that stops the symptoms of depression
coming back.
Use in children (for bed-wetting only)
Age (years)

Weight
kg

lb

Dose (mg)

6-7

20-25

44-55

10

8-11

25-35

55-77

10-20

Over 11

35-54

77-119

25-35

The dose should be given thirty minutes before bedtime. The maximum
length of treatment should be three months. Another course of treatment
should not be started until a full physical examination has been made.

Ref: 0505/031017/2/B

Paxtibi ® 25mg Tablets
(nortriptyline hydrochloride)
Patient Information Leaflet (continued)
Paxtibi tablets are for oral use.
The score line on the 25mg tablet is only there to help you break the tablet if
you have difficulty swallowing it whole.
If you take more Paxtibi tablets than you should
Go to the nearest casualty department or contact your doctor immediately.
Take the tablet carton with you.
If you forget to take Paxtibi tablets
If you miss a dose, take one as soon as you can. If you have missed several
doses, tell your doctor. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Paxtibi tablets
Do not stop taking the tablets or reduce the dose without telling your doctor
first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a
headache or feel generally unwell.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

* altered liver function
* inflamed liver (hepatitis) and liver damage
* weight gain or loss
* sweating
* flushing
* urinating often and at night
* sleepiness
* dizziness
* weakness
* tiredness
* headache
* swollen glands
* hair loss (alopecia)
* 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 on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them. 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.
All medicines can cause allergic reactions, although serious allergic
reactions are very rare. Tell your doctor straight away if you get any
sudden wheeziness, difficulty in breathing, swelling of the eyelids, face
or lips, rash or itching, especially affecting your whole body.
The following side effects have been reported:
* fast or irregular heartbeat
* palpitations
* heart attack (myocardial infarction)
* stroke
* oedema (swelling of the ankles)
* confusion (especially in the elderly) with seeing or hearing things
(hallucinations)
* not knowing where you are (disorientation)
* false beliefs (delusions)
* anxiety, restlessness, agitation
* not sleeping (insomnia)
* nightmares
* panic
* long-lasting abnormal mood
* worsening of mental illness
* numbness, tingling, pins and needles in the hands or feet
* coordination problems
* tremors
* abnormal movements
* fits (seizures)
* altered brainwave (EEG) patterns
* ringing in the ears (tinnitus)
* dry mouth
* rarely, inflamed glands under the tongue or inflammation of the gums
(gingivitis)
* blurred vision, difficulty in focusing, dilated pupils
* constipation, blockage of the digestive tract
* unable to urinate or delayed urination
* rash
* itching
* light sensitivity
* swelling (oedema)
* fever
* reaction to other similar drugs
* blood disorders which may cause you to bruise easily, become anaemic or
be unable to fight off infections
* feeling sick (nausea) and vomiting
* not eating (anorexia)
* indigestion
* diarrhoea
* constipation
* peculiar taste
* inflamed mouth
* abdominal cramps
* black tongue
* development of breasts in men, breast enlargement and milk production in
women
* increased or decreased sex drive
* failure to have an erection (impotence)
* swollen testicles
* altered blood sugar levels
* yellow eyes and skin (jaundice)

How to store Paxtibi tablets

Expiry date
Do not use this medicine after the expiry date shown on the blister label or
carton label. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine
if your doctor tells you to. If your tablets becomes discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.
Storing your medicine

* Keep out of the sight and reach of children
* Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer needed.
These measures will help to protect the environment.

Important
Remember this medicine is for you. It can only be prescribed by a doctor.
Never give your medicine to other people.
It may harm them, even if their symptoms are the same as yours. This leaflet
does not tell you everything about your medicine. If you have any questions
or are not sure about anything, ask your doctor or pharmacist. He/she will
have addtional information about this medicine and will be able to advise
you.

6

Contents of the pack and other information

What Paxtibi tablets contain:
Each film-coated tablet contains the active ingredient Nortriptyline
Hydrochloride equivalent to 25mg nortriptyline base.
The inactive ingredients are magnesium stearate, lactose, calcium
phosphate, Sunset yellow lake E110, maize starch, ethylcellulose,
hypromellose, glycerol.
What Paxtibi tablets looks like and contents of the pack
Your medicine is called Paxtibi 25mg Tablets but will be referred to as Paxtibi
throughout this leaflet. They are round orange film-coated tablets with a
scoreline on one side and plain on the other.
Paxtibi tablets comes in blister packs of 25 and 100 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Laboratorios BIOMED S.L. C/Licorers,
169-170 Nave 14, Poligon Ca'n Robiols, E-07141 Marratxi, Spain and
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL Number: 15184/0505

Paxtibi is a registered trademark of King Pharmaceuticals Ltd.
Revision date: 03/10/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Ref: 0505/031017/3/F

Nortriptyline Hydrochloride 25mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1 What Nortriptyline Hydrochloride tablets are and what they are used for
2 What you need to know before you take Nortriptyline Hydrochloride
tablets
3

How to take Nortriptyline Hydrochloride tablets

4

Possible side effects

5

How to store Nortriptyline Hydrochloride tablets

6

Contents of the pack and other information

1

What Nortriptyline Hydrochloride tablets are and what
they are used for

Nortriptyline Hydrochloride tablets contain the active ingredient nortriptyline
hydrochloride, which is a tricyclic antidepressant. Nortriptyline Hydrochloride
tablets relieve the symptoms of depression.
Nortriptyline Hydrochloride tablets may also be used for the treatment of
bed-wetting in children 6 years and older.

2

What you need to know before you take Nortriptyline
Hydrochloride tablets

Do not take Nortriptyline Hydrochloride tablets:
* If you are allergic to nortriptyline hydrochloride or any of the other
ingredients of this medicine (listed in section 6). An allergic reaction may
include rash, itching, difficulty breathing or swelling of the face, lips, throat
or tongue;
* If you have had a recent heart attack or heartbeat disorder;
* If you have severe liver disease;
* If you suffer from mania (abnormally raised mood);
* If you are breast-feeding;
* If the child is under 6 years of age;
* If you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
* If you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nortriptyline Hydrochloride
tablets
* If you feel suicidal or aggressive - tell your doctor;
* If you are agitated, overactive, or suffer from schizophrenia;
* If you have heart disease;
* If you have a thyroid condition;
* If you have a history of epilepsy;
* If you have high pressure in the eyes (glaucoma);
* If you have an enlarged prostate;
* If your child taking Nortriptyline hydrochloride tablets has a change in
behaviour;
* If you are going to have electroconvulsive therapy (electric shock);
* If you are diabetic;
* If you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
* If you have had an allergic reaction to another tricyclic antidepressant in
the past;
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 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 any of the above apply to you, tell your doctor or pharmacist.
Taking other medicines and Nortriptyline Hydrochloride tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take, any other medicines, including medicines obtained without a
prescription.
The following medicines may interact with your Nortriptyline hydrochloride
tablets:
* guanethidine, debrisoquine, bethanidine, clonidine (used to treat high
blood pressure);
* barbiturates (used for anxiety or to make you feel sleepy);
* alcohol (you should not drink alcohol);
* fluoxetine (another antidepressant);
* cimetidine (for heartburn and ulcers);
* phenothiazines (for mental illness);
* carbamazepine (for epilepsy);
* propafenone, flecainide, encainide, quinidine (for heartbeat disorders).
It may still be all right for you to be given Nortriptyline Hydrochloride tablets.
Your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
Do not take Nortriptyline Hydrochloride tablets if you are breast-feeding.
The safety of nortriptyline for use during pregnancy has not been
established. If you are pregnant, think you may be pregnant or are planning
to have a baby, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Nortriptyline Hydrochloride may affect alertness. Use caution when driving or
operating heavy machinery until you’re aware of how this drug affects you. If
you feel Nortriptyline Hydrochloride tablets affect your ability to drive or use
machines, tell your doctor immediately.
Nortriptyline Hydrochloride tablets 10mg and 25mg contain lactose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Nortriptyline Hydrochloride tablets 25mg contain sunset yellow (E110)
Sunset yellow (E110) may cause allergic reactions.

3

How to take Nortriptyline Hydrochloride tablets

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be
given once a day, usually at night. The dose should begin at a low level,
10mg, 3-4 times daily, for example and be increased gradually as required.
The maximum dose is 150mg per day.
The elderly:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start
with 10mg three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start
with 10mg three times a day.
Lower dosages are recommended for outpatients than for patients in
hospital who will be under close supervision.
Following remission maintenance treatment may be needed longer term.
This should be at the lowest dose that stops the symptoms of depression
coming back.
Use in children (for bed-wetting only)
Age (years)

Weight
kg

lb

Dose (mg)

6-7

20-25

44-55

10

8-11

25-35

55-77

10-20

Over 11

35-54

77-119

25-35

The dose should be given thirty minutes before bedtime. The maximum
length of treatment should be three months. Another course of treatment
should not be started until a full physical examination has been made.

Ref: 0505/031017/3/B

Nortriptyline Hydrochloride 25mg Tablets
Patient Information Leaflet (continued)
Nortriptyline Hydrochloride tablets are for oral use.
The score line on the 25mg tablet is only there to help you break the tablet if
you have difficulty swallowing it whole.
If you take more Nortriptyline Hydrochloride tablets than you should
Go to the nearest casualty department or contact your doctor immediately.
Take the tablet carton with you.
If you forget to take Nortriptyline Hydrochloride tablets
If you miss a dose, take one as soon as you can. If you have missed several
doses, tell your doctor. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Nortriptyline Hydrochloride tablets
Do not stop taking the tablets or reduce the dose without telling your doctor
first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a
headache or feel generally unwell.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

* altered liver function
* inflamed liver (hepatitis) and liver damage
* weight gain or loss
* sweating
* flushing
* urinating often and at night
* sleepiness
* dizziness
* weakness
* tiredness
* headache
* swollen glands
* hair loss (alopecia)
* 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 on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them. 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.
All medicines can cause allergic reactions, although serious allergic
reactions are very rare. Tell your doctor straight away if you get any
sudden wheeziness, difficulty in breathing, swelling of the eyelids, face
or lips, rash or itching, especially affecting your whole body.
The following side effects have been reported:
* fast or irregular heartbeat
* palpitations
* heart attack (myocardial infarction)
* stroke
* oedema (swelling of the ankles)
* confusion (especially in the elderly) with seeing or hearing things
(hallucinations)
* not knowing where you are (disorientation)
* false beliefs (delusions)
* anxiety, restlessness, agitation
* not sleeping (insomnia)
* nightmares
* panic
* long-lasting abnormal mood
* worsening of mental illness
* numbness, tingling, pins and needles in the hands or feet
* coordination problems
* tremors
* abnormal movements
* fits (seizures)
* altered brainwave (EEG) patterns
* ringing in the ears (tinnitus)
* dry mouth
* rarely, inflamed glands under the tongue or inflammation of the gums
(gingivitis)
* blurred vision, difficulty in focusing, dilated pupils
* constipation, blockage of the digestive tract
* unable to urinate or delayed urination
* rash
* itching
* light sensitivity
* swelling (oedema)
* fever
* reaction to other similar drugs
* blood disorders which may cause you to bruise easily, become anaemic or
be unable to fight off infections
* feeling sick (nausea) and vomiting
* not eating (anorexia)
* indigestion
* diarrhoea
* constipation
* peculiar taste
* inflamed mouth
* abdominal cramps
* black tongue
* development of breasts in men, breast enlargement and milk production in
women
* increased or decreased sex drive
* failure to have an erection (impotence)
* swollen testicles
* altered blood sugar levels
* yellow eyes and skin (jaundice)

How to store Nortriptyline Hydrochloride tablets

Expiry date
Do not use this medicine after the expiry date shown on the blister label or
carton label. If your doctor tells you to stop taking this medicine, return any
unused tablets to your pharmacist for safe disposal. Only keep this medicine
if your doctor tells you to. If your tablets becomes discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.
Storing your medicine

* Keep out of the sight and reach of children
* Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer needed.
These measures will help to protect the environment.

Important
Remember this medicine is for you. It can only be prescribed by a doctor.
Never give your medicine to other people.
It may harm them, even if their symptoms are the same as yours. This leaflet
does not tell you everything about your medicine. If you have any questions
or are not sure about anything, ask your doctor or pharmacist. He/she will
have addtional information about this medicine and will be able to advise
you.

6

Contents of the pack and other information

What Nortriptyline Hydrochloride tablets contain:
Each film-coated tablet contains the active ingredient Nortriptyline
Hydrochloride equivalent to 25mg nortriptyline base.
The inactive ingredients are magnesium stearate, lactose, calcium
phosphate, Sunset yellow lake E110, maize starch, ethylcellulose,
hypromellose, glycerol.
What Nortriptyline Hydrochloride tablets looks like and contents of the
pack
Your medicine is called Nortriptyline Hydrochloride 25mg Tablets but will be
referred to as Nortriptyline Hydrochloride throughout this leaflet. They are
round orange film-coated tablets with a scoreline on one side and plain on
the other.
Nortriptyline Hydrochloride tablets comes in blister packs of 25 and 100
tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Laboratorios BIOMED S.L. C/Licorers,
169-170 Nave 14, Poligon Ca'n Robiols, E-07141 Marratxi, Spain and
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL Number: 15184/0505

Revision date: 03/10/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

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Further information

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