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PAXTIBI 25MG TABLETS

Active substance(s): NORTRIPTYLINE / NORTRIPTYLINE HYDROCHLORIDE / NORTRIPTYLINE / NORTRIPTYLINE HYDROCHLORIDE / NORTRIPTYLINE / NORTRIPTYLINE HYDROCHLORIDE

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Ref: 0505/040315/2/F

Allegron ® 25mg Tablets
(nortriptyline hydrochloride)
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.
In this leaflet:
1 What Allegron tablets are and what they are used for
2

Before you take Allegron tablets

3

How to take Allegron tablets

4

Possible side effects

5

How to store Allegron tablets

6

Further information

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 relieves the symptoms of
depression.
Allegron tablets may also be used for the treatment of bed-wetting in
children 6 years and older.

2

Before you take Allegron tablets

Do not take Allegron tablets if
* you are allergic (hypersensitive) to nortriptyline hydrochloride or any of
the other ingredients of Allegron tablets (see list of ingredients in Section
6). An allergic reaction may include rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue;
* you have had a recent heart attack or heartbeat disorder;
* you have severe liver disease;
* you suffer from mania (abnormally raised mood);
* you are breast-feeding;
* the child is under 6 years of age;
* you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
* you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Take special care with Allegron tablets if
* you feel suicidal or aggressive - tell your doctor;
* you are agitated, overactive, or suffer from schizophrenia;
* you have heart disease;
* you have a thyroid condition;
* you have a history of epilepsy;
* you have high pressure in the eyes (glaucoma);
* you have an enlarged prostate;
* your child taking Allegron has a change in behaviour;
* you are going to have electroconvulsive therapy (electric shock);
* you are diabetic;
* you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
* you have had an allergic reaction to another tricyclic antidepressant
in the past;
* you are pregnant, think you might be pregnant or planning to become
pregnant or breast-feeding you should not take Allegron unless your
doctor tells you to.
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
You should tell your doctor if you are taking or have taken any medicines,
including medicines obtained without a prescription.
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.
Driving and using machines
Allegron 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.
Important information about some of the ingredients of Allegron tablets
Allegron tablets contain lactose. If you are lactose intolerant, contact your
doctor before taking this medicine.
Allegron 25mg tablets contain sunset yellow (E110), which may cause
allergic reactions.

3

How to take Allegron tablets

Always take Allegron tablets exactly as your doctor has told you. You should
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.
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: 0505/040315/2/B

(nortriptyline hydrochloride)
Patient Information Leaflet (continued)
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 product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Allegron tablets 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:
* low or high blood pressure
* 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)
* 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, 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 Allegron tablets

5

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

Further 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: 04/03/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0505/040315/1/F

Paxtibi ®25mg Tablets
(nortriptyline hydrochloride)
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.
In this leaflet:
1 What Paxtibi tablets are and what they are used for
2

Before you take Paxtibi tablets

3

How to take Paxtibi tablets

4

Possible side effects

5

How to store Paxtibi tablets

6

Further information

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 relieves the symptoms of
depression.
Paxtibi tablets may also be used for the treatment of bed-wetting in children
6 years and older.

2

Before you take Paxtibi tablets

Do not take Paxtibi tablets if
* you are allergic (hypersensitive) to nortriptyline hydrochloride or any of
the other ingredients of Paxtibi tablets (see list of ingredients in Section
6). An allergic reaction may include rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue;
* you have had a recent heart attack or heartbeat disorder;
* you have severe liver disease;
* you suffer from mania (abnormally raised mood);
* you are breast-feeding;
* the child is under 6 years of age;
* you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
* you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Take special care with Paxtibi tablets if
* you feel suicidal or aggressive - tell your doctor;
* you are agitated, overactive, or suffer from schizophrenia;
* you have heart disease;
* you have a thyroid condition;
* you have a history of epilepsy;
* you have high pressure in the eyes (glaucoma);
* you have an enlarged prostate;
* your child taking Paxtibi has a change in behaviour;
* you are going to have electroconvulsive therapy (electric shock);
* you are diabetic;
* you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
* you have had an allergic reaction to another tricyclic antidepressant
in the past;
* you are pregnant, think you might be pregnant or planning to become
pregnant or breast-feeding you should not take Paxtibi unless your doctor
tells you to.
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
You should tell your doctor if you are taking or have taken any medicines,
including medicines obtained without a prescription.
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.
Driving and using machines
Paxtibi 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.
Important information about some of the ingredients of Paxtibi tablets
Paxtibi tablets contain lactose. If you are lactose intolerant contact your
doctor before taking this medicine.
Paxtibi 25mg tablets contain sunset yellow (E110), which may cause
allergic reactions.

3

How to take Paxtibi tablets

Always take Paxtibi tablets exactly as your doctor has told you. You should
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.
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: 0505/040315/1/B

Paxtibi ®25mg Tablets
(nortriptyline hydrochloride)
Patient Information Leaflet (continued)
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 product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Paxtibi tablets 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:
* low or high blood pressure
* 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)

*
*
*
*
*
*
*
*
*
*
*
*
*
*

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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

How to store 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

Further 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: 04/03/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Nortriptyline Hydrochloride 25mg Tablets

Ref: 0505/040315/3/F

Patient Information Leaflet

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

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.

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.

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

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

Further 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 relieves the symptoms of depression.
Nortriptyline Hydrochloride tablets may also be used for the treatment of
bed-wetting in children 6 years and older.

2

Before you take Nortriptyline Hydrochloride tablets

Do not take Nortriptyline Hydrochloride tablets if
* you are allergic (hypersensitive) to nortriptyline hydrochloride or any of
the other ingredients of Nortriptyline Hydrochloride tablets (see list of
ingredients in Section 6). An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face, lips, throat or tongue;
* you have had a recent heart attack or heartbeat disorder;
* you have severe liver disease;
* you suffer from mania (abnormally raised mood);
* you are breast-feeding;
* the child is under 6 years of age;
* you are taking, or have taken in the last two weeks, monoamine oxidase
inhibitors (another type of antidepressant);
* you are taking adrenaline-like drugs including ephedrine, isoprenaline,
noradrenaline, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedies.
Take special care with Nortriptyline Hydrochloride tablets if
* you feel suicidal or aggressive - tell your doctor;
* you are agitated, overactive, or suffer from schizophrenia;
* you have heart disease;
* you have a thyroid condition;
* you have a history of epilepsy;
* you have high pressure in the eyes (glaucoma);
* you have an enlarged prostate;
* your child taking Nortriptyline Hydrochloride has a change in
behaviour;
* you are going to have electroconvulsive therapy (electric shock);
* you are diabetic;
* you are going to receive an anaesthetic, e.g. for an operation – tell your
doctor;
* you have had an allergic reaction to another tricyclic antidepressant
in the past;
* you are pregnant, think you might be pregnant or planning to become
pregnant or breast-feeding you should not take Nortriptyline Hydrochloride
unless your doctor tells you to.

Taking other medicines
You should tell your doctor if you are taking or have taken any 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.
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.
Important information about some of the ingredients of Nortriptyline
Hydrochloride tablets
Nortriptyline Hydrochloride tablets contain lactose. If you are lactose
intolerant contact your doctor before taking this medicine.
Nortriptyline Hydrochloride 25mg tablets contain sunset yellow (E110), which
may cause allergic reactions.

3

How to take Nortriptyline Hydrochloride tablets

Always take Nortriptyline Hydrochloride tablets exactly as your doctor has
told you. You should 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.
Children (for bed-wetting only)

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.

Age (years)

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.

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.

Nortriptyline Hydrochloride 25mg Tablets
Patient Information Leaflet (continued)
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 product, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, Nortriptyline Hydrochloride tablets 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:
* low or high blood pressure
* 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)
* altered liver function

Ref: 0505/040315/3/B

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

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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 Nortriptyline Hydrochloride tablets

5

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

Further 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: 04/03/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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