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NORTRIPTYLINE 25MG TABLETS

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

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Package leaflet: information for the user

Nortriptyline 25mg Tablets
(nortriptyline hydrochloride)

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
The name of your medicine is Nortriptyline 25mg
Tablets; it will be called Nortriptyline Tablets for
ease hereafter
This product is also available in the 10mg strength.
In this leaflet
1. What Nortriptyline Tablets are and what they are
used for
2. Before you take Nortriptyline Tablets
3. How to take Nortriptyline Tablets
4. Possible side effects
5. How to store Nortriptyline Tablets
6. Further information

1. What Nortriptyline Tablets are and what they
are used for
Nortriptyline Tablets contain the active ingredient
nortriptyline hydrochloride, which is a tricyclic
antidepressant. Nortriptyline Tablets relieve the
symptoms of depression.
Nortriptyline Tablets may also be used for the treatment
of bed-wetting in children 6 years and older.
2. Before you take Nortriptyline Tablets
Do not take Nortriptyline Tablets if
you are allergic (hypersensitive) to nortriptyline
hydrochloride or any of the other ingredients of
Nortriptyline 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 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 Tablets 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 Tablets 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
Nortriptyline 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
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 Tablets affect your ability to drive or use
machines, tell your doctor immediately.

Important information about some of the ingredients
of Nortriptyline Tablets
Nortriptyline Tablets contain lactose. If you are lactose
intolerant, contact your doctor before taking this
medicine. Nortriptyline 25mg Tablets contain sunset
yellow (E110), which may cause allergic reactions.
3. How to take Nortriptyline Tablets
Always take Nortriptyline 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)

6-7
8-11
Over 11

Weight
kg

lb

Dose (mg)

20-25
25-35
35-54

44-55
55-77
77-119

10
10-20
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.

If you take more Nortriptyline 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 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 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 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 safely of
this medicine.

5. How to store Nortriptyline Tablets

Keep out of the sight and reach of children
Do not use Nortriptyline Tablets after the expiry date,
which is stated on the label and carton. The expiry date
refers to the last day of the month.
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 Nortriptyline Tablets contain
The active substance in your tablet is nortriptyline
hydrochloride. Each film-coated tablet contains 25mg
of nortriptyline (as the hydrochloride). Other ingredients
include lactose, calcium phosphate, starch, magnesium
stearate, hydroxypropylmethylcellulose, ethylcellulose,
glycerin, sunset yellow (E110).

What Nortriptyline Tablets look like and contents of
the pack
Nortriptyline 25mg Tablets are orange, round tablets,
scored on one side and plain on the other side.
They are available in packs of 25 and 100 tablets.
PL holder: Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA
PL 14251/0049
POM
Procured from within the EU
Manufacturer: Auden Mckenzie (Pharma Division) Ltd,
Mckenzie House, Bury Street, Ruslip, Middlesex,
HA4 7TL
To request a copy of this leaflet in large print, audio or
Braille, please call 01926 482511
This leaflet was last revised 04/11/16
WIP URN: 041116-XXXX-PIL-01

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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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