NORTRIPTYLINE 10 MG TABLETS

Active substance: NORTRIPTYLINE

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Package leaflet: Information for the user

Allegron tablets
Nortriptyline hydrochloride
Read all of this leaflet carefully before you start
taking this medicine.
I Keep this leaflet. You may need to read it again.
I If you have any further questions, ask your doctor
or pharmacist.
I 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.
I 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 relieves the symptoms of
depression.
Allegron may also be used for the treatment of bedwetting in children 6 years and older.

2 Before you take Allegron tablets
Do not take Allegron tablets if
I you are allergic (hypersensitive) to nortriptyline 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;
I you have severe liver disease;
I you suffer from mania (abnormally raised mood);
I you are breast-feeding;
I the child is under 6 years of age;
I you are taking, or have taken in the last two weeks,
monoamine oxidase inhibitors (another type of
antidepressant);
I 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
I you feel suicidal or aggressive - tell your doctor;
I you are agitated, overactive, or suffer from
schizophrenia;
I you have heart disease;
I you have a thyroid condition;
I you have a history of epilepsy;
I you have high pressure in the eyes (glaucoma);
I you have an enlarged prostate;
I your child taking Allegron has a change in
behaviour;
I you are going to have electroconvulsive therapy
(electric shock);
I you are diabetic;
I you are going to receive an anaesthetic, e.g. for an
operation – tell your doctor;
I you have had an allergic reaction to another tricyclic
antidepressant in the past;
I 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:
I

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

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:
I guanethidine, debrisoquine, bethanidine, clonidine
(used to treat high blood pressure);
I barbiturates (used for anxiety or to make you
feel sleepy);
I alcohol (you should not drink alcohol);
I fluoxetine (another antidepressant);
I cimetidine (for heartburn and ulcers);
I phenothiazines (for mental illness);
I carbamazepine (for epilepsy);
I 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)
6-7
8-11
Over 11

Weight
kg
20-25
25-35
35-54

lb
44-55
55-77
77-119

Dose (mg)
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 Allegron tablets than you should
Go to the nearest casualty department or contact your
doctor immediately. Take the tablet carton with you.

I

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.

I

If you stop taking Allegron
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.

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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:
I low or high blood pressure
I fast or irregular heartbeat
I palpitations
I heart attack (myocardial infarction)
I stroke
I oedema (swelling of the ankles)
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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)

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nightmares
panic
long-lasting abnormal mood
worsening of mental illness

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numbness, tingling, pins and needles in the
hands or feet
coordination problems
tremors
abnormal movements
fits (seizures)
altered brainwave (ECG) patterns
ringing in the ears (tinnitus)

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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

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rash
itching
light sensitivity
swelling (oedema)
fever
reaction to other similar drugs

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blood disorders which may cause you to bruise easily,
become anaemic or be unable to fight off infections

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feeling sick (nausea) and vomiting
not eating (anorexia)
indigestion
diarrhoea
constipation
peculiar taste
inflamed mouth
abdominal cramps
black tongue

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development of breasts in men, breast enlargement
and milk production in women
increased or decreased sex drive

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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.

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.

5 How to store Allegron tablets
Keep out of the sight and reach of children.
Do not use the drug after the date indicated on
the carton.
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.

6 Further information
What Allegron tablets contain
The active substance is nortriptyline hydrochloride.
Each tablet contains the equivalent of 10mg or 25mg
nortriptyline base.

The other ingredients are:
Maize Starch, Magnesium Stearate, Lactose
Monohydrate, Calcium Phosphate, Purified Water,
Sunset Yellow (E110) - 25mg tablets only.
What Allegron tablets looks like and
contents of the pack
Tablets 10mg are white, film-coated, unscored and
marked ‘KING’.
Tablets 25mg are orange, film-coated, scored and
marked ‘KING’.
Blister strips of 25 tablets or plastic bottles containing
500 or 100 x 10mg or 25mg tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
King Pharmaceuticals Ltd
Donegal Street
Ballybofey
County Donegal
Manufacturer
Dales Pharmaceuticals
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
This leaflet was last revised in
June 2010

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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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