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NORTRIPTYLINE 25 MG TABLETS

Active substance(s): NORTRIPTYLINE / NORTRIPTYLINE / NORTRIPTYLINE

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Package leaflet: Information for the user
Allegron tablets 10mg & 25mg
Nortriptyline
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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
1.

What Allegron tablets are and what they are used for
What you need to know before you take Allegron tablets
How to take Allegron tablets
Possible side effects
How to store Allegron tablets
Contents of the pack and other information
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.
If any of the above apply to you, tell your doctor or pharmacist.
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.
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.
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)
6-7
8-11
Over 11

Weight
kg
20-25
25-35
35-54

Dose (mg)
lb
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.
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.
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)
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 in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:
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 Allegron tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away any medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other 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:
Tablets 10mg: Maize Starch, Magnesium Stearate, Lactose Monohydrate (see section 2), Calcium
Phosphate, Purified Water. Coat: Glycerol, Methylhydroxpropyl Cellulose.
Tablets 25mg: Maize Starch, Magnesium Stearate, Lactose Monohydrate (see section 2), Calcium
Phosphate, Purified Water, Sunset Yellow (E110) (see section 2). Coat: Glycerol,
Methylhydroxpropyl Cellulose, Ethylcellulose, Methyl Alcohol, Isopropyl Alcohol, Methylene
Chloride.
What Allegron tablets look 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 tablets 10mg or tablets 25mg.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
King Pharmaceuticals Ltd
Donegal Street
Ballybofey
County Donegal
Ireland
Manufacturer
Dales Pharmaceuticals
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
UK
This leaflet was last revised in August 2015

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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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