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NORTRIPTYLINE 25MG TABLETS

Active substance(s): NORTRIPTYLINE / NORTRIPTYLINE HYDROCHLORIDE

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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.

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.

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 02/09/14

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

DT

02/09/14
DATE OF PROOF:

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.

NEW MANUFACTURER

06464/3000B

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.

CODE:

Nortriptyline 25mg tablets
PRODUCT:

04-1957
Waymade
CUSTOMER:

ARTWORKER:

DATE:

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.

PRE-PRESS NO.:

Q.A.
APPROVED:

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.

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.

WARNING!

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Nortriptyline 25mg Tablets
(nortriptyline hydrochloride)
Patient Information Leaflet

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 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.

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 (ECG) 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.

NEW MANUFACTURER

DATE:
DATE:
02/09/14
DATE OF PROOF:
CODE:

06464/3000B

DT

CUSTOMER
APPROVED:
04-1957

Nortriptyline 25mg tablets
PRODUCT:

ARTWORKER:

Waymade
CUSTOMER:

PRE-PRESS NO.:

Q.A.
APPROVED:

PROOF HISTORY:
v.1 - waymade - 02/09/14

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

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 Nortriptyline 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 Nortriptyline tablets contain
The active substance is nortriptyline hydrochloride.
Each tablet contains the equivalent of 25mg nortriptyline (as the hydrochloride).
The other ingredients are:
Lactose, calcium phosphate, starch, magnesium stearate, F D & C yellow No. 6,
hydroxypropylmethylcellulose, glycerine and ethylcellulose.
What Nortriptyline tablets looks like and contents of the pack
Nortriptyline 25mg Tablets are orange, film-coated with a breakline on one side and plain on the reverse.
Nortriptyline 25mg Tablets are available as blister strips of 100 tablets
POM

PL No: 06464/3000

This product is manufactured by Auden Mckenzie (Pharma Division) Ltd. Mckenzie House, Bury street,
Ruislip, Middlesex, HA4 7TL, UK. and procured from within the EU and repackaged by the Product Licence
Holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision issue date: (ref.) 01.09.2014

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

lb
44 - 55
55 - 77
77 - 119

WARNING!

Weight kg
20 - 25
25 - 35
35 - 54

WARNING!

Age (years)
6-7
8 - 11
Over 11

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Children (for bed-wetting only)

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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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