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NORTRIPTYLINE 10MG TABLETS

Active substance(s): NORTRIPTYLINE HYDROCHLORIDE

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ARTWORK INFORMATION:
PRODUCT:

Nortriptyline 10/25mg Tablets

LICENCE:

20620/0018-19

APPROVED FOR
SUBMISSION:

ITEM / SIZE: Generic package leaflet / 160 mm (h) x 270 mm (w) [flat]
ID CODE:

L1000003/2

VERSION:

1; 19/05/2015

INK:

Black

APPROVED BY
HEALTH AUTHORITY:

Space for
code

NORTRIPTYLINE 10MG & 25MG TABLETS
PATIENT INFORMATION LEAFLET

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
• K
 eep 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 LEAFLET CONTAINS INFORMATION ON:
1. What Nortriptyline Tablets are and what are they 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 ARE
THEY USED FOR?
Nortriptyline belongs to a class of medicines called tricyclic
antidepressants. Nortriptyline tablets are used:
• to treat major depression.
2. BEFORE YOU TAKE NORTRIPTYLINE TABLETS
You should not take Nortriptyline Tablets until you are sure it is safe
for you to do so. Nortriptyline Tablets are for adults only.
Do not take Nortriptyline Tablets if you:
• have had a rash or any other allergic reaction to Nortriptyline.
• have recently had a heart attack or if you have other heart
problems such as palpitations or irregular heartbeats?
• are taking, or have stopped taking within the last 14 days, a
monoamine oxidase inhibitor (e.g. phenelzine, isocarboxazid or
tranylcypromine). If you are taking moclobemide you must stop
this at least 24 hours before starting nortriptyline.
Take special care with Nortriptyline Tablets
Do not take Nortriptryline Tablets without first discussing your
condition with your doctor or pharmacist if you:
• are having an operation under general anaesthetic, discuss this
with your GP. You may need to stop taking Nortriptyline Tablets
several days before the operation. If your GP tells you to carry on
taking Nortriptyline Tablets, make sure the doctors treating you
in hospital know that you are on Nortriptyline.
• are pregnant or may be pregnant
• have thyroid problem
• have suffered from an allergic type reaction with another
tricyclic antidepressant, as cross sensitivity may occur
• ever had epilepsy
• are diabetic
• are breast feeding
• have an enlarged prostate
• have glaucoma or raised intra-ocular pressure
• are agitated or suffer from schizophrenia
• have low blood pressure or heart failure
• have severe liver disease
• have suffered from urinary retention
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.

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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 a 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.
Taking other medicines
You should not take Nortriptyline Tablets without discussing with
your doctor if you:
• are taking, or you have recently been taking, any medicines
known as monoamine oxidase inhibitors (‘MAOIs’)? MAOls
include phenelzine such as Nardil, tranylcypromine such as
Parnate or Parstelin and isocarboxazid such as Marplan. Tell
your doctor or pharmacist if you are taking them now or
have taken them in the last 2 weeks
• are taking moclobemide you must stop this at least 24 hours
before starting nortriptyline.
• are taking any medicine for your heart or for high blood
pressure?
• are taking adrenaline-like drugs including ephedrine,
isoprenaline, phenylepherine and phenylpropanolamine – these
drugs may be in cold remedies?
• are taking cimetidine, such as Tagamet?
• are taking any other medicines including other antidepressants
or medicine for bowel complaints, breathing difficulties,
bronchitis, glaucoma or prostate trouble?
• are taking levothyroxine?
• are taking antifungal medicines such as fluconazole and
terbinafine?
• are taking the antihistamines astemizole or terfenadine
• are taking the pain killer tramadol?
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines obtained
with out a prescription.
Taking Nortriptyline Tablets with food and drink
You should not drink alcohol while you are being treated with
Nortriptyline Tablets. You may find that you get more drunk or feel
more depressed.
Use by pregnant or breast feeding women
The safety of nortriptyline for use during pregnancy has not been
established. Hence, it should be taken only if your doctor advises
to do so. Please ask your doctor or pharmacist for advice before
taking any medicine.
The amount of Nortriptyline in breast milk is low, and no adverse
effects on breast fed infants of mothers taking nortriptyline have
been reported. However you should discuss the fact that you are
breast-feeding with your doctor if you are prescribed nortriptyline.
Driving and using machines
Do not drive or use machinery when you are on Nortriptyline
Tablets unless you are sure your judgement and co-ordination are
not affected. Antidepressants may affect your ability to drive or to
operate machinery safely.
Nortriptyline Tablets contains lactose monohydrate
Nortriptyline Tablets 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.

19/05/2015 16:37

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.
Adults
• The usual dose an adult will start on is 25mg two to three times
daily. You will usually be told to increase your dose gradually (no
more rapidly than by 25mg every other day) until you are taking
the usual maintenance dose of 75 to 100mg a day. Once you feel
better, you will be told to carry on taking Nortriptyline Tablets at
the same dose. Do not take more than six 25mg tablets a day
(150mg).
• If your doctor tells you to take more than four 25mg tablets a
day, he or she may arrange for you to have regular blood tests.
• If you are elderly you will usually be told to start on one 10mg
tablet three times a day. Dose increases should also be gradual
by no more than 10mg every other day. If you require a dose of
50mg or over, your doctor will arrange for you to have a
recording of your heart (ECG) and blood tests.
• Antidepressants may not make you feel better for the first two
weeks or more of treatment, so keep taking Nortriptyline Tablets
until your doctor tells you to stop. Do not stop these tablets
without discussing it with your doctor first.
• Do not suddenly stop taking the tablets. Your doctor will tell you
how to cut them down gradually.
If you take more Nortriptyline Tablets than you should
Do not take more tablets than your doctor tells you to. If you ever
take too many, or if a child has taken any nortriptyline, go to the
nearest hospital casualty department or tell your doctor at once.
An overdose can be very dangerous.
If you forget to take Nortriptyline Tablets
If you forget to take a dose, take it as soon as you remember. If it is
almost time for your next dose do not take a double dose to make
up for a forgotten dose, just carry on as before. If you have missed
several doses, discuss this with your doctor.
If you stop using Nortriptyline Tablets
If you stop using Nortriptyline Tablets abruptly after prolong
therapy you may have withdrawal symptoms, including not being
able to sleep, headache, nausea, irritability and sweating.
4. P
 OSSIBLE SIDE EFFECTS
Like all medicines Nortriptyline Tablets can cause side effects
although not everybody gets them.
Tell your doctor or pharmacist immediately if you
experience any of the following:
• serious heart problems along with ringing in the ears, stomach
cramps and clumsiness
• swelling of ankles and in severe cases of the face & tongue
• alterations in brain function (including perhaps seizures)
• blood disorders along with changes in blood sugar level
• swelling of breasts & testicles in men and increase in breast size
and spontaneous lactation in women
• swelling & damage to liver cells
• flu like symptoms including sore throat if occurring during the
first 10 weeks of treatment

Very rare: Less than 1 out of 10,000 patients.
Alterations in brain function (including perhaps
seizures), swelling of ankles and in severe cases of the
face & tongue. Blood disorders may also very rarely
occur along with changes in blood sugar level. In
severe cases men may suffer from swelling of breasts
& testicles whilst women may also notice an increase in
breast size and spontaneous lactation. In extreme
cases there may be swelling & damage to liver cells.
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 NORTRIPTYLINE TABLETS
• K
 eep 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.
• Do not store above 25°C. Store in the original container. Keep
the container tightly closed.
• 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 name of this medicine is Nortriptyline 10mg or 25mg Tablets.
The active substance in your tablet is nortriptyline hydrochloride.
Each tablet contains 10mg or 25mg of nortriptyline (as the
hydrochloride) respectively. Other ingredients include lactose
monohydrate, maize starch and magnesium stearate.
What Nortriptyline Tablets look like and contents of the
pack
Nortriptyline 10 mg Tablets are white to off white, round, biconvex,
uncoated tablets, debossed ‘NO’ on one side and ‘10’ on other
side.
Nortriptyline 25 mg Tablets are white to off white, round, biconvex,
uncoated tablets, debossed ‘NO’ on one side and ‘25’ on other
side.
Nortriptyline 10mg & 25mg Tablets are packed in a white HDPE
bottle, with a white polypropylene child resistant cap and tamper
evident film, containing 100 tablets.
Marketing Authorisation Holder:
The Marketing Authorisation Holder of these tablets is
Lime Pharma Ltd., Mckenzie House, Bury Street, Ruislip,
Middlesex HA4 7TL, U.K.
Manufacturer:
Auden Mckenzie (Pharma Division) Ltd.,
Mckenzie House, Bury Street, Ruislip, Middlesex HA4 7TL, U.K.

The following side effects have also been reported:
Very common: More than 1 out of 10 patients.
Dry mouth, sweating, constipation, blurred vision, and irregular or
heavy heart beats.

This leaflet was prepared in May 2015

Common: More than 1 but less than 10 out of 100 patients.
Strange body movements and headaches, sweating, flushing,
weakness, fatigue, headache, low blood pressure, tremors,
decreases in libido and erectile dysfunction.
Uncommon: More than 1 but less than 10 out of 1,000 patients.
Dizziness, changes in sleep patterns (including nightmares),
numbness, nausea (feeling sick) & vomiting, problems urinating
(increased or decreased), high blood pressure are all uncommon
side effects.
Tingling in arms & legs, anxiety, loss of appetite, diarrhoea, liver
problems including jaundice, weight gain or loss & changes in
sexual performance may also occur.
Rare: More than 1 but less than 10 out of 10,000 patients.
Peculiar taste, mouth or gum problems, confusional states
(especially in the elderly) perhaps with anxiety & restlessness are
rare side effects. More serious heart problems along with ringing in
the ears, stomach cramps and clumsiness can also occasionally
occur. Rarely increases in libido have been reported. Some patients
have had a rash, which may be itchy or get worse in sunlight. If you
suddenly stop taking the tablets, you may not be able to sleep and
may feel irritable or sweaty.
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19/05/2015 16:37

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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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