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NORTRIPTYLINE 25 MG FILM-COATED TABLETS

Active substance(s): NORTRIPTYLINE HYDROCHLORIDE

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Package leaflet: Information for the user

Nortriptyline 10 mg Film-coated Tablets
Nortriptyline 25 mg Film-coated Tablets
Nortriptyline hydrochloride
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. What Nortriptyline Tablets are and what
they are used for
2. What you need to know before you take
Nortriptyline Tablets
3. How to take Nortriptyline Tablets
4. Possible side effects
5. How to store Nortriptyline Tablets
6. Contents of the pack and other information

1. WHAT NORTRIPTYLINE TABLETS
ARE AND WHAT THEY ARE USED FOR
Nortriptyline tablets contain the active
ingredient nortriptyline hydrochloride, which
is known as a tricyclic antidepressant.
Nortriptyline tablets relieve the symptoms of
depression.

2. WHAT YOU NEED TO KNOW 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 are allergic to nortriptyline 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
• you have had a recent heart attack or
heartbeat disorder
• you are taking, or have taken in the last
two weeks, monoamine oxidase inhibitors
(another type of antidepressant)
Warnings and precautions
Talk to your doctor or pharmacist before
taking Nortriptyline Tablets, if:
• you feel suicidal or aggressive (see the
section below for more information)
• you are agitated, overactive, or suffer from
schizophrenia or another mental illness
• you have heart disease or low blood
pressure
• you have severe liver disease
• you have a thyroid condition
• you have a history of convulsions/seizures
(epilepsy)
• you have high pressure in the eyes (raised
intra-ocular pressure) or glaucoma
• you have an enlarged prostate
• you have trouble urinating (urinary
retention)
• you are being treated for diabetes. It may
be necessary to adjust your diabetes
therapy when you start Nortriptyline
Tablets
• you are going to receive an anaesthetic,
e.g. for an operation 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 the hospital
know that you are on Nortriptyline Tablets
• 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
• you have a sore throat, fever and
symptoms of influenza in the first 10 weeks
of treatment
• you have excessive fever (hyperpyrexia)
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.
Other medicines and Nortriptyline Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
The following medicines may interact with
your Nortriptyline Tablets:
• monoamine oxidase inhibitors – ‘MAOIs’
(phenelzine (Nardil), tranylcypromine,
isocarboxazid). Tell your doctor or
pharmacist if you are taking them now
or have taken them in the last 2 weeks
• medicines for your heart or for high
blood pressure including guanethidine,
debrisoquine, bethanidine, clonidine and
methyldopa
• moclobemlde, you must stop this at least
24 hours before starting nortriptyline
• adrenaline-like drugs including ephedrine,
isoprenaline, phenylephrine and
phenylpropanolamine – these drugs may
be in cold remedies
• barbiturates (used for anxiety or to make
you feel sleepy)
• cimetidine (for heartburn and ulcers)
• other medicines including other
antidepressants, medicines for other
neurological or mental illness or medicines
for bowel complaints, breathing difficulties,
epilepsy, bronchitis, glaucoma or prostate
trouble
• levothyroxine (used to treat thyroid
conditions)
• antifungal medications (e.g. fluconazole
and terbinafine)
• antihistamines (e.g. astemizole or
terfenadine)
• tramadol (painkiller)
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.
Nortriptyline Tablets with food, drink and
alcohol
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
The safety of nortriptyline for use during
pregnancy has not been established.
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
Nortriptyline Tablets may affect alertness.
Use caution when driving or operating heavy
machinery until you are 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
have been told by your doctor that you have
intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE NORTRIPTYLINE
TABLETS
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults:
• The usual adult dose is 25 mg three or four
times daily or the dose may be given once
a day. The dose should begin at a low level,
25 mg, 2-3 times daily, for example and
be increased gradually as required. The
maximum dose is 150 mg per day.
• If there is a satisfactory response, your
doctor will continue Nortriptyline Tablets
for at least 4 weeks. Your doctor will work
with you to try to reduce to a maintenance
dose of 100 mg per day.
• If your doctor tells you to take more than
four 25 mg tablets a day, he or she may
arrange for you to have regular blood tests.
• Do not suddenly stop taking the tablets.
Your doctor will tell you how to cut them
down gradually.

Continued overleaf...

Elderly:
• The usual dose is 30 to 50 mg a day in
divided doses. Treatment may start with
10 mg once or twice a day. If necessary
your doctor may increase your dose by
10 mg every other day. If you require a
dose of 50 mg or more, your doctor will
arrange for your to have a recording of your
heart (ECG) and blood tests. The additional
tablets should be taken in the morning.
Use in children and adolescents
The use of Nortriptyline Tablets in children and
adolescents is not recommended.
Patients under 18 have an increased risk
of suicide attempts, suicidal thoughts
and hostility (predominantly aggression,
oppositional behaviour and anger) when they
are treated with drugs of this class.
If you take more Nortriptyline Tablets than
you should
Go to the nearest emergency department or
contact your doctor immediately. Take the
tablet carton with you. An overdose can be
very dangerous.
If you forget to take Nortriptyline Tablets
If you forget to take a dose, take one as soon
as you remember. Do not take a double dose
to make up for a forgotten dose. If you have
missed several doses, tell your doctor.
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 medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 and tongue
• alterations in brain function (including
perhaps seizures)
• blood disorders along with changes in
blood sugar level
• swelling of breasts and testicles in
men and increase in breast size and
spontaneous lactation in women
• alteration of your liver function (shown by
blood tests) due to swelling and damage to
liver cells
• flu like symptoms including sore throat
if occurring during the first 10 weeks of
treatment.
The following side effects have also been
reported:
Very common (may affect more than 1 in 10
people)
Shaking (tremor), dizziness, headache,
dry mouth, nausea, sweating, flushing,
constipation, trouble adjusting to see including
blurred vision (accommodation disorder),
a drop in blood pressure for example when
standing up quickly from a sitting or lying
position sometimes accompanied by dizziness
(orthostatic hypotension) and irregular or
heavy heart beat.
Common (may affect up to 1 in 10 people)
Fatigue, weakness, weight gain, abnormalities
of the ECG (electrocardiogram (ECG)),
dysfunction of the ventricles of the heart
(ventricular dysfunction), disorders in the
conduction of the heart leading to arrythmias
(atrioventricular block), conduction disorders
of the heart. High or low blood pressure.
Difficulties concentrating, taste disturbances,
sensation of tickling, itching or tingling
without any prompts (paraesthesia),
coordination problems e.g. drunken gait
(ataxia), dilation of the pupils (mydriasis),
strange body movements. Erectile
dysfunction, decreased sex drive (libido).
Uncommon (may affect up to 1 in 100
people)
Ringing in the ears (tinnitus), fits or seizures
(convulsions), numbness, increased pressure
in the eye (intraocular pressure), diarrhoea,
vomiting, fluid accumulation in the tongue
(tongue oedema), problems urinating (urinary
retention), rash, skin rash with intense itching
and hives (urticaria), fluid retention in the face
(facial oedema), increased blood pressure
(hypertension), (lighter form of) excessive
cheerfulness associated with having a lot
of energy ((hypo)mania), anxiety, insomnia,
changes in sleep pattern including nightmares.
Rare (may affect up to 1 in 1,000 people)
Weight gain or loss, diarrhoea, stomach
cramps, abnormal liver function test,
increased blood liver enzymes, disturbances
in heart rhythm (arrhythmia), decrease in
blood-forming cells in the bone marrow (bone
marrow depression), very serious blood
disorder (lack of white blood cells) associated
with sudden high fever, severe sore throat and
sores in the mouth (agranulocytosis), blood
disorder (lack of white blood cells) associated
elevated susceptibility to infections
(leucopenia), blood abnormalities (low platelet
count) associated with bruising and bleeding
(thrombocytopenia), increase salivary glands,
loss of bowel movement

(paralytic ileus), baldness (alopecia),
photosensitivity, decreased appetite,
fever, peculiar taste, mouth or gum
problems, jaundice, breast development
in men (gynecomastia), changes in sexual
performance, clumsiness, irritability, acute
confusion (delirium) especially in elderly
patients, hallucinations in schizophrenic
patients.
Very rare (may affect up to 1 in 10,000
people)
Changes in blood sugar, swelling of the
breasts (men and women) and increased/
inapropriate milk production (galactorrhoea),
swelling of testicles.
Not known (frequency cannot be estimated
from the available data)
Water retention and reduction of salt levels
(sodium glucose) in the blood. Syndrome of
inappropriate antidiuretic hormone secretion
(SIADH), cholestasis, suicidal ideation
and self-harming behaviours, agitation,
restlessness, aggressive outbursts, delusions,
orgasmic disorder in women, increased libido
(sexual desire), disorientation and higher risk
of fractures.
There are reports of people who have suicidal
or self-harming thoughts or behaviour while
taking Nortriptyline Tablets or shortly after
treatment with Nortriptyline Tablets (see
Section 2).
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 national
reporting system.
United Kingdom: Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance;
Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517,
Website: www.hpra.ie.
e-mail: medsafety@hpra.ie.
By reporting side effects you can help
provide more information on the safety of this
medicine.
5. HOW TO STORE NORTRIPTYLINE
TABLETS
Keep this medicine out of the sight and reach
of children.
This medicine does not require any special
storage conditions.
Do not use this medicine after the expiry date
which is stated on the carton and bottle and
blister after EXP. The expiry date refers to the
last day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK
AND OTHER INFORMATION
What Nortriptyline Tablets contain
− The active substance is nortriptyline
hydrochloride.
Each 10 mg tablet contains nortriptyline
hydrochloride, equivalent to 10 mg
nortriptyline.
Each 25 mg tablet contains nortriptyline
hydrochloride, equivalent to 25 mg
nortriptyline.
− The other ingredients are:
Lactose monohydrate, maize starch,
microcrystalline cellulose, magnesium
stearate, hypromellose E6, titanium dioxide,
macrogol 6000.
What Nortriptyline Tablets look like and
contents of the pack
− Nortriptyline 10 mg Tablets are white,
round shaped, film coated tablets debossed
“10” on one side with a diameter of
5.55 mm.
− Nortriptyline 25 mg Tablets are white,
round shaped, film-coated tablets,
debossed “25” on one side with a diameter
of 8.00 mm.
Nortriptyline Tablets are available in
ALU-PVC/PVDC Blisters in packs of 100
tablets (10 x blisters of 10 tablets per blister).
HDPE containers containing 100 or 500
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Alissa Healthcare Research Limited, Unit 5,
Fulcrum 1, Solent Way, Whiteley, Fareham,
Hampshire, United Kingdom, PO15 7FE
Manufacturer
Norameda UAB, Meistru g. 8A, Vilnius City,
Vilnius City Municipality, Lithuania
This medicinal product is authorised in
the Member States of the EEA under the
following names:
United Kingdom: Nortriptyline 10 & 25 mg

Film-coated Tablets
Ireland:
Nortriptyline 10 & 25 mg

Film-coated Tablets
This leaflet was last revised in 04/2016

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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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