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AMITRIPTYLINE 25MG FILM-COATED TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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ZINC Ref:

EAS1391a LEA AMITRIPTYLINE 10, 25 & 50MG FC TABS TUK Dim’s Changed?:
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YES
540 mm
160 mm
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Package leaflet: Information for the patient
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 Amitriptyline is and what it is used for
2. What you need to know before you take
Amitriptyline
3. How to take Amitriptyline
4. Possible side effects
5. How to store Amitriptyline
6. Contents of the pack and other information

What Amitriptyline is and what it is
used for

Amitriptyline belongs to a group of drugs called
tricyclic antidepressants
This medicine is used to treat:
• Depression in adults (major depressive
episodes)
• Neuropathic pain in adults
• Chronic tension type headache prophylaxis in
adults
• Migraine prophylaxis in adults
• Bed-wetting at night in children aged 6 years
and above, only when organic causes, such as
spina bifida and related disorders, have been
excluded and no response has been achieved
to all other non-drug and drug treatments,
including muscle relaxants and desmopressin.
This medicine should only be prescribed by
doctors with expertise in treating patients with
persistent bed-wetting.

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Colours Used:

AMITRIPTYLINE 10 mg, 25 mg AND
50 mg Film-coated Tablets

1

Version:

What you need to know before you take
amitriptyline

Do not take Amitriptyline:
• if you are allergic to amitriptyline or any of the
other ingredients of this medicine (listed in
section 6).
• if you recently have had a heart attack
(myocardial infraction)
• if you have any heart problems such as
disturbances in heart rhythm which are seen
on an electrocardiogram (ECG), heart block, or
coronary artery disease
• if you are taking monoamine oxidase
inhibitors (MAOIs)
• if you have taken MAOIs within the last 14 days
• if you have taken moclobemide the day before
• if you have severe liver disease
If you are treated with Amitriptyline, you have to
stop taking this medicine and wait for 14 days
before you start treatment with a MAOI.
This medicine should not be used for children
below 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amitriptyline.
Heart rhythm disorders and hypotension may occur
if you receive a high dosage of amitriptyline. This
might also occur in usual doses if you have
pre-existing heart disease.
Prolonged QT interval
A heart problem called “prolonged QT interval”
(which is shown on your electrocardiogram, ECG)
and heart rhythm disorders (rapid or irregular heart
beat) have been reported with X. Tell your doctor if
you:
• have slow heart rate,
• have or had a problem where your heart cannot
pump the blood round your body as well as it
should (a condition called heart failure),
• are taking any other medication that may
cause heart problems, or
• have a problem that gives you a low level of
potassium or magnesium, or a high level of
potassium in your blood
• have a surgery planned as it might be
necessary to stop the treatment with
amitriptyline before you are given
anaesthetics. In the case of acute surgery, the
anaesthetist should be informed about the
treatment of amitriptyline.
• have an over active thyroid gland or receive
thyroid medication.

Template

Children and adolescents
Depression, neuropathic pain, chronic tension type
headache and migraine prophylaxis
Do not give this medicine to children and
adolescents aged below 18 years for these
treatments as long term safety and efficacy have
not been established in this age group.
Bed-wetting at night
• An ECG should be performed prior to initiating
therapy with amitriptyline to exclude long QT
syndrome
• This medicines should not be taking at the same
time as an anticholinergic drug (see also section
2 Other medicines and amitriptyline)
• Suicidal thoughts and behaviours may also
develop during early treatment with
antidepressants for disorders other than
depression; the same precautions observed
when treating patients with depression should
therefore be followed when treating patients
with enuresis
Other medicines and Amitriptyline
Some medicines may affect the action of other
medicines and this can sometimes cause serious
side effects.
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines such as:
• monoamine oxidase inhibitors (MAOIs) e.g.
phenelzine, iproniazid, isocarboxazid, nialamide
or tranylcypromine (used to treat depression) or
selegiline (used to treat Parkinson's disease).
These should not be taken at the same time as
Amitriptyline (see section 2 Do not take
Amitriptyline)
• adrenaline, ephedrine, isoprenaline,
noradrenaline, phenylephrine and
phenylpropanolamine (these may be present in
cough or cold medicine, and in some
anaesthetics)
• medicine to treat high blood pressure for
example calcium-channel blockers (e.g. diltiazem
and verapamil), guanethidine, betanidine,
clonidine reserpine and methyldopa
• Anticholinergic drugs such as certain medicines
to treat Parkinsons disease and gastrointerstinal
disorders (e.g. atropine, hyoscyamine)
• thioridazine (used to treat schizophrenia)
• tramadol (painkiller)
• medicines to treat fungal infections (e.g.
fluconazole, terbinafine, ketoconazole, and
itraconazole)
• sedatives (e.g. babiturates)
• antidepressants (e.g SSRIs (fluoxetine,
paroxetine, fluvoxamine), and bupropion)
• medicines for certain heart conditions (e.g. beta
blockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• ritonavir (used to treat HIV)
• oral contraceptives
• rifampicin (to treat infections)
• phenytoin and carbamazepine (used to treat
epilepsy)
• St. John´s Wort (hypericum perforatum) – a
herbal remedy used for depression
• thyroid medication.
You should also tell your doctor if you take or have
recently taken medicine that may affect the heart´s
rhythm. e.g.:
• medicines to treat irregular heartbeats (e.g.
quinidine and sotalol)
• astemizole and terfenadine (used to treat
allergies and hayfever)
• medicines used to treat some mental illnesses
(e.g. pimozide and sertindole)
• cisapride (used to treat certain types of
indigestion)
• halofantrine (used to treat malaria)
• methadone (used to treat pain and for
detoxification)
• diuretics (“water tablets” e.g. furosemide)
If you are going to have an operation and receive
general or local anaesthetics, you should tell your
doctor that you are taking this medicine.
Likewise, you should tell your dentist that you take
this medicine if you are to receive a local
anaesthetic.
Amitriptyline with alcohol
It is not advised to drink alcohol during treatment
with this medicine as it might increase the sedative
effect.
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 for advice before taking this
medicine.

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Tell your doctor if you have, or have had in the
past, any medical problems, especially if you have:
• narrow angle glaucoma (loss of vision due to
abnormally high pressure in the eye)
• epilepsy, a history of convulsions or fits
• difficulty in passing urine
• enlarged prostate
• thyroid disease
• bipolar disorder
• schizophrenia
• severe liver disease
• severe heart disease
• pylorus stenosis (narrowing of the gastric
outlet) and paralytic ileus (blocked intestine)
• diabetes as you might need and adjustment of
your antidiabetic medicine.
If you use antidepressants such as SSRIs, your
doctor might consider changing the dose of your
medicine (see also section 2 Other medicines and
Amitriptyline and section 3)
Elderly are more likely to suffer from certain side
effects such as dizziness when you stand up due to
low blood pressure (see section 4, Possible side
effects).

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PANTONE® GREEN C

Amitriptyline is not recommended during
pregnancy unless your doctor considers it clearly
necessary and only after careful consideration of
the benefit and risk. If you have taken this medicine
during the last part of the pregnancy, the newborn
Thoughts of suicide and worsening of your
may have withdrawal symptoms such as irritability,
depression or anxiety disorder
increased muscle tension, tremor, irregular
If you are depressed you can sometimes have
breathing, poor drinking, loud crying, urinary
thoughts of harming or killing yourself. These may retention, and constipation.
be increased when first starting antidepressants,
Your doctor will advise you whether to
since these medicines all take time to work, usually
start/continue/ stop breast-feeding, or stop using
about two weeks but sometimes longer.
this medicine taking into account the benefit of
You may be more likely to think like this:
breast-feeding for your child and the benefit of
• if you have previously had thoughts about killing
therapy for you.
or harming yourself
Driving and using machines
• if you are a young adult. Information from
This medicine may cause drowsiness and dizziness,
clinical trials has shown an increased risk of
especially in the beginning of the treatment. Do not
suicidal behaviour in adults (less than 25 years
old) with psychiatric conditions who were treated drive or work with tools or machinery if you are
affected.
with an antidepressant.
If you have thoughts of harming or killing yourself Amitriptyline contains lactose
at any time, contact your doctor or go to a hospital If your doctor has told you that you have
intolerance to some sugars, contact your doctor
straight away.
before taking this medicine.
You may find it helpful to tell a relative or close
friend that you are depressed, and ask them to read
How to take Amitriptyline
this leaflet. You might ask them to tell you if they
think your depression or anxiety is getting worse,
Always
take this medicine exactly as your doctor
or if they are worried about changes in your
has told you. Check with your doctor if you are not
behaviour.
sure.
Episodes of mania
Not all dosage schemes can be achieved with all
Some patients with manic-depressive illness may
the pharmaceutical forms/strengths. The
enter into a manic phase. This is characterized by
appropriate formulation/strength should be
profuse and rapidly changing ideas, exaggerated
selected for the starting doses and any subsequent
gaiety and excessive physical activity. In such
dose increases.
cases, it is important to contact your doctor who
probably will change your medication.

04 October 2017

Depression
Adults
The recommended initial dose is 25 mg two times
daily.
Depending on the response to the medicine, your
doctor may gradually increase the dose to 150 mg
per day divided in two doses.
Elderly (above 65 years of age) and patients with
cardiovascular disease
The recommended initial dose is 10 mg – 25 mg
daily.
Depending on your response to the medicine, your
doctor may gradually increase the dose to a total
daily dose of 100 mg divided in two doses. If you
receive doses in the range of 100 mg – 150 mg,
your doctor may need to do more frequent
follow-up with you.
Use in children and adolescents
This medicine should not be given to children or
adolescents for treatment of depression. For further
information please see section 2.
Neuropathic pain, chronic tension type headache
and migraine prophylaxis
Your doctor will adjust the medication according to
your symptoms and your response to the
treatment.

ZINC Ref:

EAS1391a LEA AMITRIPTYLINE 10, 25 & 50MG FC TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

YES
540 mm
160 mm
N/A
N/A

Version:

3

04 October 2017

Colours Used:

Adults
The recommended initial dose is 10 mg - 25 mg in
the evening.

BLACK
PANTONE® GREEN C
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Other side effects:

Very common: may affect more than 1 in 10 people
• sleepiness/drowsiness
• shakiness of hands or other body parts
• dizziness
Depending on your response to the medicine, your
• headache
doctor may gradually increase the dose. If you
• irregular, hard, or rapid heartbeat
receive doses above 100 mg daily, your doctor may
• dizziness when you stand up due to low blood
need to do more frequent follow-up with you. Your
pressure (orthostatic hypotension)
doctor will instruct you whether to take the doses
• dry mouth
once daily or divide into two doses.
• constipation
Elderly (above 65 years of age) and patients with
• nausea
cardiovascular disease
• excessive sweating
The recommended initial dose is 10 mg – 25 mg in
• weight gain
the evening.
• slurred or slow speech
Depending on your response to the medicine, your
• aggression
doctor may gradually increase the dose. If you
• congested nose.
receive doses above 75 mg daily, your doctor may Common: may affect up to 1 in 10 people
need to do more frequent follow-up with you.
• confusion
• sexual disturbances (decreased sex-drive,
Use in children and adolescents
problems with erection)
This medicine should not be given to children or
• disturbance in attention
adolescents for treatments of neuropathic pain,
• changes in taste
chronic tension type headache prophylaxis and
• numbness or tingling in the arms or legs
migraine prophylaxis. For further information
• disturbed coordination
please see section 2.
• dilated pupils
Bed-wetting at night
• heart block
Use in children and adolescents
• fatigue
The recommended doses for children:
• low sodium concentration in the blood
• aged below 6 years: see section 2 Do not take
• agitation
Amitriptyline
• urination disorders
• aged 6 to 10 years: 10 mg – 20 mg daily. A
• feeling thirsty.
suitable dosage form should be used for this
Uncommon: may affect up to 1 in 100 people
age group.
• excitement, anxiety, difficulties sleeping,
• aged 11 years and above: 25 mg – 50 mg.
nightmares
The dose should be increased gradually.
• convulsions
The recommended daily dose is 25 mg - 75 mg.

Take this medicine 1-1½ hours before bedtime.

tinnitus
increased blood pressure
diarrhoea, vomiting
skin rash, nettle rash (urticarial), swelling of
the face and tongue
Your doctor will re-evaluate your treatment after
• difficulties passing urine
3 months and if needed perform a new ECG.
• increased production of breast milk or breast
Do not stop the treatment without consulting your
milk outflow without breast feeding
doctor first.
• increased pressure in the eye ball

collapse conditions
Patients with special risks
• worsening of cardiac failure
Patients with liver diseases or people known as

liver
function impairment (e.g. cholestatic liver
“poor metabolisers” usually receive lower doses.
disease).
Your doctor may take blood samples to determine
the level of amitriptyline in the blood (see also
Rare: may affect up to 1 in 1,000 people
section 2).
• decreased appetite
• delirium (especially in elderly patients),
How and when to take Amitriptyline
hallucinations (especially in patients with
This medicine can be taken with or without food.
schizophrenia),
Swallow the tablets with a drink of water. Do not
• abnormality in the heart's rhythm, or heartbeat
chew them.
pattern
• swelling of the salivary glands
Duration of treatment

hair loss
Do not change the dose of the medicine or stop taking
• increased sensitivity to sunlight
the medicine without consulting your doctor first.
• breast enlargement in men
Depression
• fever
As with other medicines for the treatment of
• weight loss
depression it may take a few weeks before you feel
• abnormal results of liver function tests.
any improvement.
Very rare: may affect up to 1 in 10,000 people
In treating depression the duration of treatment is
• heart muscle disease
individual, and is usually at least 6 months. The
• feeling of inner restlessness and a compelling
duration of treatment is decided by your doctor.
need to be in constant motion
Continue to take this medicine for as long as your
• disorder of the peripheral nerves
doctor recommends.
• acute increase of pressure in the eye
• particular forms of abnormal heart rhythm (so
The underlying illness may persist for a long time.
called torsades de pointes)
If you stop your treatment too soon, your
• allergic inflammation of the lung alveoli and of
symptoms may return.
the lung tissue.
Neuropathic pain, chronic tension type headache
Not known: frequency cannot be estimated from
and migraine prophylaxis
the available data
It might take a few weeks before your feel any
• absent sensation of appetite
improvement of your pain.
• elevation or lowering of blood sugar levels
Talk to your doctor about the duration of your
• paranoia
treatment and continue to take this medicine for as
• movement disorders (involuntary movements
long as your doctor recommends.
or decreased movements)
Bed-wetting at night
• hypersensitivity inflammation of heart muscle
Your doctor will evaluate if the treatment should be
• hepatitis
continued after 3 months.
• hot flush.
If you take more Amitriptyline than you should
An increased risk of bone fractures has been
Contact your doctor or nearest hospital casualty
observed in patients taking this type of medicines.
department immediately. Do this even if there are
Reporting of side effects
no signs of discomfort or poisoning. Take the
If you get any side effects, talk to your doctor or
container of this medicine with you if you go to a
pharmacist. This includes any possible side effects
doctor or hospital.
not listed in this leaflet. You can also report side
Symptoms of overdose include:
effects directly via the Yellow Card Scheme at:
• dilated pupils
www.mhra.gov.uk/yellowcard or search for MHRA
• fast or irregular heartbeats
Yellow Card in the Google Play or Apple App Store
• difficulties passing water
By reporting side effects you can help provide more
• dry mouth and tongue
information on the safety of this medicine.
• intestinal blockage
• fits
How to store Amitriptyline
• fever
• agitation
Keep this medicine out of the sight and reach of
• confusion
children.
• hallucinations
The tablets should be stored in the package or
• uncontrolled movements
container supplied. Do not transfer them to another
• low blood pressure, weak pulse, pallor
container.
• difficulty breathing
• blue discolouration of the skin
Do not use this medicine after the expiry date that
• decreased heart rate
is stated on the carton. The expiry date refers to the
• drowsiness
last day of that month.
• loss of consciousness
Do not throw away any medicines via wastewater
• coma
or household waste. Ask your pharmacist how to
• various cardiac symptoms such as heart block, throw away medicines you no longer use. These
heart failure, hypotension, cardiogenic shock,
measures will help to protect the environment.
metabolic acidosis, hypokalemia.
Contents of the pack and other
If you forget to take Amitriptyline
information
Take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
What Amitriptyline Tablets contains:
If you stop taking Amitriptyline
Your doctor will decide when and how to stop your • The active substance is amitriptyline
hydrochloride
treatment to avoid any unpleasant symptoms that
might occur if it is stopped abruptly (e.g. headache, • The other ingredients are lactose monohydrate,
maize starch, calcium hydrogen phosphate
feeling unwell, sleeplessness and irritability).
dihydrate, silica colloidal anhydrous, magnesium
If you have any further questions on the use of this
stearate, titanium dioxide (E171)
product, ask your doctor or pharmacist.
• The 10 mg tablets also contain macrogol, talc,
polyvinyl alcohol dispersed blue (E131) and
Possible side effects
brilliant blue (E133); the 25 mg tablets also
contain polyvinyl alcohol, talc, macrogol,
Like all medicines, this medicine can cause side
quinoline yellow (E104) and sunset yellow (E110);
effects, although not everybody gets them.
the 50 mg tablets also contain polyvinyl alcohol,
If you get any of the following symptoms you
macrogol, red iron oxide (E172), and talc.
should see your doctor immediately:
What Amitriptyline Tablets look like and contents of
- Attacks of intermittent blurring of vision, rainbow the pack:
vision, and eye pain.
• Amitriptyline 10 mg Tablets are sky blue,
You should immediately have an eye
biconvex, film-coated tablets, engraved “D” on
examination before the treatment with this
one side and plain on the reverse.
medicine can be continued. This condition may
• Amitriptyline 25 mg Tablets are yellow, biconvex,
be signs of acute glaucoma. Rare side effect, may
film-coated tablets, engraved “D” on one side
affect more than 1 in 1,000 people.
and plain on the reverse.
• Amitriptyline 50 mg Tablets are red/brown,
- A heart problem called “prolonged QT interval”
biconvex, film-coated tablets, engraved “D” on
(which is shown on your electrocardiogram,
one side and plain on the reverse.
ECG). Common side effect, may affect up to 1 in
• All strengths of tablets are available in pack sizes
10 people.
of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
- Bad constipation, a swollen stomach, fever and
120, 150, 160, 168, 500, or 15000 tablets. The 25
vomiting.
mg tablets are also available in a pack size of 25
These symptoms may be due to parts of the
tablets, and the 50 mg tablets are also available
intestine becoming paralysed. Rare side effect,
in a pack size of 250 tablets.
may affect up to 1 in 1,000 people.
Not all pack sizes may be marketed.
- Any yellowing of the skin and the white in the
Marketing Authorisation Holder and Manufacturer
eyes (jaundice).
Your liver may be affected. Rare side effect, may Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
affect up to 1 in 1,000 people.
Before starting treatment, your doctor will conduct
an ECG of your heart to check for sign of unusual
heartbeat.






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4

- Bruising, bleeding, pallor or persistent sore
throat and fever.
These symptoms can be the first signs that your
blood or bone marrow may be affected.
Effects on the blood could be a decrease in the
number of red cells (which carry oxygen around
the body), white cells (which help to fight
infection) and platelets (which help with clotting).
Rare side effect, may affect up to 1 in 1,000 people.
• Suicidal thoughts or behaviour. Rare side effect,
may affect up to 1 in 1,000 people.

Manufacturer:
Teva Operations Poland Sp. z o.o.
Mogilska Street 80, 31-546 Krakow, Poland.
This leaflet was last revised: September 2017
PL 00289/0178-0180

EAS1391a

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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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