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AMITRIPTYLINE TABLETS BP 10 MG

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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Very rare: may affect up to 1 in 10,000 people
• Attacks of intermittent blurring of vision, rainbow
vision, and eye pain. You should immediately have
an eye examination before the treatment with this
medicine can be continued. This condition may be
signs of acute glaucoma.

• weakness, poor concentration, disorientation, delusion,
restlessness, pain, poor coordination, blurred vision,
movement disorders (involuntary movements or
decreased movements)
• hypersensitivity inflammation of heart muscle, heart
attack, stroke
• hepatitis
• hot flush
• stomach pain, sore mouth, black tongue
• breast enlargement, changes in sex drive or function,
ADH secretion changes

Side effects listed below have been reported in the
following frequencies:
Very common: may affect more than 1 in 10 people
• sleepiness/drowsiness
• shakiness of hands or other body parts
• dizziness, headache, dizziness when you stand up due
to low blood pressure (orthostatic hypotension)
• irregular, hard, or rapid heartbeat
• dry mouth, constipation, nausea
• excessive sweating
• weight gain
• slurred or slow speech
• aggression
• congested nose.
Common: may affect up to 1 in 10 people
• confusion, disturbance in attention, disturbed
coordination, agitation
• sexual disturbances (decreased sex-drive, problems
with erection)
• changes in taste, feeling thirsty
• numbness or tingling in the arms or legs
• dilated pupils
• heart block
• fatigue
• low sodium concentration in the blood
• urination disorders.

Additional side effects in children
• Changes in behaviour.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

6   Contents of the pack and other

What is in this leaflet
1 W
 hat Amitriptyline tablets are and what
they are used for
2 W
 hat you need to know before you take
Amitriptyline tablets
3   How to take Amitriptyline tablets
4   Possible side effects
5   How to store Amitriptyline tablets
6 C
 ontents of the pack and other
information

What Amitriptyline tablets contain

1 W
 hat Amitriptyline tablets are and what

5   How to store Amitriptyline tablets

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place, protected from light.
Do not use Amitriptyline tablets after the expiry date
stated on the carton. The expiry date refers to the last
day of that month.
Do not throw away any medicines via household waste.
Ask your pharmacist how to throw away medicine you
no longer use. These measures will help protect the
environment.

Very rare: may affect up to 1 in 10,000 people
• heart muscle disease
• feeling of inner restlessness and a compelling need to
be in constant motion
• disorder of the peripheral nerves
• particular forms of abnormal heart rhythm (so called
torsades de pointes)
• allergic inflammation of the lung alveoli and of the
lung tissue.

information

What Amitriptyline tablets look like and
contents of the pack

Amitriptyline tablets are circular, biconvex, film-coated
tablets in the following colours:
10mg - blue 25mg - yellow 50mg - tan

Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Amitriptyline tablets

Do not take Amitriptyline tablets if you or your child (if
they are the patient):
• are allergic to amitriptyline, other tricyclic
antidepressants or any of the other ingredients of this
medicine (listed in section 6)
• recently have had a heart attack (myocardial infarction)
• have heart problems such as disturbances in heart
rhythm which are seen on an electrocardiogram (ECG),
heart block, or coronary artery disease
• are taking medicines known as monoamine oxidase
inhibitors (MAOIs)
• have taken MAOIs within the last 14 days. If you are
treated with Amitriptyline tablet you have to stop
taking this medicine and wait for 14 days before you
start treatment with a MAOI.
• have taken moclobemide the day before
• have a severe liver disease.

This leaflet was last revised in September 2017

If you would like a leaflet
with larger text, please
contact 01271 385257.

This medicine should not be used for children below
6 years of age.

Actavis, Barnstaple, EX32 8NS, UK

page 4

Warnings and precautions

Talk to your doctor or pharmacist before taking
Amitriptyline tablets.
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 Amitriptyline tablets. 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.
•h
 ave an over active thyroid gland or receive thyroid
medication.

Thoughts of suicide and worsening of your
depression

If you are depressed, you can sometimes have thoughts
of harming or killing themselves. 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
young adults (less than 25 years old) 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, 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.

Episodes of mania

Some patients with manic-depressive illness may enter
into a manic phase. This is characterized by profuse
and rapidly changing ideas, exaggerated gaiety and
excessive physical activity. In such cases, it is important
to contact your doctor who probably will change your
medication.
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

page 1

Amitriptyline 10mg, 25mg & 50mg 28 Tablets PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Technically Approved

2 W
 hat you need to know before you take

Pack sizes are 28 tablets

50939446

Date Sent:
17/08/17
Technologist: R.Wrey

Amitriptyline belongs to a group of medicines called
tricyclic antidepressant drugs. This medicine is used to
treat:
•D
 epression 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.

The other ingredients are lactose monohydrate,
microcrystalline cellulose (E460), maize starch, colloidal
anhydrous silica, magnesium stearate, hypromellose
(E464), titanium dioxide (E171), macrogol.
The 10mg tablet also contains: indigo carmine (E132).
The 25mg tablet also contains: talc (E553b), quinoline
yellow (E104), iron oxide (E172), sunset yellow (E110),
indigo carmine (E132).
The 50mg tablet also contains: talc (E553b), quinoline
yellow (E104), iron oxide (E172).

50939446 BBBA1151

Pharmacode: 4246

they are used for

The active substance is amitriptyline hydrochloride. Each
tablet contains either 10mg, 25mg or 50mg of the active
ingredient.

Marketing Authorisation Holder and
Manufacturer: Actavis, Barnstaple, EX32 8NS, UK.

Not known: frequency cannot be estimated from the
available data
• absent or increased sensation of appetite
• elevation or lowering of blood sugar levels
• paranoia

JDE No.:

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.
• T his 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 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.

An increased risk of bone fractures has been observed in
patients taking this type of medicines.

Rare: may affect up to 1 in 1,000 people
• decreased appetite
• delirium (especially in elderly patients), hallucinations
(especially in patients with schizophrenia),
• abnormality in the heart’s rhythm, or heartbeat pattern
• swelling of the salivary glands
• hair loss
• increased sensitivity to sunlight
• breast enlargement in men
• fever
• weight loss
• abnormal results of liver function tests.

Amitriptyline Tablets
all strengths x 28’s (UK)

Amitriptyline 10mg, 25mg
and 50mg tablets

By reporting side effects you can help provide more
information on the safety of this medicine

Uncommon: may affect up to 1 in 100 people
• excitement, anxiety, difficulties sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• diarrhoea, vomiting
• skin rash, nettle rash (urticarial), swelling of the face
and tongue
• difficulties passing urine
• increased production of breast milk or breast milk
outflow without breast feeding
• increased pressure in the eye ball
• collapse conditions
• worsening of cardiac failure
• liver function impairment (e.g. cholestatic liver disease).

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Package leaflet: Information for the patient

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Item no:

BBBA1151

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
24/08/17
21.09.17
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
296x210
Min Body Text Size: 7pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

• thyroid disease
• bipolar disorder
• schizophrenia
• severe heart disease
• severe liver disease
•p
 ylorus stenosis (narrowing of the gastric outlet) and
paralytic ileus (blocked intestine)
•d
 iabetes as you might need and adjustment of your
antidiabetic medicine.

• thyroid medication.
• apraclonidine and brimonidine (to treat glaucoma)
• altretamine (to treat some types of cancer)
• disulfiram (to treat alcohol addiction)
• baclofen (muscle relaxant)
• medicines to treat angina that you spray or dissolve
under your tongue (eg glyceryl trinitrate “GTN”,
isosorbide dinitrate)
• sibutramine (to suppress appetite)

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 tablets’
and section 3)

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)

Elderly are more likely to suffer from certain side effects,
such as dizziness when you stand up due to low blood
pressure (see also section 4 Possible side effects).

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.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Amitriptyline Tablets
all strengths x 28’s (UK)
JDE No.:

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Talk to your doctor about the duration of your treatment
and continue to take this medicine for as long as your
doctor recommends.
Bed-wetting at night
Your doctor will evaluate if the treatment should be
continued after 3 months.

If you take more Amitriptyline tablets than
you should

Contact your doctor or nearest hospital casualty
department immediately. Do this even if there are no
signs of discomfort or poisoning. Take the container of
this medicine with you if you go to a doctor or hospital.
Symptoms of overdose include dilated pupils, fast or
irregular heartbeats, difficulties passing water, dry mouth
and tongue, intestinal blockage, fits, fever, agitation,
confusion, hallucinations, uncontrolled movements, low
blood pressure, weak pulse, pallor, difficulty breathing,
blue discolouration of the skin, decreased heart rate,
drowsiness, loss of consciousness, coma, various cardiac
symptoms such as heart block, heart failure, cardiogenic
shock, metabolic acidosis, hypokalaemia.

Depending on your response to the medicine, your
doctor may gradually increase the dose. If you receive
doses above 75mg daily, your doctor may need to do
more frequent follow-up with you.

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.

Use in children and adolescents
This medicine should not be given to children or
adolescents for treatments of neuropathic pain, chronic
tension type headache prophylaxis and migraine
prophylaxis. For further information please see section 2.

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 may have withdrawal
symptoms such as irritability, increased muscle tension,
tremor, irregular breathing, poor drinking, loud crying,
urinary retention, and constipation.
Your doctor will advise you whether to start/continue/
stop breast-feeding, or stop using this medicine taking
into account the benefit of breast-feeding for your child
and the benefit of therapy for you.

Bed-wetting at night
Use in children and adolescents
The recommended doses for children:
• aged below 6 years: see section 2 ‘Do not take
Amitriptyline tablets’
• aged 6 to 10 years: 10mg – 20mg daily. A suitable
dosage form should be used for this age group.
• aged 11 years and above: 25mg – 50mg.

Driving and using machines

The dose should be increased gradually.

This medicine may cause drowsiness and dizziness,
especially in the beginning of the treatment. Do not
drive or work with tools or machinery if you are affected.

If you forget to take Amitriptyline tablets

Take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Amitriptyline tablets

Your doctor will decide when and how to stop your
treatment to avoid any unpleasant symptoms that might
occur if it is stopped abruptly (e.g. headache, feeling
unwell, sleeplessness and irritability).
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4   Possible side effects

Take this medicine 1-1½ hours before bedtime.
Before starting treatment, your doctor will conduct an
ECG of your heart to check for sign of unusual heartbeat.

Amitriptyline tablets contain lactose and
sunset yellow

Your doctor will re-evaluate your treatment after 3
months and if needed perform a new ECG. Do not stop
the treatment without consulting your doctor first.

If you have been told you have an intolerance to some
sugars, contact your doctor before taking this medicine.
The 25mg tablets also contain a colour called ‘sunset
yellow’ which may cause allergic reactions.
Always take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.

How and when to take Amitriptyline tablets

Not all dosage schemes can be achieved with all the
pharmaceutical forms/strengths. The appropriate
formulation/strength should be selected for the starting
doses and any subsequent dose increases.

This medicine can be taken with or without food.

Swallow the tablets with a drink of water. Do not chew
them.

Depression
Adults
The recommended initial dose is 25mg two times daily.
Depending on the response to the medicine, your
doctor may gradually increase the dose to 150mg per
day divided in two doses.

Like all medicines, this medicine can cause side effects,
although not everybody gets them. If you get any of
the following symptoms you should see your doctor
immediately:
Common side effect: may affect up to 1 in 10 people
• A heart problem called “prolonged QT interval” (which
is shown on your electrocardiogram, ECG).
Rare side effect: may affect up to 1 in 1,000 people
• Bad constipation, a swollen stomach, fever and
vomiting. These symptoms may be due to parts of the
intestine becoming paralysed.
• Any yellowing of the skin and the white in the eyes
(jaundice). Your liver may be affected.
• 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).
• Suicidal thoughts or behaviour.

Patients with special risks
Patients with liver diseases or people known as “poor
metabolisers” usually receive lower doses. Your doctor
may take blood samples to determine the level of
amitriptyline in the blood (see also section 2).

3   How to take Amitriptyline tablets

Duration of treatment
Do not change the dose of the medicine or stop taking
the medicine without consulting your doctor first.
Depression
As with other medicines for the treatment of
depression it may take a few weeks before you feel any
improvement.

page 2

page 3

Amitriptyline 10mg, 25mg & 50mg 28 Tablets PIL - UK
approved for print/date

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
17/08/17
Technologist: R.Wrey

Neuropathic pain, chronic tension type headache
and migraine prophylaxis
It might take a few weeks before your feel any
improvement of your pain.

Elderly (above 65 years of age) and patients with
cardiovascular disease
The recommended initial dose is 10mg – 25mg in the
evening.

It is not advised to drink alcohol during treatment with
this medicine as it might increase the sedative effect.

50939446

Pharmacode: 4246

The underlying illness may persist for a long time. If you
stop your treatment too soon, your symptoms may
return.

Adults
The recommended initial dose is 10mg - 25mg in the
evening. The recommended daily dose is 25mg – 75mg.
Depending on your response to the medicine, your
doctor may gradually increase the dose. If you receive
doses above 100mg daily, your doctor may need to
do more frequent follow-up with you. Your doctor will
instruct you whether to take the doses once daily or
divide into two doses.

Amitriptyline tablets with alcohol

Some medicines may affect the action of other
medicines and this can sometimes cause serious side
effects.

Continue to take this medicine for as long as your doctor
recommends.

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.

Likewise, you should tell your dentist that you take this
medicine if you are to receive a local anaesthetic.

Other medicines and Amitriptyline tablets

In treating depression the duration of treatment is
individual, and is usually at least 6 months. The duration
of treatment is decided by your doctor.

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.

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.

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 taken at the same time
as an anticholinergic drug (see also section 2 ‘Other
medicines’ and Amitriptyline tablets)
• 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.

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 tablets (see section 2 Do not
take Amitriptyline tablets)
• adrenaline/epinephrine, ephedrine, isoprenaline,
noradrenaline/norepinephrine, 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 (e.g. entacapone) and
gastrointestinal disorders (e.g. atropine, hyoscyamine)
• thioridazine (used to treat schizophrenia)
• tramadol (painkiller), nefopam, or opiod painkillers
• 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 such as amiodarone,
disopyramide, propafenone)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• ritonavir (used to treat HIV)
• oral contraceptives
• rifampicin or linezolid (to treat infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• St. John´s Wort (hypericum perforatum) – a herbal
remedy used for depression

Elderly (above 65 years of age) and patients with
cardiovascular disease
The recommended initial dose is 10mg – 25mg daily.
Depending on your response to the medicine, your
doctor may gradually increase the dose to a total daily
dose of 100mg divided in two doses. If you receive doses
in the range of 100mg – 150mg, your doctor may need
to do more frequent follow-up with you.

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1151

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

C.Grant
24/08/17
21.09.17
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
296x210
Min Body Text Size: 7pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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