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AMITRIPTYLINE 50MG TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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AMITRIPTYLINE 10 mg, 25 mg
AND 50 mg TABLETS

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

1

What Amitriptyline is and what it is used for

• Amitriptyline belongs to a group of drugs called
tricyclic antidepressants
• Amitriptyline is used to treat depression.

2

What you need to know before you take
amitriptyline

Do not take Amitriptyline:
• if you are allergic to active substance or any of the
other ingredients of this medicine (listed in section 6).
• if you are taking monoamine oxidase inhibitors
(MAOIs), or have stopped taking these medicines
within the last 14 days
• if you have any heart problems e.g. you are
recovering from a heart attack or you have an
abnormal heart rhythm
• if you have severe liver disease
• if you are pregnant or breast-feeding
• if you suffer from mania (a mood disorder
characterised by high levels of excitement and activity)
• if you are under 16 years (see section 3, How to take
Amitriptyline).
Warnings and precautions
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 a hospital
straight away.

• if you have thyroid disease
• if you are being given electroconvulsive therapy
(ECT)
• if you are planning to have surgery, as Amitriptyline
may need to be stopped before you have a general
anaesthetic.
If you are elderly, you are more likely to suffer from
certain side effects (see section 4, Possible side effects).
You may not see an improvement in your depression
during the first month of treatment. Your doctor may
want to monitor you during this time.
Other medicines and Amitriptyline
Tell your doctor or pharmacist if you are taking , have
recently taken or might take any other medicines.
Do not take Amitriptyline in combination with, or if
you have taken in the last 14 days
• antidepressants known as MAOIs e.g. moclobemide
or phenelzine.
• antidepressants or drugs to treat other mental
illnesses, e.g. pimozide, fluoxetine or clozapine
• sedatives e.g. diazepam
• anticholinergics e.g. atropine or hyoscine
• antiepileptics used to treat epilepsy such as
carbamazepine, barbiturates e.g. amobarbital or
phenobarbital
• methylphenidate (used to treat hyperactivity)
• apraclonidine and brimonidine (used to treat
glaucoma)
• sympathomimetic drugs e.g. adrenaline, ephedrine,
isoprenaline, noradrenaline, phenylephrine or
phenylpropanolamine. These may be present in
many medicines for colds and nasal stuffiness. Tell
your pharmacist that you are taking Amitriptyline
before buying such products
• blood pressure drugs e.g. guanethidine,
debrisoquine, betanidine, clonidine, and verapamil
or diltiazem (used to treat chest pain, high blood
pressure or an irregular heart beat)
• drugs used to treat an irregular heartbeat e.g.
amiodarone, disopyramide, procainamide,
propafenone, quinidine, sotalol
• diuretics ("water tablets") e.g. amiloride,
bendroflumethiazide or triamterene
• sublingual nitrates (tablets placed under the tongue
to treat chest pain)
• disulfiram (used to treat alcoholism)
• cimetidine (used to reduce acid indigestion)
• altretamine (used to treat cancer of the ovary)
• nefopam or tramadol (painkillers)
• selegiline and entacapone (used to treat Parkinson's
disease)
• levacetylmethadol (used to treat drug dependence)
• rifampicin (used to treat infections)
• Sibutramine (anti-obesity drug)
• baclofen (used to relieve spasms, cramping and
muscle rigidity)
• antihistamines such as cetirizine, loratadine or
terfenadine
• oral contraceptives (the pill)
• thyroid hormones e.g. levothyroxine
• electroconvulsive therapy (ECT)
• ritonavir (used to treat HIV infection)
• venlafaxine, sertraline, trazodone, tramadol may
lead to serotonine syndrome.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

Amitriptyline contains lactose and sunset yellow
(E110)
• Patients who are intolerant to lactose should note
that Amitriptyline Tablets contain a small amount of
lactose. If your doctor has told you that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
• The 25 mg tablets contain sunset yellow (E110),
which can cause an allergic-type reaction, including
A heart problem called “prolonged QT interval” (which
asthma. This reaction is more common in those
is shown on your electrocardiogram, ECG) and heart
people who are allergic to aspirin.
rhythm disorders (rapid or irregular heart beat) have
been reported with Amitriptyline tablets.
Amitriptyline with food and drink
• Do not drink alcohol while taking this medicine as it
Tell your doctor if you:
may increase the sedative effects of these tablets.
• have slow heart rate
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.

• 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.
Talk to your doctor or pharmacist before taking
Amitriptyline:
• if you suffer from epileptic fits
• if you have any blood disorders (you may bruise
easily, frequently suffer from infections or be
anaemic)
• if you have schizophrenia or manic-depression
• if you suffer from porphyria (a deficiency of specific
enzymes within the body, causing an increase of
substances called porphyrins)
• if you have phaeochromocytoma (an adrenal gland
tumour)
• if you have prostate trouble
• if you have liver problems
• if you suffer from narrow angle glaucoma (loss of
vision due to abnormally high pressure in the eye)
• if you have kidney problems e.g. difficulty passing
water

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.
• Amitriptyline tablets should not be taken in the first
three months and the last three months of
pregnancy. If taken in the last three months, the
newborn may have withdrawal symptoms
• Amitriptyline is not recommended if you are
breast-feeding..
Driving and using machines
• Amitriptyline may cause drowsiness, if affected do
not drive or operate machinery.

3

How to take Amitriptyline

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
If you see another doctor or go into hospital, let them
or the staff know what medicines you are taking.
The tablets should be swallowed preferably with a
glass of water.

The recommended dose is:
• Use in children and adolescents
Not recommended for children and adolescents
under 16 years.
• Adults:
The usual starting dose is 75 mg a day in divided
doses or as a single dose at night. This may then be
gradually increased if necessary, with any extra doses
taken in the late afternoon and/or at bedtime.
The maintenance dose is usually 50-100 mg a day
given as a single dose preferably in the evening or at
bedtime.
• Elderly:
The usual dose is 10-25 mg three times a day initially,
which may be gradually increased if necessary. The
dosage may be taken as divided doses, or as a single
dose, preferably in the evening or at bedtime.
You may not notice any improvement in your
condition for up to 4 weeks after starting your
treatment.
If you take more Amitriptyline than you should
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has swallowed any of
the tablets, contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause heart rate irregularities,
hot dry skin, dry mouth and tongue, dilated pupils,
squint, problems passing water, difficulty in controlling
movements, involuntary eye movement, drowsiness,
low blood pressure, vomiting, agitation, muscle
rigidity, fever, low body temperature, fits, breathing
problems and possibly coma.
Please take this leaflet, any remaining tablets, and the
container with you to the hospital or doctor so that
they know which tablets were consumed.
If you forget to take Amitriptyline
If you forget to take a tablet, take one as soon as you
remember, unless it is nearly time to take the next one.
Do not take a double dose to make up for a forgotten
dose. Take the remaining doses at the correct time.
If you stop taking Amitriptyline
Do not stop taking these tablets suddenly. You should
continue to take the tablets for as long as your doctor
tells you to.
Withdrawal symptoms which may occur if you stop
taking the tablets suddenly include feeling sick,
headache and generally feeling unwell. Gradual
withdrawal is associated with reports of symptoms
including irritability, restlessness, excitement, and
hyperactivity, as well as dream and sleep disturbances
during the first two weeks of dosage reduction. Feeling
elated or over-excited has been rarely reported when
stopping long term treatment with this type of drug.
These symptoms are transient and are not a sign of
addiction.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

• Effects on the digestive system:
Nausea (feeling sick), stomach discomfort, vomiting,
loss of appetite, diarrhoea, abdominal pains, an
unpleasant taste, black tongue, swelling of the area
around the ear, soreness of the mouth.
• Effects on liver:
Rarely hepatitis (inflammation of the liver), jaundice
characterised by yellowing of the skin and whites of
the eyes.
• Effects on the hormone system:
Inappropriate secretion of the antidiuretic hormone.
• Effects on the reproductive system and
breast-feeding:
Testicular swelling, breast enlargement in both men
and women, milk production by women even if they
are not breast-feeding, and sexual problems.
Other adverse effects include, changes in blood sugar
levels and low blood sodium levels, dizziness,
weakness, fatigue, headache, fluid retention, needing
to pass water often, increased perspiration, hair loss,
increased appetite, and weight gain (may be due to the
drug or as a result of the relief of depression).
An increased risk of bone fractures has been observed
in patients taking this type of medicines.
There have also been reports of breathing problems
and agitation in babies whose mothers took this type
of drug.
If you are elderly, you are more likely to experience
effects of agitation, confusion, low blood pressure on
standing causing dizziness, light-headedness or
fainting, or to develop low blood levels of sodium,
which can cause tiredness, confusion, muscle
twitching and fits.
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 at:
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 Amitriptyline

Keep this medicine out of the sight and reach of
children.
The tablets should be stored in the package or
container supplied. Do not transfer them to another
container.
Do not use this medicine after the expiry date that is
stated on the carton. 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 to protect the environment.

Contents of the pack and other information

Like all medicines, Amitriptyline can cause side effects, What Amitriptyline Tablets contains:
although not everybody gets them.
• The active substance is amitriptyline hydrochloride
• The other ingredients are lactose monohydrate,
If the following happens, stop taking the tablets and
maize starch, calcium hydrogen phosphate
tell your doctor immediately or go to the casualty
dihydrate, silica colloidal anhydrous, magnesium
department at your nearest hospital:
stearate, titanium dioxide (E171)
• an allergic reaction (swelling of the lips, face or neck

The 10 mg tablets also contain macrogol, talc,
leading to severe difficulty in breathing; skin rash or
polyvinyl alcohol dispersed blue (E131) and brilliant
hives).
blue (E133); the 25 mg tablets also contain polyvinyl
This is a very serious but rare side effect. You may
alcohol, talc, macrogol, quinoline yellow (E104) and
need urgent medical attention or hospitalisation.
sunset yellow (E110); the 50 mg tablets also contain
The following effects have been reported with this type
polyvinyl alcohol, macrogol, red iron oxide (E172),
of drug, although not particularly with amitriptyline:
and talc.
• Effects on the blood:
Blood disorders which may be characterised by
fever or chills, sore throat, ulcers in your mouth or
throat, unusual tiredness or weakness, unusual
bleeding or unexplained bruising. Tell your doctor
immediately if you notice any of these symptoms.
• Effects on the heart:
High or low blood pressure, changes in heart
rhythm, heart attack, stroke, a heart problem called
“prolonged QT interval” (which is shown on your
electrocardiogram, ECG).

What Amitriptyline Tablets look like and contents of
the pack:
• Amitriptyline 10 mg Tablets are sky blue, biconvex,
film-coated tablets, engraved “D” on one side and
plain on the reverse.
• Amitriptyline 25 mg Tablets are yellow, biconvex,
film-coated tablets, engraved “D” on one side and
plain on the reverse.
• Amitriptyline 50 mg Tablets are red/brown, biconvex,
film-coated tablets, engraved “D” on one side and
plain on the reverse.
• All strengths of tablets are available in pack sizes of
7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,
150, 160, 168, 500, or 15000 tablets. The 25 mg
tablets are also available in a pack size of 25 tablets,
and the 50 mg tablets are also available in a pack
size of 250 tablets.
Not all pack sizes may be marketed.

• Effects on brain and central nervous system:
Tiredness, headache, weakness, confusion,
disturbed concentration, disorientation, delusions,
hallucinations, elevated mood and hyperactivity,
excitement, anxiety, restlessness, drowsiness,
dream and sleep disturbances, numbness, pins and
needles, loss of co-ordination, uncontrolled shaking, Marketing Authorisation Holder and Manufacturer
abnormal muscle movements, slurred speech,
Marketing Authorisation holder and company
coma, and fits.
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
• Effects on the Ear:
Ringing in the ears.
This leaflet was last revised: October 2016
PL 00289/0178-0180
• Effects on the anti-cholinergic system:
Dry mouth, blurred vision, eye problems, increased
pressure in the eye, constipation, bowel problems,
problems passing urine, increased urine production,
high body temperature.
• Allergic reactions:
Swelling of the face and tongue.

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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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