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AMITRIPTYLINE 25MG TABLETS

Active substance: AMITRIPTYLINE HYDROCHLORIDE

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AMITRIPTYLINE 10 mg, 25 mg
AND 50 mg TABLETS

Taking 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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Talk to your doctor if you are taking any of the
following:
• 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)
IN THIS LEAFLET:
• sympathomimetic drugs e.g. adrenaline,
ephedrine, isoprenaline, noradrenaline,
1. What Amitriptyline is and what it is used for
phenylephrine or phenylpropanolamine. These
2. Before you take Amitriptyline
may be present in many medicines for colds and
3. How to take Amitriptyline
nasal stuffiness. Tell your pharmacist that you are
4. Possible side effects
taking Amitriptyline before buying such products
5. How to store Amitriptyline
• blood pressure drugs e.g. guanethidine,
6. Further information
debrisoquine, betanidine, clonidine, and
WHAT AMITRIPTYLINE IS AND WHAT IT IS
verapamil or diltiazem (used to treat chest pain,
USED FOR
high blood pressure or an irregular heart beat)
• Amitriptyline belongs to a group of drugs called • drugs used to treat an irregular heartbeat e.g.
amiodarone, disopyramide, procainamide,
tricyclic antidepressants
propafenone, quinidine, sotalol
• Amitriptyline is used to treat depression.
• diuretics ("water tablets") e.g. amiloride,
BEFORE YOU TAKE AMITRIPTYLINE
bendroflumethiazide or triamterene
• sublingual nitrates (tablets placed under the
DO NOT take Amitriptyline if you:
tongue to treat chest pain)
• are allergic (hypersensitive) to amitriptyline or
• disulfiram (used to treat alcoholism)
any of the other ingredients of this medicine
• cimetidine (used to reduce acid indigestion)
• are taking monoamine oxidase inhibitors
• altretamine (used to treat cancer of the ovary)
(MAOIs), or have stopped taking these medicines • nefopam or tramadol (painkillers)
within the last 14 days
• selegiline and entacapone (used to treat
• have any heart problems e.g. you are recovering
Parkinson's disease)
from a heart attack or you have an abnormal
• levacetylmethadol (used to treat drug dependence)
heart rhythm
• rifampicin (used to treat infections)
• have severe liver disease
• Sibutramine (anti-obesity drug)
• are pregnant or breast-feeding
• baclofen (used to relieve spasms, cramping and
• suffer from mania (a mood disorder characterised
muscle rigidity)
by high levels of excitement and activity)
• antihistamines such as cetirizine, loratadine or
• are under 16 years (see section 3, How to take
terfenadine
Amitriptyline).
• oral contraceptives (the pill)
• thyroid hormones e.g. levothyroxine
Take special care with Amitriptyline
• electroconvulsive therapy (ECT)
Thoughts of suicide and worsening of your
• ritonavir (used to treat HIV infection).
depression or anxiety disorder
If you are depressed and/or have anxiety disorders Please tell your doctor or pharmacist if you are
you can sometimes have thoughts of harming or
taking or have recently taken any other medicines,
killing yourself. These may be increased when first including medicines obtained without a prescription.
starting antidepressants, since these medicines all
Important information about some of the
take time to work, usually about two weeks but
ingredients of Amitriptyline
sometimes longer.
• Patients who are intolerant to lactose should
You may be more likely to think like this:
note that Amitriptyline Tablets contain a small
• if you have previously had thoughts about killing
amount of lactose. If your doctor has told you
or harming yourself
that you have an intolerance to some sugars,
• if you are a young adult. Information from clinical
contact your doctor before taking this medicine.
trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with • The 25 mg tablets contain sunset yellow (E110),
which can cause an allergic-type reaction,
psychiatric conditions who were treated with an
including asthma. This reaction is more common
antidepressant.
in those people who are allergic to aspirin.
If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a hospital Taking Amitriptyline with food and drink
straight away.
• DO NOT drink alcohol while taking this medicine
You may find it helpful to tell a relative or close
as it may increase the sedative effects of these
friend that you are depressed or have an anxiety
tablets.
disorder, and ask them to read this leaflet. You
Pregnancy and breast-feeding
might ask them to tell you if they think your
• Amitriptyline tablets should not be taken in the
depression or anxiety is getting worse, or if they
first three months and the last three months of
are worried about changes in your behaviour.
pregnancy. If taken in the last three months, the
Tell your doctor before you start to take this
newborn may have withdrawal symptoms
medicine if you:
• Amitriptyline is not recommended if you are
• suffer from epileptic fits
breast-feeding
• have any blood disorders (you may bruise easily, • If you are pregnant or planning to become
frequently suffer from infections or be anaemic)
pregnant, ask your doctor or pharmacist for
• have schizophrenia or manic-depression
advice before taking any medicine.
• suffer from porphyria (a deficiency of specific
enzymes within the body, causing an increase of Driving and using machines
• Amitriptyline may cause drowsiness, if affected
substances called porphyrins)
do not drive or operate machinery.
• have phaeochromocytoma (an adrenal gland
tumour)
HOW TO TAKE AMITRIPTYLINE
• have prostate trouble
• have liver problems
Always take Amitriptyline exactly as your doctor
• suffer from narrow angle glaucoma (loss of vision has told you. You should check with your doctor or
due to abnormally high pressure in the eye)
pharmacist if you are not sure.
• have kidney problems e.g. difficulty passing water If you see another doctor or go into hospital, let them
• have thyroid disease
or the staff know what medicines you are taking.
• are being given electroconvulsive therapy (ECT)
The tablets should be swallowed preferably with a
• are planning to have surgery, as Amitriptyline
glass of water. The usual dose is:
may need to be stopped before you have a
• Children and adolescents
general anaesthetic.
Not recommended for children and adolescents
If you are elderly, you are more likely to suffer from
under 16 years.
certain side effects (see section 4, Possible side
• Adults:
effects).
The usual starting dose is 75 mg a day in divided
doses or as a single dose at night. This may then
You may not see an improvement in your depression
be gradually increased if necessary, with any
during the first month of treatment. Your doctor
extra doses taken in the late afternoon and/or at
may want to monitor you during this time.
bedtime.
Read all of this leaflet carefully before you start
taking this medicine.
• 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. 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

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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.

• 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,
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
Withdrawal symptoms which may occur if you stop By reporting side effects you can help provide more
taking the tablets suddenly include feeling sick,
information on the safety of this medicine.
headache and generally feeling unwell. Gradual
HOW TO STORE AMITRIPTYLINE
withdrawal is associated with reports of symptoms
including irritability, restlessness, excitement, and
Keep out of the reach and sight of children.
hyperactivity, as well as dream and sleep
The tablets should be stored in the package or
disturbances during the first two weeks of dosage
container supplied. Do not transfer them to another
reduction. Feeling elated or over-excited has been
container.
rarely reported when stopping long term treatment
Do not use Amitriptyline after the expiry date that is
with this type of drug. These symptoms are
stated on the outer packaging. The expiry date
transient and are not a sign of addiction.
refers to the last day of that month.
If you have any further questions on the use of this Medicines should not be disposed of via
product, ask your doctor or pharmacist.
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
POSSIBLE SIDE EFFECTS
required. These measures will help to protect the
environment.
Like all medicines, Amitriptyline can cause side
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.

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effects, although not everybody gets them.

FURTHER INFORMATION

If the following happens, stop taking the tablets
What Amitriptyline Tablets contain:
and tell your doctor immediately or go to the
• The active ingredient is amitriptyline
casualty department at your nearest hospital:
hydrochloride
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing; skin • The other ingredients are lactose monohydrate,
maize starch, calcium hydrogen phosphate
rash or hives).
dihydrate, silica colloidal anhydrous, magnesium
This is a very serious but rare side effect. You may
stearate, hypromellose (E464), titanium dioxide
need urgent medical attention or hospitalisation.
(E171)
The following effects have been reported with this • The 10 mg tablets also contain macrogol,
type of drug, although not particularly with
dispersed blue (E131) and brilliant blue (E133);
amitriptyline:
the 25 mg tablets also contain polyethylene
• Effects on the blood:
glycol, quinoline yellow (E104) and sunset yellow
Blood disorders which may be characterised by
(E110); the 50 mg tablets also contain
fever or chills, sore throat, ulcers in your mouth or
polyethylene glycol and red iron oxide (E172)
throat, unusual tiredness or weakness, unusual
• The tablets are polished with carnauba wax.
bleeding or unexplained bruising. Tell your doctor
immediately if you notice any of these symptoms. What Amitriptyline Tablets look like and contents of
the pack:
• Effects on the heart:
• Amitriptyline 10 mg Tablets are sky blue,
High or low blood pressure, changes in heart
biconvex, film-coated tablets, engraved “D” on
rhythm, heart attack, stroke.
one side and plain on the reverse.
• Effects on brain and central nervous system:
• Amitriptyline 25 mg Tablets are yellow, biconvex,
Tiredness, headache, weakness, confusion,
film-coated tablets, engraved “D” on one side
disturbed concentration, disorientation, delusions,
and plain on the reverse.
hallucinations, elevated mood and hyperactivity,
• Amitriptyline 50 mg Tablets are red/brown,
excitement, anxiety, restlessness, drowsiness,
biconvex, film-coated tablets, engraved “D” on
dream and sleep disturbances, numbness, pins
one side and plain on the reverse.
and needles, loss of co-ordination, uncontrolled
• All strengths of tablets are available in pack sizes
shaking, abnormal muscle movements, slurred
of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
speech, coma, and fits.
120, 150, 160, 168, 500, or 15000 tablets. The 25
• Effects on the Ear:
mg tablets are also available in a pack size of 25
Ringing in the ears.
tablets, and the 50 mg tablets are also available
• Effects on the anti-cholinergic system:
in a pack size of 250 tablets.
Dry mouth, blurred vision, eye problems,
Not all pack sizes may be marketed.
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.
• 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.

REG0060226

Version 2.4

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: May 2015
PL 00289/0178-0180

Approved

72912-Y

340 x 160

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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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