AMITRIPTYLINE 25MG TABLETS

Active substance: AMITRIPTYLINE HYDROCHLORIDE

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22 October 2012

PL Number(s),
PL 00289/0178-0180. TEVA UK Limited Licence (Responsible Regulatory Officer = TEVA Post Licence Team),
MA Holder & Packer: Packed at Debrecen, Hungary.

340 mm
160 mm

If you are elderly, you are more likely to suffer from The tablets should be swallowed preferably with a
certain side effects (see section 4, Possible side
glass of water. The usual dose is:
effects).

BLACK

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

PANTONE® GREEN

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 any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Colours:

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.

(PANTONE® is a registered
trademark of Pantone, Inc.)

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

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.

UNKNOWN

3rd Party Code: UNKNOWN

AMITRIPTYLINE 10 mg, 25 mg
AND 50 mg TABLETS

L:
W:

Reason for revision: Version 1: Leaflet text updates. TEVA Post Licence Team. 09/10/12 18:46 (Trackwise: 153517).

Dimensions:

1

Base Font Size: 8 Pt

Version:

Fonts: Univers

231-30-72912-X LEA AMITRIPTYLINE A/S TAB TUK
IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Ref:

22 October 2012

PL Number(s),
PL 00289/0178-0180. TEVA UK Limited Licence (Responsible Regulatory Officer = TEVA Post Licence Team),
MA Holder & Packer: Packed at Debrecen, Hungary.

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
product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Amitriptyline can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives).
This is a very serious but rare side effect. You may
need urgent medical attention or hospitalisation.
The following effects have been reported with this
type of drug, although not particularly with
amitriptyline:
• 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.
• 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, abnormal muscle movements, slurred
speech, coma, and fits.
• Effects on the Ear:
Ringing in the ears.
• Effects on the anti-cholinergic system:
Dry mouth, blurred vision, eye problems,
increased pressure in the eye, constipation, bowel

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.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5

HOW TO STORE AMITRIPTYLINE

Keep out of the reach and sight of children.
The tablets should be stored in the package or
container supplied. Do not transfer them to another
container.
Do not use Amitriptyline after the expiry date that is
stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6

FURTHER INFORMATION

What Amitriptyline Tablets contain:
• The active ingredient is amitriptyline hydrochloride
• The other ingredients are lactose monohydrate,
maize starch, calcium hydrogen phosphate
dihydrate, silica colloidal anhydrous,
magnesium stearate, hypromellose (E464),
titanium dioxide (E171)
• The 10 mg tablets also contain macrogol,
dispersed blue (E131) and brilliant blue (E133);
the 25 mg tablets also contain polyethylene
glycol, quinoline yellow (E104) and sunset
yellow (E110); the 50 mg tablets also contain
polyethylene glycol and red iron oxide (E172)
• The tablets are polished with carnauba wax.
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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: August 2012
PL 00289/0178-0180
72912-X

BLACK

You may not notice any improvement in your
condition for up to 4 weeks after starting your
treatment.

PANTONE® GREEN



Colours:



(PANTONE® is a registered
trademark of Pantone, Inc.)



Pharma Code (top to bottom
on the front face when reading the
text design right way up):



UNKNOWN





340 mm
160 mm



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.
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.

3rd Party Code: UNKNOWN

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.

L:
W:

Reason for revision: Version 1: Leaflet text updates. TEVA Post Licence Team. 09/10/12 18:46 (Trackwise: 153517).



Dimensions:

1

Base Font Size: 8 Pt

Version:

Fonts: Univers

231-30-72912-X LEA AMITRIPTYLINE A/S TAB TUK
IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Ref:

Expand view ⇕

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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