Skip to Content

UK Edition. Click here for US version.

AMITRIPTYLINE 50 MG FILM COATED TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
24 mm

8 mm

PACKAGE LEAFLET: INFORMATION FOR USER

AMITRIPTYLINE 10 MG, 25 MG AND 50 MG
FILM-COATED TABLETS
(Amitriptyline Hydrochloride)
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 (TCADs). These medicines alter the levels of
chemicals in the brain to relieve the symptoms of depression.
Amitriptyline may be used:
• to treat the symptoms of depression.
• for the relief of bed-wetting at night by children aged 6 years and
above (known as nocturnal enuresis).

2. What you need to know before you take Amitriptyline

8 mm

Do not take Amitriptyline and tell your doctor if you or your
child (if they are the patients):
• are allergic (hypersensitive) to amitriptyline, other tricyclic
antidepressants or any of the other ingredients in these tablets
(listed in section 6).
• are taking monoamine oxidase inhibitors (MAOI), or you have
stopped taking these medicines within the last 14 days.

SAME SIZE ARTWORK
480 x 160 mm
Front

• have heart disease including irregular heart beats, heart block,
heart failure, coronary artery disease or have had a recent heart
attack.
• suffer from periods of increased and exaggerated behaviour (mania).
• are pregnant or breast-feeding.
• have severe liver disease.
• are under 16 years old.
• you have a problem with your blood called porphyria.
• prior senstitisation to amitriptyline
If this medicine has been prescribed for a child under 6 years of
age, tell your doctor as it may not be suitable for them.
Warnings and precautions
This medicinal product should be kept securely locked and out of
reach of smaller siblings because overdose may be fatal.
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.
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 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 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.
Enuresis:
• An ECG should be performed prior to initiating therapy with
amitriptyline to exclude long QT syndrome.
• 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.
Having operations and tests
Tell your doctor or dentist that you are taking amitriptyline if you
are going to have an anaesthetic for an operation or dental treatment.
Talk to your doctor or pharmacist before taking Amitryptiline
if you or your child:
• have any blood disorders (you may bruise easily, frequently suffer
from infections or be anaemic).
• have any psychiatric (mental) disorder (eg schizophrenia or manic
depression).
• have liver or cardiovascular disease
• are not able to pass water.
• have been told you have an enlarged prostate gland.
• have a diseased thyroid gland
• have a history of epilepsy.
• suffer from narrow-angle glaucoma (increased pressure in the eye
resulting in loss of vision).
• are being given electroconvulsive therapy (ECT)
• are planning to have surgery (including dental), 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).
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).
Please inform your doctor if you are taking or have previously taken
any of the following medicines:
• altretamine (used to treat cancer of ovary)
• anticholinergics e.g. atropine or hyoscine
• apraclonidine and brimonidine (used to treat glaucoma)
• baclofen (a muscle relaxant)
• disulfiram (used to treat alcohol addiction)
• painkillers (such as nefopam, tramadol,)
• medicines to treat an irregular heart beat (such as amiodarone,
diltiazem, disopyramide, procainamide, propafenone, quinidine,
sotalol, verapamil)
• medicines to treat angina that you spray or dissolve under your
tongue (eg glyceryl trinitrate “GTN”, isosorbide dinitrate)
• rifampicin or linezolid (to treat infections)
• antidepressants or medicines used to treat some mental illnesses
such as, clozapine, pimozide, fluoxetine
• carbamazepine or barbiturates (e.g. Phenobarbital or amobarbital)
(to treat epilepsy)
• terfenadine, cetirizine, loratadine (to treat allergies and hayfever)
• methylphenidate (used to treat attention deficit/hyperactivity
disorder (ADHD))
• any medicines to treat high blood pressure (such as guanethidine,
debrisoquine, bethanidine or clonidine)
• cimetidine (to treat ulcers)
• ethchlorvynol (to help you sleep)
• diuretics (“water” tablets, e.g. furosemide, bendroflumethiazide,
amiloride, triamterene)
• entacapone or selegiline (to treat Parkinson’s disease)
• oral contraceptives (“the pill”)
• sibutramine (anti-obesity drug)
• sympathomimetic medicines such as adrenaline, ephedrine,
isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in many cough and cold

remedies, tell your pharmacist that you are taking amitriptyline
before buying such products)
• ritonavir (used to treat HIV).
• levacetylmethadol (used to treat drug dependence)
• thyroid hormones (e.g.levothyroxine)
• electroconvulsive therapy (ECT)
• fluconazole (to treat fungal infections).
Amitriptyline with food, drink and alcohol
DO NOT drink alcohol with this medicine as it may increase the
sedative effects of these tablets
Pregnancy, breast-feeding and fertility
If you are pregnant or planning to become pregnant, ask your doctor
or pharmacist for advice before taking any medicine.
Do not take Amitriptyline if you are breast-feeding.
Amitriptyline 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.
Driving and using machines
Amitriptyline may impair your alertness. Do not drive or operate
machinery if you are affected.
Amitriptyline film-coated tablets contain Lactose
If you or your child has been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take Amitriptyline
Always take Amitriptyline exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
The tablets should be swallowed with a glass of water. The usual
dose is:
Depression:
Adults: The usual starting dose is 50-75 mg daily, either in divided
doses or as a single night time dose, gradually increased if necessary.
Your doctor may increase this dose to a maximum of 150-200 mg a
day. A maintenance dose of 50-100 mg at night should be given to
lessen the chances of relapse.
Adolescents and Elderly: The usual dose is 10-25 mg three times a
day initially, which may be gradually increased if necessary. The
IXXXXX

24 mm

8 mm

SAME SIZE ARTWORK
480 x 160 mm
Back

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.
Stop taking Amitriptyline and contact your doctor straight away
if you have:
• an allergic reaction. Signs may include a skin rash, which may be
itchy, sensitivity to the sun or sun lamps, puffy, swelling of your
face, lips, throat or tongue, which may be severe causing shortness
of breath, swelling, shock and collapse.
• a serious effect on your blood, such as low sodium levels. Signs
may include fever or chills, sore throat, ulcers in your mouth or
throat, unusual tiredness or weakness, unusual bleeding or
unexplained bruises. If you notice any of these, tell your doctor
straight away.
Serious side effects: tell your doctor straight away
• If you feel more depressed, including thinking about suicide.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• Effects on your blood:
bone marrow depression or reduction in some blood cells (you
may experience a sore throat, mouth ulcers and recurring
infections, bleeding or bruising easily)
• Effects on your hormones:
disturbances in sexual function or sex drive, breast swelling in
men and women, swelling of the testicles, production or overproduction of breast milk, changes in blood sugar levels, increased
appetite and weight gain. Inappropriate secretion of the hormone
ADH (antidiuretic hormone), which may make you urinate more
frequently.
• Effects on your brain and central nervous system:
dizziness, tiredness or sleepiness, weakness, headache, difficulty
concentrating, confusion, difficulty sleeping, nightmares, slight
hyperactivity, exaggerated behaviour, delusions, seeing things that
are not there (hallucinations), anxiety, excitement, disorientation
(not knowing where you are), restlessness, numbness or tingling
or pins and needles (particularly in the hands and feet), lack of

co-ordination, shaky movements, tremor, fits, unconsciousness,
slow or slurred speech. Anticholinergic effects (dry mouth, fever,
constipation, blurred or double vision, difficulty passing water
(urine), dilation of the pupil of the eye, glaucoma and blockage of
the small intestine)
• Effects on your heart:
feeling faint when getting up (postural hypotension), change in
blood pressure, fast/racing heart, palpitations, heart attack, stroke,
irregular or slow heart-beats and very low pressure.
• Effects on your stomach and intestines:
feeling or being sick, diarrhoea, change in appetite, irritation and a
nasty taste in your mouth, swollen saliva glands, abdominal pains,
black tongue, dry mouth, fever, constipation, blockage of your
small intestine.
• Effects on your liver:
hepatitis, including changes in liver function (as seen in blood
tests), jaundice (yellowing of the skin and/or whites of the eyes)
• Effects on your ears:
Buzzing or ringing in the ears.
• Effects on your eyesight:
blurred or double vision, changes in eyesight.
• General effects:
headache, dizziness, weakness, tiredness, change in weight,
drowsiness, increased sweating, hair loss, widely dilated pupils,
difficulty passing water (urine).
• Effects on the skin:
skin rashes, skin rash due to sunlight.
• Investigations
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)
• Withdrawal symptoms:
feeling sick, malaise and headache, dream and sleep disturbances,
irritability and restlessness. Mania or hypomania (exaggerated
mood and/or elation) may occur 2-7 days after stopping the tablets.
An increased risk of bone fractures has been observed in patients
taking this type of medicines.
When used for children to treat bed wetting, the side effects are less

frequent but may still happen. The most common reported effects
amongst children are drowsiness, dry mouth, blurred eyesight,
increased pressure in the eye, changes in eyesight, constipation,
fever and difficulty in passing water (urine) changes in behaviour
and “Anticholinergic effects” (as described above). There have also
been rare reports of mild sweating and itching.
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 safety of this medicine.

5. How to store Amitriptyline
• Keep out of the sight and reach of children.
• Do not store above 300C. Store in the original package (blister) in
order to protect from moisture and light.
• Do not use Amitriptyline film-coated tablets after the expiry date
which is stated on the carton (EXP.) 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 dispose of medicines you no
longer use.These measures will help protect the environment.

6. Contents of the pack and other information
What Amitriptyline film-coated tablets contain
The active substance is amitriptyline hydrochloride. Each tablet
contains either 10mg, 25mg or 50mg of the active ingredient.
The other ingredients are: lactose monohydrate, crospovidone, maize
starch, microcrystalline cellulose, colloidal anhydrous silica,
magnesium stearate and talc.
The 10 mg tablet film coat contains: hypromellose, macrogol 6000,
talc, titanium dioxide (E171), indigo carmine Al Lake (E132).
The 25 mg tablet film coat contains: hypromellose, macrogol 6000,
talc, titanium dioxide (E171), quinoline yellow (E104).
The 50 mg tablet film coat contains: hypromellose, macrogol 6000,
talc, titanium dioxide (E171), ferric oxide red (E172), quinoline yellow
(E104).
What Amitriptyline film-coated tablets look like and contents
of the pack

Amitriptyline 10 mg film-coated tablets are pale blue coloured,
circular biconvex film-coated tablets with “BL” embossed on one
side and “10” on the other side.
Amitriptyline 25 mg film-coated tablets are yellow coloured, circular
biconvex film-coated tablets with “BL” embossed on one side and
plain on the other side.
Amitriptyline 50 mg film-coated tablets are buff coloured, circular
biconvex film-coated tablets with “BL” embossed on one side and
plain on the other side.
Amitriptyline film-coated tablets are available in a pack sizes of 7,
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 or
168 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, UK
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail:
info@bristol-labs.co.uk
Amitriptyline 10 mg film-coated tablets; PL 17907/0131
Amitriptyline 25 mg film-coated tablets; PL 17907/0132
Amitriptyline 50 mg film-coated tablets; PL 17907/0133
This leaflet was last revised in February 2016
To request a copy of this leaflet in Braille, large print or audio
format, please contact the licence holder at the address (or telephone,
fax, e-mail) above.

V5 16-02-16 D0

IXXXXX

dosage may be taken as divided doses, or as a single dose, preferably
in the evening or at bedtime.
Older people and people with kidney problems:
Your doctor will start you on a lower dose and gradually increase it
as you may be more sensitive to the medicine.
Children: Not recommended for treatment of depression in children,
under 16 years of age.
Nightly bed-wetting:
Children only (for no longer than 3 months treatment):
11-16 years:
25-50 mg taken at night.
6-10 years:
10-20 mg taken at night.
Under 6 years:
Not recommended.
You may not notice any improvement in your symptoms for up to
4 weeks after starting treatment. Do not stop taking the medicine
unless your doctor tells you to as you may experience withdrawal
symptoms (see section 4).
If you take more Amitriptyline than you should
If you (or somebody else) accidentally swallow a lot of tablets at
the same time, or you think a child may have swallowed any, contact
your nearest hospital casualty department or tell your doctor
immediately. Take any remaining tablets and the container with
you.
Symptoms of an overdose include fast or irregular heartbeat, low
blood pressure, dilated pupils, drowsiness, low body temperature,
fits, coma, agitation, muscle rigidity, difficulty breathing, jerky
movements, hot dry skin, dry mouth and tongue, difficulty passing
water, intestinal blockage, uncontrolled movements, being sick or
fever.
If you forget to take Amitriptyline
Do not take a double dose to make up for a forgotten dose. If you
forget to take a dose, take another as soon as you remember and then
your next dose at the usual time.
If you stop taking Amitriptyline
You may not notice any improvement for up to 4 weeks. Do not
stop taking the medicine unless your doctor tells you to as you may
experience withdrawal symptoms (see section 4). If you stop taking
the medicine abruptly, you may get side effects such as headache
that makes you feel sick and feeling weak.

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.

Hide