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AMITRIPTYLINE 10 MG FILM-COATED TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

AMITRIPTYLINE
10 mg & 25 mg
FILM-COATED 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 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.

THIS LEAFLET CONTAINS
1. What Amitriptyline is for
2. Before you take Amitriptyline
3. How to take Amitriptyline
4. Possible side effects
5. How to store Amitriptyline
6. Further information

1. WHAT AMITRIPTYLINE IS FOR
Amitriptyline belongs to a group of medicines called tricyclic
antidepressants. These medicines alter the levels of
chemicals in your brain to relieve the symptoms of
depression.
Amitriptyline can be used to treat:
 the symptoms of depression
 bed-wetting at night by children aged 6 years and above
If you are not sure why you have been prescribed these
tablets then please ask your doctor.

2. BEFORE YOU TAKE AMITRIPTYLINE
Do not take Amitriptyline and tell your doctor if you:
 are allergic to amitriptyline or other tricyclic
antidepressants, or any of the other ingredients in the
tablets (listed in section 6 of this leaflet)
 have heart problems such as irregular heartbeats, heart
block or have recently had a heart attack
 have severe liver problems
 are taking other medicines to treat depression known as
Monoamine Oxidase Inhibitors (MAOIs) or you have
taken MAOIs within the last 14 days
 suffer from mania (feeling over-excited, which causes
unusual behaviour)
 are breast-feeding
Amitriptyline should not be given to children under 6
years of age.
Take special care with Amitriptyline
Tell your doctor before you take this medicine if you:
 have epilepsy
 have a mental health problem such as schizophrenia or
manic depression
 have problems with your liver or heart
 have increased pressure in your eye (glaucoma)
 cannot pass urine, have long-term difficulty passing
stools or have an enlarged prostate gland
 have an overactive thyroid gland or are taking medicines
to treat thyroid problems
 are having electroconvulsive therapy (ECT)
 have a tumour called phaeochromocytoma, which is
usually near the kidney and can cause high blood
pressure
 have an inherited iron disorder (porphyria)
Tell your doctor or dentist that you are taking Amitriptyline if
you are going to have an anaesthetic for an operation or
dental treatment.
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.
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.
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. 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
 have a problem that gives you a low level of potassium or
magnesium, or a high level of potassium in your blood
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines, even medicines
bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines, as they may affect how
Amitriptyline works:
 medicines to treat depression known as Monoamine
Oxidase Inhibitors (MAOIs) such as moclobemide or you
have taken MAOIs within the last 14 days
 other medicines to treat depression such as fluoxetine,
duloxetine or the herbal remedy St John’s Wort
 medicines to treat mental health problems such as
lithium, clozapine, pimozide, chlorpromazine or
prochlorperazine
 medicines to treat high blood pressure such as
moxonidine, guanethidine, debrisoquine, bethanidine or
clonidine
 medicines to increase urine production, (diuretics), such
as amiloride, furosemide or spironolactone
 medicines to treat chest pain such as glyceryl trinitrate,
nicorandil, diltiazem or verapamil
 medicines to treat an irregular heart beat such as
amiodarone, dronedarone, disopyramide, flecainide,
procainamide, propafenone or sotalol
 sympathomimetic agents such as adrenaline,
apraclonidine, brimonidine, ephedrine, isoprenaline,
noradrenaline, phenylephrine or phenylpropanolamine
(these may be found in medicines to treat heart problems
and asthma as well as cough or cold remedies)
 painkillers such as codeine, nefopam or tramadol
 medicines to help you sleep such as ethchlorvynol
 medicines to treat epilepsy such as carbamazepine,
phenytoin, primidone, valproate or barbiturates for
example phenobarbital
 medicines to treat Parkinson’s disease such as
entacapone, rasagiline or selegiline
 medicines to stop blood clots from forming such as
coumarins for example warfarin
 anticholinergic drugs such as atropine to treat spasms,
shaking, stiffness or movement disorders
 atomoxetine or methylphenidate to treat Attention Deficit
Hyperactivity Disorder (ADHD)
 disulfiram to treat alcohol addiction
 pentamidine isetionate to treat pneumonia
 moxifloxacin or rifampicin to treat bacterial infections
 fluconazole or terbinafine to treat fungal infections
 ritonavir or saquinavir to treat viral infections
 artemether and lumefantrine to treat malaria
 cimetidine to treat stomach ulcers
 medicines to treat thyroid problems
 sibutramine for weight loss
 altretamine to treat some types of cancer
 baclofen a muscle relaxant
 oestrogens used for contraception (‘the pill’) or hormone
replacement therapy (HRT)
AVOID ALCOHOL whilst taking Amitriptyline
Pregnancy and breast-feeding
Amitriptyline should not be taken if you are pregnant or
planning a pregnancy, unless your doctor has told you to.
Do not take Amitriptyline if you are breast-feeding.
Driving and using machines
Amitriptyline may make you feel less alert. If you are affected
in this way, do not drive or operate machinery.
Important information about some of the ingredients of
Amitriptyline
Amitriptyline 10 mg and 25 mg Film-coated Tablets contain
lactose. If you know you have an intolerance to some sugars,
contact your doctor before taking this medicine.
Amitriptyline 25 mg Film-coated Tablets also contain sunset
yellow (E110), which may cause allergic reactions.

3. HOW TO TAKE AMITRIPTYLINE
Always take Amitriptyline tablets exactly as your doctor
has told you. If you are not sure, check with your doctor or
pharmacist.
Swallow the tablets whole with a glass of water.
It may take two to four weeks of treatment before you notice
an improvement in your symptoms.
Dosage
Depression:
Adults: The usual starting dose is 50-75 mg a day, either as
a single dose at night or split into smaller doses over the day.
Your doctor may increase this to a maximum of 150-200 mg
a day.
For long term treatment the usual dose is 50-100 mg a day as
a single dose at night. As your condition improves you will be
prescribed the lowest effective dose necessary to treat your
symptoms.
Adolescents and Elderly: Your doctor will start you on a
lower dose (typically 10-25 mg three times a day) and then
gradually increase your dose, as you may be more sensitive
to the effects of this medicine.
Children: Not recommended for treatment of depression in
children under 16 years of age.
Bed-wetting at night
Children (for no longer than 3 months treatment):
Under 6 years: Not recommended
6-10 years: 10-20 mg at night
11 years and over: 25-50 mg at night
If you take more Amitriptyline than you should
Contact your doctor or go to the nearest hospital immediately.
Take this leaflet and the package with you.
Symptoms of an overdose may include fast or irregular
heartbeats, difficulty breathing, low blood pressure, coma,
fits, muscle rigidity, agitation, dry mouth, dilated pupils,
hallucinations,
disturbed
concentration,
confusion,
drowsiness, vomiting, a fall in body temperature or fever.
If you forget to take Amitriptyline
Don’t worry, just take it as soon as you remember. However,
if it is nearly time for your next scheduled dose, skip the
missed dose. Do not take a double dose (two doses at the
same time) to make up for the missed one.
If you stop taking Amitriptyline
DO NOT STOP taking Amitriptyline unless your doctor tells
you to. If you stop taking it abruptly, you may experience
withdrawal symptoms (see section 4). Your doctor will
gradually reduce your dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amitriptyline can cause side effects,
although not everybody gets them.
STOP TAKING Amitriptyline and see a doctor straight
away if you have:
 an allergic reaction, symptoms of which may include skin
rash, itching, red and raised lumps (hives), sensitivity to
sunlight, swelling of your face or tongue leading to
difficulty in breathing or swallowing
 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. The doctor may
wish to test your blood.
 a serious, sometimes life-threatening, condition which
results in fever, faster breathing and pulse rate, sweating,
muscle stiffness, changes in blood pressure and reduced
consciousness
Serious side effects: Tell a doctor straight away if you:
 feel more depressed or have thoughts of harming or
killing yourself.
If you get any of the following side effects, see your
doctor as soon as possible:
 Effects on your heart: feeling faint or dizzy when
standing up, high blood pressure, fast or irregular
heartbeats, palpitations, heart attack, heart block, stroke,
very low blood pressure or a heart problem called
prolonged QT interval (which is shown on your
electrocardiogram (ECG) (frequency common)
 Effects on your brain and nervous system: confusion,
disorientation (not knowing where you are), difficulty
concentrating, difficulty sleeping, nightmares, delusions,
hallucinations (hearing and seeing things that are not
there), feeling hyperactive, excited, anxious, agitated,
delirious or restless, numbness or tingling or pins and
needles (particularly in the hands and feet), difficulty
co-ordinating movements, speech difficulty, shaking, fits,
dizziness or fainting
 Effects on your liver: hepatitis, including changes in
liver function (as seen in blood tests) or yellowing of the
skin or whites of your eyes (jaundice).

 Effects on your hormones: changes in sexual function
or sex drive, breast swelling in men and women, swelling
of your testicles, production of breast milk, increased or
decreased blood sugar levels or inappropriate secretion
of Antidiuretic Hormone (ADH), which may make you
urinate more frequently.
Tell your doctor if you get any of these side effects:
 Effects on your ears: ringing in your ears
 Effects on your stomach and intestines: nausea,
vomiting, diarrhoea, constipation, blockage of your small
intestine, pains in your stomach area (the abdomen),
change in appetite, dry mouth, inflammation or irritation in
your mouth sometimes causing mouth ulcers, taste
disturbances, swollen salivary glands or black tongue.
 Effects on your eyes: blurred vision, changes in
eyesight, dilated pupils or glaucoma.
 General effects: headache, fever, weakness, tiredness,
drowsiness, increased sweating, difficulty in passing
urine, weight gain or weight loss, elevated or reduced
body temperature or hair loss.
An increased risk of bone fractures has been observed in
patients taking this type of medicines
Withdrawal symptoms: As your doctor gradually reduces
your dose you may experience irritability, restlessness or
dream and sleep disturbances. Mania or hypomania (feeling
elated or over-excited) may occur 2-7 days after stopping the
tablets.
Bed-wetting at night by children: The side effects are less
frequent but may still occur. The most common side effects
are drowsiness, dry mouth, blurred vision, glaucoma,
changes in eyesight, constipation, fever and difficulty in
passing urine. There have also been rare reports of mild
sweating and itching, as well changes in behaviour.
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 out of the reach and sight of children.
Store below 25°C and away from light. Store in the original
package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated
on the package or container. 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 Film-coated Tablets contain
The active ingredient in Amitriptyline 10 mg and 25 mg
Film-coated Tablets is amitriptyline hydrochloride.
The other ingredients are lactose monohydrate, calcium
hydrogen
phosphate
dihydrate,
maize
starch,
microcrystalline cellulose, colloidal anhydrous silica, stearic
acid, magnesium stearate, hypromellose, ethylcellulose,
diethyl phthalate, hydroxypropyl cellulose (E463) and
titanium dioxide (E171).
The 10 mg tablets also contain indigo carmine (E132). The 25
mg tablets also contain quinoline yellow (E104) and sunset
yellow (E110).
What Amitriptyline Film-coated Tablets look like and
contents of the pack
Amitriptyline 10 mg Film-coated Tablets are round, blue,
film-coated tablets with the marking MP49 on one side.
Amitriptyline 25 mg Film-coated Tablets are round, yellow,
film-coated tablets with the marking MP50 on one side and
25 mg on the other.
The tablets come in blister packs of 28 tablets and containers
of 28, 100 and 500 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill, Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 05/2016
M0049-0050/O/PIL/G5

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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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