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AMITRIPTYLINE 50MG FILM-COATED TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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Package leaflet: Information for the user
Amitriptyline 10mg Film-Coated Tablets
Amitriptyline 25mg Film-Coated Tablets
Amitriptyline 50mg Film-Coated Tablets
(referred to as Amitriptyline Tablets in this leaflet)
Read all of this leaflet carefully before you start to take 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 Tablets are and what they are used for
2. What you need to know before you take Amitriptyline Tablets
3. How to take Amitriptyline Tablets
4. Possible side effects
5. How to store Amitriptyline Tablets
6. Contents of the pack and other information
1.

What Amitriptyline Tablets are and what they are used for

The name of your medicine is Amitriptyline Tablets. Amitriptyline belongs to a group of medicines known
as tricyclic antidepressants. Everybody has substances called serotonin and noradrenaline in their brains. It is
thought that people with depression (and some other conditions) have less of these substances compared to
those without depression (or other conditions). Amitriptyline works by increasing the amounts of these
substances in the brain. Amitriptyline also effects the muscles in the bladder and reduces the need to pass
urine.
Amitriptyline Tablets are used in the treatment of:
• depression (especially when associated with sleep disturbance). Not recommended in children under 16
years of age.
• night-time bed-wetting in children aged six years and above when organic pathology has been excluded
and no response has been achieved to all other non-drug and drug treatments.
2.

What you need to know before you take Amitriptyline Tablets

Do not take Amitriptyline Tablets if you:
• are allergic (hypersensitive) to amitriptyline or to any of the other ingredients in Amitriptyline Tablets (see
section 6, Further information)
• are taking drugs called Monoamine Oxidase Inhibitors (MAOIs) for depression or have taken them within
the last two weeks
• are recovering from a heart attack
• have blockage of the coronary arteries or heart failure
• are taking drugs that increase the QT interval of the ECG (heart trace) e.g. amiodarone, terfenadine,
astemizole, sertindole, pimozide, thioridazine, sotalol
• have an abnormal heart rhythm or irregular heart block (slow conduction of the electrical impulses which
make the heart beat)
• suffer from mania (feeling high or over-excited)
• have severe liver disease
• have porphyria (a disease of blood proteins affecting the skin, gut and nervous system)
• are breast feeding

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Amitriptyline Tablets should not be used in children under 6 years.
Amitriptyline Tablets are not recommended for the treatment of depression in children under 16 years
of age.
Warnings and precautions
Talk to your doctor before taking Amitriptyline Tablets if you:
• suffer from or have a history of epilepsy
• suffer from liver problems
• have diabetes
• have problems passing water
• have an enlarged prostate
• have increased pressure in your eyes (e.g. glaucoma)
• suffer from heart disease
• have an overactive thyroid gland
• suffer from schizophrenia or manic-depression
• receive electroconvulsive therapy (ECT)
• have hiatus hernia (a weakness of the diaphragm causing heartburn)
• have phaeochromocytoma (a rare tumour of the adrenal gland)
• are due to have surgery in the near future
• smoke
• have a blood disorder
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
 have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in
your blood.
Nightly bed-wetting:
1. Should not be combined with anticholinergic agents
2. EGC (electrocardiogram) should be performed before starting therapy with Amitriptyline
3. During initiation of treatment development of suicidal thoughts and behaviours in patients receiving
treatment for depression combined with treatment of nightly bed-wetting.
Special care should be taken with elderly patients.
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.
Other medicines and Amitriptyline Tablets
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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription. It is important you do this as some medicines when
taken in combination with Amitriptyline Tablets can cause very serious side effects such as paralytic ileus
(this is when the small bowel ceases to function for a time), heart problems including a life-threatening
irregular heart beat and changes to the blood clotting process. The following medicines can affect or be
affected by treatment with Amitriptyline Tablets:
• antidepressants called monoamine oxidase inhibitors (MAOIs) – you should wait at least 14 days after
stopping an MAOI before starting amitriptyline
• medicines used to treat high blood pressure (e.g. guanethidine, debrisoquine, betanidine, clonidine)
• astemizole and terfenadine, used in hayfever and other allergic conditions
• drugs used to treat severe allergic reactions and shock such as adrenaline, ephedrine, isoprenaline,
noradrenaline, phenylephrine
• drugs used to control irregular heart rhythm, such as amiodarone, disopyramide, procainamide,
propafenone and quinidine
• anaesthetics
• nitrates, such as glyceryl trinitrate, used to treat angina
• sotalol, a beta-blocker, used in heart disease
• medicines used as sedatives to treat sleep problems (e.g. ethchlorvynol) and tranquillisers
• barbiturates and other drugs which slow down brain function
• carbamazepine and sodium valproate to treat epilepsy
• methylphenidate, a drug used to treat hyperactivity
• anticholinergic drugs, such as trihexyphenidyl hydrochloride and benzatropine mesylate, and selegiline and
entacapone, used in the treatment of Parkinson’s Disease
• nefopam, tramadol and morphine, used for pain relief
• rifampicin, moxifloxacin and linezolid, used to treat bacterial infections
• warfarin and other drugs used to thin the blood
• fluconazole, used to treat fungal infections
• diuretics (water tablets)
• disulfiram (used to treat alcoholism)
• ritonavir and saquinavir (used to treat HIV infection)
• cimetidine (used to treat problems with stomach acid)
• oral contraceptives ("the pill")
• thyroxine, used to treat an underactive thyroid gland
• sertindole, pimozide, thioridazine and phenothiazine, used to treat mental illness
• fluoxetine, reboxetine and St John’s Wort used to treat depression
• baclofen, used as a muscle relaxant
• decongestants such as phenylpropanolamine
• apraclonidine and brimonidine, used to treat glaucoma
• moclobemide (used to treat depression and social anxiety). After stopping amitriptyline do not start
moclobemide for at least one week
• anticholinergic medicines such as atropine, benzatropine, dicyclomine, doxylamine when combined with
Amitriptyline for nightly bed-wetting therapy in children or when used in elderly patients.
Amitriptyline Tablets with food, drink, and alcohol
As with all medicines that act on the central nervous system (the brain and spinal cord), it is advised that you
do not drink alcohol while taking this medicine.
Pregnancy and breast-feeding
You should not use this medicine if you are pregnant unless your doctor specifically recommends it. Tell
your doctor straight away if you think you may be pregnant or wish to become pregnant.
You should not take Amitriptyline Tablets if you are breast feeding.
Driving and using machines
Amitriptyline Tablets may cause drowsiness and reduced alertness, do not drive or operate machinery while
taking this medicine.
Amitriptyline Tablets contain tartrazine aluminium lake (E102) and sunset yellow FCF (E110)
Amitriptyline 25mg Tablets contain tartrazine aluminium lake (E102) and sunset yellow FCF (E110), which
may cause allergic reactions.
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3.
How to take Amitriptyline Tablets
Always take this medicine exactly as your doctor has told you. Your doctor will decide the right dose for
you; this will be on the pharmacist’s label. Check this carefully, it will tell you how much of this medicine to
take and how often to take it. This medicine should be swallowed. The usual doses are as follows:
Depression
Adults
• usual starting dose is 75mg given twice or as one dose before bedtime
• this may be increased to 150mg a day, with the additional doses being given in the late afternoon or before
bedtime
• usual daily maintenance dose is 50mg - 100mg
• when an improvement is seen in your condition, your doctor will reduce the dose
Elderly
• elderly patients may need a lower starting dose of 10mg to 25mg three times a day and a maintenance dose
of 50mg a day
Not recommended in children under 16 years of age.
Use in children
Nightly Bed-wetting
Children only (for no longer than 3 months, if repeated treatment required then a medical review
should be conducted every 3 months)
• children aged 6-10 years may receive 10-20mg a day
• children aged 11-16 years may need 25mg a day
Not for use in children under 6 years.
If you take more Amitriptyline Tablets than you should
If you (or anybody else, including a child), takes more Amitriptyline Tablets than you should you should
contact your doctor or nearest hospital casualty department immediately. Always take the leaflet and any
tablets you have left with you.
If you forget to take Amitriptyline Tablets
If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do
not take the missed dose at all. NEVER take a double dose to make up for the one missed.
If you stop taking Amitriptyline Tablets
Do not stop taking Amitriptyline Tablets unless you have been told to do so by your doctor. If you suddenly
stop your treatment you may experience effects such as nausea, chills, headache, sweating, irritability,
restlessness, anxiety, agitation, jerky uncontrollable movements, irregular heart rhythm, mania (persistent
extremely elevated mood and sometimes psychosis), hypomania (mild form of mania), vivid dreams and
sleep disturbances and general feeling of unwell. After stopping amitriptyline do not start moclobemide for
at least 1 week.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of
the following, seek medical help immediately:
• rash, itching, swelling of the face and tongue, difficulty breathing, increased sensitivity to sunlight
• neuroleptic malignant syndrome. Symptoms may include fever, muscle cramps, delirium.
If you experience the following side effect, carry on taking the tablets, but seek medical advice as soon as
possible:
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• problems with bone marrow and blood cell production. Symptoms may include a sore throat, mouth ulcers
and recurring infections, bleeding or bruising easily.
Side effects that have been reported with Amitriptyline Tablets are:
Heart and Blood Vessel disorders
• high blood pressure
• fainting
• low blood pressure resulting in dizziness (particularly on standing)
• palpitations
• a heart problem called “prolonged QT interval”
(which is shown on your electrocardiogram, ECG)
(frequency common)

• heart attack
• changes to ECG (Heart trace)
• stroke
• problems with heart rhythm
• abnormally fast heartbeat

Some of these side effects can be life-threatening.
Nervous System disorders
• confusion
• disorientation
• drowsiness
• excitement
• delusions
• sleep disturbance
• involuntary movements, jerking, uncontrolled shaking
• headache
• problems with coordination and balance
• speech problems
• coma
Eye problems
• blurred vision
• enlarged pupils

• nightmares
• reduced concentration
• imagining things
• hallucinations
• persistent elevated mood
• anxiety/restlessness
• dizziness
• ringing in the ears
• numbness and tingling of the
hands and feet
• shaking

• problems focussing eyes
• increased pressure in the eye

Gastrointestinal System
• dry mouth
• sore mouth
• paralysis of the gut
• stomach pains
• weight gain
• unpleasant taste in mouth
• black tongue

• constipation
• nausea and vomiting
• altered appetite
• diarrhoea
• weight loss
• inflammation of the mouth
• salivary gland swelling

Skin and Hair problems
• sensitivity to sunlight
• increased sweating
• hair loss

• itching
• rash

Kidney and Urinary complaints
• problems passing water

• increased urination

Liver complaints
• liver problems

• jaundice (yellow skin and whites
of eyes)

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Muscle and Bone complaints
• painful joints
• weakness

• fatigue
• increased risk of bone fractures

Other complaints
• altered sex drive
• delayed ejaculation, delayed orgasm in women
• swelling of testicles
• milk production
• increase in breast tissue (in men and women)
• fever
• severe reduction in number of white blood cells,
which makes infections more likely
• reduction in blood platelets, which increases risk of
antidiuretic bleeding or bruising







swelling of glands
impotence
hormonal disturbances
alteration of blood sugar levels
mouth ulcers

• delirium (in the elderly)
• sore throat
• inappropriate secretion of the
hormone (ADH)

When used for the treatment of bed wetting in children, the side effects are less frequent. The most common
side effects are drowsiness, blurred vision, dilated pupils, constipation, sweating, itching and dry mouth.
Changes in behaviour have also occurred in children receiving amitriptyline.
Some babies born to mothers who have taken amitriptyline shortly before delivery have had heart problems,
breathing difficulty, muscle spasm, irritability, fits or difficulty passing urine.
You may also have thoughts of harming or killing yourself whilst taking amitriptyline tablets, or soon after
your doctor tells you to stop taking amitriptyline tablets (read the section of this leaflet “Thoughts of suicide
and worsening of your depression or anxiety disorder” for further information). If you have thoughts of
harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Amitriptyline Tablets

Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date
refers to the last day of that month.
• Do not use this medicine if you notice signs of "going off" such as discolouration.
Do not throw medicines away 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 Tablets contain
The active ingredient is: amitriptyline hydrochloride. The tablets are available in three strengths, 10mg,
25mg and 50mg.
Amitriptyline 10mg Tablets also contain: Calcium hydrogen phosphate dihydrate, sodium starch glycollate,
maize starch, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
macrogol and indigo carmine aluminium lake (E132).
Amitriptyline 25mg Tablets also contain: Calcium hydrogen phosphate dihydrate, sodium starch glycollate,
maize starch, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
macrogol, tartrazine aluminium lake (E102) and sunset yellow FCF (E110).
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Amitriptyline 50mg Tablets also contain: calcium hydrogen phosphate dihydrate, sodium starch glycollate,
maize starch, microcrystalline cellulose, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
macrogol, iron oxide yellow (E172), iron oxide black (E172) and iron oxide red (E172).
What Amitriptyline Tablets look like and the contents of the pack
Amitriptyline 10mg Tablets are pale blue, film coated, circular tablets marked A on one face and 10 on the
reverse.
Amitriptyline 25mg Tablets are yellow, film coated, circular tablets marked A on one face and 25 on the
reverse.
Amitriptyline 50mg Tablets are buff, film coated, circular tablets marked A on one face and 50 on the
reverse.
Amitriptyline Tablets are available in containers of 100 and 500 tablets or blister packs containing 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800
198 5000 (UK Only). Please be ready to give the following information:
Product name
Amitriptyline 10mg Film-Coated Tablets
Amitriptyline 25mg Film-Coated Tablets
Amitriptyline 50mg Film-Coated Tablets

Reference number
PL 29831/0007
PL 29831/0008
PL 29831/0009

This is a service provided by the Royal National Institute of Blind People.
The leaflet was last revised in: 01/2016

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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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