AMITRIPTYLINE 50MG FILM-COATED TABLETS

Active substance: 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.
− Keep this leaflet. You may need to read it again while you are receiving your
treatment.
− If you have any further questions, please 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.
In this leaflet:
1. What Amitriptyline Tablets are and what they are used for
2. Before you take Amitriptyline Tablets
3. How to take Amitriptyline Tablets
4. Possible side effects
5. How to store Amitriptyline Tablets
6. Further 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.
2. 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 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
• are breast feeding
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.
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)
• have porphyria (a disease of blood proteins affecting the skin, gut and nervous system)
• are due to have surgery in the near future
• smoke
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 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, used in
the treatment of Parkinson’s Disease
• nefopam and morphine, used for pain relief
• rifampicin, 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 (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
Taking Amitriptyline Tablets with food and drink
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 machinery
Amitriptyline Tablets may cause drowsiness and reduced alertness, do not drive or operate machinery while taking
this medicine.
Important information about some of the ingredients in Amitriptyline Tablets
Amitriptyline 25mg Tablets contain tartrazine aluminium lake (E102) and sunset yellow FCF (E110), which may
cause allergic reactions.
3. HOW TO TAKE AMITRIPTYLINE TABLETS
Always take Amitriptyline Tablets 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
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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.
Bed-wetting
• children aged 6-10 years may receive 10-20mg a day
• children aged 11-16 years may need 25mg a day
• treatment should be no longer than 3 months
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, 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amitriptyline Tablets 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
Side effects that have been reported with Amitriptyline Tablets are:
Heart and Blood Vessel disorders
• high blood pressure
• heart attack
• fainting
• stroke
• low blood pressure resulting in dizziness (particularly on standing) • problems with heart rhythm
• palpitations
• abnormally fast heartbeat
Nervous System disorders
• confusion
• nightmares
• disorientation
• reduced concentration
• drowsiness
• imagining things
• excitement
• hallucinations
• delusions
• persistent elevated mood
• sleep disturbance
• anxiety/restlessness
• involuntary movements, jerking, uncontrolled shaking
• dizziness
• headache
• ringing in the ears
• problems with coordination and balance
• numbness and tingling of the hands and feet
• speech problems
• shaking
• Neuroleptic Malignant Syndrome (fever, muscle cramps, delirium)
Eye problems
• blurred vision
• problems focussing eyes
• enlarged pupils
• increased pressure in the eye
Gastrointestinal System
• dry mouth
• constipation
• sore mouth
• nausea and vomiting
• paralysis of the gut
• altered appetite
• stomach pains
• diarrhoea
• weight gain
• weight loss
• unpleasant taste in mouth
• inflammation of the mouth
Skin and Hair problems
• sensitivity to sunlight
• itching
• increased sweating
• rash
• hair loss
Kidney and Urinary complaints
• problems passing water
• increased urination
Liver complaints
• liver problems
• jaundice (yellow skin and whites of eyes)
Muscle and Bone complaints
• painful joints
• fatigue
• weakness
• increased risk of bone fractures
Other complaints
• altered sex drive
• swelling of glands
• delayed ejaculation, delayed orgasm in women
• impotence
• swelling of testicles
• hormonal disturbances
• milk production
• alteration of blood sugar levels
• increase in breast tissue (in men and women)
• mouth ulcers
• problems with bone marrow and blood cell production
• fever
• severe reduction in number of white blood cells,
• delirium (in the elderly)
which makes infections more likely
• reduction in blood platelets, which increases risk of
bleeding or bruising
• sore throat
• inappropriate secretion of the antidiuretic 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.
If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.
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.
5. HOW TO STORE AMITRIPTYLINE TABLETS
Keep out of the reach and sight of children.
• Do not store above 25°C.
• Amitriptyline Tablets should not be taken after the expiry date on the label and carton; the expiry date refers to the
last day of the month.
• Do not take this medicine if the tablets show signs of "going off" such as discolouration.
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 protect the environment.
6. FURTHER 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).
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.
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
Reference number
Amitriptyline 10mg Film-Coated Tablets
PL 29831/0007
Amitriptyline 25mg Film-Coated Tablets
PL 29831/0008
Amitriptyline 50mg Film-Coated Tablets
PL 29831/0009
This is a service provided by the Royal National Institute of Blind People.
The leaflet was last revised in: July 2010
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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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