Skip to Content

UK Edition. Click here for US version.

AMITRIPTYLINE 50MG FILM-COATED TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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, 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 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

4th fold

(26.25mm)

3rd fold

(26.25mm)

2nd fold

(26.25mm)

1st fold

(26.25mm)

Neutral code not required on the leaflet artworks.

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.

(26.25mm)

16th fold

(26.25mm)

15th fold

(26.25mm)

14th fold

(26.25mm)

13th fold

(26.25mm)

12th fold

(26.25mm)

11th fold

(26.25mm)

10th fold

9th fold

(26.25mm)

8th fold

(26.25mm)

7th fold

(26.25mm)

6th fold

(26.25mm)

5th fold

(26.25mm)

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 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
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)
• are due to have surgery in the near future
• smoke
• have a blood disorder
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, 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.
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
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.

102530/7

pg1/2

Process
Black

1st fold

(26.25mm)

2nd fold

(26.25mm)

3rd fold

(26.25mm)

4th fold

(26.25mm)

5th fold

(26.25mm)

6th fold

(26.25mm)

7th fold

(26.25mm)

8th fold

(26.25mm)

9th fold

(26.25mm)
(26.25mm)

10th fold

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
• 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:
• 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
• heart attack
• fainting
• changes to ECG (Heart trace)
• stroke
• low blood pressure resulting in dizziness (particularly on standing)
• problems with heart rhythm
• palpitations
• abnormally fast heartbeat
Some of these side effects can be life-threatening.
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
• coma
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
• black tongue
• salivary gland swelling
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
• fever
• delirium (in the elderly)
• severe reduction in number of white blood cells,
• sore throat
which makes infections more likely
• inappropriate secretion of the
• reduction in blood platelets, which increases risk of
hormone (ADH)
bleeding or bruising
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.

(26.25mm)

4. POSSIBLE SIDE EFFECTS

11th fold

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, 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.

(26.25mm)

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.

12th fold

5. HOW TO STORE AMITRIPTYLINE TABLETS

This is a service provided by the Royal National Institute of Blind People.
The leaflet was last revised in: 08/2015

102530/7
221152

pg2/2

(26.25mm)
(26.25mm)

14th fold

(26.25mm)

15th fold

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

(26.25mm)

Product name
Amitriptyline 10mg Film-Coated Tablets
Amitriptyline 25mg Film-Coated Tablets
Amitriptyline 50mg Film-Coated Tablets

16th fold

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:

13th fold

6. FURTHER INFORMATION

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