Skip to Content

UK Edition. Click here for US version.

AMITRIPTYLINE HYDROCHLORIDE 10MG/5ML ORAL SOLUTION

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Amitriptyline Hydrochloride 10mg/5ml Oral Solution
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, please 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.

• you are a young adult. Information from clinical trials has shown an
increased risk in suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

What is in this leaflet
1. What Amitriptyline Oral Solution is and what it is used for
2. What you need to know before you take Amitriptyline Oral Solution
3. How to take Amitriptyline Oral Solution
4. Possible side effects
5. How to store Amitriptyline Oral Solution
6. Contents of the pack and other information

Children and adolescents
Amitriptyline Oral Solution should not be used in children under 6 years.
Amitriptyline Oral Solution is not recommended for the treatment of depression
in children under 16 years of age.

1. What Amitriptyline Oral Solution is and what it is used for
The name of your medicine is Amitriptyline Oral Solution. 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 affects the muscles in the bladder and reduces the need to
pass urine.
Amitriptyline Oral Solution is used in the treatment of:
• depression (especially when associated with sleep disturbance)
• night-time bed-wetting in children aged six years and above.
2. What you need to know before you take Amitriptyline Oral Solution
Do not take Amitriptyline Oral Solution if you:
• are allergic to amitriptyline or to any of the other ingredients of this medicine
(listed in section 6)
• are taking drugs called Monoamine Oxidase Inhibitors (MAOIs) for depression
• 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
• suffer from mania (feeling high or over-excited)
• have severe liver disease
• suffer from porphyria (a disease of blood proteins affecting the skin, gut and
nervous system)
• are breast feeding.
Warnings and precautions
Talk to your doctor before taking Amitriptyline Oral Solution if you:
• suffer from epilepsy
• suffer from liver disease
• 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
• are taking medicines for thyroid disease
• suffer from schizophrenia
• receive electroconvulsive therapy (ECT)
• are due to have surgery in the near future
· have a blood disorder
· have diabetes
· have hiatus hernia (a weakness of the diaphragm causing heartburn)
· have phaeochromocytoma (a rare tumour of the adrenal gland)
· smoke.
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 Oral Solution. 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.
When the medicine is given for bed-wetting:
1. you should not take amitriptyline with medicines known as anticholinergic
such as atropine, oxybutynin or orphenadrine.
2. your doctor may monitor your heart with an ECG (electrocardiogram) test
before giving this medicine
3. suicidal thoughts may occur when taking this medicine for bed-wetting.
See the information in the following section for advice.
Special care should be taken with elderly patients.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed 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 have these kinds of thoughts if:
• you have previously had thoughts about killing or harming yourself

If you have thoughts about harming or killing yourself at any time,
contact your doctor or go to hospital straight away. You may find it
helpful to tell a close friend or relative that you are depressed, 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 Oral Solution
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 Oral Solution can cause a very serious side effect called paralytic
ileus (this is when the small bowel ceases to function for a time).
The following medicines can affect or be affected by treatment with Amitriptyline
Oral Solution:
• 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)
• medicines used as sedatives to treat sleep problems (e.g. ethchlorvynol)
• medicines used to maintain blood pressure in critically ill patients
(e.g. ephedrine, isoprenaline, noradrenaline, phenylephrine,
phenylpropanolamine)
• disulfiram (used to treat alcoholism)
• ritonavir (used to treat HIV infection)
• cimetidine (used to treat problems with stomach acid)
• sertindole, pimozide, thioridazine and phenothiazine (used to treat mental
illness)
• St John’s Wort (a herbal remedy often used for depression)
· astemizole and terfenadine (used in hayfever and other allergic conditions)
· 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)
· barbiturates and other drugs which slow down brain function
· carbamazepine and sodium valproate (used to treat epilepsy)
· methylphenidate (used to treat hyperactivity)
· anticholinergic drugs, such as trihexyphenidyl hydrochloride, benzatropine
mesylate, atropine, oxybutynin and orphenadrine when combined
with amitriptyline for bed-wetting therapy in children or when used in
elderly patients. These medicines should not be given to patients treated
for bed-wetting with amitriptyline
· 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)
· oral contraceptives (“the pill”)
· thyroxine, used to treat an underactive thyroid gland
· fluoxetine and reboxetine (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
Amitriptyline Oral Solution with food, drink, and alcohol
As with all medicines that act on the central nervous system, it is advised that
you do not drink alcohol while taking this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine. 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 Oral Solution if you are breast feeding.
Driving and using machines
Amitriptyline oral solution may cause drowsiness and reduced alertness, do not
drive or operate machinery while taking this medicine.
Amitriptyline Oral Solution contains maltitol, ethanol (alcohol) and
preservatives known as para hydroxybenzoates
This medicine contains:
• Maltitol; if you have been told by your doctor that you have an intolerance to
some sugars contact your doctor before taking this medicine.
• small amounts of ethanol (alcohol), less than 100mg per dose.
• preservatives known as para hydroxybenzoates; these ingredients may
cause allergic reactions that could happen some time after starting the
medicine.
23LF01418PW

3. How to take Amitriptyline Oral Solution
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure. 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 recommended doses are as follows:
Depression
Adults
• recommended starting dose is 75mg given twice or as one dose before bedtime
• this may be increased to 150mg a day, given as one dose in the evening or
before bedtime
• when an improvement is seen in your condition, your doctor will reduce the
dose.
Use in children
Bed-wetting (Enuresis)
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 25-50mg a day
Higher strength preparations are available.
If your doctor prescribes a single dose of 25mg per 5ml spoonful or more, the
following products may be more suitable for you.
· Amitriptyline Hydrochloride 25mg/5ml Oral Solution (Wockhardt PL
29831/0356)
· Amitriptyline Hydrochloride 50mg/5ml Oral Solution (Wockhardt PL
29831/0439)
If you take more Amitriptyline Oral Solution than you should
If you (or anybody else, including a child), takes more Amitriptyline Oral
Solution than you should, you should contact your doctor or nearest hospital
casualty department immediately. Always take the bottle and leaflet with you.
If you forget to take Amitriptyline Oral Solution
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. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Amitriptyline Oral Solution
Do not stop taking Amitriptyline Oral Solution unless you have been told to do so
by your doctor. If you suddenly stop your treatment you may experience
effects such as nausea, headache, chills, sweating, irritability, restlessness,
anxiety, agitation, jerky uncontrollable movements, irregular heart rhythm, vivid
dreams and sleep disturbances and a general feeling of being unwell.
Even with gradual withdrawal of treatment you may still experience some side
effects in the first two weeks such as irritability, restlessness and dream and
sleep disturbances.
Rarely, some patients develop mania (persistent extremely elevated mood and
sometimes psychosis) and hypomania (mild form of mania) within 2-7 days of
stopping long-term therapy of amitriptyline.
Withdrawal symptoms seem to be more common and more severe in children.
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.
If you experience any of the following, seek medical help immediately:
· allergic reaction. Symptoms may include rash, itching, difficulty breathing
· 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 Oral Solution are:
Heart and Blood Vessel Disorders
• high blood pressure
• fainting
• low blood pressure (particularly on
standing)
• a heart problem called “prolonged
QT interval” (which is shown on
your electrocardiogram, ECG)

• heart attack
• stroke
• problems with heart rhythm








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

• itching
• rash

constipation
nausea and vomiting
altered appetite
diarrhoea
weight loss
inflammation of the mouth

Kidney and Urinary Complaints
• problems passing water
• increased urination
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
• swelling of glands
• impotence

hormonal disturbances
alteration of blood sugar levels
swelling of face and tongue
delirium (particularly in the elderly)
syndrome of inappropriate
antidiuretic hormone (SIADH),
symptoms of which may include
hyponatraemia (drowsiness,
confusion or fits)

Additional side effects in children
Changes in behaviour have occurred in children receiving amitriptyline for
treatment of night-time bed-wetting.
Some babies born to mothers who have taken amitriptyline shortly before
delivery have had heart problems, breathing difficulty, muscle spasm, irritability,
agitation, fits or difficulty passing urine.
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 Oral Solution
• Keep this medicine out of the sight and reach of children.
• Amitriptyline Oral Solution should not be stored above 25°C. Store in the
original bottle and outer carton to protect from light; do not transfer to
another container.
• 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.
• Once opened the product should be used within 1 month.
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 Oral Solution contains
The active ingredient is: amitriptyline hydrochloride.
Amitriptyline Hydrochloride 10mg/5ml Oral Solution contains 10mg of the active
ingredient in 5ml.
The other ingredients are: methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), propylene glycol, ascorbic acid, orange flavour
10950-56 (contains ethanol), orange/tangerine flavour 10888-56 (contains
ethanol), sucralose powder, liquid maltitol and purified water.
What Amitriptyline Oral Solution looks like and the contents of the pack
Amitriptyline Oral Solution is a clear, colourless solution that becomes pale
yellow over time. It has an orange/tangerine odour. The medicine is supplied in
150ml amber glass bottle, with a child resistant cap, in a cardboard outer carton.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.

Some of these side effects can be life-threatening.
Nervous System Disorders
• confusion
• reduced concentration
• hallucinations
• disorientation
• excitement
• persistent elevated mood
• delusions
• anxiety/restlessness
• sleep disturbance · agitation
• coma
• involuntary movements
• dizziness
• fits
• headache
• ringing in the ears
• problems with coordination
• numbness and tingling
and balance of the extremities
• nightmares
Eye Problems
• blurred vision
• enlarged pupils

Gastrointestinal System
• dry mouth
• paralysis of the gut
• stomach pains
• black tongue
• liver disease
• weight gain
• unpleasant tastes in mouth

• problems focussing eyes
• increased pressure in the eye

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

UK Reference number

Amitriptyline 10mg/5ml Oral Solution

PL 29831/0460

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 04/2016

105402/3
23LF01418PW

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