Patient leaflet - Amitriptyline Hydrochloride 50 mg / 5 ml oral solution
1. What Amitriptyline Oral Solution is and what it is used for
The name of your medicine is Amitriptyline Hydrochloride 50mg/5ml Oral Solution, called Amitriptyline Oral Solution throughout the rest of this leaflet. It belongs to a group of medicines called tricyclic antidepressants.
This medicine is used to treat:
Depression in adults (major depressive episodes). Neuropathic pain in adults.
Chronic tension type headache prophylaxis in adults. Migraine prophylaxis in adults.
Bed-wetting at night in children aged 6 years and above, only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including muscle relaxants and desmopressin. This medicine should only be prescribed by doctors with expertise in treating patients with persistent bed-wetting.
2. What you need to know before you take Amitriptyline Oral Solution
Do not take Amitriptyline Oral Solution:
if you are allergic to amitriptyline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
if you have recently had a heart attack (myocardial infarction);
if you have heart problems, such as disturbances in heart rhythm, which are seen on an
electrocardiogram (ECG), heart block or coronary artery disease;
if you are taking medicines known as monoamine oxidase inhibitors (MAOIs);
if you have taken MAOIs within the last 14 days; if you have taken moclobemide the day before; if you have a severe liver disease.
If you are treated with amitriptyline, you have to stop taking this medicine and wait for 14 days before you start treatment with a MAOI.
This medicine should not be used for children below 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amitriptyline Oral Solution.
Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline. This might also occur in usual doses if you have pre-existing heart disease.
The use of Buprenorphine together with Amitriptyline Oral Solution can lead to serotonin syndrome, a potentially life threatening condition (see ‘Other medicines and Amitriptyline Oral Solution’).
Prolonged QT interval
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 a slow heart rate;
have or had a problem where your heart cannot pump the blood around 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;
have surgery planned, as it might be necessary to stop the treatment with amitriptyline before you are given anaesthetics. In the case of acute surgery, the anaesthetist should be informed about the treatment with amitriptyline;
have an over active thyroid gland or receive thyroid medication.
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. This is because these medicines all take about two weeks, but sometimes longer, to work properly. You may be more likely to think like this if:
you have previously had thoughts about killing or harming yourself;
you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults 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. Episodes of mania
Some patients with manic-depressive illness may enter into a manic phase. This is characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. In such cases, it is important to contact your doctor who probably will change your medication. Tell your doctor if you have, or have had in the past, any medical problems, especially if you have:
narrow-angle glaucoma (loss of vision due to abnormally high pressure in the eye);
epilepsy, a history of convulsions or fits; difficulty in passing urine;
enlarged prostate;
thyroid disease;
bipolar disorder;
schizophrenia;
severe liver disease;
severe heart disease;
pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine);
diabetes, as you might need an adjustment to your diabetic medication.
If you use antidepressants such as SSRIs, your doctor might consider changing the dose of your medicine (see also section 2 “Other medicines and Amitriptyline Oral Solution” and section 3 “How to take Amitriptyline Oral Solution”).
Take special care with Amitriptyline Oral Solution: Serious cutaneous reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with amitriptyline treatment. Stop using Amitriptyline Oral Solution and seek medical attention immediately if you notice any of the symptoms related to these serious cutaneous reactions described in section 4.
Elderly are more likely to suffer from certain side effects, such as dizziness when you stand up, due to low blood pressure (see also section 4 “Possible side effects”). Children and adolescents
Depression, neuropathic pain, chronic tension type headache and migraine prophylaxis
Do not give this medicine to children and adolescents below 18 years of age for these treatments, as safety and efficacy have not been established in this age group. Bed-wetting at night
An ECG should be performed prior to initiating therapy with amitriptyline, to exclude long QT syndrome. This medicine should not be taken at the same time as an anticholinergic drug (see also section 2 “Other medicines and Amitriptyline Oral Solution”). Suicidal thoughts and behaviours may also
develop during early treatment with antidepressants for disorders other than depression; the same precautions observed when treating patients with depression should therefore be followed when treating patients with enuresis.
Other medicines and Amitriptyline Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines bought without a prescription, including herbal medicines.
In particular, tell your doctor if you are taking any of the following medicines:
monoamine oxidase inhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson’s disease). These should not be taken at the same time as amitriptyline (see section 2 “Do not take Amitriptyline Oral Solution”);
adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics);
medicine to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine reserpine and methyldopa;
anticholinergic drugs such as certain medicines to treat Parkinsons disease and gastrointestinal disorders (e.g. atropine, hyoscyamine);
thioridazine (used to treat schizophrenia); nefopam, tramadol and morphine (painkillers); buprenorphine (a drug used for severe pain or opioid drug addiction). This medicine may interact with amitriptyline and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole); sedatives (e.g. barbiturates);
antidepressants (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine, and bupropion; medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics);
cimetidine (used to treat stomach ulcers); methylphenidate (used to treat ADHD);
ritonavir (used to treat HIV);
oral contraceptives;
rifampicin (to treat infections);
phenytoin and carbamazepine (used to treat epilepsy); St. John´s Wort (hypericum perforatum) - a herbal remedy used for depression
thyroid medication;
baclofen (muscle relaxant)
nitrate tablets placed under the tongue, such as glyceryl trinitrate, used to treat angina valproic acid.
You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm such as:
medicines to treat irregular heartbeats (e.g. quinidine and sotalol);
astemizole and terfenadine (used to treat allergies and hayfever);
medicines used to treat some mental illnesses (e.g. pimozide and sertindole);
cisapride (used to treat certain types of indigestion); halofantrine (used to treat malaria);
methadone (used to treat pain and for detoxification); diuretics (“water tablets” e.g. furosemide). If you are going to have an operation and receive general or local anaesthetics, you should tell your doctor that you are taking this medicine.
Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic. Amitriptyline Oral Solution and alcohol
It is not advised to drink alcohol during treatment with this medicine, as it might increase the sedative effect. 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. Amitriptyline is not recommended during pregnancy, unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention and constipation.
Your doctor will advise you whether to start/continue/stop breast-feeding or stop using this medicine, taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Driving and using machines
This medicine may cause drowsiness and dizziness, especially in the beginning of the treatment. Do not drive or work with tools or machinery if you are affected. Amitriptyline Oral Solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, liquid malitol and propylene glycol
Methyl and propyl parahydroxybenzoates: These may cause an allergic reaction. This allergic reaction may happen sometime after starting this medicine. Liquid maltitol (a type of sweetener): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The amount of maltitol in Amitripyline Oral Solution is equivalent to a calorific value of 2.3 kcal/g. This may have a mild laxative effect.
Propylene glycol: This product contains 55mg of propylene glycol in each 5ml dose, which is equivalent to 11mg/ml.
3. How to take Amitriptyline Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increases. Amitriptyline Oral Solution is available in two strengths. In addition to Amitriptyline 50mg/5ml Oral Solution, a lower strength is also available called Amitriptyline 25mg/5ml Oral Solution.
Use the measuring syringe to measure the quantity you will need to take. The syringe is for oral administration, with graduations per 0.5ml. Each 0.5ml corresponds to 5mg of amitriptyline for the 50mg/5ml strength. Instructions for use:
Open the bottle: press the cap and turn it anticlockwise (see figure 1)
Take the syringe and put it in the
adaptor opening (figure 2).Turn the bottle upside down (figure 3).
Fill the syringe with a small amount of solution by pulling the piston down (figure 3A), then push the piston upward in order to remove any possible bubble (figure 3B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 3C).
Package leaflet: Information for the user Amitriptyline Hydrochloride
50mg/5ml Oral Solution
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As stated in design
Package leaflet
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Black C
Turn the bottle
the right way
up (figure 4A).
Remove the
syringe from
the adaptor
(figure 4B).
Press the
plunger down
slowly and gently to release the medicine Close the bottle with the plastic screw cap. Wash the syringe with water only.
Depression
Adults
The recommended initial dose is 25mg (2.5ml of the 50mg/5ml strength) two times daily.
Depending on the response to the medicine, your doctor may gradually increase the dose to 150mg (15ml of the 50mg/5ml strength) per day divided in two doses. Elderly (above 65 years of age) and patients with cardiovascular disease
The recommended initial dose is 10mg (1ml of the 50mg/5ml strength) - 25mg (2.5ml of the 50mg/5ml strength) daily.
Depending on your response to the medicine, your doctor may gradually increase the dose to a total daily dose of 100mg (10ml of the 50mg/5ml strength) divided in two doses. If you receive doses in the range of 100mg (10ml of the 50mg/5ml strength) - 150mg (15ml of the 50mg/5ml strength), your doctor may need to do a more frequent follow-up with you.
Use in children and adolescents
This medicine should not be given to children or adolescents for treatment of depression.
For further information please see section 2. Neuropathic pain, chronic tension type headache and migraine prophylaxis
Your doctor will adjust the medication according to your symptoms and your response to the treatment. Adults
The recommended initial dose is 10mg (1ml of the 50mg/5ml strength) - 25mg (2.5ml of the 50mg/5ml strength) in the evening.
The recommended daily dose is 25mg (2.5ml of the 50mg/5ml strength) - 75mg (7.5ml of the 50mg/5ml strength).
Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 100mg (10ml of the 50mg/5ml strength) daily, your doctor may need to do a more frequent follow-up with you. Your doctor will instruct you whether to take the doses once daily or divide into two doses. Elderly (above 65 years of age) and patients with cardiovascular disease
The recommended initial dose is 10mg (1ml of the 50mg/5ml strength) - 25mg (2.5ml of the 50mg/5ml strength) in the evening.
Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 75mg (7.5ml of the 50mg/5ml strength) daily, your doctor may need to do a more frequent follow-up with you. Use in children and adolescents
This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. For further information, please see section 2 “What you need to know before you take Amitriptyline Oral Solution”.
Bed-wetting at night
Use in children and adolescents
The recommended doses for children:
aged below 6 years: see section 2 “Do not take Amitriptyline Oral Solution”
aged 6 to 10 years: 10mg (1ml of the 50mg/5ml strength) - 20mg (2.5ml of the 50mg/5ml strength) daily. aged 11 years and above: 25mg (2.5ml of the 50mg/5ml strength) - 50mg (5ml of the 50mg/5ml strength).
The dose should be increased gradually.
Take this medicine 1-1½ hours before bedtime. Before starting treatment, your doctor will conduct an ECG of your heart to check for signs of an unusual heartbeat. Your doctor will re-evaluate your treatment after 3 months and, if needed, perform a new ECG.
Do not stop the treatment without consulting your doctor first.
Patients with special risks
Patients with liver diseases or people known as “poor metabolisers” usually receive lower doses. Your doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2 “What you need to know before you take Amitriptyline Oral Solution”).
How and when to take Amitriptyline Oral Solution
This medicine can be taken with or without food. Duration of treatment
Do not change the dose of the medicine or stop taking the medicine without consulting your doctor first. Depression
As with other medicines for the treatment of depression, it may take a few weeks before you feel any improvement. In treating depression, the duration of treatment is individual and is usually at least 6 months. The duration of treatment is decided by your doctor.
Continue to take this medicine for as long as your doctor recommends.
The underlying illness may persist for a long time. If you stop your treatment too soon, your symptoms may return. Neuropathic pain, chronic tension type headache and migraine prophylaxis
It might take a few weeks before your feel any improvement in your pain.
Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends.
Bed-wetting at night
Your doctor will evaluate if the treatment should be continued after 3 months.
If you take more Amitriptyline Oral Solution than you should
Contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the container of this medicine with you if you go to a doctor or hospital. Symptoms of overdose include:
dilated pupils
fast or irregular heartbeats
difficulties passing water
dry mouth and tongue
intestinal blockage
fits
fever
agitation
confusion
hallucinations
uncontrolled movements
low blood pressure, weak pulse, pallor
difficulty breathing
blue discolouration of the skin
decreased heart rate
drowsiness
loss of consciousness
coma
various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia
Overdose with amitriptyline in children could have serious consequences. Children are especially susceptible to coma, cardiac symptoms, difficulty in breathing, seizures, low blood sodium level, lethargy, drowsiness, nausea, vomiting and high blood sugar level.
If you forget to take Amitriptyline Oral Solution
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose. If you stop taking Amitriptyline Oral Solution
Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache, feeling unwell, sleeplessness and irritability).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following symptoms you should see your doctor immediately:
Signs of a severe allergic reaction (anaphylaxis), such as difficulty breathing or swelling of your face, lips, throat or tongue. Not known, frequency cannot be
estimated from the available data.
Attacks of intermittent blurring of vision, rainbow vision, and eye pain. You should immediately have an eye examination before the treatment with this medicine can be continued. This condition may be signs of acute glaucoma. Very rare side effect, may affect up to 1 in 10,000 people.
A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG). Common side effect, may affect up to 1 in 10 people. Bad constipation, a swollen stomach, fever and vomiting. These symptoms may be due to parts of the intestine becoming paralysed. Rare side effect, may affect up to 1 in 1,000 people.
Any yellowing of the skin and the white in the eyes (jaundice).
Your liver may be affected. Rare side effect, may affect up to 1 in 1,000 people.
Bruising, bleeding, pallor or persistent sore throat and fever. These symptoms can be the first signs that your blood or bone marrow may be affected. Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting). Rare side effect, may affect up to 1 in 1,000 people.
Suicidal thoughts or behaviour. Rare side effect, may affect up to 1 in 1,000 people.
Side effects listed below have been reported in the following frequencies:
Very common (may affect more than 1 in 10 people) sleepiness/drowsiness
shakiness of hands or other body parts dizziness
headache
irregular, hard, or rapid heartbeat
dizziness when you stand up due to low blood pressure (orthostatic hypotension)
dry mouth
constipation
nausea
excessive sweating
weight gain
slurred or slow speech
aggression
congested nose
Common (may affect up to 1 in 10 people)
confusion
sexual disturbances (decreased sex-drive, problems with erection)
disturbance in attention
changes in taste
numbness or tingling in the arms or legs disturbed coordination
dilated pupils
heart block
fatigue
low sodium concentration in the blood agitation
urination disorders
feeling thirsty
Uncommon (may affect up to 1 in 100 people) excitement, anxiety, difficulties sleeping, nightmares convulsions
tinnitus
increased blood pressure
diarrhoea, vomiting
skin rash, nettle rash (urticarial), swelling of the face and tongue
difficulties passing urine
increased production of breast milk or breast milk outflow without breast feeding
increased pressure in the eye ball
collapse conditions
worsening of cardiac failure
liver function impairment (e.g. cholestatic liver disease) Rare (may affect up to 1 in 1,000 people)
decreased appetite
delirium (especially in elderly patients), hallucinations abnormality in the heart’s rhythm, or heartbeat pattern swelling of the salivary glands
hair loss
increased sensitivity to sunlight
breast enlargement in men
fever
weight loss
abnormal results of liver function tests
Very rare (may affect up to 1 in 10,000 people) heart muscle disease
feeling of inner restlessness and a compelling need to be in constant motion
disorder of the peripheral nerves
acute increase of pressure in the eye particular forms of abnormal heart rhythm (so called torsades de pointes)
allergic inflammation of the lung alveoli and of the lung tissue
Not known (frequency cannot be estimated from the available data)
absent sensation of appetite
elevation or lowering of blood sugar levels paranoia
movement disorders (involuntary movements or decreased movements)
hypersensitivity inflammation of heart muscle hepatitis (inflammation of the liver) with signs such as dark urine, weight loss and jaundice hot flush
dry eyes
stomach pain, sore mouth
itching.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Stop using Amitriptyline Oral Solution and seek medical attention immediately if you notice any of the following symptoms:
Widespread rash, high body temperature and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). 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.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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. Do not store above 25°C. Store in the original package in order to protect from light.
Discard any unused contents 6 months after opening. Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice anything wrong with this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Amitriptyline 50mg/5ml Oral Solution contains
The active substance is amitriptyline.
Each 5ml of the 50mg/5ml oral solution contains 50mg of amitriptyline. The other ingredients are liquid maltitol (E965), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ascorbic acid (E300), sucralose, orange flavour and purified water. What Amitriptyline Oral Solution looks like and contents of the pack
Amitriptyline Oral Solution is a clear, colourless to pale yellow solution, with an orange flavour. It is supplied in a 150ml amber glass bottle, with a child resistant cap, syringe adaptor and a 10ml graduated syringe which is used to measure the dose.
Marketing Authorisation Holder
Tillomed Laboratories Limited, 220 Butterfield Great Marlings, Luton, LU2 8DL, United Kingdom Manufacturer
Tillomed Laboratories Limited, 220 Butterfield Great Marlings, Luton, LU2 8DL, United Kingdom Tillomed Malta Limited, Malta Life Sciences Park LS2.01.06 Industrial Estate, San Gwann, SGN 3000, Malta Other formats
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This leaflet was revised in
May 2026
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