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AMITRIPTYLINE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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Effects on your brain and nervous system: feeling confused, difficulty concentrating, feeling disorientated (not
knowing where you are), delusions and hearing or seeing things that are not there (hallucinations), feeling excited,
restless or stressed, difficulty sleeping, nightmares, feeling slightly hyperactive, numbness or tingling or pins and
needles (particularly in the hands and feet), difficulty in co-ordinating movements, shaking, fits, unconsciousness,
slow or slurred speech
n Effects on your liver: hepatitis including changes in liver function that would be identified by a blood test, yellowing
of the skin and the whites of your eyes (jaundice)
n Effects on your hormones: change in sexual function and sex drive, breast swelling in men and women, swelling of
your testicles, production of breast milk, increased or decreased blood sugar levels, inappropriate secretion of the
hormone ADH (antidiuretic hormone) that may make you pass water (urinate) more frequently.
Tell your doctor if you get any of these side effects:
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
n Effects on your ears: buzzing or ringing in the ears
n Effects on your stomach and intestines: feeling or being sick,
change in appetite, diarrhoea, irritation and a nasty taste in your
mouth, swollen saliva glands, black tongue, pain in and around
your stomach area (the abdomen), dry mouth, fever,
constipation, blockage of your small intestine
n Effects on the skin: skin rashes, skin rash due to sunlight
n Effects on your eyesight: blurred or double vision, changes in eyesight
n General effects: headache, dizziness, weakness, tiredness, change in weight, drowsiness,

increased sweating, hair loss, widely dilated pupils, difficulty passing water (urine).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
When used for children, the side effects are less frequent but may still happen. The most common reported effects
amongst children are drowsiness, dry mouth, blurred eyesight, increased pressure in the eye, changes in eyesight,
constipation, fever and difficulty in passing water (urine). There have also been rare reports of mild sweating and itching.
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 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.

Patient Information Leaflet






5. How to store Amitriptyline Oral Solution
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Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use 6 months after you first open it.
Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to the last day of
that month.
n If it is out of date or you no longer want it, take it back to the pharmacy.
n Do not use Amitriptyline Oral Solution if you notice anything wrong with the medicine. Talk to your pharmacist.
n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.



6. Contents of the pack and other information

What Amitriptyline 50mg Oral Solution contains
n The active ingredient is amitriptyline hydrochloride. Each 5ml contains 50mg of amitriptyline hydrochloride.
n The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene
glycol (E1520), ascorbic acid (E300), quinoline yellow (E104), fruit cup flavour (containing colour E122), orange
flavour, liquid maltitol (E965) and purified water.
What Amitriptyline 50mg/5ml Oral Solution looks like and contents of the pack
A pale yellow to yellow/orange solution with a fruity odour.
It comes in a brown glass bottle holding 150ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 12/2015

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Amitriptyline Hydrochloride 50mg/5ml Oral Solution

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or pharmacist.
n 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.
n 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 50mg/5ml Oral Solution is and what it is used for
2. What you need to know before you take Amitriptyline 50mg/5ml Oral Solution
3. How to take Amitriptyline 50mg/5ml Oral Solution
4. Possible side effects
5. How to store Amitriptyline 50mg/5ml Oral Solution
6. Contents of the pack and other information


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1. What Amitriptyline 50mg/5ml Oral Solution is and what it is used for

The name of your medicine is Amitriptyline Hydrochloride 50mg/5ml Oral Solution (called Amitriptyline in this leaflet).
This belongs to a group of medicines called tricyclic antidepressants.
Amitriptyline alters the levels of chemicals in your brain to relieve the symptoms of depression.
Amitriptyline can be used:
n to treat the symptoms of depression
n to treat bed-wetting at night by your child over the age of 6 years.

2. What you need to know before you take Amitriptyline 50mg/5ml Oral
Solution
Do not take Amitriptyline and tell your doctor if:
n you are allergic (hypersensitive) to amitriptyline or any other ingredients in this liquid (see section 6).
An allergic reaction can include a rash, itching or shortness of breath
n you are pregnant, likely to become pregnant or breast-feeding
n you have heart problems including unusual heart beats, heart block or if you have recently had a heart attack
n you are taking other medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as
phenelzine or you have taken MAOIs within the last 14 days. Do not start taking MAOIs for at least 7-14 days after
stopping amitriptyline
n you suffer from periods of increased and exaggerated unusual behaviour (mania)
n you have liver disease
n you have a problem with your blood called porphyria.
If this medicine has been prescribed for a child under 6 years of age, tell your doctor as it may not be suitable for them.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking amitriptyline.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
n you have epilepsy
n you are not able to pass water (urine) or you have an enlarged prostate gland
n you have increased pressure in your eye (known as narrow-angle glaucoma)
n you have thyroid problems or you are taking medicine to treat a thyroid problem
n you have a mental illness such as schizophrenia or manic depression
n you are having electroconvulsive therapy (ECT).
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:
n have slow heart rate,
n 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),
n are taking any other medication that may cause heart problems, or
n have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amitriptyline.
Continued overleaf

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:
n you have previously had thoughts about killing or harming yourself.
n 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.
When the medicine is given for bed-wetting
n your doctor may monitor your hearth with an ECG test before giving this medicine
n you should not take amitriptyline with medicines known as anticholinergic such as

atropine, oxybutynin or orphenadrine
n suicidal thoughts may occur when taking this medicine for bed-wetting. See the section
above for advice.
Having operations and tests
Tell your doctor or dentist that you are taking amitriptyline if you are going to have an anaesthetic for an operation or
dental treatment.
Other medicines and Amitriptyline
Please tell your doctor or pharmacist if you are taking or have recently taken 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:
■■ medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or you have
taken MAOIs within the last 14 days
■■ other medicines used to treat depression, including reboxetine, fluoxetine, citalopram, duloxetine, venlafaxine,
moclobemide or the herbal remedy St John's Wort
■■ medicines used to treat some mental illnesses such as clozapine, pimozide, thioridazide, chlorpromazine, haloperidol,
prochlorperazine, sulpiride, zuclopenthixol or lithium
■■ medicines used to lower high blood pressure such as guanethidine, debrisoquine, betanidine and clonidine or
diuretics ("water tablets")
■■ medicines to treat some heart conditions such as amiodarone, diltiazem, disopyramide, flecainide, procainamide,
propafenone, quinidine, sotalol, verapamil
■■ medicines to treat angina that you spray or dissolve on your tongue (e.g. glyceryl trinitrate “GTN”, isosorbide dinitrate)
■■ sympathomimetic medicines such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine or
phenylpropanolamine. These may be found in cough and cold remedies. Tell your pharmacist that you are taking
amitriptyline before buying these medicines
■■ medicines used to thin the blood such as warfarin
■■ anticholinergic medicines such as atropine, oxybutynin or orphenadrine. This applies to treatment for depression and
bed-wetting
■■ painkillers such as nefopam, tramadol, codeine or dihydrocodeine
■■ apraclonidine and brimonidine, used to treat glaucoma
■■ baclofen, used as a muscle relaxant
■■ medicines to help you sleep such as ethchlorvynol
■■ barbiturates - used to treat epilepsy such as phenobarbital, phenytoin, primidone or carbamazepine
■■ methylphenidate - used to treat attention deficit/ hyperactivity disorder in children (ADHD)
■■ disulfiram - used to treat patients with alcohol problems
■■ medicines used to treat Parkinson's disease such as entacapone, selegiline or rasagiline
■■ ritonavir and saquinavir - used to treat HIV
■■ rifampicin, moxifloxacin or linezolid, used to treat infections
■■ medicines used to treat allergies, such as cetirizine or chlorphenamine
■■ fluconazole, used to treat fungal infections
■■ cimetidine - used to treat stomach acid problems
■■ medicines to treat thyroid problems e.g. levothyroxine
■■ oral contraceptives (“the pill”).
Amitriptyline with food and drink
Do not drink alcohol whilst taking amitriptyline.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant or breast-feeding. Do
not take Amitriptyline Oral Solution during pregnancy.
Driving and using machines
Amitriptyline may make you feel drowsy. If you experience this, do not drive or use machinery.
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Amitriptyline 50mg/5ml Oral Solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, liquid
maltitol and E122:
n methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time
after starting the medicine
n liquid maltitol (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor
before taking this medicine
n a colouring agent E122. This may cause allergic reactions.

3. How to take Amitriptyline 50mg/5ml 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.
Taking this medicine
n this medicine contains 50mg of amitriptyline hydrochloride in
each 5ml
n take this medicine by mouth.
The usual doses are given below. These may be changed by your doctor:
Adults
To treat depression:
n the usual dose is 75mg each day either as a single dose at night or split into smaller doses over the day
n your doctor may increase this to a maximum of 150mg a day
n for long term treatment the usual dose is 50 to 100mg each day as a single dose at night.
Older people and people with kidney problems
Your doctor will start you on a lower dose and gradually increase it as you may be more sensitive to the medicine.
Children
To treat bed-wetting:
n It is not recommended for children under the age of 6 years to take this medicine.
n your doctor should perform an ECG before you take this medicine
n aged 6 to10 years: 10 to 20mg each day
n aged 11 to16 years: 25 to 50mg each day
n the dose should be increased gradually
n The medicine will not be given for more than 3 months. Your doctor should review your treatment after this time.
Children under 16 years of age should not take this medicine for depression.
If you take more Amitriptyline 50mg/5ml Oral Solution than you should
If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the
medicine pack with you.
If you forget to take Amitriptyline Oral Solution
n 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
n Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Amitriptyline Oral Solution
You may not notice any improvement for up to 4 weeks. Do not stop taking the medicine unless your doctor tells you to.
If you stop taking the medicine abruptly, you may get side effects such as headache that makes you feel sick and feeling
weak.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Amitriptyline Oral Solution can cause side effects although not everybody gets them.
Stop taking Amitriptyline Oral Solution and see a doctor straight away if you have:
n an allergic reaction. Signs may include swelling of your face, lips, tongue or throat or difficulty breathing or
swallowing severe itching of your skin with raised lumps.
n a serious effect on your blood. Signs may include fever or chills, sore throat, ulcers in your mouth or throat, unusual
tiredness or weakness, unusual bleeding or unexplained bruises. If you notice any of these, tell your doctor straight
away.
Serious side effects: tell a doctor straight away
n If you feel more depressed, including thinking about suicide
If you get any of the following side effects, see your doctor as soon as possible:
n Effects on your heart: feeling faint and dizzy when standing up, change in blood pressure, fast or unusual
heart beats, heart attack, stroke. A common side effect is a heart problem called “prolonged QT interval” (which is
shown on your electrocardiogram, ECG)
Continued overleaf

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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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