AMITRIPTYLINE HYDROCHLORIDE 25MG/5ML ORAL SOLUTION

Active substance: AMITRIPTYLINE HYDROCHLORIDE

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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)
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.

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5. How to store Amitriptyline Oral Solution
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Keep out of the reach and sight 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.
If it is out of date or you no longer want it, take it back to the pharmacy.
Do not use Amitriptyline Oral Solution if you notice anything wrong with the medicine. Talk to your
pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicine no longer required. These measures will help to protect the environment.



6. Further information

What Amitriptyline 25mg Oral Solution contains
n The active ingredient is 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 25mg/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 approved in
06/2010


MHRA Safety Update for TCAs

Patient Information Leaflet
Amitriptyline Hydrochloride 25mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed only for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
n If any of these side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What is Amitriptyline 25mg/5ml Oral Solution and what is it used for
2. Before you take Amitriptyline 25mg/5ml Oral Solution
3. How to take Amitriptyline 25mg/5ml Oral Solution
4. Possible side effects
5. How to store Amitriptyline 25mg/5ml Oral Solution
6. Further information
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1. What is Amitriptyline 25mg/5ml Oral Solution and what is it used for

The name of your medicine is Amitriptyline Hydrochloride 25mg/5ml Oral Solution. 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.

2. Before you take Amitriptyline 25mg/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
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
amitritpyline.
Take special care with amitriptyline
Before you take this medicine, tell your doctor 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).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amitriptyline.



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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.
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.
Taking other medicines
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:
n medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or
you have taken MAOIs within the last 14 days
n other medicines used to treat depression, including the herbal remedy St John’s Wort
n medicines used to lower high blood pressure such as guanethidine, debrisoquine, betanidine and clonidine
n medicines found in cough and cold remedies such as phenylephrine or phenylpropanolamine. Tell your
pharmacist that you are taking amitriptyline before buying these medicines
n medicines to help you sleep such as ethchlorvynol
n barbiturates - used to treat epilepsy such as phenobarbital
n methylphenidate - used to treat attention deficit/hyperactivity disorder in children (ADHD)
n disulfiram - used to treat patients with alcohol problems
n medicines used to treat Parkinson’s disease
n ritonavir - used to treat HIV
n cimetidine - used to treat stomach acid problems
n thioridazine - used to treat mental illness
n medicines to treat thyroid problems.
Taking 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 breastfeeding. 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.
Important information about what is in Amitriptyline 25mg/5ml Oral Solution:
This medicine contains:
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.

MHRA Safety Update for TCAs

3. How to take Amitriptyline 25mg/5ml Oral Solution
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist
if you are not sure.
Taking this medicine
n this medicine contains 25mg 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 aged 6 to10 years: 10 to 20mg each day
n aged 11 to16 years: 25 to 50mg each day
n The medicine should not be taken for more than 3 months.
Children under 16 years of age should not take this medicine for depression.
If you take more Amitriptyline 25mg/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, such as low sodium levels. 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
n 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

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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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