Amitriptyline Hydrochloride 50mg/5ml Oral Solution
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Thame Laboratories
Thame Laboratories
Package Leaflet: Information for the user
Amitriptyline hydrochloride 50mg/5ml Oral Solution
(amitriptyline hydrochloride)
2. What you need to know before you take _Amitriptyline
Read all of this leaflet carefully before you start taking 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, 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.
The name of your medicine is Amitriptyline hydrochloride 50mg/5ml Oral Solution but it will be referred to as Amitriptyline throughout this leaflet.
What is in this leaflet
1. What Amitriptyline is and what it is used for
2. What you need to know before you take Amitriptyline
3. How to take Amitriptyline
4. Possible side effects
5. How to store Amitriptyline
6. Contents of the pack and other information
1. What Amitriptyline is and
what it is used for
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This product contains an active substance called amitriptyline (as hydrochloride). This belongs to a group of medicines called tricyclic antidepressants. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression.
Amitriptyline is used:
► to treat the symptoms of depression
► for the relief of bed-wetting at night by children.
Do not take Amitriptyline if:
► you are allergic (hypersensitive) to amitriptyline, other tricyclic antidepressants or any of the other ingredients (see section 6)
► you have heart disease such as irregular heartbeats, heart block or have recently had a heart attack
► you suffer from periods of increased and exaggerated unusual behaviour (mania)
► you have liver disease
► you are taking monoamine oxidase inhibitors (MAOIs) or you have taken MAOIs within the last 14 days
► you have a problem with your blood called porphyria
► you are breast-feeding.
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amitriptyline if you have:
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 all these medicines 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 young adults (less than 25 years old) 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.
Check with your doctor or pharmacist before taking Amitriptyline if you or your child (if they are the patient):
► have any blood disorders (you may bruise easily, frequently suffer from infections or be anaemic)
► have mental illness such as schizophrenia or manic depression
► have liver or cardiovascular disease
► are not able to pass water (urine) or have an enlarged prostate gland
► have thyroid problems or you are taking medicine to treat a thyroid problem
► have epilepsy
► are having electroconvulsive therapy (ECT)
► have increased pressure in the eye (known as narrow-angle
g I aucoma).
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
Tell your doctor or pharmacist if
you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including herbal medicines, especially:
► 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 the herbal remedy St John's Wort
► medicines used to lower high blood pressure such as guanethidine, debrisoquine, betanidine and clonidine
► medicines found in cough and cold remedies such as phenylephrine or phenylpropanolamine. Tell your pharmacist that you are taking amitriptyline before buying these medicines
► medicines to help you sleep such as ethchlorvynol
► barbiturates - used to treat epilepsy such as phenobarbital
► 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
► ritonavir - used to treat HIV
► cimetidine - used to treat stomach acid problems
► thioridazine - used to treat mental illness
► medicines to treat thyroid problems.
Amitriptyline with food, drink
and alcohol
Do not drink alcohol whilst taking
Amitriptyline.
Pregnancy and breast-feeding
Do not take Amitriptyline during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Amitriptyline may make you feel drowsy. If you experience this, do not drive or use machinery.
Amitriptyline contains:
This medicine contains methyl and propyl hydroxybenzoate. These may cause allergic reactions (possibly delayed).
3. How to take Amitriptyline
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended doses are given below. These may be changed by your doctor:
Adults
To treat depression:
► the usual dose is 75mg each day either as a single dose at night or split into smaller doses over the day
► your doctor may increase this to a maximum of 150mg a day
► for long-term treatment the usual dose is 50mg 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.
Use in children and adolescents To treat bed-wetting:
► It is not recommended for children under the age of 6 years to take this medicine.
► aged 6 to 10 years: 10mg to 20mg each day
► aged 11 to 16 years: 25mg to 50mg each day
► The medicine should not be taken for more than 3 months.
Children under 16 years of age should not take this medicine for depression.
Your doctor will decide the administered dose.
TURN OVER
Method of administration
► Use the double-ended spoon supplied with the pack to measure the exact quantity (see figure below)
► Do not overfill the spoon
► Swallow the solution
► Wash the spoon with clean water after taking every dose.
Double-ended Spoon
If you take more Amitriptyline than you should
Contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include fast regular heart beat, dilated pupils, drowsiness, coma, difficulty breathing, jerky movements, hot dry skin, dry mouth and tongue, difficulty passing water, intestinal blockage, uncontrolled eye movement.
If you forget to take Amitriptyline
If you forget a dose, take it as soon as you remember. 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
You may not notice any improvement for up to 4 weeks. Do not stop taking this 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. Tell your doctor if this happens.
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.
□ Stop taking Amitriptyline and contact your doctor immediately if you develop the following symptoms:
► 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
► 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.
Serious side effects:
Tell your doctor straight away 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:
Blood:
► bone marrow, depression or reduction in some blood cells ► a sore throat, mouth ulcers and recurring infections, bleeding or bruising easily.
Endocrine system and metabolism:
► disturbances in sexual function or sex drive
► breast swelling in men and women, swelling of the testicles, production or over-production of breast milk
► changes in blood sugar levels, increased appetite and weight gain
► inappropriate secretion of the hormone ADH (antidiuretic hormone), which may make you urinate more frequently.
Brain and central nervous system:
► feeling confused, difficulty concentrating
► feeling disoriented (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.
Heart:
► feeling faint when getting up (postural hypotension)
► increased blood pressure
► fast/racing heart
► heart attack
► stroke.
Stomach and intestines:
► feeling or being sick
► diarrhoea, loss of appetite inflammation of the mucus membranes in the mouth
► swollen salivary glands
► black tongue, impairment of taste
► irritation and a nasty taste in your mouth
► constipation
► blockage of your small intestine
► abdominal pains.
Liver:
► hepatitis, including changes in liver function (as seen in blood tests)
► jaundice (yellowing of the skin and/or whites of the eyes).
Others:
► increased sweating
► hair loss
► ringing in the ears
► difficulty urinating
► an increased risk of bone fractures has been observed in patients taking this type of medicine
► weakness
► tiredness
► headaches
► dizziness
► widely dilated pupils
► change in weight.
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.
5. How to store Amitriptyline
► Keep out of the sight and reach of children.
► Do not use after the expiry date, which is clearly marked on the carton and bottle label after 'Exp'.
The expiry date refers to the last day of that month.
► Do not store above 25°C.
► Discard after 30 days of first opening.
► Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
► Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
These measures will help to protect the environment.
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6. Contents of the pack and other information
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What Amitriptyline contains
Each 5ml solution contains 50mg amitriptyline hydrochloride.
The other ingredients are ascorbic acid (E300), disodium edetate, saccharin sodium (E954), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and purified water.
What Amitriptyline looks like and contents of the pack
Amitriptyline is a clear, colourless to yellow coloured solution supplied in amber glass bottles with tamper-evident child-resistant polypropylene plastic screw cap and a 2.5-5ml double ended spoon for measuring the dose.
Amitriptyline is supplied in bottles containing 150ml, 200ml, 300ml and 500ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Syri Limited, t/a Thame Laboratories, Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK.
Tel: +44 208 515 3700 POM
If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help.
This leaflet was last revised in 03/2015.
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Thame Laboratories
PIL/UK/MFG006/04/V1