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TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION

Active substance(s): TRAZODONE HYDROCHLORIDE

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Package Leaflet: Information for the user

TRAZODONE HYDROCHLORIDE 50MG/5ML ORAL SOLUTION
Trazodone Hydrochloride
Read all of this leaflet carefully before you start using 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.
WHAT IS IN THIS LEAFLET:
1. What trazodone hydrochloride oral solution is and what it is used for.
2. What you need to know before you take trazodone hydrochloride oral
solution
3. How to take trazodone hydrochloride oral solution
4. Possible side effects
5. How to store trazodone hydrochloride oral solution
6. Contents of the pack and other Information
1. WHAT TRAZODONE HYDROCHLORIDE ORAL SOLUTION IS AND
WHAT IT IS USED FOR?
The name of your medicine is Trazodone hydrochloride 50mg/5ml Oral
solution (called trazodone oral solution throughout this leaflet). Trazodone
oral solution contains a medicine called trazodone hydrochloride which
belongs to a group of medicines called antidepressants. Trazodone oral
solution can be used to treat all types of depression including depression
accompanied by anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE
HYDROCHLORIDE ORAL SOLUTION
Do not take trazodone oral solution:
• If you are allergic to trazodone hydrochloride or any of the other
ingredients of this medicine (listed in Section 6 Further information). The
signs of an allergic reaction include a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
• If you have recently had a heart attack
• If you are a heavy drinker or taking sleeping tablets.
Do not take trazodone oral solution if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking trazodone oral solution.
Warnings and Precautions
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, since these medicines all 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 adults aged 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.
Talk to your doctor or pharmacist before taking trazodone oral solution if
you:
• Have or have ever had fits or seizures
• Have severe liver, kidney or heart problems
• Have an overactive thyroid gland (hyperthyroidism)
• Have problems passing water or need to pass water (urine ) frequently
• Have narrow angle glaucoma (an eye disorder)
• Have schizophrenia or other type of mental disorder.
If you are elderly, you may be more prone to side effects, increased caution
is necessary especially when taking other medicines at the same time as
trazodone oral solution or if you have some other diseases.
Children and adolescents
Trazodone should not be used in children and adolescents under 18 years of
age.

Other medicines and Trazodone oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines and trazodone may interfere with each other. Tell your
doctor if you are taking any of the following medicines:
• MAOI (Mono Amine Oxidase Inhibitors) medicines such as
tranylcypromine, phenelzine and isocarboxazid (for depression) or
selegiline (for Parkinson’s disease). Tell your doctor or pharmacist if
you are taking them now or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or fluoxetine)
• Sedatives (Such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
• Medicines used to treat high blood pressure (e.g. clonidine) or heart
disease (e.g. digoxin)
• Medicines used to treat fungal infections such as ketoconazole and
itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin (a type of antibiotic used to treat infections)
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting).
Anaesthetics
If you are going to have an anaesthetic (for an operation), tell your doctor or
dentist that you are taking trazodone.
Trazodone oral solution with food, drink and alcohol
You should avoid drinking alcohol while taking trazodone. This is because
trazodone can change the way alcohol affects you.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are:
• pregnant, might become pregnant, or think you may be pregnant
• breast-feeding.
Taking Trazodone in the late stages of pregnancy may lead to your baby
experiencing withdrawal symptoms when they are born.
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.
Driving and using machines
Trazodone oral solution is a drug which acts on the central nervous system
and may make you feel sleepy or less alert. Do not drive, operate machinery
or do anything that requires you to be alert until you know how your medicine
affects you.
Trazodone oral solution contains sorbitol & glycerol.
Trazodone oral solution contains sorbitol. If you have been told that you
cannot digest or tolerate some sugars, talk to your doctor before taking
trazodone.
Trazodone oral Solution also contains glycerol which may cause headache,
stomach upset and diarrhoea.
3. HOW TO TAKE TRAZODONE HYDROCHLORIDE
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.
The dose of trazodone will depend on your needs and the illness being
treated.
Taking this medicine
• Take this medicine by mouth
• Take with or after food. This can help lower the chances of side effects
• If you have been told to take trazodone oral solution only once each day
then you should take it before going to bed
• If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor.
DEPRESSION:
The Recommended dose is Adults:
• Adults usually start by taking 150mg (15ml) each day
• Your doctor may increase the dose to 300mg (30ml) each day depending
on your condition
• For adults in hospital the dose may be as high as 600mg (60ml) each
day.

Elderly:
• Older people or those who are frail will usually be given a starting dose of
100mg (10ml) each day
• Your doctor may increase the dose to 300mg (30ml) each day depending
on your condition
• Doses of more than 300mg (30ml) will not normally be given.
ANXIETY:
The recommended dose is • Adults usually start by taking 75mg (7.5ml) each day
• Your doctor may increase the dose to 300mg (30ml) each day.
Use in children and adolescents
Trazodone should not be used in children and adolescents under 18 years of
age.
If you take more trazodone oral solution than you should
It is important to stick to the dose on the label of the medicine. If you or
someone else takes more trazodone oral solution than you should, contact
your doctor or nearest hospital emergency department immediately. Always
take any medicine left over with you along with the box, as this will allow
easier identification of the medicine.
The following effects may happen:
Feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures).
Confusion, breathing or heart problems.
If you forget to take trazodone oral solution
If you forget to take a dose, take it as soon as you remember. If it is almost
time for your next dose do not take a double dose to make up for a forgotten
dose, just carry on as before.
If you stop taking trazodone oral solution
• Keep taking trazodone oral solution until your doctor tells you to stop. Do
not stop taking trazodone oral solution just because you feel better
• When your doctor tells you to stop taking this medicine he/she will help
you stop taking them gradually
• Stopping your medicine too quickly could cause sleep problems, leave
you feeling more irritable than usual and cause you to sweat more than
usual.
If you have further 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.
Stop taking trazodone oral solution and tell your doctor immediately if you
experience:
• You get swelling of the hands, feet, ankles, face, lips or throat which may
cause difficulty swallowing or breathing, itching of the skin and nettle
rash. This may mean you are having an allergic reaction to trazodone oral
solution
• Painful erection of the penis, unrelated to sexual activity, that will not go
away (priapism)
• Yellowing of the eyes or skin which could be a liver problem (such as
jaundice) or other abnormalities of liver function
• Getting infections more easily than usual. This could be because of a
blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be because of a blood
disorder (thrombocytopenia)
• You have severe abdominal pain and bloating, are being sick (vomiting)
and have constipation. These may be signs that your intestine is not
working properly (paralytic ilius).
Talk to your doctor straight away if you notice the following side-effects:
• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of
anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or
creeping on the skin (paraesthesia)
• Feeling confused, restless, sweating, shaking, shivering, hallucinations
(strange visions or sounds), sudden jerks of the muscles or a fast
heartbeat, you may have something called Serotonin syndrome
• Feeling very unwell possibly with shortness of breath (dyspnoea),
difficulty in walking or walking with a shuffling gait, shaking, uncontrolled
muscle twitching, and a high temperature (above 38ºC). This could be a
rare condition known as Neuroleptic Malignant Syndrome
• Rapid, slow or irregular heartbeat.
The following side effects have also been reported (Not known: frequency
cannot be estimated from the available data):
• Feeling drowsy or sleepy, tiredness
• Headache, dizziness, confusion, feeling less alert, irritability,
• Sweating, unexplained fever or shivering
• Nausea and vomiting
• Constipation or diarrhoea

• Feeling dizzy or light-headed on standing or sitting up quickly (postural
hypotension), fainting (syncope)
• Dry mouth and blurred vision
• Weakness
• Loss of appetite and weight loss
• Slow or racing pulse
• Water retention which may cause swollen arms or legs
• Restlessness or difficulty sleeping
• Difficulty in urination
• Skin rashes
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain in your joints
• Any uncontrolled body movements, including tremor, twitching, spasms,
muscle rigidity and an inability to sit still
• Frequent infections with high temperature, severe chills, sore throat or
mouth ulcers. These could be signs of blood problem called leucopenia.
• Feeling anxious or more nervous than usual, feeling agitated
• Overactive behaviour or thoughts (mania), believing things that are not
true (delusions), memory disturbance
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a “spinning” feeling (vertigo)
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells (seen by blood test)
• High levels of liver enzymes in your blood (shown by blood test)
• Severe liver disorders like hepatitis
• Liver failure with potential fatal outcome
• Feeling tired, week and confused, having muscle that ache, are stiff or do
not work well. There may also be headache, loss of appetite, nausea or
vomiting, convulsion. This may be due to low sodium levels in your
blood.
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. (See details below)
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie, E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety
of this medicine.
5. HOW TO STORE TRAZODONE HYDROCHLORIDE ORAL SOLUTION
• Keep this medicine out of the sight and reach of children
• Do not use trazodone oral solution after the expiry date, which is stated
on the label and carton. The expiry date refers to the last day of the
month
• Store in the original package (bottle) in order to protect from light. This
medicinal product does not require any special temperature storage
conditions
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What trazodone oral solution contains
The name of this medicine is Trazodone hydrochloride 50mg/5ml oral
solution.
The active substance in your medicine is trazodone hydrochloride. Each 5ml
Spoonful contains 50mg of the active ingredient trazodone hydrochloride. The
other ingredients are benzoic acid, glycerol, sorbitol liquid, orange flavour
(containing propylene glycol), sodium saccharin, sodium hydroxide and
purified water.
What trazodone oral solution looks like and contents of the pack
Trazodone hydrochloride 50mg/5ml oral solution is a clear, colourless to pale
yellow coloured solution, with orange colour, free from foreign particles. Each
Bottle contains 120ml of solution.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London EC4N 7BL, UK
The leaflet was last revised in August 2017.

LF-102788-01

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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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