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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
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms
are the same as yours.
• 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.
In this leaflet:
1. What trazodone hydrochloride oral solution is and what it
is used for
2. 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. Further information
1. What trazodone hydrochloride oral solution
is and what it is used for
The name of your medicine is Trazodone hydrochloride
50mg/5mg Oral Solution (called trazodone in this leaflet).
It contains a medicine called trazodone hydrochloride.
This belongs to a group of medicines called antidepressants.
Trazodone can be used to treat anxiety and depression.
2. Before you take trazodone hydrochloride oral
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to trazodone
hydrochloride or any of the other ingredients of
trazodone (listed in Section 6 Further Information).
Signs of an allergic reaction can include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue.
 You have recently had a heart attack
 You are a heavy drinker or are taking sleeping tablets
 You are under 18 years of age.
Do not take this medicine if any of the above this applies to
you. If you are not sure, talk to your doctor or pharmacist
before taking trazodone.
Take special care with trazodone
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 like 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
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
Trazodone should not be used in children and
adolescents under 18 years of age.
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 or if you
have some other diseases.
Check with your doctor or pharmacist before taking
this medicine if you:
L Have or have ever had fits or seizures
L Have severe liver, kidney or heart problems
L Are pregnant, trying to become pregnant or are
L Have an overactive thyroid gland (hyperthyroidism)
L Have problems passing water or need to pass water
(urine ) frequently
L Have narrow angle glaucoma (an eye disorder)
L Have schizophrenia or other type of mental disorder
L Are elderly, as you may be more prone to side effects
If you are not sure if any of the above applies to you, talk
to your doctor or pharmacist before taking trazodone.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without with prescription, including
herbal medicines. This is because trazodone can affect
the way some other medicines work. Also some
medicines can affect the way trazodone works.
Tell your doctor if you are taking any of the following
• MAOI (MonoAmine Oxidase Inhibitors) medicine such
as tranylcypromine, phenelzine and isocarboxazid
(for depression) or selegiline (for Parkinson’s
disease), or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or

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Trazodone hydrochloride
Oral Solution

How much to take

• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as
carbamazepine and phenytoin
• Medicines used to treat high blood pressure, for
example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as
ketoconozole and itraconazole
• Some medicines used to treat HIV such as ritonavir
and indinavir
• Erythromycin, an 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)

• Adults usually start by taking 150mg (15mg) 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
• Adults usually start by taking 75mg (7.5ml) each day
• Your doctor may increase the dose to 300mg (30ml)
each day
• Older people or those who are frail will usually be
given a starting dose of 100mg (10ml) each day
Doses of more than 300mg (30ml) will not normally be

If you are going to have an anaesthetic (for an operation),
tell your doctor or dentist that you are taking trazodone.
Taking trazodone with food and drink
You should avoid drinking alcohol while taking trazodone.

Children and adolescents under 18 years should not take

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are
pregnant, might become pregnant, or think you may be

If you take more trazodone than you should
If you take more trazodone than you should, tell a doctor
or go to a hospital casualty department straight away.
Take the medicine pack with you. This is so the doctor
knows what you have taken.

Taking trazodone in the late stages of pregnancy may lead
to your baby experiencing withdrawal symptoms when
they are born.
If you are breast-feeding or planning to breast-feed, talk
to your doctor or pharmacist before taking any medicine.

The following effects may happen: feeling sick or being
sick, feeling sleepy, dizzy or faint, fits (seizures),
confusion, breathing or heart problems.

Driving and using machines
Trazodone may make you feel sleepy or dizzy. If this
happens do not drive or use any tools or machines.

If you forget to take trazodone
If you forget to take a dose, take it as soon as you
remember it. However, if it is nearly time for the next
dose, skip the missed dose.

Important information about some of the ingredients
of trazodone
• Trazodone contains sorbitol. If you have been told
that you cannot digest or tolerate some sugars, talk to
your doctor before taking trazodone.
• Trazodone contains glycerol which may cause a
headache, an upset stomach and diarrhoea.

Do not take a double dose to make up for a forgotten
If you stop taking trazodone
Keep taking trazodone until your doctor tells you to stop.
Do not stop taking trazodone just because you feel better.
When your doctor tells you to stop taking this medicine
he/she will help you to stop taking it gradually.

3. How to take trazodone hydrochloride oral solution
Always take trazodone exactly as your doctor has told
you. You should check with your doctor of pharmacist if
you are not sure.

4. Possible side effects
Like all medicines, trazodone can cause side effects,
although not everybody gets them.

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 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
strong, do not change the dose yourself, but ask your

Stop taking trazodone and see a doctor or go to a
hospital straight away if:
• 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

• Painful erection of the penis, unrelated to sexual
activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver
problem (such as jaundice)
• 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 (parasthesia)
• 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 38°C). This could be a
rare condition known as Neuroleptic Malignant
• Rapid, slow or irregular heartbeat
Below is a list of other side effects that have been
• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting), indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva,
blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or sitting up
quickly (postural hypotension), fainting (syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain
in your joints
• Jerking movements that you can not control, mainly in
of the arms and legs, uncontrolled muscle movements
or twitches

• Frequent infections with high temperature, severe
chills, sore throat or mouth ulcers. These could be
signs of a blood problem called leucopenia.
• Feeling anxious or more nervous than usual, feeling
• Overactive behaviour or thoughts (mania), believing
things that are not true (delusions), memory
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a “spinning” feeling
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells
(seen by a blood test)
• High levels of liver enzymes in your blood (shown by a
blood test)
• Severe liver disorders such as hepatitis.
• Liver failure with potential fatal outcome.
• Feeling tired, weak 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.
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 via
the Yellow Card Scheme at:
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 in a safe place where children cannot
see or reach it.
Do not use trazodone after the expiry date which is stated
on the label and carton after EXP. The expiry date refers
to the last day of that month.
Store below 25°C and protect from light.
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. Further information
What trazodone contains
• Each 5ml of trazodone contains 50mg of the active
substance, trazodone hydrochloride
• Other ingredients include glycerol, sorbitol, benzoic
acid, saccharin sodium, orange flavour FC 901775,
sodium hydroxide solution 1N, purified water and
What Trazodone Liquid looks like and contents of the pack
Trazodone is a clear colourless solution that smells and
tastes of orange. It is supplied in an amber glass
bottle containing 120ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Winthrop Pharmaceuticals
PO Box 611
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS,
Unither Liquid Manufacturing
1-3 Allee de la Neste
Z.I. d’en Sigal
31770 Colomiers,
This leaflet does not contain all the information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.

302228 - 228

This leaflet was last revised in 01/2015


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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.