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TRAZODONE HYDROCHLORIDE 100MG/5ML ORAL SOLUTION

Active substance(s): TRAZODONE HYDROCHLORIDE

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Children and adolescents
Trazodone Oral Solution 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 or have recently taken any other
medicines. This includes medicines you

Trazodone Oral Solution contains
Sorbitol and Ethanol
• Trazodone Oral Solution contains
sorbitol. If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicinal product.
• Trazodone Oral Solution contains
ethanol. This medicinal product
contains small amounts of ethanol
(alcohol), less than 100mg per 30ml.

3. How to take Trazodone Oral
Solution
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.
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 strong, do not change
the dose yourself, but ask your doctor.
How much to take
Adults:
Depression
• Adults usually start by taking 150mg
(7.5ml) each day
• Your doctor may increase the dose to
300mg (15ml) each day depending
on your condition
• For adults in hospital the dose may be
as high as 600mg (30ml) each day
Anxiety
• Adults usually start by taking 75mg
(3.75 ml) each day
• Your doctor may increase the dose to
300mg (15 ml) each day
Elderly:
• Older people or those who are frail
will usually be given a starting dose of
100mg (5ml) each day
• Doses of more than 300mg (15ml) will
not normally be given
Children and adolescents:
Children and adolescents under 18 years
should not take trazodone oral solution
Note:
If necessary, Trazodone Oral Solution
can be administered via a nasogastric,
nasoduodenal or nasojejunal feeding
tube that should be rinsed twice with
10ml of water immediately after
administration.
If you take more Trazodone Oral
Solution than you should
If you take more Trazodone Oral
Solution 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.
The following effects may happen:
feeling sick or being sick, feeling sleepy,

What Trazodone Oral Solution
contains
• Each 5 ml of Trazodone Oral Solution
contains 100 mg of the active
substance, trazodone hydrochloride.
• Other ingredients include sorbitol
solution 70% (E420), glycerol (E422),
sodium benzoate (E211), saccharin
sodium (E954), hydrochloric acid,
solution 1.0 N, purified water,
nitrogen and orange flavour
(14104/04) containing ethyl alcohol.
What Trazodone Oral Solution looks
like and contents of the pack
Trazodone Oral Solution is a colourless
to yellowish clear solution with an
orange odour. It is available in an amber
glass bottle containing 120 ml of
medicine.
The pack also contains a 15 ml plastic
dosing cup with intermediate
graduations.
Marketing Authorisation Holder
Creo Pharma Ltd
Felsted Business Centre
Felsted
Essex CM6 3LY, UK
Manufacturer
Rafarm SA,
Thesi Pousi-Xatzi,
Agiou Louka,
Paiania Attiki,
19002,
PO Box 37,
Greece
This leaflet was last revised in
April 2017.

Below is a list of other side effects
that have been reported:
• 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 (shaking)
• 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 cannot
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 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 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 muscles 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 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,

CRE-TZDOS100-PIL-310_04
18/09/2017

Typefaces
Myriad Pro
Artwork prepared by David Heaton +44 (0)1462 431277 dc.heaton@ntlworld.com

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
• Are pregnant, trying to become
pregnant or are breast-feeding
• 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
• 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
Oral Solution.

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

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 38°C). This could
be a rare condition known as
Neuroleptic Malignant Syndrome.
• Rapid, slow or irregular heartbeat

6. Contents of the pack and other
information

Pantone
Pantone
Black
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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.
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.

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

Stop taking Trazodone Oral Solution
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
Trazodone Oral Solution.
• 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 ileus).

1

Do not take Trazodone Oral Solution:
• If you are allergic (hypersensitive) to
trazodone hydrochloride or any of
the other ingredients of Trazodone
Oral Solution (listed in Section 6,
Further Information).
• Signs of an allergic reaction can
include:
- red and lumpy skin rash,
swallowing or breathing
problems, swelling of your
eyelids, lips, face, throat or
tongue, unexplained high
temperature (fever) and feeling
faint
• If you have recently had a heart attack
• If you are a heavy drinker or are
taking sleeping tablets
• If 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 Oral Solution.

Trazodone Oral Solution with food,
drink and alcohol
You should avoid drinking alcohol while
taking Trazodone Oral Solution.

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

Important
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2. What you need to know before
you take Trazodone Oral
Solution

4. Possible side effects

Reason for Draft
New file
Corrections
Text revisions
Text revision

The name of your medicine is Trazodone
100 mg/5 ml Oral Solution (called
Trazodone Oral Solution throughout
this leaflet). It contains a medicine called
trazodone hydrochloride. This belongs
to a group of medicines called
antidepressants.
Trazodone Oral Solution can be used to
treat anxiety and depression.

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 to stop taking it gradually.

Keep this medicine in a safe place 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 after EXP. The
expiry date refers to the last day of that
month.
Keep bottle in the outer carton in order
to protect from light.
After first opening do not store above
25°C and use within 1 month.
Do not throw away any medicines 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.

Date
26/05/2017
26/05/2017
08/09/2017
18/09/2017

1. What Trazodone Oral Solution is
and what it is used for

Tell your doctor if you are taking any
of the following medicines:
• 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 fluoxetine)
• 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 ketoconazole 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)
Anaesthetics If you are going to have
an anaesthetic (for an operation), tell
your doctor or dentist that you are
taking Trazodone Oral Solution.

5. How to store Trazodone Oral
Solution

No. of Draft
_01
_02
_03
_04

What is in this leaflet:
1. What Trazodone Oral Solution is and
what it is used for
2. What you need to know before you
take Trazodone Oral Solution
3. How to take Trazodone Oral Solution
4. Possible side effects
5. How to store Trazodone Oral Solution
6. Contents of the pack and other
information

buy without prescription, including
herbal medicines. This is because
trazodone can affect the way some
other medicines work. Also some
medicines can affect the way Trazodone
Oral Solution works.

25/05/2017
Creo Pharma
UK
CRE-TZDOS100-PIL-310

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.

If you forget to take Trazodone Oral
Solution
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.
Do not take a double dose to make up
for a forgotten dose.

Date
Client
Country
Job No.

Trazodone Hydrochloride

Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.

Trazodone OS
100 mg/5 ml
135 x 550 mm

Trazodone Hydrochloride 100 mg/5 ml Oral Solution

dizzy or faint, fits (seizures), confusion,
breathing or heart problems.

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Package leaflet: Information for the user

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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