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TRAZODONE HYDROCHLORIDE 50MG/5ML SUGAR FREE ORAL SOLUTION

Active substance(s): TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE

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Package leaflet: Information for the user

Trazodone hydrochloride 50mg/5ml Sugar Free Oral Solution
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 “Trazodone hydrochloride
50mg/5ml Sugar Free Oral Solution" but it will be referred to
as “Trazodone” throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Trazodone is and what it is used for
What you need to know before you take Trazodone
How to take Trazodone
Possible side effects
How to store Trazodone
Contents of the pack and other information

1. What Trazodone is and what it is used for
This medicinal product contains trazodone hydrochloride. This
belongs to a group of medicines called antidepressants.






If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Trazodone.
Other medicines and Trazodone
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
you buy without or 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
medicines:









Trazodone can be used to treat anxiety and depression.



2. What you need to know before you take Trazodone



Do not take Trazodone if:






you are allergic (hypersensitive) to trazodone
hydrochloride or any of the other ingredients of Trazodone
(listed in Section 6). 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 applies to you. If
you are not sure, talk to your doctor or pharmacist before
taking Trazodone.
Warnings and precautions
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 likely to think like this if:
 you have previously had thoughts about killing or harming
yourself
 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.
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:





have or have ever had fits or seizures
have severe liver, kidney or heart problems
are pregnant, trying to become pregnant or are breastfeeding
have an overactive thyroid gland (hyperthyroidism)

PIL/UK/MFG129/01/v1

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.





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.
Trazodone with food, drink and alcohol
You should avoid drinking alcohol while taking Trazodone.
Pregnancy and breast-feeding
Talk to you doctor before taking this medicine if you are
pregnant, might become pregnant, or think you may be
pregnant.
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.
Driving and using machines
Trazodone may make you feel sleepy or dizzy. If this happens
do not drive or use any tools or machines.
Trazodone contains:
Sorbitol (E420): If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor
before taking this medicinal product. If you are given more
than 50ml of this medicine daily, the sorbitol in this medicine
may have a laxative effect (calorific value 2.6kcal/g sorbitol).
Glycerol (E422): May cause a headache, an upset stomach
and diarrhoea.
3. How to take Trazodone
Always take Trazodone exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Taking this medicine
take this medicine by mouth using dosing device
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
doctor.



The recommended dose is:
Adults:
Depression




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.

TURN OVER

Anxiety



adults usually start by taking 75mg (7.5ml) each day
your doctor may increase the dose to 300mg (30ml) each
day depending on your condition.

Elderly
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 given.



Children
Children and adolescents under 18 years should not take
Trazodone.
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.



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



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.
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.

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 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 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 have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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.

4. Possible side effects

By reporting side effects you can help provide more
information on the safety of this medicine.

Like all medicines, Trazodone can cause side effects, although
not everybody gets them.
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 trazodone
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 Syndrome
rapid, slow or irregular heartbeat.

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)

PIL/UK/MFG129/01/v1

5. How to store Trazodone









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.
Store in a refrigerator (2°C - 8°C). Protect from light.
Discard 30 days after 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.
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 contains
Each 5ml of Trazodone contains 50mg of trazodone
hydrochloride.
Other ingredients include glycerol (E422), liquid sorbitol
(non-crystallising) (E420), benzoic acid (E210), saccharin
sodium (E954), orange flavour [contains propylene glycol
(E1520)], sodium hydroxide (for pH-adjustment) and purified
water.
What Trazodone looks like and contents of the pack
Trazodone is a clear colourless to yellow colour oral solution
with an orange odour and taste supplied in amber glass bottles
with tamper-evident child-resistant polypropylene plastic screw
cap and a 30ml measuring cup having 5ml graduation with
intermediate graduation at 2.5ml and 7.5ml only.
Trazodone is supplied in bottles containing 120ml oral solution.
Marketing Authorisation Holder and Manufacturer:
Thame Laboratories
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
POM
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK and MT: Trazodone hydrochloride 50mg/5ml Sugar Free
Oral Solution
This leaflet was last revised in 09/2016.

Expand Transcript

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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