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TRAZODONE HYDROCHLORIDE TABLETS 150MG

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Read all 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.
•  you have any further questions, ask your
If
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.
•  you get any side effects, talk to your
If
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 is and
what it is used for
2. 
What you need to know before you take
Trazodone hydrochloride
3. 
How to take Trazodone hydrochloride
4. 
Possible side effects
5. 
How to store Trazodone hydrochloride
6. 
Content of the pack and other information

1. What Trazodone is
and what it is used for
Trazodone Hydrochloride belongs to a class
of medicines known as antidepressants. It is
used to make you feel less depressed and
less anxious.
Trazodone Hydrochloride helps to treat your
depression, if you follow the treatment it will:
• 
Improve your general feeling of well being
or mood.
• 
Help to restore your interest in every
day activities.

2. 
What you need to know before
you take Trazodone Hydrochloride
Do not take Trazodone Hydrochloride:
•  you are allergic (hypersensitive) to
if
trazodone or any of the other ingredients
of this medicine (listed in section 6).
•  you are a heavy drinker or are taking
if
sleeping tablets
•  you have suffered heart attack
if
•  you are under 18 years of age.
if

Warnings and precautions
Talk to your doctor or pharmacist before
taking Trazodone hydrochloride, particularly
if any of the following applies to you.

1111121

TBC

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:
•  you have previously had thoughts about
If
killing or harming yourself.
•  you are a young adult. Information from
If
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.
You must tell your doctor before taking
your medicine:
•  you are pregnant or think you may
if
be or could become pregnant
•  you are breast feeding your baby
if
•  you have or had fits or seizures
if
•  you have heart disease
if
•  you have kidney or liver disease
if
•  you have hypotension
if
•  you have narrow angle glaucoma (an
if
eye disorder)
•  you have problems in passing water
if
or need to pass water urine frequently,
prostate enlargement
•  you are elderly, as you may be more
if
prone to side effects
•  you have an overactive thyroid gland
if
(hyperthyroidism)
•  you have schizophrenia or other type
if
of mental disorders

Children and adolescents
This medicine should not be given to
children and adolescents under 18 years old.
Other medicines and Trazodone
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
• 
MAOIs (Monoamine Oxidase Inhibitors)
medicines such as tranylcypromine,
phenelzine and isocarboxide (for
depression) or selegiline (for Parkinson's
disease), or have taken them in the last
two weeks
• 
other medicines for depression (such as
amitriptyline or fluoxetine)
• 
medicines used to produce calmness or
to help you sleep (such as tranquilizers or
sleeping pills)
• 
medicines to treat epilepsy, eg. phenytoin,
carbamazepine
• antihistaminic drugs
• oral contraceptives
• 
medicines to treat high blood pressure and
heart disease, including clonidine, digoxin
and guanethidine 
• 
ritonavir and indinavir (used to control HIV
infection), itraconazole and ketoconazole
(used to treat fungal infections)
• 
cimetidine (used to treat ulcers)
• 
erythromycin (antibiotic used to treat
infections)
• 
levodopa (used to treat Parkinson's disease)
• chlorpromazine, fluphenazine,
levomepromazine, perphenazine (all used
to block the effect of chemicals in the brain)
•  John's wort (herbal remedy)
St
• 
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.
Heart problems
Caution should be taken when using this kind
of medicine, if you were born with or have
family history of prolonged QT interval (seen
on ECG, electrical recording of the heart).
Trazodone hydrochloride with food,
drink and alcohol
You should avoid drinking alcohol while
taking trazodone.
Pregnancy and breast-feeding
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.
Taking Trazodone in the late stages
of pregnancy may lead to your baby
experiencing withdrawal symptoms when
they are born.

Driving and using machines
Trazodone may make you feel sleepy, dizzy
or you can be affected by blurred vision. If
this happens do not drive or use any tools
or machines.
Trazodone hydrochloride contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. 
How to take Trazodone
Hydrochloride
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Adult:
Depression
• 
The recommended dose is 150 mg each day.
• 
Your doctor may increase the dose to 300 mg
each day depending on your condition.
 adults in hospital the dose may be as
For
high as 600 mg each day.
Anxiety
•  recommended dose is 75 mg each day
the
• 
your doctor may increase the dose to
300 mg each day.
Older people:
The recommended dose is 100 mg each day.
Use in children and adolescents
Trazodone Hydrochloride Tablets should not
be given to children below 18 years old.

Date: 02 Jun 2015
Description Trazodone Hydrochloride 150 mg

No. of colours

Component Type Leaflet

Pharma Code TBC

Colours

Affiliate Item Code 527790

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 527790
MA No. N/A

Vendor Job No. 241423
Proof No. 5
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

1111121

Trazodone
Hydrochloride
150 mg Tablets

Older people more often experience dizziness
on standing up, especially when getting up
from a sitting or lying position (orthostatic
hypotension), sleepiness and drowsiness
(somnolence) particularly concomitant
administration of other medicines used to
treat certain mental conditions or medicines
used to help lower blood pressure or in the
presence of risk factor such as comorbid
disease. It is recommended to the older
patients/carer to exercise caution for such
effects during initiation of therapy.

TBC

Package leaflet: Information for the patient

1

Time: 16:48
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 10 pt
Min Text Size used 9 pt

Method of administration
When taking Trazodone hydrochloride:
• 
swallow the tablets with water
• 
always take with or after a meal. This
can lower the chance of side effects
•  you been told to take Trazodone tablets
if
only once each day then you should take it
before going to bed
•  you feel the effect of your medicine is too
if
weak or too strong, do not change the dose
yourself, but ask your doctor.
If you take more Trazodone
hydrochloride than you should
If you accidentally take too many tablets,
contact your doctor or nearest hospital
emergency department immediately
for advice.
The following effects may happen: feeling
sick or being sick, sleepy, dizzy or faint, fits
(seizures), confusion, breathing problems,
low blood pressure or heart problems.

If you forget to take Trazodone
hydrochloride
If you forget to take your Trazodone
Hydrochloride Tablets, do not take the missed
dose at all and do not double the next dose,
just carry on as before. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking
Trazodone hydrochloride
Keep taking Trazodone hydrochloride tablets
until your doctor tells you to stop.
Do not stop taking Trazodone hydrochloride
tablets just because you feel better. When
your doctor tell you to stop taking these
tablets he/she will help you to stop taking
them gradually to minimise the risk of nausea,
headache and malaise.
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 trazodone and see a doctor
or go to the hospital straight away if:
• ou get swelling of the hands, feet, ankles,
y
face, lips or throat which may cause
difficulty swallowing or breathing, itching of
the skin and nettle rash (allergic reaction).
This may means you are having an allergic
reaction to trazodone
• 
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, 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
• 
painful erection of the penis, unrelated to
sexual activity, that will not go away
• 
yellowing of the eye or skin. This could be a
liver problem
• 
getting infections more easily than usual.
This could be because of a blood disorder
(decrease in number of white blood cells
that fight infection)
• 
bruising more easily than usual. This could
be because of a blood disorder (decrease
in number of blood platelets that help your
blood clot)
• 
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.
Talk to your doctor straight away if
you notice the following side effects:
• ou have thoughts of harming or killing
y
yourself (that can especially occurs during
the first weeks of treatment or following
dose changes)
• 
feeling tired, faint, dizzy, having pale skin
• convulsions/fits
• 
unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on
the skin
• 
this medicine may cause irregular heart
beats in patients with heart disease,
abnormal fast heart rhythm, life-threatening
irregular heart rhythm, alteration of the
heart rhythm (called 'prolongation of QT
interval', seen on ECG, electrical activity
of the heart).

Other side effects that can occur:
• rowsiness on starting treatment (this
d
usually goes away)
• 
slow or racing pulse
• 
swelling of the ankles
• 
dizziness, headache, nausea, vomiting,
weakness, decreased alertness,
confusion, shaking
• 
weight loss, loss of appetite, indigestion
•  mouth, altered taste, increased amount
dry
of saliva, blocked nose
• 
fainting on standing up, confusion
• difficulty passing water, constipation, diarrhoea
• blurred vision
• restlessness or difficulty sleeping and skin rash
• 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
(decrease in number of white blood cells
that fight infection)
• 
feeling anxious or more nervous than usual,
feeling agitated
• 
overactive behaviour or thoughts, believing
things that are not true, memory disturbance
• nightmares
• 
decreased sex drive
• 
sweating more than usual, itching
• 
high blood pressure
• 
high temperature, flu type symptoms
• 
difficulty with speaking
• 
high levels of liver enzymes in your blood
• 
feeling tired, weak and confused, having
muscles that ache, are stiff or do not work well.
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.  ow to store
H
Trazodone Hydrochloride
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the label or carton after
'EXP'. The expiry date refers to the last day of
that month.
There are no special storage requirements for
this medicine.
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
protect the environment.

6. 
Contents of the pack
and other information
What Trazodone Hydrochloride
tablets contains
Each tablet contains 150 mg of the active
ingredient trazodone hydrochloride.
The other ingredients are lactose
monohydrate, microcrystalline cellulose,
maize starch, crospovidone, povidone,
magnesium stearate and opadry coating
containing titanium dioxide (E171), lactose,
hydroxypropylmethy lcellulose, polyethylene
glycol, iron oxide red (E172), indigo carmine
(E132) and iron oxide yellow (E172).

What Trazodone Hydrochloride tablets
look like and contents of the pack
The 150 mg are dusty mauve film-coated tablets
TO
debossed '150' on one side with 'G' on the reverse.
Trazodone Hydrochloride is available in blister
packs of 20, 28, 30, 56, 84, 90, 100, 112, 120,
168 & 180 tablets and HDPE or polypropylene
bottle with polyethylene caps in packs of 5, 7,
10, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100,
112, 120, 168, 180, 200, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland

This leaflet was last revised in 06/2015.

Date: 02 Jun 2015
Description Trazodone Hydrochloride 150 mg

No. of colours

Component Type Leaflet

Pharma Code TBC

Colours

Affiliate Item Code 527790

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 527790
MA No. N/A

Vendor Job No. 241423
Proof No. 5
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

1

527790

Time: 16:48
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 10 pt
Min Text Size used 9 pt

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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