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TRAZODONE HYDROCHLORIDE 150 MG TABLETS

Active substance(s): TRAZODONE HYDROCHLORIDE

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Trazodone
Hydrochloride
150 mg Tablets

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.
• 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 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:
• if you are allergic to trazodone or any of the
other ingredients of this medicine (listed in
section 6).
• if you are a heavy drinker or are taking
sleeping tablets
• if you have suffered from a heart attack
• if you are under 18 years of age.

Warnings and precautions

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

Thoughts of suicide and worsening of
your depression or anxiety disorder

TBC

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.
You must tell your doctor before taking
your medicine:
• if you are pregnant or think you may be or
could become pregnant
• if 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
eye disorder)
• if you have problems in passing water or
need to pass water urine frequently, prostate
enlargement
• if you are elderly, as you may be more prone to
side effects
• if you have an overactive thyroid gland
(hyperthyroidism)
• if you have schizophrenia or other type of
mental disorders
While being treated with Trazodone
Hydrochloride, if you experience loss of appetite,
unusual weakness, stomach pain, nausea,

vomiting and yellowing of the skin and/or eyes;
these may be signs of life-threatening liver
disease. Contact your doctor immediately, he/
she should carry out some liver function tests
and may decide to stop your treatment with
this medicine.
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.

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)
• St John's wort (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.

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.
For adults in hospital the dose may be as high
as 600 mg each day.

Anxiety

• the recommended dose is 75 mg each day
• your doctor may increase the dose to 300 mg
each day.

Older people:

The recommended dose is 100 mg each day.

TBC

Package leaflet: Information for the patient

Use in children and adolescents

Trazodone Hydrochloride Tablets should not be
given to children below 18 years old.

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
• if you been told to take Trazodone tablets 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.

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:

• 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 (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, feeling sick,
being sick, loss of appetite, unusual weakness,
stomach pain; these may be signs of severe
liver disease which could lead to lifethreatening liver failure.
• 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:

• you have thoughts of harming or killing
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:

• drowsiness on starting treatment (this 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
• dry mouth, altered taste, increased amount 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. How to store 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 11/2015.

764848
LT1942AB

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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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