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TRAZODONE HYDROCHLORIDE 150MG FILM-COATED TABLETS

Active substance(s): TRAZODONE HYDROCHLORIDE

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Package leaflet: Information for the user

TRAZODONE HYDROCHLORIDE
150 MG FILM-COATED TABLETS
Trazodone hydrochloride
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

Children and adolescents:
Trazodone Tablet should not be used in children and
adolescents under 18 years of age.




Taking other medicines
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
is because Trazodone Tablets can affect the way some
other medicines work. Also some medicines can affect
the way Trazodone Tablets work.
• MAOI (Monoamine Oxidase Inhibitors) medicines
such as tranylcypromine, phenelzine and
isocarboxazid (for depression) or selegiline (for
Parkinson’s disease), or have taken them in the
last 2 weeks
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as
carbamazepine and phenytoin
• Other antidepressants (such as amitriptyline or
fluoxetine)
• Medicines used to treat fungal infections such as
ketoconozole and itraconazole
• Medicines used to treat high blood pressure for
example, clonidine
• Eyrthromycin, an antibiotic used to treat infections
• Medicines used to treat Parkinson’s disease (such
as Levodopa)
• Some medicines used to treat HIV such as ritonavir
and indinavir
• St. John’s Wort (a herbal remedy)
• Digoxin (used to treat heart problems)
• Warfarin (used to stop your blood from clotting)



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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 Tablets are and what they are
used for
2. What you need to know before you take Trazodone
Tablets.
3. How to take Trazodone Tablets
4. Possible side effects
5. How to store Trazodone Tablets
6. Contents of the pack and other information

1. What Trazodone Tablets are and
what they are used for
The name of this medicine is Trazodone hydrochloride
150 mg film-coated tablets (referred to as Trazodone
Tablets throughout this leaflet). Trazodone Tablets
contain a medicine called trazodone hydrochloride.
Trazodone belongs to a group of medicines called
antidepressants.
Trazodone Tablets are used to treat depression and
depression accompanied by anxiety.

2. What you need to know before you take
Trazodone Tablets
Do not take Trazodone Tablets if






You are allergic to active substance or any of the
other ingredients of this medicine (listed in Section
6).The symptoms of an allergic reaction can include:
a rash, swelling of your lips, face, throat or tongue,
swallowing or breathing problems
You have recently had a heart attack
You are taking sleeping tablets or a heavy drinker
You are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Trazodone
Tablets if any of the following points apply to you:
• Have or have ever had fits or seizures (epilepsy)
• 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
Tablet.
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.

Trazodone with food and drink and alcohol
You should avoid drinking alcohol while taking
Trazodone. This is because trazodone can change the
way alcohol affects you.
Pregnancy and breast-feeding and fertility
Pregnancy
Talk to your doctor before taking this medicine if you
are pregnant, might become pregnant, or think you
may be pregnant. Taking Trazodone Tablets in the late
stages of pregnancy may lead to your baby
experiencing withdrawal symptoms when they are
born.
Breast-feeding
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 Tablets may make you feel sleepy or dizzy.
Do not drive or use hazardous machinery unless you
are sure that you are not affected.
Trazodone Tablet contains lactose monohydrate
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product

3.How to take Trazodone Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth.
• Swallow the tablets whole with a drink of water.
The tablets may begin disintegrating as soon as
they are placed in the mouth.
• Take with or after food. This can help lower the
chances of side effects
• If you have 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
strong, do not change the dose yourself, but ask
your doctor
• The score line is only there to help you break the
tablet if you have difficulty swallowing it whole.
How much to take
Adults:
Depression
• Adults usually start by taking 75 mg to 150 mg each
day
• Your doctor may increase this to up to 300 mg per
day depending on your condition
• For adults in hospital the dose may be as high as
600 mg per day
A starting dose of 75 mg is not achievable with this 150
mg tablet, therefore another formulation/strength should
be used.

IXXXXXX

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 you have some other diseases.

Anaesthetics
If you are going to have an anaesthetic (for an operation),
tell your doctor or dentist that you are taking Trazodone
Tablet.

SAME SIZE ARTWORK
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30 mm

Elderly
Older people or those who are frail will usually be given
a starting dose of 100 mg each day.
A dose of 100mg is not achievable with this 150mg tablet,
therefore another formulation/strength should be used.
Children
Trazodone Tablet is not recommended for children and
adolescents under the age of 18.










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 potentially 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 take more Trazodone than you should
If you take more Trazodone Tablets 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.

Reporting of side effects
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
as below
In UK: via the Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard.
In Ireland: via the HPRA website: www.hpra.ie or email
to: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

If you stop taking Trazodone
Keep taking Trazodone Tablet until your doctor tells you
to stop. Do not stop taking Trazodone Tablet just because
you feel better. When your doctor tells you to stop taking
these Tablet he/she will help you stop taking them
gradually.





5. How to store Trazodone tablets
4. Possible side effects


Stop taking Trazodone Tablet 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 Tablet
• 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)
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

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






Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which
is stated on the blister and carton after EXP. The
expiry date refers to the last day of that 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 protect the environment.

6. Contents of the pack and other information
What Trazodone Tablets contain
• The active substance is Trazodone (as the
hydrochloride).
• Each tablet contains 150 mg of Trazodone
hydrochloride.
• The other ingredients are:
Core: Lactose monohydrate, Microcrystalline
cellulose, Magnesium stearate
Coating: Hypromellose, Propylene glycol, Titanium
dioxide (E171), Red Iron oxide (E172) and Yellow
Iron Oxide (E172).
What Trazodone Tablets look like and contents of
the pack
• Trazodone 150mg Tablets are salmon pink colour,
round biconvex film coated tablets having lipped break
line on one side and “BL 150” embossing on other
side (11.00mm in diameter).
• Trazodone Tablets are available in blister packs of 28
and 100 Tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
This medicinal product is authorised in the Member
States of the EEA under the following names:
Ireland: Trazodone hydrochloride 150 mg Film-coated
Tablets; PA 1240/015/003
United Kingdom: Trazodone hydrochloride 150 mg
Film-coated Tablets; PL 17907/0433
This leaflet was last revised in October 2016
To request a copy of this leaflet in braille, large print or audio
format, please contact the licence holder at the address (or
telephone, fax, email) above.

V5 20-10-16 D0

IXXXXXX

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

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