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TRAZODONE 100MG CAPSULES

Active substance(s): TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE

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Package leaflet: Information for the user

TRAZODONE 50MG & 100MG CAPSULES
Trazodone hydrochloride

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING 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, pharmacist or nurse.
• 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is either Trazodone 50mg or 100mg capsules.
It will be referred to as Trazodone capsules for ease hereafter.
What is in this leaflet
1. What Trazodone Capsules are and what they are used for
2. What you need to know before you take Trazodone Capsules
3. How to take Trazodone Capsules
4. Possible side effects
5. How to store Trazodone Capsules
6. Contents of the pack and other information
1. WHAT TRAZODONE CAPSULES ARE AND
WHAT THEY ARE USED FOR
Trazodone capsules belongs to a group of medicines called
antidepressants and can be used to treat all types of depression including
depression accompanied by anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE
CAPSULES
Do not take Trazodone capsules:
• if you are allergic to trazodone hydrochloride or any of the other
ingredients of this medicine (listed in Section 6). The signs of an allergic
reaction include a rash, swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• if you have recently had a heart attack
• if you are a heavy drinker or if you are taking sleeping tablets
• if you are under 18 years of age.
Do not take trazodone if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist prior to taking this medicine.
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.
Trazodone should not be used by children or adolescents under 18 years of
age.
Talk to your doctor, pharmacist or nurse before taking Trazodone tablets:
• if you suffer from Epilepsy (fits or seizures)
• if you have severe liver, kidney or heart problems
• if you have an overactive thyroid gland (hyperthyroidism)
• if you have problems passing water or needing to pass water (urine)
more frequently
• if you have narrow angle glaucoma (an eye disease)
• if you suffer from schizophrenia or other type of mental disorder
• if you are Pregnant, trying to become pregnant or are breast-feeding
• if you are elderly, as you may be more prone to side effects, especially if
you are taking medicines used to treat high blood pressure or other
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 capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because some medicines
and trazodone may interfere with each other.
Tell your doctor if you are taking any of the following medicines:
• MAOI (Mono Amine Oxidase Inhibitors) medicines such as
tranylcypromine, phenelzine and isocarboxazid (for depression) or
selegiline (for Parkinson’s disease). Tell your doctor or pharmacist if
you are taking them now or have taken them in the last 2 weeks
• Muscle relaxants and inhaled anaesthetics
• Other antidepressants such as amitriptyline or fluoxetine
• Sedatives such as tranquilizers and sleeping pills
• Medicines used to treat epilepsy (e.g. carbamazepine or phenytoin)
• Medicines used to treat high blood pressure (e.g. clonidine) or heart
disease (e.g. digoxin)
• Medicines used to treat fungal infections such as ketoconazole and
itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin (a type of antibiotic used to treat infections)
• Levodopa (used for Parkinson's disease)
• St. John’s Wort (a herbal medicine)
• Warfarin (a drug used to stop 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 capsules with food, drink and alcohol
You should avoid drinking alcohol while taking trazodone capsules. This is
because trazodone can change the way alcohol affects you.
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.
Pregnancy
Trazodone capsules should not be taken during the first three months of
pregnancy.
Breast-feeding
Trazodone can pass into breast-milk and should only be used if the benefit
to the mother outweighs the risk to the child.
Driving and using machines
Trazodone is a drug which acts on the central nervous system and may
make you feel sleepy or less alert. Do not drive, operate machinery or do
anything that requires you to be alert until you know how this medicine
affects you.
Trazodone contains lactose
Trazodone capsules contain lactose. If you have been told by your doctor
that you have intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. HOW TO TAKE TRAZODONE CAPSULES
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure. The dose of
trazodone will depend on your needs and the illness being treated. The
capsules should always be taken with plenty of water. Taking trazodone
with, or soon after, food will lower the risk of side effects. If you are to take
your dose as a single dose it should be taken just 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.
DEPRESSION AND DEPRESSION ACCOMPANIED BY ANXIETY:
Adults:
The recommended starting dose is 150mg each day in divided doses after
food or as a single dose at bedtime. This may be increased up to 300mg
each day in single or divided doses. The major portion of a divided dose is
to be taken at bedtime. If you are in hospital the dose may be further
increased to 600mg each day in divided doses.

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

LF-102852-01

Component:
Product Code:
Country:
Vendor Name:
CRF(s):
Revised by:

1
16-Jun-2017
Trazodone 50mg
& 100mg Tablets 84s & 56s
Leaflet
103569-67
UK
Indoco Remedies
PR 6296
ADD

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:

200 x 240 mm
N/A
N/A
N/A
Black

Non-Print Colours:
Min. Font Size:

Cutter
7.5 pt

PAGE 1 OF 2

Elderly:
Dosage in elderly or frail patients should be started at 100mg each day in
divided doses or as a single dose at bedtime. This may be increased by
your doctor depending on how you react to this medicine. Dosages above
300mg each day are unlikely to be required.
Use in children and adolescents
Trazodone is not recommended for use in children and adolescents under
18 years of age.
ANXIETY:
The recommended starting dose is 75mg each day and this may be
increased to 300mg each day as necessary.
If you take more trazodone capsules than you should
It is important to stick to the dose on the label of the medicine. Do not
adjust your dose without consulting with your doctor.
If you or someone else swallows several of these capsules all together,
contact your doctor or nearest hospital emergency department
immediately. Always take any capsules left over with you along with
the box, as this will allow easier identification of the capsules.
The following effects may occur: nausea, sickness, drowsiness, dizziness,
fainting, fits (seizures), confusion and problems with your heart or
breathing.
If you forget to take trazodone capsules
If you forget to take a dose, take it as soon as you remember. If it is almost
time for your next dose do not take a double dose to make up for a
forgotten dose, just carry on as before.
If you stop taking trazodone capsules
• 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 these capsules he/she will
help you stop taking them gradually
• Stopping your medicine too quickly could cause sleep problems, leave
you feeling more irritable than usual and cause you to sweat more than
usual.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.
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 a hospital straight
away if you experience:
• A long lasting and painful erection, unrelated to sexual activity that will
not go away (priapism)
• You get swelling of your face, lips, tongue, throat, hands or ankles,
swallowing or breathing difficulties or itching of the skin and nettle rash.
This is an allergic reaction to trazodone
• Yellowing of the eyes or skin which could be a liver problem (such as
jaundice) or other abnormalities of liver function
• You have severe abdominal pain and bloating, which may be
accompanied by vomiting or constipation. These may be signs that
your intestine is not working properly (paralytic ileus)
• Bruising more easily than usual. This could be because of a blood
disorder (thrombocytopenia)
• Getting more infections than usual (sore throat, skin infections) which
may indicate a blood disorder (agranulocytosis).
Talk to your doctor straight away if you notice the following side-effects:
• Thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of
anaemia
• Convulsions, fits (seizures)
• 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 with the
following frequency:
Not known (frequency cannot be estimated from available data)
• 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 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)
• 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 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 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 CAPSULES
• Keep this medicine out of the sight and reach of children
• Do not store above 25°C. Store in the original packaging
• Do not use this medicine after the expiry date which is stated on the
blister and carton. 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Trazodone Capsules contain
- The active ingredient is trazodone hydrochloride.
Each Trazodone 50mg Capsule contains 50mg of trazodone
hydrochloride.
Each Trazodone 100mg Capsule contains 100mg of trazodone
hydrochloride.
- The other ingredients are lactose monohydrate, colloidal silica
anhydrous, magnesium stearate, gelatin, titanium dioxide (E171),
yellow iron oxide (E172), erythrosin (E127) and patent blue V (E131). In
addition to these Trazodone 50mg Capsules also contain indigo
carmine (E132).
What Trazodone Capsules look like and contents of the pack
Trazodone 50mg Capsules are green-violet capsules.
Trazodone 100mg Capsules are yellow-violet capsules.
Trazodone 50mg Capsules are supplied in blister packs of 84 capsules and
Trazodone 100mg Capsules are supplied in blister packs of 56 capsules.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 85 King William Street,
London EC4N 7BL UK
Manufacturer
Mercury Pharmaceuticals Limited,
Capital House, 85 King William Street, London EC4N 7BL, UK
This leaflet was last revised in June 2017.
LF-102852-01

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

LF-102852-01

Component:
Product Code:
Country:
Vendor Name:
CRF(s):
Revised by:

1
16-Jun-2017
Trazodone 50mg
& 100mg Tablets 84s & 56s
Leaflet
103569-67
UK
Indoco Remedies
PR 6296
ADD

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:

200 x 240 mm
N/A
N/A
N/A
Black

Non-Print Colours:
Min. Font Size:

Cutter
7.5 pt

PAGE 2 OF 2

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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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