UK Edition. Click here for US version.
TRAZODONE 150MG TABLETS
Active substance(s): TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE
Package leaflet: Information for the user
TRAZODONE 150MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATON 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
• 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 Trazodone 150mg tablets. It will be referred
to as Trazodone tablets for ease hereafter.
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
Trazodone tablets belongs to a group of medicines called antidepressants
and can be used to treat all type of depression including depression
accompanied by anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAZODONE
Do not take Trazodone tablets:
• 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
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
Talk to your doctor, pharmacist or nurse before taking Trazodone
• 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)
• 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
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 tablets
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
• 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).
If you are going to have an anaesthetic (for an operation), tell your doctor
or dentist that you are taking trazodone.
Trazodone tablets with food, drink and alcohol
You should avoid drinking alcohol while taking trazodone tablets. 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.
Trazodone tablets should not be taken during the first three months of
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
Trazodone tablets contains lactose
Trazodone tablets 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 TABLETS
Always take this medicine exactly as your doctor or pharmacist have 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
tablets 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:
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
Tablets - 28s
Core Spec Ref.:
200 x 240 mm
Min. Font Size:
PAGE 1 OF 2
AMS Component No.:
hospital the dose may be further increased to 600mg each day in divided
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.
The recommended starting dose is 75mg each day and this may be
increased to 300mg each day as necessary.
If you take more trazodone tablets 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 tablets all together,
contact your doctor or nearest hospital emergency department
immediately. Always take any tablets left over with you along with the box,
as this will allow easier identification of the tablets.
The following effects may occur: nausea, sickness, drowsiness, dizziness,
fainting, fits (seizures), confusion and problems with your heart or
If you forget to take trazodone tablets
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 tablets
• 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 tablets 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
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 medicines 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
• Getting more infections than usual (sore throat, skin infections) which
may indicate a blood disorder.
Talk to your doctor straight away if you notice the following
• Thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of
• 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
• Rapid, slow or irregular heartbeat.
Below is a list of other side effects that have been reported with the
Not known (frequency cannot be estimated from the 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
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
• 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
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE TRAZODONE TABLETS
• 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 Tablets contain
- The active ingredient is trazodone hydrochloride.
Each Trazodone 150mg Tablet contains 150mg of trazodone
- The other ingredients are lactose monohydrate, maize starch, povidone
K30, calcium hydrogen phosphate dihydrate, sodium starch glycolate,
magnesium stearate, microcrystalline cellulose, hypromellose type E5,
titanium dioxide (E171),propylene glycol, red iron oxide (E172) and
What Trazodone Tablets look like and contents of the pack
Trazodone 150mg Tablets are pink film coated tablets.
Trazodone 150mg Tablets are supplied in blister packs of 28 tablets.
Marketing Authorization Holder
Focus Pharmaceuticals Limited,
Capital House, 85 King William Street, London EC4N 7BL, UK
Mercury Pharmaceuticals Limited,
Capital House, 85 King William Street, London EC4N 7BL, UK
This leaflet was last revised in June 2017.
Tablets - 28s
Core Spec Ref.:
200 x 240 mm
Min. Font Size:
PAGE 2 OF 2
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.