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TRAZODONE HYDROCHLORIDE 50MG CAPSULES HARD

Active substance(s): TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE / TRAZODONE HYDROCHLORIDE

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Package leaflet: Information for the user

Trazodone hydrochloride 50 mg and 100 mg Capsules, Hard
Trazodone hydrochloride

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

1. What Trazodone Capsule is and
what it is used for
The name of this medicine is Trazodone hydrochloride
50 mg and 100 mg Capsules, Hard (referred to as
Trazodone Capsule throughout this leaflet). Trazodone
Capsules contain a medicine called trazodone
hydrochloride. Trazodone belongs to a group of medicines
called antidepressants.
Trazodone Capsule is used to treat depression and
depression accompanied by anxiety.

2. What you need to know before you take
Trazodone Capsule
Do not take Trazodone Capsule 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
Capsule 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 apply to you, talk
to your doctor or pharmacist before taking Trazodone
Capsules.
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.
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.
Children and adolescents
Trazodone Capsules should not be used in children and
adolescents under 18 years of age.

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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 Capsules can affect the way some
other medicines work. Also some medicines can affect
the way Trazodone Capsules 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)
• St. John’s Wort (a herbal remedy)
• Digoxin (used to treat heart problems)
• Warfarin (used to stop your blood from clotting)
• Some medicines used to treat HIV such as ritonavir
and indinavir
Anaesthetics
If you are going to have an anaesthetic (for an operation),
tell your doctor or dentist that you are taking Trazodone
Capsules.
Trazodone Capsule 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 Capsules 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 Capsules may make you feel sleepy or
dizzy. Do not drive or use hazardous machinery unless
you are sure that you are not affected.
Trazodone Capsules contain lactose
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 Capsule
Always take this medicine exactly as your or pharmacist
doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Taking this medicine
• Take this medicine by mouth.
• Swallow the capsules whole with a drink of water.
• Take with or after food. This can help lower the chances
of side effects.
• If you have been told to take Trazodone Capsules
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.
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.
If a starting dose of 75 mg or 150 mg is not achievable
with this product, another formulation/strength should be
used.
Elderly
Older people or those who are frail will usually be given
a starting dose of 100 mg each day.
Children
Trazodone Capsules is not recommended for children
and adolescents under the age of 18.
If you take more Trazodone than you should
If you take more Trazodone Capsules 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.

IXXXXXX

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Trazodone Capsules 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 Capsules
• 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
ilius).
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
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.

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.

5. How to store Trazodone capsule
• This medicinal product does not require any special
storage conditions.
• 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 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 Capsule contains
• The active substance is Trazodone (as the
hydrochloride).
• The 50 mg capsule contains 50 mg of Trazodone
hydrochloride.
• The 100 mg capsule contains 100 mg of Trazodone
hydrochloride.
• The other ingredients are Lactose monohydrate, Silica
colloidal anhydrous, Magnesium stearate. Capsule
body and shell: Erythrosine (E127), Patent blue V
(E131), Titanium dioxide (E171), Iron oxide yellow
(E172), Gelatin and Edible ink (Shellac and black iron
oxide (E172)). The 50 mg capsule shell additionally
contains Indigotine (E132).
What Trazodone Capsule looks like and contents of
the pack
• Trazodone 50 mg Capsules are purple/green hard gelatin
capsules of size ‘3’ and imprinted with ‘BL’ and ‘50’ on
cap/body, containing white to off white granular powder.
• Trazodone 100 mg Capsules are purple/yellow hard
gelatin capsules of size ‘2’ and imprinted with ‘BL’ and
‘100’ on cap/body, containing white to off white granular
powder.
• Trazodone Capsules are available in blister packs of
56, 84 and 100 capsules. 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 50 mg and 100 mg
Capsules, Hard; PA 1240/015/001 & PA 1240/015/002
United Kingdom: Trazodone hydrochloride 50 mg and
100 mg Capsules; PL 17907/0431 & PL 17907/0432
This leaflet was last revised in November 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.

IXXXXXX

The following effects may happen: feeling sick or being
sick, feeling sleepy, dizzy or faint, fits (seizures), confusion,
breathing or heart problems.

V5 17-11-16 D0

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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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