TRAZODONE HYDROCHLORIDE 50 MG CAPSULES

Active substance: TRAZODONE HYDROCHLORIDE

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Trazodone hydrochloride 50 mg Capsules
Trazodone hydrochloride 100 mg Capsules
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Trazodone hydrochloride
Capsules are and what they are
used for
2. Before you take Trazodone
hydrochloride Capsules
3. How to take Trazodone
hydrochloride Capsules
4. Possible side effects
5. How to store Trazodone
hydrochloride Capsules
6. Further information

1. What Trazodone
hydrochloride Capsules
are and what they are
used for
Trazodone hydrochloride belongs
to a group of medicines called
anti-depressants.
Your medicine is used for the
relief of symptoms of all types of
depression including depression
accompanied by anxiety.

2. Before you take Trazodone
hydrochloride Capsules
Do not take Trazodone
hydrochloride Capsules if you
are allergic (hypersensitive) to
Trazodone hydrochloride, or
any of the other ingredients (see
section 6 - Further information).
Trazodone hydrochloride Capsules
are not recommended for children
and adolescents under the age of
18 years.
Take special care with Trazodone
hydrochloride Capsules
Please tell your doctor before
taking this medicine if:
• You are pregnant, think you
might be pregnant or are
planning to become pregnant
• You are breast-feeding
• You suffer from epilepsy
• You suffer from kidney or liver
disease (you may need to have
your liver function monitored)
• You suffer from heart problems
• You suffer from an overactive
thyroid
• You suffer from urinary disorders,
such as prostate hypertrophy
(enlargement of the prostate)
• You suffer from acute narrow
angle glaucoma, or raised
intra-ocular pressure
Taking other medicines with
Trazodone hydrochloride Capsules
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines, including medicines
obtained with or without a
prescription;
• Muscle relaxants and inhaled
anaesthetics - if you go to
hospital to have surgery, please
inform the anaesthetist that you
are taking your medicine
• Clonidine (a medicine used to
lower high blood pressure or to
treat migraine)
• Medicines used in the treatment
of epilepsy (e.g. phenytoin)
• Drugs used to treat anxiety,
schizophrenia, sleep problems
or allergies
• Drugs used to treat infections
such as erythromycin,
ketoconazole, itraconazole,
ritonavir or indinavir
• Carbamazepine - your doctor
may want to monitor you and
increase your trazodone dose
• Fluoxetine for the treatment of
depression
• Tricyclic antidepressants such
as amitriptyline, dosulepin or
imipramine
• Drugs used to treat schizophrenia
called phenothiazines, such as
chlorpromazine, fluphenazine or
prochlorperazine
• Levodopa
• Drugs known to prolong the QT
interval

• Monoamine Oxidase Inhibitors
(MAOIs) used to treat depression
such as phenelzine. These
should be stopped two weeks
before you start taking your
medicine.
Do not take MAOIs for at least
seven days after stopping your
medicine
• Medicines used in heart disease
(e.g. digoxin, your doctor may
want to monitor you)
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 young
adults (less than 25 years old)
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.
Pregnancy and breast-feeding
Trazodone hydrochloride Capsules
should not be taken during
pregnancy, or whilst breast-feeding,
unless recommended by your
doctor.
Ask your doctor or pharmacist for
advice before taking any medicine.
Taking Trazodone hydrochloride
Capsules with food and drink
Do not drink alcohol when you are
being treated with your medicine.
The capsules should be swallowed
whole with a glass of water. Your
doctor may want you to take your
capsules in divided doses after
food or as a single dose as you go
to bed.
Important information about
some of the ingredients of
Trazodone hydrochloride Capsules
This product 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.
Driving and using machines
Your medicine can make you
drowsy, dizzy, or give you blurred
vision. If affected, you should not
drive or operate machinery.

3. How to take Trazodone
hydrochloride Capsules
Always take your medicine exactly
as your doctor has told you. If you
have any concerns about your
dose, speak to your doctor or
pharmacist. Continue taking your
medicine until your doctor tells
you to stop. When your doctor
wants you to stop taking your
medicine the dose will be reduced
gradually.
The capsules should be swallowed
whole with a glass of water. Your
doctor may want you to take your
capsules in divided doses after food
or as a single dose as you go to bed.

Depression and depression
accompanied by anxiety
The usual starting dose for adults
is 150 mg a day. Your doctor may
afterwards decide to increase your
daily dose to 300 mg. Elderly or
frail people will be prescribed a
lower dose of 100 mg a day.

5. How to store Trazodone
hydrochloride Capsules

Anxiety
The daily dose may vary from 75 mg
to 300 mg a day.

Do not use your medicine after
the expiry date which is stated on
the carton.

If you have taken more Trazodone
hydrochloride Capsules than you
should call your doctor or go
to the nearest hospital casualty
department immediately.

Medicines should not be disposed
of via wastewater or household
waste. Ask your pharmacist how
to dispose of medicines no longer
required. These measures will
help protect the environment.

If you forget to take Trazodone
hydrochloride Capsules take your
dose as soon as you remember.
Do not take a double dose to
make up for a forgotten dose.

4. Possible side effects
Like all medicines, your medicine
can cause side effects, although
not everybody gets them.
Stop taking your medicine and
seek immediate medical advice
if you experience any of the
following rare side effects:
• Low white blood cell count (the
blood cells that fight infection),
which makes infections more
likely
• Low platelet count (the blood
cells which help the blood clot),
which increases the risk of
bleeding or bruising
• Anaemia (reduction in red blood
cells), which may make you
pale, breathless or weak
• Jaundice (yellowing of the skin
and/or eyes)
• Abnormalities of liver function
• Long-lasting and painful erections
In most people, the most common
side effect is drowsiness. This
occurs during the first few days
of your treatment and usually
disappears as your treatment
continues.
The following symptoms have
also been reported, frequency not
known (cannot be estimated from
the available data):
• headache, dizziness, drowsiness,
vertigo, disorientation, confusion,
insomnia (difficulty in sleeping),
memory disturbance, expressive
aphasia (loss of the ability to
produce language -spoken or
written), blurred vision, delusion,
agitation, nervousness, anxiety,
mania, hallucinations, nightmares
• nausea (feeling sick), vomiting
(being sick), stomach pain,
indigestion, diarrhoea,
gastroenterisis (symptoms
include severe diarrhoea),
increased salivation, constipation,
altered taste, increased appetite
or anorexia, weight loss
• weakness, fatigue (tiredness),
limb, joint or back pain, decreased
alertness, tremor, dystonia
(contracting muscles cause
twisting or abnormal posture),
muscle twitching, restlessness,
neuroleptic malignant syndrome,
a rare neurological disorder
(symptoms include muscle
rigidity, autonomic instability
and delirium)
• flu-like symptoms, chest pain,
fever, nasal congestion, difficulty
breathing, fainting, tingling or
numbness of skin
• slow or racing heartbeat, low
or high blood pressure, low
sodium in the blood, high levels
of eosinophils in the blood, or
excessive ADH release by the
pituitary gland
• urination disorders, dry mouth,
skin rash or itch, increased
sweating, swelling of the ankles
(oedema), convulsions, serotonin
syndrome, aggressive reaction,
decreased libido, withdrawal
syndrome
You may experience suicidal
thoughts / behaviour, although
the frequency cannot be
determined from available data
(see the section “Before you take
your Trazodone hydrochloride
capsules”).
If you suffer from any of these
unwanted side effects or any
other effects not mentioned in this
leaflet, please talk to your doctor.

Keep out of the reach and sight of
children.
Do not store above 25°C. Store in
the original package.

6. Further Information
Your medicine is available in two
strengths:
• Trazodone hydrochloride 50 mg
Capsules:
Each hard capsule contains 50 mg
trazodone hydrochloride as an
active ingredient. The capsules
are green-violet coloured and
are printed with ‘T50’.
Your medicine is available in
blister packs containing 84
capsules.
• Trazodone hydrochloride 100 mg
Capsules:
Each capsule contains 100 mg
trazodone hydrochloride as an
active ingredient. The capsules
are yellow-violet coloured and
are printed with ‘T100’.
Your medicine is available in
blister packs containing 56
capsules.
Both strengths contain the
following inactive ingredients:
lactose monohydrate, colloidal
anhydrous silica, magnesium
stearate, gelatin, titanium dioxide
(E171), yellow iron oxide (E172),
erythrosin (E127) and patent blue
V (E131). The 50 mg capsules also
contain indigo carmine (E132). The
printing ink also contains the
following ingredients: shellac,
propylene glycol, potassium
hydroxide and black iron oxide
(E172).
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-ArcoStrasse 3, D-89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-MerckleStrasse 3, D-89143 Blaubeuren,
Germany.
or
ratiopharm UK Ltd, 5 Jackson Close,
Grove Road, Cosham, Portsmouth,
Hampshire, UK PO6 1UP.

For a large print, audio,
Braille or CD-rom
version of this patient
information leaflet,
phone 02392 313592.
This leaflet was last approved:
July 2010.

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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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