Trazodone 50mg capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Trazodone hydrochloride

Доступно од:

Advanz Pharma

АТЦ код:

N06AX05

INN (Међународно име):

Trazodone hydrochloride

Дозирање:

50mg

Фармацеутски облик:

Oral capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04030100; GTIN: 05060064792919

Информативни летак

TRAZODONE 50MG & 100MG CAPSULES
Trazodone hydrochloride
Package leaflet: Information for the user
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 red and lumpy skin rash, swallowing or breathing
problems, swelling of your eyelids, lips, face, throat or tongue,
unexplained high temperature (fever) and feeling faint
•
if you have recently had a heart attack
•
if you are a heavy drinker or if you are taking sleeping capsules
•
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 P

Карактеристике производа

OBJECT 1
TRAZODONE 50MG CAPSULES
Summary of Product Characteristics Updated 01-Aug-2018 | ADVANZ Pharma
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1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Trazodone 50 mg Capsules
2. Qualitative and quantitative composition
Each capsule contains 50mg of trazodone hydrochloride
Excipient with known effect
Each capsule contains 77.660 mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
4. Clinical particulars
4.1 Therapeutic indications
Relief of symptoms in all types of depression, including accompanied
by anxiety.
4.2 Posology and method of administration
Posology
DEPRESSION:
Adults:
Initially 150mg/day in divided doses after food or as a single dose on
retiring.
This may be increased up to 300mg/day in single or divided doses. The
major portion of a divided dose to
be taken on retiring. The dose may be further increased to 600mg/day
in divided doses in hospitalised
patients.
Elderly:
For very elderly or frail pat