DOLASED tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

codeine phosphate hemihydrate, Quantity: 10 mg; doxylamine succinate, Quantity: 5.1 mg; paracetamol, Quantity: 499.95 mg

Доступна с:

Aspen Pharmacare Australia Pty Ltd

ИНН (Международная Имя):

codeine phosphate hemihydrate,doxylamine succinate,Paracetamol

Фармацевтическая форма:

Tablet, uncoated

состав:

Excipient Ingredients: lactose monohydrate; magnesium stearate; crospovidone; povidone; stearic acid; self-emulsifying glyceryl monostearate; pregelatinised maize starch

Администрация маршрут:

Oral

Штук в упаковке:

20, 40

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

For the temporary relief of acute moderate pain and fever

Обзор продуктов:

Visual Identification: A white, 17.0 mm x 6.7 mm biconvex capsule shaped tablet; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Registered

Дата Авторизация:

2008-12-15

тонкая брошюра

Dolased – Consumer Medicine Information
Page 1 of 4
DOLASED
Paracetamol, Codeine Phosphate Hemihydrate and Doxylamine Succinate
tablets
CONSUMER MEDICINE INFORMATION
WARNINGS
_LIMITATIONS OF USE _
Dolased should only be used when your doctor decides that other
treatment options are
not able to effectively manage your pain or you cannot tolerate them
_HAZARDOUS AND HARMFUL USE _
Dolased poses risks of abuse, misuse and addiction which can lead to
overdose and
death. Your doctor will monitor you regularly during treatment.
_LIFE THREATENING RESPIRATORY DEPRESSION _
Dolased can cause life-threatening or fatal breathing problems (slow,
shallow, unusual
or no breathing).even when used as recommended. These problems can
occur at any
time during use, but the risk is higher when first starting Dolased
and after a dose
increase, if you are older, or have an existing problem with your
lungs. Your doctor will
monitor you and change the dose as appropriate
_ USE OF OTHER MEDICINES WHILE USING DOLASED _
Using Dolased with other medicines that can make you feel drowsy such
as sleeping
tablets (e.g. benzodiazepines), other pain relievers, antihistamines,
antidepressants,
antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin),
cannabis and alcohol
may result in severe drowsiness, decreased awareness, breathing
problems, coma and
death. Your doctor will minimise the dose and duration of use; and
monitor you for signs
and symptoms of breathing difficulties and sedation. You must not
drink alcohol while
using Dolased
Dolased – Consumer Medicine Information
Page 2 of 4
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about _ Dolased_. It does
not
contain
all
the
available
information.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
_Dolased _ against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMAC

Характеристики продукта

Dolased-pi-27nov20
1
AUSTRALIAN PRODUCT INFORMATION
DOLASED
(PARACETAMOL, CODEINE PHOSPHATE HEMIHYDRATE,
DOXYLAMINE SUCCINATE) TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Dolased
should only be used
in patients for whom other treatment options, including non-opioid
analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management
of pain (see section 4.4 Special Warnings and Precautions for Use).
_HAZARDOUS AND HARMFUL USE _
Dolased poses risks of hazardous and harmful use which can lead to
overdose and
death. Assess the patient’s risk of hazardous and harmful use before
prescribing and
monitor the patient regularly during treatment (see section 4.4.
Special Warnings and
Precautions for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of
Dolased. Be aware of situations which increase the risk of respiratory
depression,
modify dosing in patients at risk and monitor patients closely,
especially on initiation
or following a dose increase (see section 4.4 Special Warnings and
Precautions for
Use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines,
tricylic antidepressants, antipsychotics, cannabis or other central
nervous system
(CNS) depressants, including alcohol, may result in profound sedation,
respiratory
depression, coma, and death. Limit dosages and durations to the
minimum required;
and monitor patients for signs and symptoms of respiratory depression
and sedation.
Caution patients not to drink alcohol while taking Dolased.
1
NAME OF THE MEDICINE
Dolased Paracetamol, codeine phosphate hemihydrate and doxylamine
succinate
tablets
Dolased-pi-27nov20
2
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dolased tablet contains paracetamol 500 mg, codeine phosphate
hemihydrate
10 mg, doxylamine succinate 5.1 mg.