Dolased Forte (paracetamol 450 mg, codeine phosphate hemihydrate 30 mg, doxylamine succinate 5 mg) tablets blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

codeine phosphate hemihydrate, Quantity: 30 mg; doxylamine succinate, Quantity: 5 mg; paracetamol, Quantity: 450 mg

Dostopno od:

Aspen Pharmacare Australia Pty Ltd

INN (mednarodno ime):

codeine phosphate hemihydrate,doxylamine succinate,Paracetamol

Farmacevtska oblika:

Tablet, uncoated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

2, 20 & 40

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Dolased Forte is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Povzetek izdelek:

Visual Identification: Round, flat, white, uncoated, bevelled edge tablets with a break-bar on one side and 'T' embossed below the break-bar.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2013-12-18

Navodilo za uporabo

August 2020
Page 1 of 4
DOLASED FORTE
_Paracetamol, codeine phosphate, doxylamine succinate_
CONSUMER MEDICINE INFORMATION
WARNINGS
_LIMITATIONS OF USE _
Dolased Forte 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 Forte 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 Forte 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 Forte 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 FORTE _
Using Dolased Forte 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 Forte.
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Dolased Forte 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 Forte
against the benefits they expect it will
have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to re

Lastnosti izdelka

Dolased Forte-PI-25sep20
1
AUSTRALIAN PRODUCT INFORMATION
DOLASED FORTE (PARACETAMOL, CODEINE PHOSPHATE
HEMIHYDRATE, DOXYLAMINE SUCCINATE) TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Dolased Forte
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 Forte tablets 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 Forte tablets. 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,
tricyclic 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 Forte
tablets.
Dolased Forte-PI-25sep20
2
1
NAME OF THE MEDICINE
Paracetamol, codeine phosphate hemihydrate and doxylamine succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
List of excipients with known effect: Contains sugars as lactos