DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

hydromorphone hydrochloride

Disponible desde:

Mundipharma Pty Ltd

Estado de Autorización:

Registered

Información para el usuario

DILAUDID
® ORAL LIQUID
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING DILAUDID?
DILAUDID contains the active ingredient hydromorphone hydrochloride.
DILAUDID is used for the short-term relief of severe pain for
which other treatment options have failed or otherwise unsuitable to
provide sufficient management of pain.
For more information, see Section 1. Why am I using DILAUDID? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DILAUDID?
Do not use if you have ever had an allergic reaction to hydromorphone
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
DILAUDID? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DILAUDID and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DILAUDID?
•
Your doctor will tell you exactly how much to take.
•
Follow the instructions given to you by your doctor or pharmacist
exactly.
•
You must only take DILAUDID Oral Liquid by mouth.
More instructions can be found in Section 4. How do I use DILAUDID? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DILAUDID?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
DILAUDID
•
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY OTHER MEDICINES
THAT YOU USE TO HELP YOU
RELAX, ANYTHING THAT CONTAINS ALCOHOL (LIKE COUGH SYRUP) OR OTHER
MEDICINES THAT TREAT PAIN.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not

Ficha técnica

DILAUDID
®
ORAL LIQUID and TABLETS
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – DILAUDID
®
(HYDROMORPHONE HYDROCHLORIDE) ORAL LIQUID AND TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, DILAUDID
preparations 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 _
DILAUDID preparations pose 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 DILAUDID
preparations. 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 DILAUDID preparations.
1
NAME OF THE MEDICINE
hydromorphone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DILAUDID
tablets, 2 mg contains hydromorphone hydrochloride 2 mg.
DILAUDID
tablets, 4 mg contains hydromorphone hydrochl