KAPANOL morphine sulfate pentahydrate 10 mg capsule blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

morphine sulfate pentahydrate, Quantity: 10 mg

Tilgjengelig fra:

Mayne Pharma International Pty Ltd

Legemiddelform:

Capsule, modified release

Sammensetning:

Excipient Ingredients: purified talc; purified water; maize starch; Gelatin; sucrose; methacrylic acid copolymer; ethylcellulose; hypromellose; macrogol 6000; diethyl phthalate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administreringsrute:

Oral

Enheter i pakken:

20 capsules, 28 capsules, 60 capsules

Resept typen:

(S8) Controlled Drug

Indikasjoner:

Management of Severe Pain KAPANOL 10, 20, 50 and 100 mg capsules are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. KAPANOL is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. KAPANOL is not indicated as an as-needed (PRN) analgesia.,Symptom Reduction of Chronic Breathlessness KAPANOL 10 and 20 mg capsules are indicated for the symptomatic reduction of chronic breathlessness in the palliative care of patients with distressing breathlessness due to severe COPD, cardiac failure, malignancy or other cause. KAPANOL should only be used after treatments for the underlying cause(s) of the breathlessness have been optimised and nonpharmacological treatments are not effective. Treatment with KAPANOL in this setting should only be initiated by a specialist knowledgeable in its use.

Produkt oppsummering:

Visual Identification: Hard gelatin caps, size 4, natural cap & natural body, printed K10 in black on cap & discontinuous black band printed on body, containing creamy-white to light tan spheroidal pellets.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

1999-03-31

Informasjon til brukeren

KAPANOL®
1
KAPANOL®
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 KAPANOL?
KAPANOL contains the active ingredient morphine sulfate pentahydrate.
KAPANOL 10, 20, 50 and 100 mg capsules are used for
the relief of severe pain which is opioid-responsive. KAPANOL 10 and
20 mg capsules are also used for the relief of distressing
chronic breathlessness in the palliative care of patients with severe
chronic obstructive pulmonary disease (COPD), cardiac
failure, malignancy or other causes. For more information, see Section
1. Why am I using KAPANOL?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KAPANOL?
Do not use if you have ever had an allergic reaction to morphine
sulfate pentahydrate 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 KAPANOL?
in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KAPANOL 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 KAPANOL?
Pellets in KAPANOL capsules must be swallowed whole and taken either
once (every 24 hours) or twice (every 12 hours) daily.
The amount of KAPANOL needed varies. The doctor will choose your dose
and how often to take it. More instructions can be
found in Section 4. How do I use KAPANOL?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KAPANOL?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, pharmacist, surgeon or anaesthetist you
visit that you are
using KAPANOL.
•
Tell your doctor if you become pregnant or are trying to become
pregnant and

Preparatomtale

v 8.0
1
AUSTRALIAN PRODUCT INFORMATION
KAPANOL
® (MORPHINE SULFATE PENTAHYDRATE) MODIFIED
RELEASE CAPSULES
WARNINGS
LIMITATIONS OF USE IN SEVERE PAIN
Because of the risks associated with the use of opioids, KAPANOL
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_
). For full therapeutic indications see
_section 4.1 Therapeutic Indications_
.
HAZARDOUS AND HARMFUL USE
KAPANOL 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
KAPANOL. 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 KAPANOL.
1.
NAME OF THE MEDICINE
Morphine sulfate pentahydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KAPANOL capsules 10, 20, 50 and 100 mg contain identical
polymer-coated sustained-
release pellets of morphine sulfate pentah