Methadone - AFT

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Methadone hydrochloride 10mg

Saatavilla:

AFT Pharmaceuticals Ltd

Annos:

10 mg

Lääkemuoto:

Tablet

Koostumus:

Active: Methadone hydrochloride 10mg Excipient: Lactose monohydrate Magnesium stearate Starch

Prescription tyyppi:

Class B3 Controlled Drug

Käyttöaiheet:

Methadone is indicated for relief of severe pain. Methadone is sometimes used as an antitussive when severe pain is present, and coughing cannot be relieved by other means. Methadone is not recommended for obstetric analgesia because its long duration of action increases the risk of neonatal respiratory depression.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC foil heat sealed with Al foil - 10 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC foil heat sealed with Al foil - 20 tablets - 60 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle with child resistant screw cap - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Valtuutus päivämäärä:

2021-02-22

Pakkausseloste

Methadone-AFT
1
METHADONE-AFT
METHADONE HYDROCHLORIDE TABLETS 5 MG AND 10 MG
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Methadone-AFT.
This leaflet answers some common questions about
Methadone-AFT. 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 has
weighed the risks of you using Methadone-AFT against the
benefits they expect it will have for you.
If you have any concerns about using this medicine, ask
your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read
it again.
WHAT METHADONE-AFT IS USED FOR
Methadone-AFT contains the active ingredient methadone
hydrochloride which belongs to a group of medicines
called opioid analgesics.
Methadone-AFT is used for the treatment of severe pain
and treatment of dependence on opioid drugs.
Your doctor may have prescribed Methadone-AFT for
another reason.
Ask your doctor if you have any questions about why
Methadone-AFT has been prescribed for you.
This medicine is available only with a doctor's prescription.
You can become addicted to Methadone-AFT tablets even
if you take it exactly as prescribed. Methadone-AFT tablets
may become habit forming causing mental and physical
dependence. If abused, it may become less able to reduce
pain.
BEFORE YOU USE METHADONE-AFT
WHEN YOU MUST NOT USE IT
DO NOT USE METHADONE-AFT IF:
•
you have ever had an allergic reaction to methadone
hydrochloride (the active ingredient in Methadone-
AFT tablets); any other opioid drug; or any of the
ingredients listed at the end of this leaflet.
•
you have:
- respiratory depression
- bronchial asthma
- alcoholism
- head injury and raised intracranial pressure
•
you are taking or have recently taken (within 14 days)
antidepressants of the type called monoamine oxidase
inhibitors (MAOIs)
•
you suffer from ulcerative colitis
•
you suffer from hepatic impairment
•
you suffer fr

Valmisteyhteenveto

1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Methadone – AFT tablets, 5 mg and 10 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methadone hydrochloride is a synthetic opioid analgesic with the
general properties of
morphine.
5 mg tablets: Methadone-AFT tablets contain methadone hydrochloride 5
mg
10 mg tablets: Methadone-AFT tablets contain methadone hydrochloride
10 mg
Excipients with known effect: lactose monohydrate
For the full list of excipients, see 6.1 List of excipients
3
PHARMACEUTICAL FORM
Methadone-AFT tablets are white coloured round-shaped tablets with
“5” (for 5 mg
tablets) or “10” (for 10 mg tablets) marking on one side and
score-line on other side. The
tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methadone-AFT is indicated for:
The treatment of severe pain
Methadone is indicated for relief of severe pain. Methadone is
sometimes used as an
antitussive when severe pain is present, and coughing cannot be
relieved by other means.
Methadone is not recommended for obstetric analgesia because its long
duration of
action increases the risk of neonatal respiratory depression.
The treatment of dependence on opioid drugs
Methadone is indicated as a suppressant to permit detoxification. Oral
Methadone is also
indicated as maintenance therapy to discourage addicts from returning
to illicit use of
other opioid drugs.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment of severe pain
Starting oral doses of Methadone may range from 5 to 10 mg given every
6 to 8 hours or
longer and thereafter adjusted as necessary.
Treatment of dependence on opioid drugs
A dose of 10 to 20 mg by mouth may be given initially and increased as
necessary by 5 to
10 mg daily. The dose must not be increased by more than 5 to 10 mg
daily, and by no
2
more than 30 mg in any 7-day period. After stabilisation, which can
often be achieved
with a dose of 30 to 50 mg daily (up to a maximum of 80 mg daily), the
dose of Methadone
is gradually decreased until total withdrawal is achieved. Some
treatm