Methadone 1mg/ml oral solution sugar free

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Methadone hydrochloride

Dostupné s:

Thornton & Ross Ltd

ATC kód:

N07BC02

INN (Mezinárodní Name):

Methadone hydrochloride

Dávkování:

1mg/1ml

Léková forma:

Oral solution

Podání:

Oral

Třída:

Schedule 2 (CD)

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04100300; GTIN: 5011309872811

Informace pro uživatele

_Data Matrix:_
_ _
22908108 VERIFIED
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
500ml
22908108
210mm x 297mm flat (105mm x 148mm folded)
2
29.06.2016
Methadone 1mg/ml Oral Solution B.P.
Sugar Free
Yes
A
gill.kennedy
669242
12799
Spelling correction of “carba-
mezapine” to “carbamazepine”.
PIQU submission.
Times New Roman
Process Black
Keyline (non-printing)
MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
500ml
22908108
210mm x 297mm flat (105mm x 148mm folded)
2
29.06.2016
Methadone 1mg/ml Oral Solution B.P.
Sugar Free
Yes
A
gill.kennedy
669242
12799
Spelling correction of “carba-
mezapine” to “carbamazepine”.
PIQU submission.
Times New Roman
Process Black
Keyline (non-printing)
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
• This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
pharmacist.
• If any of the side effects become serious, or if you notice any
side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET
1. What is the medicine and what does it do?
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. How to store the medicine
6. Further information
1. WHAT IS THE MEDICINE AND
WHAT DOES IT DO?
The name of your medicine is Methadone 1mg/ml Oral Solution B.P.
Sugar Free. It is a solution to be swallowed and is intended for adult
use only.
WHAT IS IT FOR?
The product works to prevent withdrawa

Charakteristika produktu

OBJECT 1
METHADONE 1MG/ML ORAL SOLUTION BP - SUGAR
FREE
Summary of Product Characteristics Updated 21-Apr-2015 | Thornton &
Ross Ltd
1. Name of the medicinal product
Methadone 1mg/ml Oral Solution BP - Sugar Free.
2. Qualitative and quantitative composition
Methadone Hydrochloride 1mg/ml.
For excipients, see 6.1
3. Pharmaceutical form
An oral solution, which is a green coloured free flowing mobile
liquid.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of dependence on opioid drugs.
4.2 Posology and method of administration
_Adults_
10 – 20mg (10 – 20ml) should be taken as an initial daily dose by
oral administration. The dose should
be increased cautiously by 10 – 20mg daily until no signs of
withdrawal or intoxication occur. The usual
dose for maintenance is 40 – 60mg daily. The dose can then be
gradually decreased, when appropriate,
until total withdrawal is achieved.
_Elderly_
Methadone 1mg/ml Oral Solution B.P. - Sugar Free, should be used
cautiously in elderly patients.
_Children_
Not recommended for use in children.
4.3 Contraindications
• Hypersensitivity to methadone or to any of the excipients.
• Respiratory depression, obstructive airways disease and during an
acute asthma attack_,_
• Patients dependent on non-opioid drugs,
• Concurrent administration with monoamine oxidase inhibitors
(including moclobemide) or within 2
weeks of discontinuation of them.
• Head injury and raised intracranial pressure (further rise in
intracranial pressure – papillary response
affected; see section 4.8).
• Where there is a risk of paralytic ileus.
• Acute alcoholism (see section 4.5).
• Use during labour (prolonged duration of action increases the risk
of neonatal depression).
• Children (serious risk of toxicity).
4.4 Special warnings and precautions for use
In the case of elderly or ill patients, repeated doses should only be
given with extreme caution.
Methadone is a drug of addiction and is controlled under the Misuse of
Drugs Act 1971 (Schedule 2).
Tolerance and dependenc