Methadone Mixture DTF (Sugar Free) 1 mg in 1 ml Oral Solution

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Methadone hydrochloride

Disponibbli minn:

Martindale Pharmaceuticals Ltd

Kodiċi ATC:

N07BC; N07BC02

INN (Isem Internazzjonali):

Methadone hydrochloride

Dożaġġ:

1 milligram(s)/millilitre

Għamla farmaċewtika:

Oral solution

Tip ta 'preskrizzjoni:

Product subject to prescription which may not be renewed (A)

Żona terapewtika:

Drugs used in opioid dependence; methadone

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1996-01-26

Fuljett ta 'informazzjoni

100MM MEASUREMENT VERIFICATION BAR
100MM MEASUREMENT VERIFICATION BAR
D04404
D04404
4404-D
WHAT IS IN THIS LEAFLET
1.
What Methadone Mixture (Sugar Free) is and what it is
used for
2. What you need to know before you take Methadone
Mixture (Sugar Free)
3. How to take Methadone Mixture (Sugar Free)
4. Possible side effects
5. How to store Methadone Mixture (Sugar Free)
6. Contents of the pack and other information
1.
WHAT METHADONE MIXTURE (SUGAR FREE) IS AND
WHAT IT IS USED FOR
Methadone is a synthetic opiate (a morphine-like drug) used
in the treatment of addiction in order to reduce withdrawal
symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METHADONE MIXTURE (SUGAR FREE)
DO NOT TAKE METHADONE MIXTURE (SUGAR FREE) IF:
•
You are allergic to methadone or any of the ingredients of
this medicine ( listed in section 6).
•
You have any problem with your breathing, any chronic lung
disease or have an asthma attack.
•
You are addicted to alcohol.
•
You have a head injury and the pressure inside your brain is
higher than it should be (check this with your doctor). You
might be getting bad headaches.
•
You are taking, or have recently stopped taking , a type of
medicine called Monoamine Oxidase Inhibitors (MAOIs) ,
including moclobemide which are used to treat depression,
within the past two weeks.
• You are taking central nervous systems (CNS) depressants
(medicines that dull the senses including tranquillisers,
sedatives and antidepressants)
•
You are in labour.
•
You have a bowel problem called ulcerative colitis.
•
You are dependent on other non-opioid drugs.
•
You have severe liver disease.
•
You suffer from sudden involuntary muscle contraction of
the bile ducts and kidney.
CHILDREN AND ADOLESCENTS
Methadone Mixture (Sugar Free) is not suitable for children
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Methadone
Mixture (Sugar Free) if:
•
You are extremely ill or an older person. You may be more
sensitive to the medicine.
•
You have history of asthma or breathi

Karatteristiċi tal-prodott

Health Products Regulatory Authority
14 March 2019
CRN008JZ6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methadone Mixture DTF (Sugar Free) 1 mg in 1 ml Oral Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains methadone hydrochloride 1 mg.
Excipients with known effect
Sunset yellow (E110) 0.008 mg/ml
Liquid maltitol (E965) 0.4 ml/ml
Sodium Benzoate (E211) 1.2 mg/ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
A clear, green solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of opioid addiction as substitution or maintenance
therapy, within a broader treatment protocol/program,
accompanied by regular reviews and reassessment. This treatment must
be supervised by specialist services.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosing and duration should be individualised based on a careful
evaluation of subjective and patient data, bearing in mind
clinical status, including hepatic or renal function of the patient.
Addition:
Adults: Initially 10 – 20 mg per day, increasing by 10 - 20 mg per
day until there are no signs of withdrawal or intoxication. The
usual dose is 40-60mg per day.
The dose is adjusted according to the degree of dependence with the
aim of gradual reduction.
Elderly:
In the case of elderly or ill patients repeated doses should only be
given with extreme caution.
Paediatric population:
Not recommended for children.
Dosage in pregnancy:
Drug withdrawal needs to be achieved 4-6 weeks before delivery if
neonatal abstinence syndrome is to be certain to be
avoided, but abrupt withdrawal can cause intrauterine death.
Detoxification to abstinence is least stressful to mother and
foetus if undertaken during the mid-trimester.
Abstinence syndrome may not occur in the neonate for some days after
birth. In the event that withdrawal is not possible prior
to delivery, methadone administered to the mother may result in
prolonged respiratory depression in the neonate and the
administra