Methadone Alkaloid 1 mg/ml oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METHADONE HYDROCHLORIDE

Available from:

Alkaloid-INT d.o.o. Šlandrova ulica 4, 1231 Ljubljana-Crnuce, Slovenia

ATC code:

N07BC02

INN (International Name):

METHADONE HYDROCHLORIDE 1 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

METHADONE HYDROCHLORIDE 1 mg/ml

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Authorised

Authorization date:

2019-06-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHADONE ALKALOID 1 MG/ML ORAL SOLUTION
Methadone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Methadone Alkaloid is and what it is used for
2. What you need to know before you take Methadone Alkaloid
3. How to take Methadone Alkaloid
4. Possible side effects
5. How to store Methadone Alkaloid
6. Contents of the pack and other information
1.
WHAT METHADONE ALKALOID IS AND WHAT IT IS USED FOR
This medicine contains methadone hydrochloride, which belongs to a
group of medicines called narcotic
analgesics. It is used as part of the treatment of opioid addiction.
All patients receiving Methadone Alkaloid must be routinely monitored
for signs of misuse, abuse, and
addiction during treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHADONE ALKALOID
DO NOT TAKE METHADONE ALKALOID IF:
-
you are allergic to methadone or any of the other ingredients of this
medicine (listed in section 6). An
allergic reaction includes a rash, itching or shortness of breath;
-
you are having an asthma attack. You should not use this medicine
during an asthma attack. If you give
this medicine to yourself (self-administration), wait until the asthma
attack has passed and you are fully
recovered;
-
your breathing is very slow or shallow (respiratory depression);
-
you are addicted to alcohol;
-
you have suffered a recent head injury or have an increased pressure
in the brain;
-
you are taking monoamine oxidase inhibitors (MAOIs) used to treat
depression or if you

Summary of Product characteristics

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methadone Alkaloid 1 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of the oral solution contains 1 mg of methadone
hydrochloride.
Excipients with known effect:
Sorbitol (E420): 21.0 mg per 1 ml
Sodium Benzoate (E211): 3.0 mg per 1 ml
Sunset Yellow FCF (E110): 0.009 mg per 1ml
Each 1 ml of the oral solution contains 0.478 mg (0.021 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear green solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Substitution therapy for maintenance of opioid dependence in adults in
conjunction with appropriate
medical, social and psychosocial care.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral administration only.
This medicinal product should always be taken orally with or without
food.
This product must not be injected.
Dosage should be titrated to individual needs of patients. Local
clinical guidance may differ from the
posology described hereafter and should be followed.
Substitution treatment with methadone should be prescribed by a doctor
with experience in treating
opiate/opioid-dependent patients, preferably at centres that have
specialised in the treatment of opiate/opioid
dependency.
The dose is administered exclusively by the doctor or someone
appointed by the doctor. The amount to be
taken is never measured by the patient. The appropriate dose is given
to the patient for immediate use only
and used as directed by the doctor.
Page 2 of 15
The dose is based on the occurrence of withdrawal symptoms and must be
adjusted for each patient
according to his or her individual situation and the way he or she
feels. In general, after adjustment of the
dose, the aim is to administer the lowest possible maintenance dose.
_Adults_
In general the initial dose will be between 10-30 mg. The first dose
given to a patient who has not recently
used opioids should be no greater than 10-20 mg. In cases where
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