Prefibin 0.4mg sublingual tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-07-2022
Summary of Product characteristics
(SPC)
01-07-2022
Active ingredient:
Buprenorphine hydrochloride
Available from:
Sandoz Ltd
ATC code:
N02AE01
INN (International Name):
Buprenorphine hydrochloride
Dosage:
400microgram
Pharmaceutical form:
Sublingual tablet
Administration route:
Sublingual
Class:
Schedule 3 (CD No Register)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070200; GTIN: 5050650092011
Patient Information leaflet
Prefibin is used to treat
•
OPIOID DEPENDENCE.
Prefibin is part of a medical, social and psychological
treatment programme for patients addicted to opiate
(narcotic) drugs. Treatment is prescribed and monitored
by doctors who are specialists in the treatment of drug
dependence.
Treatment with Prefibin is intended for use in adults
and adolescents aged 15 years and over.
DO NOT TAKE PREFIBIN
if you are/have
•
allergic to:
- buprenorphine or
- any of the other ingredients of this medicine
(listed in section 6)
•
serious breathing problems
•
serious liver problems
•
intoxicated due to alcohol
•
or have trembling, sweating, anxiety confusion or
hallucinations caused by alcohol
•
under 15 years of age
•
breast-feeding a baby
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Prefibin if any of the following apply to you:
•
breathing problems such as asthma
You must not use Prefibin if you have
serious breathing problems.
•
recent head injury or brain disease
•
have had fits (seizures)
•
reduced kidney function
•
reduced liver function
Acute liver problems have been reported which
could be due to:
- misuse, especially through administration into a
vein and at a high dose
- previous existing liver problems
- viral infections, such as hepatitis B or hepatitis C
- alcohol abuse
- anorexia
- liver damaging medicines
Inform your doctor immediately if you experience
symptoms of liver problem such as severe fatigue,
itching and yellow skin or eyes. You can then receive
the proper treatment.
However, you must not use Prefibin if you have a
serious liver disease.
•
low blood pressure
•
a urinary disorders (especially linked to enlarged
prostate in men)
•
thyroid problems
•
disorder of the kidney cortex (e.g. Addison’s disease)
•
bile problems
•
depression or other conditions that are treated
with antidepressants
The use of these medicines together with Prefibin
can lead to serotonin syndrome, a potentially
life-threatening condition (see “Other medicines and
Prefib
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prefibin 0.4 mg sublingual tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.4 mg of buprenorphine (as buprenorphine
hydrochloride).
Excipient(s) with known effect:
Each 0,4 mg sublingual tablet contains 42.5 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sublingual tablet.
White to off-white, round, biplane tablet with facet and one-sided
ornamental notch
(diameter: approximately 5.0 mm).
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug dependence, within a framework
of medical,
social and psychological treatment.
Prefibin is indicated in adults and adolescents aged 15 years and over
who have
agreed to be treated for addiction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be under the supervision of a physician experienced in
the
management of opiate dependence/addiction.
The result of the treatment depends on the dose prescribed as well as
on the combined
medical, psychological, social and educational measures taken in
monitoring the
patient.
Precautions to be taken before dosing
Prior to treatment induction, physicians should be aware of the
partial agonist profile
of buprenorphine to the opiate receptors, which may precipitate a
withdrawal
syndrome in opioid-dependent patients.
Baseline liver function tests and documentation of viral hepatitis
status is
recommended prior to commencing therapy.
Consideration should be given to the types of opioid dependence (i.e.
long- or short-
acting opioid), the time since last opioid use and the degree of
opioid dependence. To
avoid precipitating withdrawal, induction with buprenorphine should be
undertaken
when objective and clear signs of withdrawal are evident, e.g. a score
higher than 12
on the Clinical Opioid Withdrawal Scale (COWS).
Posology
The initial dose is from 0.8 mg to 4 mg, administered as a single
daily dose.
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