Prefibin 2mg sublingual tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
31-03-2023
Summary of Product characteristics
(SPC)
31-03-2023
Active ingredient:
Buprenorphine hydrochloride
Available from:
Sandoz Ltd
ATC code:
N07BC01
INN (International Name):
Buprenorphine hydrochloride
Dosage:
2mg
Pharmaceutical form:
Sublingual tablet
Administration route:
Sublingual
Class:
Schedule 3 (CD No Register)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04100300; GTIN: 5050650092028
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.
•
certain heart rhythm conditions (long QT
syndrome or prolonged QT interval)
•
low blood pressure
•
urinary disorders, especially due to enlarged
prostate in men
•
thyroid problems
•
disorder of the kidney cortex (e.g. Addison’s
disease)
•
bile problems
•
you are below 18 years or over 65 years old
In general, all patients have to undergo a liver test
prior to Prefibin therapy and your doctor may monitor
your
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prefibin 2 mg sublingual tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of buprenorphine (as hydrochloride).
Excipient(s) with known effect:
Each 2 mg sublingual tablet contains 69.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sublingual tablet.
White to off-white, oval tablet with a breaking notch on both sides
(9.4 x 4.0
mm).
The 2 mg and 8 mg tablets can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug dependence, within a framework
of
medical, social and psychological treatment.
Treatment is intended for use 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.
-
For patients dependent _ on heroin or s
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