Espranor 2 mg Oral Lyophilisate

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Buprenorphine hydrochloride

Saadav alates:

Martindale Pharmaceuticals Ltd

ATC kood:

N07BC; N07BC01

INN (Rahvusvaheline Nimetus):

Buprenorphine hydrochloride

Annus:

2 milligram(s)

Ravimvorm:

Oral lyophilisate

Retsepti tüüp:

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

Terapeutiline ala:

Drugs used in opioid dependence; buprenorphine

Volitamisolek:

Authorised

Loa andmise kuupäev:

2017-07-14

Infovoldik

3. Remove the wafer carefully from the foil and take
out from the packaging immediately.
4. Place the wafer on the tongue and close your
mouth. Allow it to remain there for a few seconds
until it has dissolved. Try to avoid swallowing during
the first 2 minutes.
Do not eat or drink for at least 5 minutes.
IF YOU TAKE MORE ESPRANOR THAN YOU SHOULD
Tell your doctor immediately or contact your nearest
hospital casualty department. Remember to take the
pack and any remaining wafers with you.
IF YOU FORGET TO TAKE ESPRANOR
You should tell your doctor and follow their
instructions. Do not take a double dose to make up for
the missed dose, unless your doctor tells you to.
IF YOU STOP TAKING ESPRANOR
Do not suddenly stop taking the wafers unless told
to do so by your doctor, as this may cause withdrawal
symptoms.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
LIKE ALL MEDICINES, THIS MEDICINE CAN CAUSE SIDE
EFFECTS, ALTHOUGH NOT EVERYONE GETS THEM.
For the first 24 hours of treatment, you may feel
uncomfortable with some mild opiate withdrawal
symptoms.
TELL YOUR DOCTOR IMMEDIATELY OR SEEK URGENT
MEDICAL ATTENTION if you experience uncommon side
effects, such as:
• swelling of the face, lips, tongue or throat which
may cause difficulty in swallowing or breathing,
severe hives/nettle rash. These may be signs of a
life-threatening allergic reaction.
• feeling sleepy and uncoordinated, have blurred
vision, have slurred speech, cannot think well or
clearly, or your breathing gets much slower than is
normal for you.
ALSO TELL YOUR DOCTOR IMMEDIATELY if you experience
uncommon side effects such as:
• severe tiredness, itching with yellowing of skin or
eyes. These may be symptoms of liver damage.
• seeing of hearing things that are not there
(hallucination)
Very common side effects (may effect more than 1 in
10 people) include:
Insomnia (inability to sleep), constipation, feeling
or being sick (nausea), sweating, headache, drug
withdrawal syndrome.
C

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Espranor 2 mg Oral Lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral lyophilisate contains 2 mg of buprenorphine (as
hydrochloride).
Each oral lyophilisate contains 0.50 mg aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate.
White to off-white circular oral lyophilisate with a diameter of 10.3
mm, debossed with ‘M2’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug dependence, within a framework
of medical, social and psychological treatment.
Treatment with Espranor oral lyophilisate is intended for use in
adults and adolescents aged 15 years or over who have
agreed to be treated for addiction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TREATMENT SHOULD BE UNDER THE SUPERVISION OF A CLINICIAN EXPERIENCED
IN THE MANAGEMENT OF OPIATE
DEPENDENCE/ADDICTION.
Administration is oromucosal. The oral lyophilisate should be taken
from the blister unit with dry fingers, and placed
whole on the tongue until dispersed, which usually occurs within 15
seconds, and then absorbed through the
oromucosa. Swallowing should be avoided for 2 minutes. The oral
lyophilisate should be taken immediately after
opening the blister. Patients should not consume food or drink for 5
minutes after administration.
Physicians must advise patients that the oromucosal route of
administration is the only effective and safe route
of administration for this medicinal
product. If the oral
lyophilisate,
or saliva containing buprenorphine are
swallowed, the buprenorphine will be metabolised and excreted and have
minimal effect.
Adults and adolescents aged 15 years or over
Precautions to be taken before induction:
Prior to treatment initiation, consideration should be given to the
type 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 buprenorphi