Zubsolv
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
10-10-2023
Fachinformation
(SPC)
10-10-2023
Öffentlichen Beurteilungsberichts
(PAR)
12-01-2018
Wirkstoff:
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate
Verfügbar ab:
Accord Healthcare S.L.U.
ATC-Code:
N07BC51
INN (Internationale Bezeichnung):
buprenorphine, naloxone
Therapiegruppe:
Other nervous system drugs
Therapiebereich:
Opioid-Related Disorders
Anwendungsgebiete:
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Produktbesonderheiten:
Revision: 10
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-11-10
Gebrauchsinformation
48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZUBSOLV 0.7 MG/0.18 MG SUBLINGUAL TABLETS
ZUBSOLV 1.4 MG/0.36 MG SUBLINGUAL TABLETS
ZUBSOLV 2.9 MG/0.71 MG SUBLINGUAL TABLETS
ZUBSOLV 5.7 MG/1.4 MG SUBLINGUAL TABLETS
ZUBSOLV 8.6 MG/2.1 MG SUBLINGUAL TABLETS
ZUBSOLV 11.4 MG/2.9 MG SUBLINGUAL TABLETS
buprenorphine/naloxone
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 Zubsolv is and what it is used for
2.
What you need to know before you take Zubsolv
3.
How to take Zubsolv
4.
Possible side effects
5.
How to store Zubsolv
6.
Contents of the pack and other information
1.
WHAT ZUBSOLV IS AND WHAT IT IS USED FOR
Zubsolv contains the active substances buprenorphine and naloxone.
Zubsolv is used to treat
dependence on opioid (narcotic) drugs such as heroin or morphine in
drug addicts who have agreed
to be treated for their addiction. Zubsolv is used in adults and
adolescents over 15 years of age,
who are also receiving medical, social and psychological support.
HOW ZUBSOLV WORKS
The tablet contains buprenorphine which is responsible for the
treatment of opioid (narcotic)
dependence. It also contains naloxone which is used to deter
intravenous abuse of the product.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZUBSOLV
DO NOT TAKE ZUBSOLV
IF YOU:
-
are allergic to buprenorphine, naloxone or any of the other
ingredients of this medicine
(listed in section 6)
-
have SERIOUS BREATHING PROBLEMS
-
have
SERIOUS LIVER PROBLEMS
-
are intoxicated due to alcohol or have trembling, sweating, anxiety
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zubsolv 0.7 mg/0.18 mg sublingual tablets
Zubsolv 1.4 mg/0.36 mg sublingual tablets
Zubsolv 2.9 mg/0.71 mg sublingual tablets
Zubsolv 5.7 mg/1.4 mg sublingual tablets
Zubsolv 8.6 mg/2.1 mg sublingual tablets
Zubsolv 11.4 mg/2.9 mg sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zubsolv 0.7 mg/0.18 mg sublingual tablets
Each 0.7 mg/0.18 mg sublingual tablet contains 0.7 mg buprenorphine
(as hydrochloride) and
0.18 mg naloxone (as hydrochloride dihydrate).
Zubsolv 1.4 mg/0.36 mg sublingual tablets
Each 1.4 mg/0.36 mg sublingual tablet contains 1.4 mg buprenorphine
(as hydrochloride) and
0.36 mg naloxone (as hydrochloride dihydrate).
Zubsolv 2.9 mg/0.71 mg sublingual tablets
Each 2.9 mg/0.71 mg sublingual tablet contains 2.9 mg buprenorphine
(as hydrochloride) and
0.71 mg naloxone (as hydrochloride dihydrate).
Zubsolv 5.7 mg/1.4 mg sublingual tablets
Each 5.7 mg/1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as
hydrochloride) and 1.4 mg
naloxone (as hydrochloride dihydrate).
Zubsolv 8.6 mg/2.1 mg sublingual tablets
Each 8.6 mg/2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as
hydrochloride) and 2.1 mg
naloxone (as hydrochloride dihydrate).
Zubsolv 11.4 mg/2.9 mg sublingual tablets
Each 11.4 mg/2.9 mg sublingual tablet contains 11.4 mg buprenorphine
(as hydrochloride) and
2.9 mg naloxone (as hydrochloride dihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
Zubsolv 0.7 mg/0.18 mg sublingual tablets
A white to off-white, oval tablet, length 6.8 mm and width 4.0 mm,
debossed with “.7” on one side.
Zubsolv 1.4 mg/0.36 mg sublingual tablets
A white to off-white, triangular tablet, base 7.2 mm and height 6.9
mm, debossed with “1.4” on one
3
side.
Zubsolv 2.9 mg/0.71 mg sublingual tablets
A white to off-white, D-shaped tablet, height 7.3 mm and width 5.65
mm, debossed with “2.9” on
one side.
Zubsolv 5.7 mg/1.4 mg sublingual tablets
A white to off-whit
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