Addictex 2mg sublingual Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUPRENORPHINE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N07BC01

INN (International Name):

BUPRENORPHINE 2 mg

Pharmaceutical form:

SUBLINGUAL TABLET

Composition:

BUPRENORPHINE 2 mg

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Withdrawn

Authorization date:

2013-10-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

ADDICTEX 0.4 MG SUBLINGUAL TABLETS 
ADDICTEX 2 MG SUBLINGUAL TABLETS 
ADDICTEX 8 MG SUBLINGUAL TABLETS 
buprenorphine 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
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. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Addictex is and what it is used for 
2. 
Before you take Addictex  
3. 
How to take Addictex 
4. 
Possible side effects 
5. 
How to store Addictex 
6. Further 
information 

1. 
WHAT ADDICTEX IS AND WHAT IT IS USED FOR 

Addictex is a medicinal product used in opioid (narcotic)
dependence. 

Addictex sublingual tablets are used as a part of a medical, social
and psychological treatment 
programme for patients addicted to opiate (narcotic) drugs. A
sublingual tablet is a tablet that is 
placed under your tongue and allowed to dissolve.  

Treatment is prescribed and monitored by physicians who are
specialists in the treatment of drug 
dependence. 

Treatment with Addictex sublingual tablets is intended for use in
adults and adolescents over 15 
years of age. 

2. 
BEFORE YOU TAKE ADDICTEX 

DO NOT TAKE ADDICTEX 
- 
if you are allergic (hypersensitive) to buprenorphine or any of the
other ingredients of 
Addictex (see section 6 for a list of ingredients). 
- 
if you have serious breathing problems. 
- 
if you have serious problems with your liver. 
- 
if you are intoxicated due to alcohol or have delirium tremens (the
“shakes” and 
hallucinations). 

TAKE SPECIAL CARE WITH ADDICTEX 
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Tell your doctor if you have any of the

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Addictex 0.4 mg sublingual tablets 
Addictex 2 mg sublingual tablets 
Addictex 8 mg sublingual tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each sublingual tablet contains 0.4 mg of buprenorphine (as
buprenorphine hydrochloride). 
Excipient: Each tablet contains 63.6 mg of lactose monohydrate.  

Each sublingual tablet contains 2 mg of buprenorphine (as
buprenorphine hydrochloride). 
Excipient: Each tablet contains 43.9 mg of lactose monohydrate and
0.19 mg of sunset yellow 
(E110).  

Each sublingual tablet contains 8 mg of buprenorphine (as
buprenorphine hydrochloride). 
Excipient: Each tablet contains 175.6 mg of lactose monohydrate and
0.76 mg of sunset yellow 
(E110). 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Sublingual tablet. 

0.4 mg: Uncoated, white or almost white, 6 mm round, flat tablets
with “B” on one side. 
2 mg: Uncoated, light orange, 5x8 mm oval, biconvex tablets with
“B” on one side. 
8 mg: Uncoated, light orange, 7.35x13.35 mm oval, biconvex tablets
with “B” 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. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

TREATMENT MUST BE UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN
THE MANAGEMENT OF 
OPIATE DEPENDENCE/ADDICTION. 

Treatment with buprenorphine sublingual tablets is intended for use in
adults and adolescents aged 
over 15 years who have agreed to be treated for addiction. 

When initiating buprenorphine treatment, the physician should be aware
of the partial agonist 
profile of buprenorphine and that it can precipitate withdrawal
symptoms in opioid-dependent 
patients. Buprenorphine binds to the µ (mu) and κ (kappa) opiate
receptors. 
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