Stresam capsule

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Werkstoffen:

ETIFOXINE HYDROCHLORIDE

Beschikbaar vanaf:

Biocodex 7 Avenue Gallieni- 94250 Gentilly, France

ATC-code:

N05BX03

INN (Algemene Internationale Benaming):

ETIFOXINE HYDROCHLORIDE 50 mg

farmaceutische vorm:

CAPSULE

Samenstelling:

ETIFOXINE HYDROCHLORIDE 50 mg

Prescription-type:

POM

Therapeutisch gebied:

PSYCHOLEPTICS

Autorisatie-status:

Authorised

Autorisatie datum:

2006-02-28

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STRESAM 50 MG, CAPSULE
_ETIFOXINE HYDROCHLORIDE _
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 effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET
1 What STRESAM 50 mg, capsule is and what it is used for
2 What you need to know before you take STRESAM 50 mg, capsule
3 How to take STRESAM 50 mg, capsule
4 Possible side effects
5 How to store STRESAM 50 mg, capsule
6 Contents of the pack and other information
1 WHAT STRESAM 50 MG, CAPSULE IS AND WHAT IT IS USED FOR
PHARMACOTHERAPEUTIC CLASS
ANXIOLYTIC
THERAPEUTIC INDICATIONS
This drug is recommended to decrease the various emotional and body
reactions which accompany
the anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STRESAM 50 MG, CAPSULE
If your doctor has informed you that you suffer from intolerance to
some sugars, contact him/her
before taking this medicine.
DO NOT TAKE STRESAM 50 MG, CAPSULE:
•
If you are in state of shock
•
If you suffer from severe hepatic insufficiency _ _
•
If you suffer from severe renal insufficiency _ _
•
If you suffer from myasthenia _ _
•
If you have had severe liver problems, such as inflammation of the
liver (hepatitis) or
cytolytic hepatitis, during previous treatment with STRESAM
_ _
•
If you have had severe skin reactions during previous treatment with
STRESAM
_ _
_WHEN IN DOUBT ASK YOUR PHYSICIAN OR YOUR PHARMACIST FOR ADVICE. _
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WARNINGS AND PRECAUTIONS
SPECIAL WARNINGS
Talk to your doctor or pharmacist BEFORE TAKING STRESAM, CAPSULE.
•
In case of allergic or cutaneous reactions, or of severe hepatic
trouble, the treatment w

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
STRESAM
®
, capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etifoxine hydrochloride
............................................................................................................
0.05 g
For one capsule.
Other ingredient: lactose
For the complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stresam is indicated for the treatment of psychosomatic manifestations
of anxiety.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Usually 3 to 4 capsules a day, taken as 2 or 3 divided doses.
Treatment duration: a few days to a few weeks.
METHOD OF ADMINISTRATION
Swallow the capsules with a little amount of water.
4.3
CONTRAINDICATIONS
-
hypersensitivity to the active ingredient or to any of the excipient
listed in section 6.1.
- states of shock,
-
severely impaired liver and/or renal function,
-
myasthenia.
- patients who have had severe cases of hepatitis or cytolytic
hepatitis, during previous
treatment with etifoxine;
- patients who have had severe dermatological reactions, including
DRESS syndrome,
Stevens Johnson Syndrome (SJS) and dermatitis exfoliative generalized,
during previous
treatment with etifoxine.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
WARNING
Because of the presence of lactose, this medicine is contraindicated
in patients with lactase
deficit.
Severe dermatological reactions
Severe
dermatological
reactions,
including
Drug
Rash
with
Eosinophilia
and
Systemic
Symptoms (DRESS) syndrome, Stevens Johnson Syndrome (SJS) and
dermatitis exfoliative
generalized, have been reported with etifoxine with a very rare
frequency. The onset of skin
toxicity with STRESAM usually ranged from a few days to 1 month,
depending on the
reactions. As per post-marketing data, outcome of skin reactions is
mostly favorable after
etifoxine withdrawal. No fatal outcome due to severe cutaneous adverse
reactions has been
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reported with etifoxine. Pati