Sedoxil 1mg Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-10-2023
Summary of Product characteristics
(SPC)
01-10-2023
Active ingredient:
MEXAZOLAM
Available from:
Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
ATC code:
N05BA
INN (International Name):
MEXAZOLAM 1 mg
Pharmaceutical form:
TABLET
Composition:
MEXAZOLAM 1 mg
Prescription type:
POM
Therapeutic area:
PSYCHOLEPTICS
Authorization status:
Authorised
Authorization date:
2005-10-18
Patient Information leaflet
SEDOXIL
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 further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you personally and you should
not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
IN THIS LEAFLET
:
1.
What SEDOXIL is and what it is used for
2.
Before you take SEDOXIL
3.
How to take SEDOXIL
4.
Possible side effects
5
Storing SEDOXIL
1.
WHAT SEDOXIL IS AND WHAT IT IS USED FOR
SEDOXIL
, tablets – mexazolam 1 mg, per tablet.
The other ingredients are mannitol, maize starch, hydroxypropyl
cellulose, sodium lauryl sulphate, and
calcium stearate.
PHARMACEUTICAL FORM:
SEDOXIL, tablets, box with 60 tablets.
PHARMACOTHERAPEUTIC CATEGORY:
The active substance is mexazolam.
SEDOXIL is an anxiolytic agent, benzodiazepines group.
SEDOXIL is used for the management of anxiety disorder associated or
not to psychoneurotic
conditions.
Benzodiapezines are only indicated when the disorder is severe,
disabling or subjecting the individual
to extreme distress.
Marketing Authorisation Holder: BIAL– Portela & Cª, S.A., Portugal
Manufacturer: BIAL – Portela & Cª, S.A., Portugal
2.
BEFORE YOU TAKE SEDOXIL
DO NOT TAKE SEDOXIL:
−
if you are hypersensitive (allergic) to mexazolam or to
benzodiazepines;
−
if you suffer from a disease called myasthenia gravis;
−
if
you
have
severe
respiratory
insufficiency,
sleep
apnoea
syndrome
or
severe
hepatic
insufficiency.
TAKE SPECIAL CARE WITH SEDOXIL:
−
Benzodiazepines should be used with extreme caution in patients with a
history of drug abuse and
alcoholism.
−
SEDOXIL should be used with caution in patients with cardiac, renal or
hepatic disorders and in
patients with encephalic organic disorders.
TAKING SEDOXIL WITH FOOD AND DRINK:
Do not take SEDOXIL with alcohol. The sedative effect may be enhanced
when SEDOXIL is used in
combination with alcohol; this affects the ability to drive or use
machi
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sedoxil, 1 mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Mexazolam 1 mg.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SEDOXIL is indicated for the management of anxiety disorder associated
or not to psychoneurotic
conditions.
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual
to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage should be individualised according to the age of patient and
severity of symptoms.
_Adults_
: average dose is 1 – 3 mg daily, preferably divided in three doses.
_Elderly patients_
: do not exceed 1,5 mg daily.
_Children_
: Not for paediatric use.
Treatment of anxiety should be as short as possible. The patient
should be reassessed regularly and the
need for continued treatment should be evaluated, especially in case
the patient is symptom free. The
overall duration of treatment generally should not be more than 8-12
weeks including the tapering off
process. In certain cases extension beyond the maximum treatment
period may be necessary; if so, it
should not take place without revaluation of the patient’s status
with special expertise.
In any case treatment should be started with the lowest recommended
dose.
In case of a missing dose after more than 1 hour as scheduled do not
take it. Do not double the dose.
The patient should be checked regularly observed at the start of the
treatment in order to decrease if
necessary, the dose or frequency of administration to prevent overdose
due to accumulation.
4.3
CONTRAINDICATIONS
Hypersensitivity to mexazolam or to any of the excipients. Myasthenia
gravis, hypersensitivity to
benzodiazepines, severe respiratory insufficiency, sleep apnoea
syndrome and severe hepatic
insufficiency.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Dependence _
2
Use of benzodiazepines may lead to the development of physical and
psychic depende
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