Akamon 1.5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BROMAZEPAM

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N05BA08

INN (International Name):

BROMAZEPAM 1.5 mg

Pharmaceutical form:

TABLET

Composition:

BROMAZEPAM 1.5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2006-11-16

Patient Information leaflet

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“AKAMON” TABLETS PATIENT INFORMATION LEAFLET 

“AKAMON” TABLETS 

PLEASE READ THIS LEAFLET CAREFULLY BEFORE STARTING YOUR TREATMENT
WITH “AKAMON”. 
THIS LEAFLET ONLY GIVES A SUMMARY OF THE INFORMATION THAT IS
AVAILABLE ON YOUR 
MEDICINE. IF YOU ARE NOT SURE ABOUT ANYTHING OR HAVE ANY QUESTIONS,
ASK YOUR 
DOCTOR OR PHARMACIST. 

WHAT YOU SHOULD KNOW ABOUT YOUR 
MEDICINE

The name of your medicine is “Akamon” tablets. “Akamon”
tablets are for oral 
administration. They are available in two strengths,
containing 1.5mg of bromazepam 
and containing 3mg of bromazepam. Bromazepam is the active
ingredient. 

“Akamon” 1.5mg tablets also contain lactose, microcrystalline
cellulose, cellulose, 
pregelatinised maize starch, croscarmellose sodium, silicon
dioxide, magnesium 
stearate and tartrazine. They are supplied in blister packs of 60
tablets. 

“Akamon” 3mg tablets also contain
lactose, microcrystalline cellulose, sodium starch 
glycollate and magnesium stearate. They are supplied in blister
packs of 40 tablets. 

Bromazepam is one of a group of medicines called
benzodiazepines, and it is used for 
the symptomatic relief of anxiety. 

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The marketing authorisation holder and manufacturer of “Akamon”
is: 
MEDOCHEMIE Ltd, p.o box 51409, Limassol, Cyprus 

“Akamon” is used to treat the symptoms of anxiety that
is severe or causing a lot of 
stress, either on its own or also associated with sleep
difficulties and certain mental 
states. It is only for use over a two to four week period. Your
doctor can explain what 
you are being treated for. 

BEFORE STARTING TREATMENT WITH “AKAMON” 

You must talk to your doctor before starting your treatment
with “Akamon” if any of 
the following apply to you: 
•  you have ever had an allergic reaction, skin
ras

Summary of Product characteristics

Page 1 of 10 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Akamon 1.5mg 
Akamon 3mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Akamon tablets 1.5 mg: Each tablet contains 1.5 mg bromazepam 
Akamon tablets 3 mg: Each tablet contains 3 mg bromazepam 

3. PHARMACEUTICAL 
FORM 

Tablets for oral administration 

CLINICAL PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

Bromazepam is a pyridylbenzodiazepine compound
with anxiolytic properties. 
It is indicated for short term therapy, usually not
exceeding two to four weeks, as 
symptomatic treatment of severe, disabling or causing
unacceptable stress, anxiety. The 
anxiety can be occurring alone or in combination with insomnia
or short term psychotic, 
organic or psychosomatic illness. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

_Adult:_ 
The dosage should be individually titrated and optimised, as
should frequency of 
administration, on the basis of the individual response, severity of
symptoms and any 
available history of previous response to psychotropic drugs. 
The usual dose in normal circumstances ranges from 3mg to 18mg a
day, administered in 
two or three divided doses. 
Page 2 of 10 
Hospital patients may, in exceptional conditions,
require a daily dosage of up to 60mg in 
divided doses. The maximum dose of 60mg a day should not
be exceeded. 

_Children:_ 
Not indicated for paediatric use. 

_Elderly and /or debilitated patients: _
Elderly patients and those with impaired hepatic and/or renal
function require lower doses 
because of individual variations in sensitivity and
pharmacokinetics; closes should not 
exceed half those normally recommended.  

For all categories of patient, the lowest dose that control
symptoms should be used. The use 
of the full dosage regime should not be prolonged beyond
four weeks. Withdrawal of 
t