资料单张
LEXOTAN
®
Bromazepam (1.5 mg tablet)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Lexotan is used for
2. How Lexotan works
3. Before you use Lexotan
4. How to use Lexotan
5. While you are using Lexotan
6. Side effects
7. Storage and disposal of Lexotan
8. Product Description
9. Manufacturer and Product
Registration Holder
1. WHAT LEXOTAN IS USED FOR
_ _
Lexotan contains the active ingredient
bromazepam.
Lexotan is used to treat the following:
•
_Emotional _
_disturbances._
Acute
tension
and
anxiety
states.
Difficulties
in
interpersonal
contact.
Agitation,
insomnia.
Anxious,
agitated
depressive
reactions.
•
_Functional _
_disturbances _
_in _
_the _
_heart _
_and _
_lung _
_systems _
(pseudoangina
pectoris,
precordial
anxiety,
tachycardia,
emotiogenic
hypertension,
dyspnea, hyperventilation)
•
_In _
_the _
_gastrointestinal _
_system_
(irritable
bowel
syndrome,
epigastric pain, spasm, bloating
diarrhea, etc.)
•
_ In _
_the _
_genitourinary _
_system _
(frequency,
irritable
bladder;
dysmenorrhea).
•
_Psychosomatic _
_disorders._
Headache
or
skin
problems
caused by mental disturbances.
Asthma.
Gastric
and
duodenal
ulcer, ulcerative colitis
•
_Emotional reactions to chronic _
_organic disease._
Your
doctor,
however,
may
have
prescribed
Lexotan
for
another
purpose.
Ask
your
doctor
if
you
have
any
questions
why
Lexotan
has
been
prescribed for you.
This medicine may be addictive.
This medicine is available only with a
doctor’s prescription.
2. HOW LEXOTAN WORKS
_ _
Lexotan
belongs
to
a
group
of
medicines
called
benzodiazepines.
They are thought to work by their
action on brain chemicals.
3. BEFORE YOU USE LEXOTAN
_ _
_-_
_ _
_When you must not use it_
1.
YOU
HAVE
HAD
AN
ALLERGIC
REACTION
TO
LEXOTAN,
OTHER
BENZODIAZEPINES
OR
ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some
of
the
symptoms
of
an
allergic reaction may include:
•
Shortness of breath
•
Wheezing
or
difficulty
breathing
•
Swelling of the face, lips,
tongue or other parts of
the body
•
Rash, i
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产品特点
Leaflet 1,5 mg Lexotan MY
DRAFT (DATE) 17.12.2019 [12:50 uhr] (4)
COLOURS Pantone Black linework
DIMENSIONS 150+150x304,5 mm
MATERIAL NUMBER 90002931/10
FONT SIZE 9 pt
PRODUCT CODE Delpharm Milano 86067044 MY-CP
Lexotan ®
Bromazepam 1. DESCRIPTION
1.1 Therapeutic / Pharmacologic Class of Drug
Anxiolytic
ATC code: N05BA08
1.2 Type of Dosage Form
Tablets
1.3 Route of Administration
Oral
1.4 Qualitative and Quantitative Composition
Active ingredient: bromazepam
Tablets 1.5 mg
The tablets are of a slightly yellowish colour.
Excipients: Lexotan tablets contain lactose. For
warning related to lactose, see section 2.4.1
General (Warnings and Precautions). 2. CLINICAL PARTICULARS
2.1 Therapeutic Indication(s)
Emotional disturbances. Acute tension and
anxiety states. Difficulties in interpersonal
contact. Agitation, insomnia. Anxious, agitated
depressive reactions.
Functional disturbances in the vascular and
respiratory systems (pseudoangina pectoris,
precordial anxiety, tachycardia, emotiogenic
hypertension, dyspnea, hyperventilation); in the
gastrointestinal system (irritable bowel syndro -
me, epigastric pain, spasm, bloating diarrhea,
etc); in the genitourinary system (frequency,
irritable bladder; dysmenorrhea).
Psychosomatic disorders. Psychogenic heada -
che. Psychogenic dermatosis. Asthma. Gastric
and duodenal ulcer, ulcerative colitis.
Emotional reactions to chronic organic disease.
Adjuvant to psychotherapy in psychoneurosis.
2.2 Dosage and Administration
Standard dosage
Average dosing for outpatient therapy: 1.5-3 mg
up to three times daily.
Severe cases, especially in hospital: 6-12 mg
two or three times daily.
These amounts are general recommendations,
and dosage should be individually determined.
Treatment of outpatients should begin with low
doses, gradually increasing to the optimum level.
Duration of treatment
The duration of treatment should be as short as
possible. The patient should be reassessed regu -
larly and the need for continued treatment should
be evaluated, especially in case the patient is
s
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