DORMICUM TABLETS 7.5 MG

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

MIDAZOLAM MALEATE

Предлага се от:

DKSH MALAYSIA SDN BHD

INN (Международно Name):

MIDAZOLAM MALEATE

Броя в опаковка:

100 Tablets

Произведено от:

Recipharm Leganes S.L.U.

Листовка

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DORMICUM
®
_ _
_Midazolam (7.5 mg) _
1
WHAT IS IN THIS LEAFLET
1. What Dormicum is used for
2. How Dormicum works
3. Before you take Dormicum
4. How to take Dormicum
5. While you are using Dormicum
6. Side effects
7.
Storage
and
disposal
of
Dormicum
8. Product Description
9. Manufacturer & Product
Registration Holder
10. Date of revision
1. WHAT DORMICUM IS USED FOR
Dormicum tablets are used for the
short
term
treatment
of
insomnia
(inability to sleep).
Dormicum tablets may also be given
to you before an operation to produce
sleepiness
or
drowsiness
and
to
relieve anxiety.
Your
doctor,
however,
may
have
prescribed
Dormicum
for
another
purpose. Ask your doctor if you have
any questions about why Dormicum
has been prescribed for you.
This medicine is available only with
a doctor’s prescription.
2. HOW DORMICUM WORKS
Dormicum
belongs
to
a
group
of
medicines
called
benzodiazepines.
They are thought to work by their
action on brain chemicals. Dormicum
tablets will cause sedation and help
you sleep.
3. BEFORE YOU TAKE DORMICUM
-
_WHEN YOU MUST NOT TAKE IT _
•
You have had an allergic reaction
to
Dormicum,
any
other
benzodiazepine medicine, or any
of the ingredients listed at the end
of this leaflet.
•
You
have
severe
muscle
weakness,
also
known
as
myasthenia gravis
•
You have respiratory problems
•
You have a condition called sleep
apnea syndrome
•
You have severe liver damage or
liver disease
•
You
are
taking
antifungal
medicines such as ketoconazole,
itraconazole or voriconazole
•
You
are
taking
HIV
protease
inhibitor
medicines
including
ritonavir-boosted
protease
inhibitors.
If
you
are
not
sure
whether
you
should be given Dormicum, talk to
your doctor.
Do not give Dormicum to children.
Do not take Dormicum if the expiry
date printed on the pack has passed.
If the pharmacist has repacked the
medicine for you, there may not be
an expiry date on the pack.
-
_BEFORE YOU START TO TAKE IT_
Your doctor must know about all the
following
before
you
receive
D

Данни за продукта

PACK INSERT FOR MALAYSIA
DORMICUM
®
TABLETS
MIDAZOLAM
1. DESCRIPTION
1.1
THERAPEUTIC/ PHARMACOLOGIC CLASS OF DRUG
Dormicum Tablet is a sleep-inducing agent belonging to the
benzodiazepines.
1.2
TYPE OF DOSAGE FORM
Tablets.
1.3
ROUTE OF ADMINISTRATION
Oral use.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ midazolam as the maleate.
Tablets containing midazolam maleate equivalent to 7.5 mg
of midazolam.
The 7.5 mg tablet is oval, cylindrical, biconvex and of a
white to almost white colour.
_Excipients:_ described as per local requirements (Dormicum
tablets contain anhydrous lactose. For warning related to
lactose monohydrate, see section 2.4.1).
2. CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Disturbances of sleep rhythm and all forms of insomnia,
particularly difficulty in falling asleep either initially or
after premature awakening. Sedation in premedication
before surgical or diagnostic procedures.
2.2 DOSAGE AND ADMINISTRATION
Duration of treatment should be as short as possible.
Generally, the duration of treatment varies from a few days
to a maximum of 2 weeks. The tapering-off process should
be tailored to the individual. Treatment with Dormicum
should not be terminated abruptly (see section 2.4.2).
In certain cases, extension beyond the maximum treatment
period may be necessary; if so, it should not take place
without reevaluation of the patient’s status. Owing to the
rapid onset of action, Dormicum tablets should be taken
immediately before going to sleep, and swallowed whole
with fluid. Dormicum can be taken at any time of the day,
provided the patient is subsequently assured of at least 7-8
hours undisturbed sleep.
_Standard dosage_
Dosage range: 7.5-15 mg.
Treatment should be started with the lowest recommended
dose. The maximum dose should not be exceeded because
of the increased risk of CNS adverse effects possibly
including clinically relevant respiratory and cardiovascular
depression.
_Premedication_
In premedication, Dormicum should be given 30-60
minutes before the proce