Hypnovel

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Midazolam maleate 20.8mg Equivalent to 15 mg midazolam

Dostupné z:

Roche Products (NZ) Ltd

INN (Medzinárodný Name):

Midazolam maleate 20.8 mg (Equivalent to 15 mg midazolam)

Dávkovanie:

15 mg

Forma lieku:

Tablet

Zloženie:

Active: Midazolam maleate 20.8mg Equivalent to 15 mg midazolam Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose

Trieda:

Class C5 Controlled Drug

Typ predpisu:

Class C5 Controlled Drug

Výrobca:

F Hoffmann-La Roche Ltd

Dátum Autorizácia:

1984-10-10

Príbalový leták

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Hypnovel Tablets170918
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
HYPNOVEL
®
MIDAZOLAM TABLETS 7.5 MG
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Hypnovel tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your using Hypnovel
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT HYPNOVEL IS USED FOR
Hypnovel tablets are used for the short term treatment of serious
insomnia (inability to sleep).
Hypnovel tablets may also be given to you before an operation to
produce sleepiness or drowsiness and
to relieve anxiety.
Hypnovel belongs to a group of medicines called benzodiazepines. They
are thought to work by their
action on brain chemicals. Hypnovel tablets will cause sedation and
help you sleep.
Your doctor, however, may have prescribed Hypnovel for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY HYPNOVEL HAS BEEN
PRESCRIBED FOR YOU.
If you will be receiving Hypnovel before minor surgery, your doctor
will give you the medicine and
closely follow your progress.
This medicine is available only with a doctor’s prescription.
BEFORE YOU RECEIVE HYPNOVEL
_DO NOT USE HYPNOVEL TABLETS IF _
§
YOU HAVE HAD AN ALLERGIC REACTION TO HYPNOVEL, 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 APNOEA SYNDROME
§
YOU HAVE SEVERE LIVER DAMAGE OR LIVER DISEASE
§
YOU ARE SUFFERING FROM SHOCK, COMA OR ACUTE ALCOHOLIC INTOXICATION
§
YOU ARE TAKING ANTIFUNGAL MEDICINES SUCH AS KETOCONAZOLE, ITRACONAZOLE
OR VORICONAZOLE
§
YOU ARE TAKING HIV PROTEASE INHIBITORS INCLUDING RITONAVIR BOOSTED
PROTEASE INHIBITORS
§
YOU AR

Súhrn charakteristických

NEW ZEALAND DATA SHEET
1
Hypnovel 170717
1.
PRODUCT NAME
Hypnovel
®
7.5mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: midazolam as the maleate
Tablets containing midazolam maleate equivalent to 7.5 mg of
midazolam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Midazolam 7.5mg tablets are white, oval, cylindrical, biconvex.
Imprint above is ROCHE
7.5 and below is a single break bar. Dimensions of the tablets are
length 11.6mm, width
6.1mm, thickness 3.6mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
•
Short-term treatment of insomnia.
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the
individual to extreme distress.
•
Sedation in premedication before surgical or diagnostic procedures.
4.2
DOSE AND METHOD OF ADMINISTRATION
In order to minimise the risk of dependence, benzodiazepines should
only be prescribed after
careful consideration of the indication and should be taken for the
shortest possible duration.
Generally the duration of treatment varies from a few days to a
maximum of 2 weeks.
Treatment with Hypnovel should not be terminated abruptly. The
tapering-off process should
be tailored to the individual. The necessity of continuing treatment
should be closely
monitored.
In certain cases extension beyond the maximum treatment period may be
necessary; if so, it
should not take place without re-evaluation of the patient’s status.
DOSE
The standard dosage range: 7.5-15 mg.
NEW ZEALAND DATA SHEET
2
Hypnovel 170717
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
_ADULTS _
In premedication, 15mg of Hypnovel should be given 30-60 minutes
before the procedure.
SPECIAL POPULATIONS_ _
_Elderly and/or debilitated patients _
In elderly and/or debilitated patients the recommended dose is 7.5 mg.
In eld