HYPNODORM flunitrazepam 1mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flunitrazepam, Quantity: 1 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; pregelatinised maize starch; magnesium stearate; indigo carmine; titanium dioxide; hypromellose; brilliant blue FCF; sunset yellow FCF; quinoline yellow; macrogol 4000

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Severe cases of insomnia

Product summary:

Visual Identification: 12.6 x 6 mm, oval, convex, green film-coated tablet. Debossed "FM/1" on one side and an alpha symbol on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2001-10-16

Patient Information leaflet

HYPNODORM
_contains the active ingredient flunitrazepam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Hypnodorm.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Hypnodorm
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT HYPNODORM IS
USED FOR
Hypnodorm is used to treat severe
cases of insomnia (trouble sleeping).
Hypnodorm belongs to a group of
medicines called benzodiazepines.
These medicines are thought to work
by their action on brain chemicals.
In general, benzodiazepines such as
Hypnodorm need only be taken for a
few nights and then discontinued by
gradually decreasing the dosage.
Continuous long term use of
Hypnodorm is not recommended.
The use of benzodiazepines may lead
to dependence on the medicine.
Your doctor may have prescribed
Hypnodorm for another reason. Ask
your doctor if you have any questions
about why Hypnodorm has been
prescribed for you.
Hypnodorm is available only with a
doctor's prescription.
BEFORE YOU TAKE
HYPNODORM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE HYPNODORM IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
FLUNITRAZEPAM, ANY OTHER
BENZODIAZEPINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing,
wheezing or shortness of breath.
DO NOT TAKE HYPNODORM IF YOU
HAVE:
•
severe and chronic lung disease
•
myasthenia gravis, condition
where there is severe muscle
weakness
•
sleep apnoea, condition where
you temporarily stop breathing
while you are asleep
•
severe liver disease.
DO NOT TAKE HYPNODORM IF YOU ARE
BREASTFEEDING.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
HYPNODORM
_flunitrazepam tablets _
1
NAME OF THE MEDICINE
Flunitrazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Hypnodorm tablet contains 1 mg flunitrazepam.
Hypnodorm also contains sugars (as lactose and galactose) and trace
amounts of sulfites. For the full list of
excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Flunitrazepam 1 mg tablets: green, oval, normal convex, scored, film
coated tablet debossed "FM |1" on one
side and "α" on the other
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe cases of insomnia.
4.2
DOSE AND METHOD OF ADMINISTRATION
In most patients, Hypnodorm need only be administered for a few
nights. Treatment should be discontinued
gradually by decreasing the dosage.
Dosage should be selected carefully, due consideration being given to
the patient's age and general condition,
as well as the type of sleep disturbance.
The drug should be taken immediately before going to bed. In general,
the following dosages are
recommended.
ADULTS
1 to 2 mg on going to bed.
ELDERLY PATIENTS
0.5 to 1 mg.
IN IMPAIRED RENAL OR HEPATIC FUNCTION
Elimination of metabolites will be impaired. For these patients,
commence treatment with small doses which
are increased slowly until the desired response is attained.
4.3
CONTRAINDICATIONS
Hypnodorm is contraindicated in:

Patients with known hypersensitivity to flunitrazepam or to any other
components of Hypnodorm

Patients with known hypersensitivity to benzodiazepines

Patients with chronic obstructive airways disease with incipient
respiratory failure

Myasthenia gravis

Sleep apnoea

Children

Severe hepatic insufficiency.
Hypnodorm – PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SEVERE ALLERGIC REACTIONS
Rare cases of angioedema involving the tongue, glottis or larynx have
been reported in patients after taking
the first or subsequent doses of sedative-hypnotics. Some patients
have had additional symptoms such as
dyspnea, throat closing, or nausea and vo