Alodorm Nitrazepam 5mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitrazepam, Quantity: 5 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: purified talc; lactose monohydrate; colloidal anhydrous silica; pregelatinised maize starch; maize starch; magnesium stearate

Administration route:

Oral

Units in package:

50 tablets, 1000 tablets, 25 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Insomnia, organic and inorganic in origin.

Product summary:

Visual Identification: 12 mm white flat bevelled edged tablet marked NM/5 on one side, G on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1995-11-14

Patient Information leaflet

ALODORM
_nitrazepam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alodorm.
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 Alodorm against
the benefits expected 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 ALODORM IS USED
FOR
Alodorm is used to treat insomnia
(sleeping problems).
Alodorm contains the active
ingredient nitrazepam, which belongs
to a group of medicines called
benzodiazepines. These medicines
are thought to work by their action
on brain chemicals.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALODORM HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Alodorm for another reason.
In general, benzodiazepines such as
Alodorm should be taken for short
periods only (for example 2 to 4
weeks). Continuous long-term use is
not recommended unless advised by
your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
Alodorm is available only with a
doctor's prescription.
BEFORE YOU TAKE
ALODORM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALODORM IF YOU ARE
ALLERGIC TO:
•
nitrazepam
•
any other benzodiazepine
medicines such as diazepam,
temazepam, oxazepam,
alprazolam and clonazepam
•
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 ALODORM IF YOU HAVE:
•
severe and chronic lung disease
(e.g. chronic obstructive airway
disease) and difficulty breathing
•
severe liver disease.
DO NOT TAKE ALODORM AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ALODORM
_nitrazepam tablets _
1
NAME OF THE MEDICINE
Nitrazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of nitrazepam as the active ingredient.
Excipients with known effect: Sugars (as lactose). Also contains
traces of galactose and sulfites. For the full
list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Nitrazepam 5 mg tablet: white, flat bevelled edged, marked NM/5 on one
side, G on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Insomnia, organic and inorganic in origin.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS:_
1 to 2 tablets (5 to 10 mg) before retiring. This average dosage may
be increased if necessary, up to
20 mg for in-patients.
_ELDERLY PATIENTS:_
½ to 1 tablet.
_CHILDREN:_
Not approved for use as a hypnotic in children.
4.3
CONTRAINDICATIONS
Alodorm is contraindicated in:
•
Patients with known hypersensitivity to benzodiazepines.
•
Patients with chronic obstructive airway disease with incipient
respiratory failure.
•
Severe liver insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
HYPOTENSION
Although hypotension has occurred only rarely, Alodorm should be
administered with caution to patients in
whom a drop in blood pressure might lead to cardiac or cerebral
complications. This is particularly important
in elderly patients (See SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE – Use in the
Elderly).
AMNESIA
Transient amnesia or memory impairment has been reported in
association with the use of benzodiazepines.
MYASTHENIA GRAVIS
Nitrazepam could increase the muscle weakness in myasthenia gravis and
should be used with caution in this
condition.
ACUTE NARROW ANGLE GLAUCOMA
Caution should be used in the treatment of patients with acute
narrow-angle glaucoma (because of atropine-
like side effects).
Alodorm – PRODUCT INFORMATION
2
BRONCHIAL HYPERSECRETION AND EXCESSIVE SALIVATION
In infants and young children, as well as in elderly, bedridden
patients, bronchial hypersecretion an