VALIUM diazepam 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diazepam, Quantity: 5 mg

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; iron oxide yellow; magnesium stearate

Administration route:

Oral

Units in package:

50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Valium is indicated for the management of anxiety disorders or for the short term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, VALIUM may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. VALIUM is a useful adjunct for the relief of reflex muscle spasm due to local trauma (injury, inflammation) to muscles, bones and joints. It can also be used to combat spasticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, as well as in athetosis and stiff-man syndrome. Intravenous VALIUM is useful in controlling status epilepticus and the spasms of tetanus

Product summary:

Visual Identification: Cylindrical, biplanar, yellow tablet, upper face marked 5 V, lower face scored.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-05-17

Patient Information leaflet

VALIUM
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VALIUM?
Valium contains the active ingredient diazepam. Valium is used for
anxiety, to relax muscles, to treat trembling, confusional states or
anxiety associated with alcohol withdrawal, and to treat panic
attacks. For more information, see Section 1. Why am I using Valium?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VALIUM?
Do not use if you have ever had an allergic reaction to Valium, any
other benzodiazepine medicine, or any of the ingredients listed
at the end of the CMI. The use of Valium may lead to dependence on the
medicine. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, HAVE DRUG OR ALCOHOL ADDICTION, DRINK ALCOHOL,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use Valium? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Valium and affect how it works. A
list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE VALIUM?
•
Take Valium exactly as your doctor has prescribed. Your doctor will
tell you how many Valium tablets to take each day.
•
The usual adult dose is between 5 and 40 mg daily. Children, elderly
and very ill patients may need to take less.
•
Valium should be taken for short periods only (for example, 2-4
weeks), unless advised by your doctor.
More instructions can be found in Section 4. How do I use Valium? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VALIUM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist visit that you are using
Valium.
•
Do not take any other medicines without first telling your doctor.
•
Call your doctor straight away if you become pregnant while taking
Valium.
THINGS YOU
SHOULD NOT DO
•
Do not tak

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - VALIUM
(DIAZEPAM)
1. NAME OF THE MEDICINE
Diazepam
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Valium tablet contains 5 mg diazepam.
EXCIPIENTS WITH KNOWN EFFECT: contains sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Valium 5 mg tablets are cylindrical, biplanar, yellow tablet, upper
face marked V 5, lower face scored.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Valium is indicated for the management of anxiety disorders or for the
short term relief of the symptoms of
anxiety. Anxiety or tension associated with the stress of everyday
life usually does not require treatment with an
anxiolytic.
In acute alcohol withdrawal, Valium may be useful in the symptomatic
relief of acute agitation, tremor, impending
or acute delirium tremens and hallucinosis.
Valium is a useful adjunct for the relief of reflex muscle spasm due
to local trauma (injury, inflammation) to
muscles, bones and joints. It can also be used to combat spasticity
due to upper motor neuron lesions such as
cerebral palsy and paraplegia, as well as in athetosis and stiff-man
syndrome.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
For maximal beneficial effect, the dosage should be carefully
individualised. Dosage may need to be reduced in
patients with hepatic or renal disease as the elimination half-life
may be prolonged in this sub-group.
USUAL ADULT DOSAGE
5 - 40 mg daily.
AVERAGE DOSAGE FOR AMBULATORY PATIENTS
2 mg three times daily or 5 mg in the evening and 2 mg once or twice
during the day.
ELDERLY OR DEBILITATED PATIENTS
2 mg twice daily or half the usual adult dose.
CHILDREN
_6 MONTHS TO 3 YEARS _
1 - 6 mg daily.
_4 TO 14 YEARS _
4 - 12 mg daily or calculated from 0.1 - 0.3 mg/kg bodyweight.
2
HOSPITAL TREATMENT OF TENSION, EXCITATION, MOTOR UNREST
10 - 15 mg three times daily until the acute symptoms subside.
MUSCLE SPASM
10 - 30 mg daily.
SPECIAL POPULATIONS
_ELDERLY PATIENTS _
Elderly patients should be given a reduced dose. These pa