ZOLPIDEM SANDOZ PHARMA zolpidem tartrate 10 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

zolpidem tartrate, Quantity: 10 mg

Beschikbaar vanaf:

Sandoz Pty Ltd

INN (Algemene Internationale Benaming):

zolpidem tartrate

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; silicon dioxide; succinic acid; magnesium stearate; titanium dioxide; hypromellose; macrogol 4000

Toedieningsweg:

Oral

Eenheden in pakket:

20 tablets, 14 tablets, 7 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

For the short-term treatment of insomnia in adults.

Product samenvatting:

Visual Identification: White tablets, biconvex, oblong, scored in half on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisatie-status:

Licence status A

Autorisatie datum:

2006-07-24

Bijsluiter

Zolpidem Sandoz® Pharma
1
ZOLPIDEM SANDOZ®
PHARMA
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING ZOLPIDEM SANDOZ PHARMA?
Zolpidem Sandoz Pharma contains the active ingredient zolpidem
tartrate. Zolpidem Sandoz Pharma is used to initiate and
maintain sleep in those with sleeping difficulties, also called
insomnia in patients over 18 years of age. For more information,
see Section 1. Why am I using Zolpidem Sandoz Pharma?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZOLPIDEM SANDOZ PHARMA?
Do not use if you have ever had an allergic reaction to Zolpidem
Sandoz Pharma or any of the ingredients listed at the end of
the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
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 Zolpidem
Sandoz Pharma? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Zolpidem Sandoz Pharma 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 ZOLPIDEM SANDOZ PHARMA?
•
In adults: Usual dose is one 10 mg tablet taken just before bedtime.
•
In people over 65 years of age: The usual dose is half a Zolpidem
Sandoz Pharma tablet (5 mg) taken just before bedtime.
More instructions can be found in Section 4. How do I use Zolpidem
Sandoz Pharma? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZOLPIDEM SANDOZ PHARMA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Zolpidem Sandoz Pharma.
•
If you become pregnant or suspect that you are pregnant while you are
taking this medicine, stop
taking it and tell your doctor or pharmacist immed

Productkenmerken

210114-zolpidem-sandoz-pharma-pi
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
ZOLPIDEM SANDOZ
® PHARMA (ZOLPIDEM TARTRATE) TABLETS
WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH POTENTIALLY DANGEROUS COMPLEX
SLEEP-
RELATED BEHAVIOURS WHICH MAY INCLUDE SLEEP WALKING, SLEEP DRIVING AND
OTHER BIZARRE
BEHAVIOURS. ZOLPIDEM IS NOT TO BE TAKEN WITH ALCOHOL. CAUTION IS
NEEDED WITH OTHER CNS
DEPRESSANT DRUGS. LIMIT USE TO FOUR WEEKS MAXIMUM UNDER CLOSE MEDICAL
SUPERVISION.
1.
NAME OF THE MEDICINE
Zolpidem tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zolpidem Sandoz Pharma 10 mg tablets contains 10 mg zolpidem
tartrate.
_Excipient with known effect_
: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Zolpidem Sandoz Pharma 10 mg tablets are white tablets, biconvex,
oblong, scored in half on
one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Zolpidem Sandoz Pharma is indicated for the
s
hort-term treatment of insomnia in adults (see
Section 4.2 Dose and method of administration).
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
As with all hypnotics, long-term use is not recommended and a course
of treatment should be
as short as possible and should not exceed four weeks.
_ADULTS. _
10 mg to be taken at night.
_INFANTS AND CHILDREN. _
The use of Zolpidem Sandoz Pharma in children under 18 years is
contraindicated.
_WITHDRAWAL EFFECTS. _
See Section 4.4 Special warnings and precautions for use.
_DISCONTINUATION OF TREATMENT._
See Section 4.8 Adverse effects (Undesirable effects).
METHOD OF ADMINISTRATION
Zolpidem acts rapidly and should therefore be taken immediately before
retiring.
DOSAGE ADJUSTMENT IN:

renal impairment
No dosage adjustment is necessary in these patients, although they
should be closely monitored.
210114-zolpidem-sandoz-pharma-pi
Page 2 of 18

hepatic impairment
5 mg to be taken at night. In adults less than 65 years the dosage may
be increased if the clinical
response is inadequate and the drug is well tolerated.

e