STILDEM zolpidem tartrate 10 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

zolpidem tartrate, Quantity: 10 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

zolpidem tartrate

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; hypromellose; magnesium stearate; titanium dioxide; macrogol 400

관리 경로:

Oral

패키지 단위:

3 blister packs of 10 tablets, 1 blister pack of 10 tablets, 2 blister packs of 14 tablets, 1 blister pack of 7 tablets, 1 blister pack of 14 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Short-term treatment of insomnia in adults.

제품 요약:

Visual Identification: White, oval, bi-convex, film coated tablets, scored on both sides and embossed with "ZIM 10" on one side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2007-07-23

환자 정보 전단

STILDEM
1
STILDEM
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 STILDEM?
STILDEM contains the active ingredient zolpidem tartrate. STILDEM 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
STILDEM? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE STILDEM?
Do not use if you have ever had an allergic reaction to zolpidem or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, HAVE
BEEN DRINKING 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 STILDEM? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with STILDEM 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 STILDEM?
•
In Adults: Usual dose is one 10 mg tablet taken just before bedtime.
•
In people over 65 years of age: The dose is one 5 mg tablet taken just
before bedtime.
More instructions can be found in Section 4. How do I use STILDEM?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING STILDEM?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
STILDEM.
•
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
immediately.
THINGS YOU SHOULD NOT DO
•
Do not take STILDEM if you have sleep apnoea, myasthenia gravis,
severe liver problems,
acute and / or severe lung problems or if you have previously
experienced complex sleep
behavi

제품 특성 요약

AUSTRALIAN
PRODUCT
INFORMATION
–
STILDEM
(ZOLPIDEM
TARTRATE) TABLETS
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 STILDEM tablet contains zolpidem tartrate 10 mg
Excipients with known effect: Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
STILDEM _(AUST R 131917) _10 mg tablets are white, oval, biconvex,
film-coated tablets, scored on both
sides and embossed with "ZIM" and "10" on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
STILDEM is indicated for the short-term treatment of insomnia in
adults (see section 4.2 DOSE AND
METHOD OF ADMINISTRATION).
4.2
D
OSE AND METHOD OF ADMINISTRATION
STILDEM acts rapidly and should therefore be taken immediately before
retiring, or in bed. STILDEM
should be taken in a single intake and not be re-administered during
the same night. As with all hypnotics,
long-term use is not recommended, and a course of treatment should be
as short as possible and not
exceed four weeks.
For oral use only.
Discontinuation of treatment: see section 4.8 ADVERSE EFFECTS
(UNDESIRABLE EFFECTS).
Withdrawal effects: see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE.
DOSAGE:
Adults: 10 mg to be taken at night. The lowest effective daily dose of
STILDEM should be used and must
not exceed 10 mg.
RENAL IMPAIRMENT
No dosage adjustment is necessary in these patients, although they
should be closely monitored.
HEPATIC IMPAIRMENT
As clearance and metabolism of Zolpidem is reduced in hepatic
impairment, a dosage of 5 mg to be taken
at night, is recommended, with particular caution being exercised in
elderly patients. In adults, less than
65 years, the dosage may be i