CIZINATE cinnarizine 20 mg / dimenhydrinate 40 mg uncoated tablets blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

cinnarizine, Quantity: 20 mg; dimenhydrinate, Quantity: 40 mg

Հասանելի է:

Southern XP IP Pty Ltd

Դեղագործական ձեւ:

Tablet, uncoated

Կազմը:

Excipient Ingredients: microcrystalline cellulose; maize starch; purified talc; croscarmellose sodium; hypromellose; colloidal anhydrous silica; magnesium stearate

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

100 tablets, 50 tablets, 30 tablets, 20 tablets

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Short-term, symptomatic treatment of vertigo of various causes, in adults who have not responded to alternative treatments.

Ապրանքի ամփոփագիր:

Visual Identification: White to almost white, round, biconvex uncoated tablets with diameter 8mm; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2019-01-08

Տեղեկատվական թերթիկ

CIZINATE
1
CIZINATE
®
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 CIZINATE?
CIZINATE contains the two active ingredients, cinnarizine and
dimenhydrinate. CIZINATE is used for the short term treatment
of the symptoms of vertigo.
For more information, see Section 1. Why am I taking CIZINATE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE CIZINATE?
Do not use if you have ever had an allergic reaction to CIZINATE 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 take
CIZINATE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CIZINATE 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 CIZINATE?
•
The standard dose for this medicine is one tablet three times a day,
although your doctor may have prescribed a different dose.
•
CIZINATE tablets should be swallowed without chewing and with a glass
of liquid, following a meal, at the same time each day.
•
Usually you will take CIZINATE for up to 4 weeks. Your doctor will
however decide how long you will need to take this medicine.
More instructions can be found in Section 4. How do I take CIZINATE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIZINATE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CIZINATE.
•
If you are about to be started on a new medicine, tell your doctor,
dentist or pharmacist that you are taking CIZINATE.
•
Tell your doctor if you have kidney or liver problems, suffer from an
eye disease, have convulsions, fits or
seizures, have increased pressure in the brain, suffer from alcohol
abuse or

Ապրանքի հատկությունները

CIZINATE
®
Page 1 of 14
7 July 2021
AUSTRALIAN PRODUCT INFORMATION
CIZINATE
® (CINNARIZINE/DIMENHYDRINATE) 20 MG/40 MG TABLET
1
NAME OF THE MEDICINE
Cinnarizine
Dimenhydrinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIZINATE tablets contain the active ingredients cinnarizine and
dimenhydrinate.
Each
CIZINATE
20
mg/40
mg
tablet
contains
20
mg
of
cinnarizine
and
40
mg
of
dimenhydrinate.
Cinnarizine is a white to almost white powder. It is practically
insoluble in water, freely soluble
in methylene chloride, soluble in acetone and slightly soluble in
ethanol and methanol.
Dimenhydrinate, the chlorotheophylline salt of diphenhydramine, is a
white to almost white,
crystalline powder or colourless crystals. It is slightly soluble in
water and freely soluble in
ethanol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CIZINATE 20 mg/40 mg tablets are a white to almost white, round,
biconvex uncoated tablet 8
mm in diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term, symptomatic treatment of vertigo of various causes, in
adults who have not
responded to alternative treatments.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose for adults is one tablet three times daily. The
lowest dose for the shortest
duration to achieve symptom control should be used. The recommended
dose should not be
exceeded.
CIZINATE tablets should be swallowed without chewing with some liquid
after meals to
minimise any gastric irritation.
CIZINATE
®
Page 2 of 14
7 July 2021
In general, the duration of treatment should not exceed four weeks.
Patients should undergo a
reassessment of the risk/benefit if treatment beyond 4 weeks is
contemplated.
ELDERLY
No dose adjustment is necessary.
RENAL IMPAIRMENT
CIZINATE is contraindicated in patients with a creatinine clearance of
≤ 25mL/min (severe
renal impairment) (see Section 4.3 CONTRAINDICATIONS).
CIZINATE should be used with caution in patients with mild to moderate
renal impairment (see
Section 4.4 SPECIAL WARNINGS A