Allereze loratadine 10 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

loratadine, Quantity: 10 mg

제공처:

Alphapharm Pty Ltd

INN (국제 이름):

Loratadine

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: Carnauba Wax; lactose monohydrate; magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; maize starch; purified talc; silicon dioxide; hypromellose; PEG-150 distearate; lauromacrogol 400

관리 경로:

Oral

패키지 단위:

50 tablets, 70 tablets, 90 tablets, 30 tablets, 10 tablets

수업:

Medicine Registered

처방전 유형:

(S2) Pharmacy Medicine

치료 징후:

In adults and children 12 years and older: treatment of seasonal and perennial allergic rhinitis; relief of symptoms and signs of chronic urticaria.

제품 요약:

Visual Identification: White, circular, biconvex tablets, scored on one side and marked with "LR" over "10" on the other. Diameter 7.5mm and thickness 3.2mm.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2005-03-15

환자 정보 전단

ALLEREZE
®
ACTIVE INGREDIENT(S): _Loratadine_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
ALLEREZE. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING ALLEREZE.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using ALLEREZE?
2. What should I know before I use ALLEREZE?
3. What if I am taking other medicines?
4. How do I use ALLEREZE?
5. What should I know while using ALLEREZE?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING ALLEREZE
ALLEREZE CONTAINS THE ACTIVE INGREDIENT LORATADINE.
ALLEREZE is a non-sedating antihistamine.
ALLEREZE IS USED TO RELIEVE THE SYMPTOMS OF SNEEZING;
RUNNY NOSE; WATERY, ITCHY OR RED EYES IN THE FOLLOWING
ALLERGIC CONDITIONS:
•
HAYFEVER (ALSO KNOWN AS SEASONAL ALLERGIC RHINITIS),
WHICH USUALLY OCCURS DURING THE WARMER SEASONS
•
PERENNIAL ALLERGIC RHINITIS, WHICH MAY OCCUR
THROUGHOUT THE YEAR.
ALLEREZE CAN ALSO BE USED TO RELIEVE THE SYMPTOMS OF
HIVES OR NETTLE RASH (ALSO KNOWN AS CHRONIC URTICARIA),
WHICH APPEARS AS A PINKISH SKIN RASH WITH ITCHY, SWOLLEN
LUMPS.
The body releases histamine in response to substances it
recognises as 'foreign', such as pollen, dust and dyes. This
can cause the symptoms mentioned above. Antihistamines
can relieve allergic symptoms by blocking the effects of
histamine.
The severity of your condition will depend how sensitive you
are to 'foreign substances'.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT WHY ALLEREZE HAS BEEN RECOMMENDED.
They may have recommended ALLEREZE for another
reason.
There is no evidence that ALLEREZE is addictive.
2.
WHAT SHOULD I KNOW BEFORE I USE
ALLEREZE?
WARNINGS
DO NOT USE ALLEREZE IF:
•
you are allergic to any other medicines containing:
o
loratadine (e.g. Claratyne, Clarinase, Lorastyne)
o
desloratadine (e.g. Claramax)
o
or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use
this m

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
ALLEREZE
®
_Loratadine tablets _
1
NAME OF THE MEDICINE
Loratadine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of loratadine as the active ingredient.
Excipients with known effect: lactose and gluten
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Loratadine 10 mg film-coated tablets: white, round, biconvex, scored
on one side and marked “LR” over “10”
on the reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and children 12 years +and older, ALLEREZE tablets are
indicated for the:
•
treatment of seasonal and perennial allergic rhinitis
•
relief of symptoms and signs of chronic urticaria.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and children 12 years of age and over. 10 mg (one tablet)
daily.
For patients with severe hepatic impairment a lower initial dose (5 mg
daily) is recommended.
4.3
CONTRAINDICATIONS
ALLEREZE tablets are contraindicated in patients who have shown
hypersensitivity or idiosyncrasy to
loratadine, desloratadine or any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Immune system
In a 17-month study in monkeys, loratadine demonstrated no functional
impairment of the immune system as
indicated by mortality, peripheral leucocyte count or incidences of
inflammatory reactions, autoimmune
disease and malignancy. Specific studies investigating the effect of
loratadine on immune function in man
have not been performed.
Hepatic
As with all drugs metabolised by the liver, loratadine should be used
with caution in patients with severe liver
dysfunction.
USE IN THE ELDERLY
No data available.
ALLEREZE
®
– PRODUCT INFORMATION
2
PAEDIATRIC USE
No data available.
EFFECTS ON LABORATORY TESTS
ALLEREZE
should
be
discontinued
approximately
48
hours
prior
to
skin
testing
procedures
since
antihistamines may prevent or diminish otherwise positive reactions to
dermal reactivity indicators.
4.5
INTERACTIONS
WITH
OTHER
MEDICINES
AND
OTHER
FORMS
OF
INTERACTIONS
Various