환자 정보 전단
Date: 2 May 2023
Page 1 of 7
Initials: A.G
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S2
Ebastine 10 mg Adco, film coated tablet
Ebastine 10 mg
Contains sugar: Lactose 62 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Ebastine 10 mg Adco is available without a doctor’s prescription,
for you to treat a mild illness.
Nevertheless, you still need to use Ebastine 10 mg Adco carefully to
get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share Ebastine 10 mg Adco with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
10 days.
What is in this leaflet
1.
What Ebastine 10 mg Adco is and what it is used for
2.
What you need to know before you Ebastine 10 mg Adco
3.
How to Ebastine 10 mg Adco
4.
Possible side effects
5.
How to store Ebastine 10 mg Adco
6.
Contents of the pack and other information
1.
WHAT EBASTINE 10 MG ADCO IS AND WHAT IT IS USED FOR
Ebastine 10 mg Adco contains active ingredient ebastine which belongs
to a group of medicines
called antihistamines.
Date: 2 May 2023
Page 2 of 7
Initials: A.G
Ebastine 10 mg Adco is used for the symptomatic treatment of seasonal
and perennial allergic
rhinitis (runny or stuffy nose) and idiopathic chronic urticaria.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBASTINE 10 MG ADCO
DO NOT TAKE EBASTINE 10 MG ADCO
If you are allergic to the active substance or to any of the other
ingredients of this medicine (listed
in section 6).
CHILDREN AND ADOLESCENTS
This medicine should not be given to children under 12 years of age.
WARNINGS AND PRECAUTIONS:
TAKE SPECIAL CARE WITH EBASTINE 10 MG ADCO:
•
If you develop a sudden emergency allergic reaction 1 to 3 hours after
taking Ebastine 10 mg
Adco.
•
If you have heart disease.
•
If your doctor told you that you have low levels of potassium in the
blood.
Do not exceed the usual daily dose of 10 mg if you have severe
전체 문서 읽기
제품 특성 요약
Date: 2 May 2023
Page 1 of 8
Initial: A.G
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S2
1.
NAME OF THE MEDICINE
Ebastine 10 mg Adco (film coated tablet)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 10 mg of ebastine.
Excipients with known effect:
Each film coated tablet contains sugar: 62 mg lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablets)
White lenticular
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
Ebastine 10 mg Adco is indicated for the symptomatic treatment of
allergic rhinitis (seasonal and
perennial) and idiopathic chronic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY
_Adults and children over 12 years old:_
The recommended dose is 10 mg of Ebastine 10 mg Adco once daily.
Date: 2 May 2023
Page 2 of 8
Initial: A.G
Special populations
_Elderly patients _
No dose adjustment is necessary.
_Renal impairment _
No dose adjustment is necessary.
_Hepatic impairment _
No dose adjustment is necessary.
_Paediatric population _
The safety and efficacy of Ebastine 10 mg Adco in children under 12
years have not been
established.
METHOD OF ADMINISTRATION:
Ebastine 10 mg Adco is for oral administration with a glass of water
and may be taken with or
without food.
4.3 CONTRAINDICATIONS:
Hypersensitivity to ebastine or any of the excipients listed in
section 6.1
The safety of Ebastine 10 mg Adco during pregnancy and lactation has
not been established (see
section 4.6).
The safety and efficacy of Ebastine 10 mg Adco in children under 12
years have not been
established.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Ebastine 10 mg Adco lacks significant sedative effects.
Administer with caution in patients with known cardiac risk such as QT
prolongation, hypokalaemia
or concomitant treatment with medicines that increase the QT interval
or inhibit the CYP3A4
enzyme, such as azole antifungals and macrolide antibiotics (see
section 4.5).
Date: 2 May 2023
Page 3 of 8
Initial: A.G
Since Eb
전체 문서 읽기
환자 정보 전단 