LORASTINE TABLETS

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

LORATADINE

可用日期:

BAYER ISRAEL LTD

ATC代码:

R06AX

药物剂型:

TABLETS

组成:

LORATADINE 10 MG

给药途径:

PER OS

处方类型:

Not required

厂商:

BAYER BITTERFELD GMBH, GERMANY

治疗组:

OTHER ANTIHISTAMINES FOR SYSTEMIC USE

疗效迹象:

Seasonal allergic rhinitis, perennial allergic rhinitis, chronic urticaria.

授权日期:

2016-06-30

资料单张

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
LORASTINE TABLETS, 10 MG
Each tablet contains:
Loratadine 10 mg
See section 6 for a list of inactive ingredients. See also section 2
under ’Important information
about some of this medicine’s ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further
questions, consult your doctor or pharmacist.
Take this medicine according to the instructions in the section about
dose in this leaflet.
Consult your pharmacist if you need further information.
Consult your doctor if your symptoms of illness get worse or do not
get better.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Lorastine Tablets are used to treat allergic rhinitis and the symptoms
associated with it, such
as sneezing, runny or itchy nose, and burning or itchy eyes. They are
also used to treat
allergy of the skin - hives )urticaria(.
HOW THIS MEDICINE WORKS
Lorastine Tablets relieve your allergy symptoms by preventing the
effects of a substance
called histamine, which is produced by the body when you are allergic
to something.
THERAPEUTIC GROUP: This medicine contains the active ingredient
loratadine which belongs
to a class of medicines called “antihistamines”.
2. BEFORE USING THIS MEDICINE
X DO NOT USE THIS MEDICINE IF:
−
You are allergic )sensitive( to loratadine or to any of the other
ingredients of this medicine
)see section 6 for a list of inactive ingredients(.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
! TALK TO YOUR DOCTOR, PHARMACIST, OR NURSE BEFORE TAKING LORASTINE
TABLETS IF:
-
You have liver disease.
-
You are about to have any skin tests for allergies. Do not take
Lorastine Tablets for two
days before having these tests. This is because the medicine may
affect the test results.
If any of the conditions described above apply to you )or if you are
not sure(, consult your
doctor, pha

产品特点

Revised in April 2020
1.
NAME OF THE MEDICINAL PRODUCT
LORASTINE
®
TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
Excipients with known effect:
The quantity of lactose monohydrate in the loratadine 10 mg tablet
composition is 71.3 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off-white, oval tablet with flask and bowl, score and
“10” on one side, plain on the
other side.
The score line of the tablet is only to facilitate breaking for ease
of swallowing and not to divide
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lorastine tablets are indicated for:
Seasonal allergic rhinitis, perennial allergic rhinitis, chronic
urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
One tablet once daily.
_Paediatric population: _
Children 6 years of age and older with a body weight greater than 30
kg:
One tablet once daily.
For appropriate dosing in children younger than 6 years or with body
weight of 30 kg
or less, there are other formulations more suitable.
Children under 2 years of age:
The safety and efficacy of Lorastine Tablets have not been
established. No data are available.
_Patients with hepatic impairment_
Patients with severe liver impairment should be administered a lower
initial dose because they
may have reduced clearance of loratadine. An initial dose of 10 mg
every other day is
recommended for adults and children weighing more than 30 kg.
_Patients with renal impairment_
No dosage adjustments are required in patients with renal
insufficiency.
_Elderly_
No dosage adjustments are required in the elderly.
_Method of administration_
Oral use. The tablet may be taken without regard to meal time.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lorastine Tablets should be administered with caution in patients with
severe liver impairment
(see section 4.2).
This medicinal product c