CLARITYNE 5MG/5ML ΣΙΡΟΠΙ

País: Chipre

Idioma: griego

Fuente: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredientes activos:

ΛΟΡΑΤΑΔΊΝΗ

Disponible desde:

BAYER HELLAS ABEE

Código ATC:

R06AX13

Designación común internacional (DCI):

LORATADINE

Dosis:

5MG/5ML

formulario farmacéutico:

ΣΙΡΟΠΙ

Composición:

0079794755 - LORATADINE - 1 MG

Vía de administración:

ORAL USE

tipo de receta:

Χωρίς Ιατρική Συνταγή

Área terapéutica:

LORATADINE

Resumen del producto:

01 - 1 BOTTLE X 120ML - 120 - MILLILITRE - 240005501 - Εγκεκριμένο

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITYNE 1 MG/ML SYRUP
Loratadine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist, or nurse
has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
-
You must talk to a doctor if you do not feel better or if you feel
worse. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What CLARITYNE is and what it is used for
2.
What you need to know before you take CLARITYNE
3.
How to take CLARITYNE
4.
Possible side effects
5
How to store CLARITYNE
6.
Contents of the pack and other information
1.
WHAT CLARITYNEIS AND WHAT IT IS USED FOR
The full name of your medicine is CLARITYNE syrup.
WHAT CLARITYNE IS
CLARITYNE syrup contains the active substance loratadine which belongs
to a class of medicines
called “antihistamines”.
HOW CLARITYNE WORKS
CLARITYNE helps to reduce your allergy symptoms by stopping the
effects of a substance called
“histamine”, which is produced in the body when you are allergic
to something.
WHEN CLARITYNE SHOULD BE TAKEN
CLARITYNE relieves symptoms associated with allergic rhinitis (for
example, hay fever), such as
sneezing, runny or itchy nose, and burning or itchy eyes in adults and
children over the age of 2 years.
CLARITYNE may also be used to help relieve symptoms of urticaria
(itching, redness and number
and size of hives).
The effect of CLARITYNE will last a whole day and should help you to
continue your normal daily
activities and sleep.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITYNE
DO NOT TAKE CLARITYNE IF

you are allergic (hypersensitive) to loratadine or any of the other
ingredients of this me

Ficha técnica

1.
NAME OF THE MEDICINAL PRODUCT
CLARITYNE 1 mg/ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 1 mg loratadine.
Excipients with known effect:
The quantity of sucrose in the loratadine syrup composition is 600
mg/ml. The amount of sucrose per
5 ml (5 mg) dose is 3 grams.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
Clear, colourless to light yellow syrup.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CLARITYNE is indicated for the symptomatic treatment of allergic
rhinitis and chronic idiopathic
urticaria in adults and children over the age of 2 years_._
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: 10 ml (10 mg) of the syrup
once daily.
_Paediatric population_
Children 2 to 12
years of age
are dosed by weight:
Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily.
Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily.
The safety and efficacy of CLARITYNE in children under 2 years of age
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, and for children
weighing 30 kg or less, 5 ml (5 mg)
every other day is recommended.
_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 syrup may be taken without regard to mealtime.
1
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
CLARITYNE should be administered with caution in patients with severe
liver impairment
(see section 4.2).
This medicinal product contains sucrose; thus patients with rare
heredi