Claratyne

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Loratadine 10mg

Disponible desde:

Bayer New Zealand Limited

Designación común internacional (DCI):

Loratadine 10 mg

Dosis:

10 mg

formulario farmacéutico:

Tablet

Composición:

Active: Loratadine 10mg Excipient: Lactose monohydrate Magnesium stearate Maize starch

tipo de receta:

General sale

indicaciones terapéuticas:

The treatment of seasonal allergic rhinitis in adults and children 12 years of age and older.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 1 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 5 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C

Fecha de autorización:

2013-10-11

Información para el usuario

_Claratyne CMI _
_31 March 2015_
Consumer Medicine Information
1
CLARATYNE

CLARATYNE - LORATADINE 10 MG TABLETS
CHILDREN’S CLARATYNE – LORATADINE 1 MG/ML SYRUP (PEACH FLAVOUR)
CHILDREN’S CLARATYNE – LORATADINE 5 MG CHEWABLE TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Claratyne.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor or pharmacist has
weighed the risks of
you taking Claratyne against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CLARATYNE IS USED FOR
Claratyne relieves symptoms associated with allergic rhinitis
(hayfever), such as sneezing,
runny or itchy nose, and burning or itchy eyes.
Claratyne may also be used to relieve symptoms associated with a skin
condition called
urticaria (also called hives); these symptoms include itching, redness
and lumps on the skin.
Claratyne can be used in adults and children.
Claratyne belongs to a class of medicines known as antihistamines.
Antihistamines help reduce allergic symptoms by preventing the effects
of a substance called
histamine. Histamine is produced by the body in response to foreign
substances which the
body is allergic to.
Your doctor or pharmacist, however, may prescribe Claratyne for
another purpose. ASK
YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY
CLARATYNE HAS BEEN
PRESCRIBED FOR YOU.
Claratyne tablets, chewable tablets and syrup can be bought without a
doctor’s prescription.
BEFORE YOU TAKE CLARATYNE
_Claratyne CMI _
_31 March 2015_
Consumer Medicine Information
2
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CLARATYNE IF:

YOU HAVE AN ALLERGY TO CLARATYNE, LORATADINE OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction may include skin rash, difficulty in
breathing or faintness.

Ficha técnica

NEW ZEALAND DATA SHEET
CLARATYNE
CLARATYNE TABLETS – LORATADINE 10 MG
CHILDREN’S CLARATYNE - CHEWABLE TABLETS LORATADINE 5 MG
AND SYRUP LORATADINE 1 MG/ML
NAME OF MEDICINE
CLARATYNE and CHILDREN’s CLARATYNE (loratadine)
PRESENTATION
_CLARATYNE TABLETS _
White to off-white, oval, convex tablets with score on one side and
flask and logo above the score and
number 10 below the score. Each tablet contains loratadine 10mg and
the inactive ingredients maize starch,
lactose and magnesium stearate.
_CHILDREN’S CLARATYNE CHEWABLE TABLETS _
Light to medium purple slightly speckled/mottled round tablet debossed
with ”C” on one side. Each tablet
contains loratadine 5 mg, and the inactive ingredients mannitol,
microcrystalline cellulose, aspartame,
anhydrous citric acid, colloidal silicon dioxide, sodium starch
glycollate, stearic acid, magnesium stearate,
artificial grape flavour (059145 AP0551), Blue dye #2 FD&C (aluminium
lake 09902) and Red dye #27 D&C
(aluminium lake C6527).’
_CHILDREN’S CLARATYNE SYRUP (PEACH FLAVOUR) _
Clear, light yellow coloured, peach flavoured syrup. Each mL of syrup
contains loratadine 1mg and the
inactive ingredients propylene glycol, glycerin, citric acid -
anhydrous, sodium benzoate, sucrose, peach
flavour and purified water.
_CHILDREN’S CLARATYNE SYRUP (GRAPE FLAVOUR) (NOT AVAILABLE) _
Clear, light yellow coloured, grape flavoured syrup. Each mL of syrup
contains loratadine 1mg/mL, and the
inactive ingredients sodium phosphate monobasic monohydrate,
phosphoric acid, disodium edetate,
artificial flavouring grape (856.435), glycerol, propylene glycol,
macrogol 400, sucralose, maltitol
solution, sorbitol solution 70%, purified water with sodium benzoate
as preservative.
_CLARATYNE LIQUI-GELS LIQUID CAPSULES (NOT AVAILABLE) _
Oval, clear blue liquid filled (softgel) capsules printed on one side
with a C-10 logo. Each capsule contains
loratadine 10 mg, and the inactive ingredients mono- and di-
glycerides, polysorbate 80, povidone, lecithin,
medium chain triglycerides, Opacode WB