Zaditen 250micrograms/ml eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketotifen fumarate

Available from:

Thea Pharmaceuticals Ltd

ATC code:

S01GX08

INN (International Name):

Ketotifen fumarate

Dosage:

250microgram/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040200; GTIN: 5016833008453

Patient Information leaflet

THIS PRINTING PROOF REPRESENTS EXACTLY THE WAY THE PI WILL BE
PRINTED.
This means that by puting your signature on it, you fully accept its
design, texts and that anything comply on a regulatory point of view
to your local requirements.
Name:
Date:
Signature:
Your signature on this pdf means that you guarantee that technicals
aspects of this PI comply with the size of the PI, the cutting shapes,
the margins, the codes and their positions, the reserved areas, the
varnished areas, the braille and all the embossed elements and all
the necessary marks in order to ensure that the fi nished product will
look at what is shown below.
YOU SHOULD NOT MODIFY THIS PDF.
Name:
Date:
Signature:
!! Customer approval !!
!! Manufacturer approval !!
Product :
MOCKUP ZADITEN 5ML UK IE - 2900C5ASP
PI Théa’s Code :
N2900C5ASP/0113
Manufacturer :
EXCELVISION
PI Manufacturer’s Code :
000000
Type of PI :
LEAFLET
Dimensions (WH) :
120 x 420 mm
Remarks :
-
Théa’s Template :
EXCE-N-120x420-0609-6
Fonts :
Formata, News Gothic
Title size :
18 pt
Subtitle size :
9 pt
Text size :
9 pt
Interline size :
10,8 pt
Code size :
7 pt
Soft :
InDesign 7.5.1 (CS5.5)
Global version :
0113-1
Global version date :
07 janvier 2013
Customer version : 1
Customer version date :
07 janvier 2013
Technical version : 0
Technical version date :
-
Black
Black 67%
Used colours
LA MACHINE
0000000
R92
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZADITEN
0.25 MG/ML, EYE DROPS, SOLUTION
Ketotifen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Zaditen is and what it is used for
2. Before you use Zaditen
3. How to use

Summary of Product characteristics

OBJECT 1
ZADITEN 0.25 MG/ML, EYE DROPS, SOLUTION.
Summary of Product Characteristics Updated 19-Feb-2015 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
Zaditen 0.25 mg/ml, eye drops, solution
2. Qualitative and quantitative composition
One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg
ketotifen.
Each drop contains 8.5 microgram ketotifen fumarate.
Excipient(s) with known effect: Benzalkonium chloride (0.1 mg/ml).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, colourless to faintly yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of seasonal allergic conjunctivitis.
4.2 Posology and method of administration
Adults, elderly and children (age 3 and older): one drop of Zaditen
into the conjunctival sac twice a day.
The contents and dispenser remain sterile until the original closure
is broken.
To avoid contamination do not touch any surface with the dropper tip.
The safety and efficacy of Zaditen in children aged from birth to 3
years have not yet been established.
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
The formulation of Zaditen eye drops contains benzalkonium chloride as
a preservative, which may be
deposited in soft contact lenses; therefore Zaditen eye drops should
not be instilled while the patient is
wearing these lenses. The lenses should be removed before application
of the drops and not reinserted
earlier than 15 minutes after use.
All eye drops preserved with benzalkonium chloride may possibly
discolour soft contact lenses.
Benzalkonium chloride may cause eye irritation.
4.5 Interaction with other medicinal products and other forms of
interaction
If Zaditen is used concomitantly with other eye medications there must
be an interval of at least 5 minutes
between the two medications.
The use of oral dosage forms of ketotifen may potentiate the effect of
CNS depressan