Zaditen 0.25 mg/ml, eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

KETOTIFEN FUMARATE

Available from:

Laboratoires Thea

ATC code:

S01GX; S01GX08

INN (International Name):

KETOTIFEN FUMARATE

Dosage:

0.25 milligram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiallergics; ketotifen

Authorization status:

Marketed

Authorization date:

2000-11-24

Patient Information leaflet

1
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 BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Zaditen is and what it is used for
2.
What you need to know before you use Zaditen
3.
How to use Zaditen
4.
Possible side effects
5.
How to store Zaditen
6.
Contents of the pack and other information
1.
WHAT ZADITEN IS AND WHAT IT IS USED FOR
Zaditen contains the active substance ketotifen, which is an
anti-allergic substance. Zaditen is used to
treat eye symptoms of hay fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZADITEN
DO NOT USE ZADITEN
If you are allergic (hypersensitive) to ketotifen or any of the other
ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Zaditen.
OTHER MEDICINES AND ZADITEN
If you need to apply any other medicinal products to your eyes
together with Zaditen, wait at least
5 minutes between applying each product.
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. This is particularly important for medicines which are used
to treat:
-
depression, anxiety and sleep disorders
-
allergy (e.g. antihistamines)
ZADITEN WITH FOOD, DRINK AND ALCOHOL
Zaditen may increase the effect of alcohol.
PREGNANCY AND BREAST-FEEDING
If you are pregnant, think you may be pregnant or are planning to have
a baby, ask your doctor or
pharmacist for advice before using this medicine.
Zaditen can be used during br

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2020
CRN009SVW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
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 0.25mg
ketotifen.
Each drop contains 8.5 microgram ketotifen fumarate.
Excipient(s) with known effect: Benzalkonium chloride (0.1mg/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
Posology
Adults, elderly and children (age 3 and older): one drop of Zaditen
into the conjunctival sac twice a day.
_Paediatric population _
The safety and efficacy of Zaditen in children aged from birth to 3
years have not yet been established.
Method of administration
The contents and dispenser remain sterile until the original closure
is broken. To avoid contamination do not touch any surface
with the dropper tip.
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
This medicine contains 2.6 micrograms benzalkonium chloride in each
drop.
Benzalkonium chloride may be absorbed by soft contact lenses and may
change the colour of the contact lenses. Remove
contact lenses prior to application and wait at least 15 minutes
before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in dry
eyes or disorders of the cornea.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
If Zaditen is used concomitantly with other eye medications there must
be an interval of at least 5 minutes between the two
medications.
Health Products Regulatory Authority
27 October 2020
CRN009SVW
Page 2 of 4
The use of oral dosage forms of ketotifen may potentiate the effect of
CNS depressant