Zaditen

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

KETOTIFEN

Available from:

Laboratoires THEA 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France

ATC code:

S01GX08

INN (International Name):

KETOTIFEN 0.25 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

KETOTIFEN 0.25 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2005-12-12

Patient Information leaflet

Zaditen
®  
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,  please ask your
doctor  or pharmacist.

•
  This medicine has been prescribed  for you personally and you should not pass
it on to others. 
It may harm them,  even if their symptoms  are the same as
yours.

•   The active  ingredient is ketotifen 0.25mg/ml.

•   The
other ingredients are benzalkonium chloride,  glycerol, sodium hydroxide,  water  for 
injections.

Marketing Authorisation Holder:  
Laboratoires THEA 
12 rue Louis Blériot 
63017 Clermont-Ferrand Cedex 2 
France 

Manufacturer:

EXCELVISION,

Rue de la  Lombardière,

07100 Annonay, 
France

1.   What Zaditen Eye Drops is and what it is used for

The name  of your  eye drops  is Zaditen
®
.  The active  ingredient is  0.25mg  ketotifen  per ml  of ophthalmic 
solution
and is packaged  in a dropper bottle containing 5ml of eye drops. Ketotifen is an anti-allergic agent.

Zaditen
® 
Eye Drops is used for the treatment  and prevention of signs and symptoms of seasonal allergic 
conjunctivitis (itchy, watery, red or swollen eyes and/or eyelids).

Your doctor  will explain your condition.

2. Before you use Zaditen
®  
Eye Drops

Zaditen
® 
Eye Drops can be used by adults, elderly and children of
12 years and older. Efficacy has not 
been tested  in children below
12 years, however limited safety documentation is available  for
Zaditen
® 
Eye Drops in children from 3 years of age.

Do not use Zaditen
®  
Eye Drops

If you are allergic to ketotifen or
to any  of the excipients.

Pregnancy

There is limite

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISITICS  
1.   NAME OF THE MEDICINAL PRODUCT  
ZADITEN
® 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
One mL contains 0.345 mg of ketotifen hydrogen fumarate corresponding
to 0.25 mg of ketotifen.  
For excipients, see 6.1.  
3.   PHARMACEUTICAL FORM  
Eye drops, Solution in a 5 mL bottle. 
4. CLINICAL PARTICULARS  
4.1 THERAPEUTIC INDICATIONS  
Treatment and prevention of signs and symptoms of seasonal allergic
conjunctivits.  
4.2   DOSAGE ANDADMINISTRATION  

Dosage 

Use in adults  
One drop of Zaditen eye drops 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.  
Safety and effectiveness in paediatric patients below the age of 3
years have not been established.  
GERIATRICS  
No dosage adjustment is required in patients above 65 years of age. 
RENAL IMPAIRMENT  
No dosage adjustment is required in patients with renal impairment. 
HEPATIC IMPAIRMENT  
No dosage adjustment is required in patients with hepatic
impairment. 

METHOD OF ADMINISTRATION 
_ _
ZADITEN: 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
dropper tip should also not come into 
contact with the eye as this may cause injury to the eye. 

If Zaditen eye drops are used concomitantly with other eye medications
there must be an interval of at least 
5 minutes between the two medications. 

4.3   CONTRAINDICATIONS  
Known hypersensitivity to ketotifen or any other excipients of the
formulation.  
4.4 WARNINGS AND PRECAUTIONS   
The multidose 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 re