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Zaditen

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Document: Zaditen eye drops, solution in single dose containers ENG PL change

Package leaflet: Information for the user


Zaditen 0.25 mg/ml, eye drops, solutionin single-dose containers

Ketotifen


<Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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.>


<Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, phamacist or nurse have told you.

You must talk to a doctor if you do not feel better or if you feel worse.>


<[To be completed nationally]>


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

How to store Zaditen

6. Contents of the pack and other information


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.


<You must talk to your doctor if you do not feel better or if you feel worse <after [to be completed nationally] days.>>


What you need to know before you use Zaditen


Do not use Zaditen


If you are allergic to ketotifen or any of the other ingredients of this medicine (listed in section 6).


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:


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 breast-feeding.


Driving and using machines


Zaditen may cause blurred vision or drowsiness. If this happens to you, wait until this has cleared before driving or operating machinery.


How to use Zaditen


<Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.>


<Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure. >


The recommended dose for adults, elderly and children (age 3 and older) is one drop into the affected eye(s) twice a day (in the morning and evening).


One single-dose container contains enough solution to treat both eyes in one application.


Instructions for use


1. Wash your hands.

2. Open the blister pack/pouch and pull out the block of single-dose containers.

3. Remove one of the single-dose containers from the strip (Fig. 1).

4. Place the remaining single-dose containers back and close the blister/pouch by folding the edge over. Place the blister pack/pouch in the carton.

5. Open the single-dose container by twisting off the tip. Do not touch the tip after opening the container (Fig 2).

6. Lean your head back (Fig. 3).

7. Pull down your lower eyelid with your finger and hold the container in your other hand. Squeeze the container so that one drop falls into the eye (Fig 4).

8. Close your eyes and press the tip of one finger against the inner corner of the eye for around 1‑2 minutes. This will prevent the drop running through the tear duct into your throat and most of the drop will remain in the eye (Fig 5). If necessary repeat steps 6 to 8 with your other eye.

9. Discard the container after use.


Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.


If you use more Zaditen than you should


There is no danger if you have accidentally taken Zaditen by mouth or if you have used more than one drop in the eye. If you have any doubt, contact your doctor for advice.


If you forget to use Zaditen


If you forget to use Zaditen you should treat your eyes as soon as you remember. Then continue with your normal routine. Do not take a double dose to make up for a forgotten dose.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


The following side effects have been reported.


Common (affecting less than 1 in every 10 patients)


Uncommon (affecting less than 1 in every 100 patients)


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.


5. How to store Zaditen


Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

After opening a blister/pouch, any unused single-dose containers can be stored for 3 months if in the outer carton or else for 4 weeks.

The single-dose container is not sterile itself, but its contents are sterile until the container is opened.

Once opened, the contents of the single dose container should be used immediately and not saved.

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


6. Contents of the pack and other information


What Zaditen contains


The active substance is ketotifen (as fumarate). Each ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen.

The other ingredients are glycerol (E422), sodium hydroxide (E524) and water for injections.


What Zaditen looks like and contents of the pack


Zaditen is a clear, colourless to faint yellow solution. One single-dose container contains 0.4 ml.

Zaditen is available in packs containing 5, 10, 20, 30, 50 and 60 single-dose containers.

Not all pack sizes may be marketed in your country.


Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder:

<[To be completed nationally]>


Manufacturer:

EXCELVISION, 27 rue de la Lombardière, 07100 Annonay, France.


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria Zaditen konservierungsmittelfrei 0,025% - Augentropfen in Einzeldosisbehältnissen

Czech Republic Zaditen SDU 0,025%

Denmark Zaditen

Finland Zaditen 0,25 mg/ml silmätipat, liuos kerta-annospakkauksessa

France Zalerg, 0,25 mg/ml, collyre en solution en récipient unidose

Germany Zaditen ophtha sine 0,25 mg/ml Augentropfen Lösung in Einzeldosisbehältnissen

Greece Zaditor οfθaλµικέςstaγόνeς

Iceland Zaditen

Ireland Zaditen 0.25mg/ml,eye drops, solution in single-dose containers

Italy Zaditen 0,25 mg/ml collirio soluzione (5, 10, 20, 30, 50, 60) contenitori monodose

Luxembourg Zaditen Unidose 0,25 mg/ml, collyre en solution en récipient unidose

Norway Zaditen

Portugal Zaditen 0,25 mg/ml colírio, solução em unidoses

Spain Zaditen colirio monodosis

Sweden Zaditen 0,25 mg/ml, ögondroppar, lösning i endosbehållare

The Netherlands Zaditen Unidose 0,25 mg/ml, oogdruppels, oplossing


This leaflet was last revised in 2016-04-29



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