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Document: leaflet MAH BRAND_PL 20162-0019 change

• leaflet MAH BRAND_PL 20162-0019
• leaflet MAH BRAND_PLPI 10383-1056

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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 Zaditen

4.    Possible side effects

5.    How to store Zaditen

6.    Further 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.    BEFORE YOU USE ZADITEN

Do not use Zaditen

If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Zaditen. Using other medicines

If you need to apply any other medicinal products to your eyes together with Zaditen, wait at least 5 minutes between applying each product.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important for medicines which are used to treat:

•    depression

•    allergy (e.g. antihistamines)

Using Zaditen with food and drink

Zaditen may increase the effect of alcohol.

Pregnancy and breast-feeding

If you are pregnant or think you might be, ask your doctor or pharmacist for advice before using Zaditen.

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.

Important information about some of the ingredients of Zaditen

Zaditen contains benzalkonium chloride and may cause eye irritation.

If you wear soft contact lenses you should remove them before using Zaditen as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Zaditen before reinserting your contact lenses into your eyes.

3. HOW TO USE ZADITEN

Always use Zaditen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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).

Instructions for use

1.    Wash your hands.

2.    Open the bottle. Do not touch the tip after opening the bottle.

3.    Lean your head back (Fig. 1).

4.    Pull down your lower eyelid with your finger and hold the bottle in your other hand. Squeeze the bottle so that one drop falls into the eye (Fig. 2).

5.    Close your eyes and press the tip of one finger against the 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. 3). If necessary repeat steps 3 to 5 with your other eye.

6.    Close the bottle after use.

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

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.

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