ZADITEN

ZADITEN ophtha 0.25 mg/ml eye drops

Important notes (mandatory information)

Zaditen ophtha 0.25 mg/ml eye drops, solution. Active ingredient: Ketotifen fumarate. Areas of application: for the treatment of eye complaints in hay fever.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Zaditen ophtha 0.25 mg/ml eye drops, solution
Active ingredient: Ketotifen fumarate

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist or medical professional has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor, pharmacist or medical professional. This also applies to side effects that are not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT ARE ZADITEN OPHTHA EYE DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ZADITEN OPHTHA EYE DROPS?
3. HOW TO USE ZADITEN OPHTHA EYE DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ZADITEN OPHTHA EYE DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE ZADITEN OPHTHA EYE DROPS AND WHAT ARE THEY USED FOR?

Zaditen ophtha eye drops contain the active ingredient ketotifen fumarate, which is an anti-allergic agent. Zaditen ophtha eye drops are used to treat eye complaints in hay fever.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ZADITEN OPHTHA EYE DROPS?

Zaditen ophtha eye drops must not be used if you are hypersensitive (allergic) to ketotifen fumarate or any of the other ingredients of this medicine listed in section 6.1.

Using Zaditen ophtha eye drops with other medicines

If you need to use other eye drops in addition to Zaditen ophtha, the two medicines should be used at least 5 minutes apart. Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. This applies in particular to medicines for the treatment of depression and allergies (e.g. antihistamines).

Use with food, drinks and alcohol

Zaditen ophtha eye drops can enhance the effect of alcohol.

Pregnancy and breast-feeding

If you are pregnant or if you suspect that you are pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Zaditen ophtha eye drops may be used during breast-feeding.

Driving and using machines

Zaditen ophtha eye drops can cause visual disturbances or drowsiness. If you notice this, wait until these symptoms have disappeared before driving or operating machinery.

Zaditen ophtha eye drops contain benzalkonium chloride

Zaditen ophtha eye drops contain benzalkonium chloride and can cause eye irritation.

If you wear soft contact lenses, you should remove them before using Zaditen ophtha eye drops, as soft contact lenses can become discoloured. Wait at least 15 minutes after using Zaditen ophtha eye drops before reinserting your contact lenses.

3. HOW TO USE ZADITEN OPHTHA EYE DROPS?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist or medical professional. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults, the elderly and children (3 years and older) is one drop in the affected eye (or eyes) twice a day (morning and evening).

Instructions for use

1. Wash your hands.
2. Open the bottle. Do not touch the tip of the bottle after opening.
3. Tilt your head back.
4. Pull down the lower eyelid with your finger and take the bottle in the other hand. Press the bottle so that a drop can fall into the eye.
5. Close your eyes and press your fingertip against the corner of your eye for 1-2 minutes. This prevents the drop from draining into the throat through the tear duct, and most of the drop remains in the eye. Repeat steps 3 to 5 for the other eye if necessary.
6. Close the bottle after use.

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

If you have used more Zaditen ophtha eye drops than you should

There is no danger if Zaditen ophtha eye drops are accidentally swallowed or if more than one drop is accidentally put in the eye. If in doubt, ask your doctor for advice.

If you forget to use Zaditen ophtha eye drops

If you forget to use Zaditen ophtha eye drops, do so as soon as possible. Then continue with your normal routine. Do not use a double dose to make up for a forgotten application.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported

Common (may affect up to 1 in 10 people):

• Eye irritation or eye pain
• Eye inflammation

Uncommon (may affect up to 1 in 100 people):

• blurred vision after instillation into the eye
• dry eyes
• eyelid irritation
• conjunctivitis
• increased sensitivity of the eyes to light
• visible bleeding in the white of the eye
• headache
• drowsiness
• rash (also in conjunction with itching)
• eczema (itchy, reddened, burning rash)
• dry mouth
• allergic reaction (including swelling of the face and eyelid) and increased severity of existing allergic conditions, such as asthma and rash

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ZADITEN OPHTHA EYE DROPS?

Keep this medicine out of the reach of children. Do not store above 25°C. The bottle itself is not sterile. However, the contents are sterile until the bottle is opened. After opening the bottle, the drops can be stored for a maximum of 4 weeks. Do not use this medicine after the expiry date which is stated on the carton and the container after "Use by:" ("Use by:"). The expiry date refers to the last day of the month. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Zaditen ophtha eye drops contain

The active ingredient is ketotifen fumarate. 1 ml of eye drops contains 0.345 mg of ketotifen fumarate (equivalent to 0.25 mg of ketotifen). The other ingredients are glycerol (E 422), sodium hydroxide (E 524), water for injections and benzalkonium chloride.

What Zaditen ophtha eye drops look like and contents of the pack

Zaditen ophtha eye drops are a clear, colourless to slightly yellow solution. The solution is available in a pack containing one 5 ml bottle.

Pharmaceutical entrepreneur

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

Manufacturer

Excelvision
27, rue de la Lombardière
07100 Annonay
France

Local representative

Thea Pharma GmbH
Schillerstraße 3
10625 Berlin

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 12/2016
Active ingredient: Ketotifen fumarate. Areas of application: for the treatment of eye complaints in hay fever.