ZADITEN ophtha sine 0.25 mg/ml eye drops single dose

Dosage form:Single-dose pipettesZaditen ophtha sine 0.25 mg/ml eye drops. Active ingredient: ketotifen fumarate. Indications: for the treatment of seasonal allergic conjunctivitis (itchy, watery, red or swollen eyes and/or eyelids).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Zaditen ophtha sine 0.25 mg/ml eye drops, solution in single-dose containers for use in children aged 3 years and over and adults
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 leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not notice any improvement or even feel worse, consult your doctor.

What is in this leaflet:

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

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

Zaditen ophtha sine eye drops contain the active ingredient ketotifen fumarate, which is an anti-allergy medicine. Zaditen ophtha sine eye drops are used to treat seasonal allergic conjunctivitis (itchy, watery, red, or swollen eyes and/or eyelids).

2. WHAT YOU NEED TO KNOW BEFORE USE ZADITEN OPHTHA SINE EYE DROPS?

Do not use Zaditen ophtha sine eye drops if you are allergic to ketotifen fumarate or any of the other ingredients of this medicine (listed in section 6).

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

Using Zaditen ophtha sine eye drops with food, drink and alcohol:
Zaditen ophtha sine may increase the effects of alcohol.

Pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Zaditen ophtha sine can be used while breastfeeding.

Driving and using machines:
Zaditen ophtha sine eye drops may cause visual disturbances or dizziness. If you experience blurred vision or drowsiness after using Zaditen ophtha sine eye drops, you should wait to drive or operate machinery until these symptoms have disappeared.

3. HOW TO USE ZADITEN OPHTHA SINE EYE DROPS

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. 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(s) twice a day (morning and evening). The contents of one single-dose container are sufficient for one drop in each eye.

How to use:
How to use Zaditen ophtha sine eye drops:

1. Wash your hands.
2. Open the blister pack/sachet and remove the strip from connected unit-dose containers.
3. Detach a single-dose container from the strip.
4. Return the remaining single-dose containers to the carton and close the blister/sachet by folding over the edge. Store the blister/sachet in the carton.
5. Open the single-dose container by twisting off the tip. Be careful not to touch the tip of the container after opening.
6. Tilt your head back.
7. Pull your lower eyelid down with your finger and hold the single-dose container in your other hand. Gently press down on the container and drop one drop into your eye.
8. Close your eyes and press your fingertip against the inner corner of your eye for 1-2 minutes. This prevents the drop from flowing through the tear duct into the throat, and most of the drop remains in the eye. Repeat steps 6 to 8 for the other eye if necessary.
9. Discard the single-dose container after use.

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

If you use more Zaditen ophtha sine eye drops than you should:
There is no danger if you accidentally take Zaditen ophtha sine eye drops by mouth or if you accidentally put more than one drop in your eye. If in doubt, ask your doctor.

If you forget to use Zaditen ophtha sine eye drops:
If you forget to use Zaditen ophtha sine, use it as soon as possible. Then go back to your regular dosing schedule. Do not use 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 (may affect up to 1 in 10 people):

• Eye irritation or eye pain
• Eye infections

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

• Blurred vision after instillation into the eye
• dry eyes
• Eyelid irritations
• Conjunctivitis
• Increased sensitivity to light
• Visible bleeding under the surface of the eye
• Headache
• Dizziness
• Rash (also associated with itching)
• Eczema (itchy, red, burning rash)
• dry mouth
• Allergic reactions (including swelling of the face and eyelids) and increased severity of existing allergic conditions such as asthma and skin rash

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. 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 SHOULD ZADITEN OPHTHA SINE EYE DROPS BE STORE?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after ###EXP:### (###EXP:###). The expiry date refers to the last day of that month. The single-dose container itself is not sterile, but the contents are sterile until the container is opened. Storage conditions: Once the blister pack/sachet has been opened, unused single-dose containers can be stored in the carton for 3 months or outside the carton for 1 month. Do not store above 25°C. Shelf life after opening: The contents of a single-dose container must be used immediately after opening and must not be stored. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Zaditen ophtha sine eye drops contain:
The active ingredient is: ketotifen fumarate. 1 ml of eye drops contains: 0.345 mg ketotifen fumarate (equivalent to 0.25 mg ketotifen). The other ingredients are: Glycerol (E 422), sodium hydroxide (E 524), water for injections.

What Zaditen ophtha sine eye drops look like and contents of the pack:
Zaditen ophtha sine eye drops are a clear, colorless to slightly yellow solution. One single-dose container contains 0.4 ml. Zaditen ophtha sine eye drops are available in packs of 10, 20, and 50 single-dose containers.

Marketing Authorisation Holder:
Laboratoires Thea
12, rue Louis Bleriot
63017 CLERMONT-FERRAND Cedex 2
France

Manufacturer:
Excelvision
27, rue de la Lombardiere
07100 Annonay
France

Local Representative:
THEA PHARMA GmbH
Schillerstraße 3
10625 Berlin

This package leaflet was last revised in January 2025.

Source: Information from the package leaflet.
Version: 10/2024

Active ingredient: Ketotifen fumarate. Indications: For the treatment of seasonal allergic conjunctivitis (itchy, watery, red, or swollen eyes and/or eyelids).