0.25 mg/ml eye drops, solution
ketotifen
What Zaditen is and what it is used for
Zaditen contains the active substance ketotifen which is an anti-allergic agent.
Zaditen is used in the treatment of eye problems due to pollen allergy.
The ketotifen contained in Zaditen may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
You must speak to a doctor if you do not feel better or if you feel worse within a few days.
What you need to know before using Zaditen
Do not use the Zadie
If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Zaditen.
Other medicines and Zaditen
If you use other eye products at the same time as Zaditen, you should wait 5 minutes between using the products.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important if you are taking medicines used to treat:
- depression, anxiety, and sleep disorders
- allergy (e.g. antihistamines )
Zaditen with food, drink, and alcohol
It is possible that Zaditen can increase the effect of alcohol.
Pregnancy and breastfeeding
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.
Zadie can be used during breastfeeding.
Driving ability and use of machinery
If you experience blurred vision or fatigue after taking Zaditen eye drops, you should wait until these symptoms have subsided before driving or operating machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Zadite contains benzalkonium chloride
This medicine contains 2.6 micrograms of benzalkonium chloride per drop.
Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How to use Zaditen
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
The recommended dose for adults, the elderly, and children from the age of 3 is one drop in each eye twice daily (morning and evening).
Instructions for use
- Wash your hands.
- Open the bottle. Do not touch the tip after opening.
- Bend your head back (picture 1).
- Pull down the lower eyelid with a finger. Hold the eye drop bottle in the other hand. Press the bottle so that a drop falls into the eye (picture 2).
- Close the eye and press a fingertip against the corner of the eye for about 1-2 minutes. This prevents the drop from flowing down the throat through the tear duct. A larger part of the drop then remains in the eye (picture 3). Repeat steps 3-5 with the other eye if necessary.
- Close the bottle after use.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
If you have used too much Zaditen
There is no risk if you accidentally get a few drops of Zaditen in your mouth. Nor should you be worried if more than one drop happens to fall into one eye. If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Zaditen
If you have forgotten to take your eye drops, take them as soon as possible and then go back to your usual dosage.
Do not take a double dose to make up for a missed dose.
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 (affects less than 1 in 10 users):
- eye irritation or eye pain
- inflammation of the eye
Uncommon (affects less than 1 in 100 users):
- blurred vision when applying the eye drops to the eye
- dry eyes
- eyelid changes
- inflammation of the surface layer of the eye
- increased sensitivity to light in the eyes
- visible bleeding under the surface of the eye
- headache
- drowsiness
- skin rash (which may also be itchy)
- eczema (itchy, red, burning rash)
- dry mouth
- allergic reaction (including swelling of the face and eyelids) and worsening of existing allergic conditions such as asthma and eczema
How the Zaditen should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 ºC.
The bottle is not sterile in itself, but the contents are sterile until the bottle is opened.
The eye drops must be used within 4 weeks after opening the package.
Use before the expiry date stated on the carton and bottle after Ex. data/EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ketotifen. Each ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen.
- Other ingredients are benzalkonium chloride, glycerol (E 422), sodium hydroxide (E 524), and water for injections.
Appearance and package sizes of the medicine
Zaditen eye drops are a clear solution, colorless to pale yellow. One bottle contains 5 ml.
Marketing Authorisation Holder
Laboratoires THEA, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
Manufacturer:
Excelvision – 27 rue de la Lombardière – 07100 Annonay – France
This medicine is approved in the European Economic Area under the names:
| Austria | Zaditen 0.025% – Augentropfen |
| Denmark | The Zadie |
| Finland | Zaditen 0.25 mg/ml eye tip, liuos |
| France | Zalergonium, 0.25 mg/ml, collyre en solution |
| Germany | Zaditen ophtha 0.25 mg/ml Augentropfen |
| Greece | Zaditor οfθaλμικές staγόneς |
| Iceland | The Zadie |
| Ireland | Zaditen 0.25mg/ml eye drops, solution |
| Luxembourg | Zaditen 0.25 mg/ml, collyre en solution |
| Norway | The Zadie |
| Portugal | Zaditen 0.25 mg/ml collírio, solução |
| Spain | Zadite collirio |
| Sweden | Zaditen 0.25 mg/ml eye drops, solution |
| Netherlands | Zaditen 0.25 mg/ml, eye drops, solution |
| England | Zaditen 0.25 mg/ml eye drops, solution |