Package Insert: Information for the User

Zaditen 0.25 mg/ml Eye Drops in Solution

Ketotifen

Read this entire package insert carefully before starting to use this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What Zaditen is and for what it is used

2.What you need to know before starting to use Zaditen

3.How to use Zaditen

4.Possible adverse effects

5.Storage of Zaditen

6.Contents of the package and additional information

Zaditen contains the active ingredient ketotifeno, which is an antiallergic substance. Zaditen is used to treat ocular symptoms of seasonal allergic conjunctivitis.

You should consult a doctor if it worsens or does not improve.

Do not use Zaditen

If you are allergic (hypersensitive) to ketotifen or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Zaditen.

Use of Zaditen with other medications

If you need to apply any other medication to your eyes in addition to Zaditen, wait at least 5 minutes between the application of each product.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is especially important in the case of medications used to treat:

• depression, anxiety, and sleep disorders
• allergy (for example antihistamines)

Use of Zaditen with food, drinks, and alcohol

Zaditen may increase the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Zaditen can be used during breastfeeding.

Driving and operating machinery

Zaditen may cause blurred vision or drowsiness.Do not drive or operate machinery until these effects have disappeared.

Zaditen contains benzalkonium chloride.

This medication contains 2.6 micrograms of benzalkonium chloride in each drop.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you experience any unusual sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Usage Instructions

1.Wash your hands.

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

3.Tilt your head back (Fig.1).

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

5.Close your eyes and press the inner corner of the eye with the tip of a finger for 1-2 minutes approximately. This prevents the drop from flowing down the tear duct into the throat and most of the drop will remain in the eye (Fig.3). If necessary, repeat steps 3 to 5 with the other eye.

6.Close the bottle after use.

Fig.1Fig.2Fig.3

If you have any other doubts about 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 accidentally take Zaditen orally or if more than one drop accidentally falls into your eye. If in doubt, consult your doctor. Also, in case of overdose or accidental ingestion, you can contact the Toxicological Information Service Tel.: 91 562 04 20.

If you forget to use Zaditen

If you forget to use Zaditen, apply the treatment as soon as you remember. Then return to your regular treatment schedule.

Do not take a double dose to make up for the missed dose.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported.

Frequent(affect less than 1 in 10 patients)

-Eye irritation or eye pain

-Eye inflammation

Rare(affect less than 1 in 100 patients)

-Blurred vision when the drops are applied to the eye

-Eye dryness

-Palpebral alteration

-Conjunctivitis

-Increased sensitivity of the eyes to light

-Visible hemorrhage in the white area of the eye

-Headache

-Drowsiness

-Rash (which may also cause itching)

-Eczema (itching, redness, rash with burning sensation)

-Mouth dryness

-Allergic reaction (including facial and eyelid swelling) and worsening of an existing allergic condition such as asthma and eczema

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above25°C.

The bottle itself is not sterile, but its contents are sterile until the bottle is opened.

After the first opening of the bottle, the eye drops can only be stored for 4 weeks.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREPoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment..

Composition of Zaditen

The active ingredient is ketotifeno (in the form of fumarate). Each ml contains 0.345 mg of ketotifeno fumarate, which corresponds to 0.25 mg of ketotifeno.

The other components are glycerol (E422), sodium hydroxide (E524), water for injection, and benzalkonium chloride.

Appearance of the product and contents of the package

Zaditen is a transparent, colorless to pale yellow solution. The solution is presented in a package containing a 5 ml vial.

Holder of the marketing authorization

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

Responsible for manufacturing

EXCELVISION – 27 rue de la Lombardière – 07100 Annonay - France.

Local representative

Laboratorios THEA S.A. – Pg. Sant Joan 91, 08009 Barcelona

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaZaditen 0.025% - Augentropfen

DenmarkZaditen

FinlandZaditen 0.25 mg/ml silmätipat, liuos

FranceZalergonium, 0.25 mg/ml, collyre en solution

GermanyZaditen ophtha 0.25 mg/ml Augentropfen

GreeceZaditorοfθaλµικ?ςstaγ?νeς

IcelandZaditen

IrelandZaditen 0.25mg/ml, eye drops, solution

LuxembourgZaditen 0.25 mg/ml, collyre en solution

NorwayZaditen

PortugalZaditen 0.25 mg/ml colírio, solução

SpainZaditen 0.25 mg/ml colirio en solución

SwedenZaditen 0.25 mg/ml, ögondroppar, lösning

NetherlandsZaditen 0.25 mg/ml, oogdruppels, oplossing

United KingdomZaditen 0.25 mg/ml, eye drops, solution

Last review date of this leaflet:10/2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/