Prospecto : Information for the User

Zaditen0.25 mg/ml eye drops in single-dose solution

Ketotifen

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, 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,evenifthey are not listed in this prospectus. See section 4.

1.What is Zaditen and what it is used for

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 to ketotifen or 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.

Using 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 or have recently used 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)

Using Zaditen with food, drinks and alcohol

Zaditen may increase the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or intend to become 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

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

A single-dose container contains the amount of solution sufficient to treat both eyes in one application.

Instructions for use

1.Wash your hands.

2.Open the blister pack and remove the single-dose container.

3.Separate a single-dose container from the strip (Fig.1).

4.Store the remaining single-dose containers back in the blister pack and close the blister pack by folding the edge of it. Store the blister pack in the carton.

5.Open the single-dose container by twisting its upper end. After opening the container, do not touch the dropper tip (Fig.2).

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

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

8.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.5). If necessary, repeat steps 6 to 8 with the other eye.

9.Dispose of the container after use.

Fig.1Fig.2Fig.3Fig.4Fig.5

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. In case of doubt, consult your doctor. Also, in case of overdose or accidental ingestion, you can consult the Toxicological Information Service Tel.: 91 562 04 20.

If you forgot to use Zaditen

If you forgot 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 compensate for the missed doses.

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 itching)

-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 or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through 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 this medication out of the sight and reach of children.

Do not store at a temperature above25°C.

After opening a blister/pouch, unused single-dose containers can be stored for 3 months if kept in the outer cardboard packaging, or for 4 weeks if not.

The single-dose container itself is not sterile, but its contents are sterile until the container is opened.

Once opened, the contents of the single-dose container must be used immediately and not stored.

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

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

Composition of Zaditen

The active ingredient is ketotifeno (as 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), and water for injection preparations.

Appearance of the product and contents of the package

Zaditen is a transparent, colorless to pale yellow solution. A single-dose container contains 0.4 ml. Zaditen is presented in containers containing 5, 10, 20, 30, 50, and 60 single-dose containers.

Only some package sizes may be marketed in your country.

Marketing Authorization Holder

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

Responsible for manufacturing

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

Or

Laboratoire UNITHER, 1 rue de l’Arquerie, 50200 COUTANCES, France

Local Representative

Laboratorios THEA S.A. –C/ Enric Granados nº 86-88, 2nd floor, 08008 Barcelona

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

AustriaZaditen konservierungsmittelfrei 0.025% - Eye drops in single-dose containers

Czech RepublicZaditen SDU

DenmarkZaditen

FinlandZaditen 0.25 mg/ml eye drops, solution in single-dose containers

FranceZagrapa, 0.25 mg/ml, eye drops in solution in single-dose containers

GermanyZaditen ophtha sine 0.25 mg/ml eye drops solution in single-dose containers

GreeceZaditorοfθaλµικ?ςstaγ?νeς

IcelandZaditen

LuxembourgZaditen Unidose, 0.25 mg/ml, eye drops in solution in single-dose containers

NorwayZaditen

PortugalZaditen 0.25 mg/ml eye drops, solution in single-dose containers

SpainZaditen0.25 mg/ml eye drops in solution in containerssingle-dose

SwedenZaditen 0.25 mg/ml, eye drops, solution in endos containers

NetherlandsZaditen Unidose 0.25 mg/ml, eye drops, solution

Last review date of this leaflet:03/07/2020

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/