KETOTIFEN DERMOGEN 0.25 mg/ml EYE DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

2. What you need to know before starting to use Ketotifeno Dermogen

Do not use Ketotifeno Dermogen:

• if you are allergic to ketotifeno 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 Ketotifeno Dermogen.

Using Ketotifeno Dermogen with other medications

If you need to apply any other eye medication besides Ketotifeno Dermogen, wait at least 5 minutes between the application of each product.

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

• depression
• allergies (e.g., antihistamines)

Using Ketotifeno Dermogen with food, drinks, and alcohol

Ketotifeno Dermogen may increase the effects of alcohol.

Pregnancy and breastfeeding

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

Ketotifeno Dermogen can be used during breastfeeding.

Driving and using machines

Ketotifeno Dermogen may cause blurred vision or drowsiness. Do not drive or use machines until these effects have disappeared.

3. How to use Ketotifeno Dermogen

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

The recommended dose for adults, the 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 enough solution to treat both eyes in one application.

Instructions for use:

1. Wash your hands.
2. Open the blister pack and remove the block of single-dose containers.
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. Store the blister pack in the carton.
5. Open the single-dose container by twisting the top. After opening, do not touch the tip of the dropper (Fig. 2).
6. Tilt your head back (Fig. 3).
7. Pull the lower eyelid down with your finger and hold the container with your other hand. Squeeze the container so that one drop falls into the eye (Fig. 4).
8. Close your eyes and press the inner corner of your eye with the tip of your finger for 1-2 minutes. 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 6-8 with the other eye.
9. Discard the container after use.

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

If you have any further questions about using this product, ask your doctor, pharmacist, or nurse.

If you use more Ketotifeno Dermogen than you should

There is no danger if you accidentally take Ketotifeno Dermogen orally, nor 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 Toxicology Information Service Tel.: 91 562 04 20.

If you forget to use Ketotifeno Dermogen

If you forget to use Ketotifeno Dermogen, 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 missed doses.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been reported.

Frequent (affecting less than 1 in 10 patients)

• eye irritation or eye pain
• eye inflammation

Uncommon (affecting less than 1 in 100 patients)

• blurred vision when applying the drops to the eye
• eye dryness
• eyelid alteration
• conjunctivitis
• increased sensitivity of the eyes to light
• visible bleeding in the white part of the eye
• headache
• drowsiness
• rash (which can also cause itching)
• eczema (itching, redness, rash with itching)
• dry mouth
• allergic reaction (including swelling of the face and eyelids) and increased severity of an existing allergic condition such as asthma and eczema

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ketotifeno Dermogen

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Keep the single-dose container in the aluminum bag.

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

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be thrown away in drains or trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

Ketotifeno Dermogen composition

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), phosphoric acid, and purified water.

Product appearance and container contents

Ketotifeno Dermogen is a colorless solution. Each single-dose container contains 0.4 ml.

Ketotifeno Dermogen is available in containers containing 5, 10, and 20 single-dose containers.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

NUTRA ESSENTIAL OTC, S.L.

La Granja, 1

28108 Alcobendas Madrid

Manufacturer

Unolab Manufacturing S.L.

Avenida de las Flores nº 6

28970 Humanes de Madrid (Madrid), Spain

or

Farmalider S.A.

C/Aragoneses2

28108 Alcobendas (Madrid) Spain

Date of the last revision of this leaflet:July 2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/