BENTIFEN 0.25mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Bentifen 0.25mg/ml eye drops solution

Ketotifene

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bentifen and what is it used for
2. What you need to know before using Bentifen
3. How to use Bentifen
4. Possible side effects
5. Storage of Bentifen
6. Package Contents and Additional Information

1. What is Bentifen and what is it used for

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

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

2. What you need to know before using Bentifen

Do not use Bentifen

If you are allergic (hypersensitive) to ketotifene 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 Bentifen.

Using Bentifen with other medications

If you need to apply any other eye medication in addition to Bentifen, 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, anxiety, and sleep disorders
• Allergies (e.g., antihistamines)

Using Bentifen with food, beverages, and alcohol

Bentifen 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.

Bentifen can be used during breastfeeding.

Driving and Using Machines

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

Bentifen contains benzalkonium chloride

This medication contains 2.6 micrograms of benzalkonium chloride per drop.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medication and wait 15 minutes before putting them back on.

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

3. How to use Bentifen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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 night).

Instructions for use

1. Wash your hands.
2. Open the bottle. Do not touch the tip of the dropper 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. Squeeze 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 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. 3). If necessary, repeat steps 3 to 5 with the other eye.
6. Close the bottle after use.

Fig. 1 Fig. 2 Fig. 3

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

If you use more Bentifen than you should

There is no danger if you accidentally take Bentifen orally, nor if more than one drop falls accidentally into your eye. If in 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 Bentifen

If you forget to use Bentifen, 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 forgotten 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)

• irritation or pain in the eye
• inflammation in the eye

Uncommon(affecting less than 1 in 100 patients)

• blurred vision when applying the drops in the eye
• dryness in the eye
• alteration in the eyelid
• 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 side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance 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 Bentifen

Keep this medication out of the sight and reach of children.

Do not store above 25°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 medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Bentifen Composition

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

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

Appearance of the Product and Package Contents

Bentifen is a clear, colorless to pale yellow solution. The solution is presented in a package containing a 5 ml bottle.

Marketing Authorization Holder

Holder:

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

Local Representative:

Laboratorios THEA S.A. - C/ Enric Granados, nº 86-88, 2ª planta - 08008 Barcelona

Manufacturer:

Excelvision,

27 rue de la Lombardière,

07100 Annonay, France

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet: 10/2020

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