Leaflet: information for the user

Bentifen 0.25mg/ml eye drops in solution

Ketotifeno

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

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

1. What is Bentifen and what it is used for

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

3. How to use Bentifen

4. Possible side effects

5. Storage of Bentifen

6. Contents of the pack and additional information

Bentifen contains the active ingredient ketotifeno, 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.

Do not use Bentifen

If you are allergic (hypersensitive) 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 Bentifen.

Use of Bentifen with other medications

If you need to apply any other medication to your eyes 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 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 Bentifen with food, drinks, and alcohol

Bentifen may increase the effects of alcohol.

Pregnancy, and breastfeeding

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

Bentifen can be used during breastfeeding.

Driving and operating machines

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

Bentifen 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 feel a strange sensation, burning, or pain in your eye after using this medication.

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

Follow exactly the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

In case of 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 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 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 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 contact the Toxicological Information Service Tel.: 91 562 04 20.

If you forgot to use Bentifen

If you forgot 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 compensate for the missed dose.

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

The following adverse effects have been reported.

Frequent(affecting less than 1 in 10 patients)

-eye irritation or pain

-eye inflammation

Rare(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 hemorrhage in the white area of the eye

-headache

-drowsiness

-eruption (which may also cause itching)

-eczema (itching, redness, eruption with pruritus)

-dry mouth

-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 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.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature 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 that appears on the packaging 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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bentifen

The active principle 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 packaging

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

Holder of the marketing authorization

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, 2nd floor- 08008 Barcelona

Responsible for manufacturing:

Excelvision,

27 rue de la Lombardière,

07100 Annonay, France

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

Last review date of this prospectus: 10/2020

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