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Bentifen

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Package leaflet: Information for the user

Bentifen 0.25 mg/ml, eye drops, solutionin single-dose containers

Ketotifen


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


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

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.


What is in this leaflet:

1. What Bentifen is and what it is used for

2. What you need to know before you use Bentifen

3. How to use Bentifen

4. Possible side effects

How to store Bentifen

6. Contents of the pack and other information


What Bentifen is and what it is used for


Bentifen contains the active substance ketotifen, which is an anti-allergic substance. Bentifen is used to treat eye symptoms of hay fever.


<You must talk to a doctor if you do not feel better or if you feel worse after [to be completed nationally] days.>


What you need to know before you use Bentifen


Do not use Bentifen


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


Other medicines and Bentifen


If you need to apply any other medicinal products to your eyes together with Bentifen, wait at least 5 minutes between applying each product.


Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important for medicines which are used to treat:

Bentifen with food, drink and alcohol


Bentifen may increase the effect of alcohol.


Pregnancy and breast-feeding


If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Bentifen can be used during breast-feeding.


Driving and using machines


Bentifen may cause blurred vision or drowsiness. If this happens to you, wait until this has cleared before driving or operating machinery.


How to use Bentifen


<Always use this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.>


<Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.>

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


One 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/pouch and pull out the block of single-dose containers.

3. Remove one of the single-dose containers from the strip (Fig. 1).

4. Place the remaining single-dose containers back and close the blister/pouch by folding the edge over. Place the blister pack/pouch in the carton.

5. Open the single-dose container by twisting off the tip. Do not touch the tip after opening the container (Fig 2).

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

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

8. Close your eyes and press the tip of one finger against the inner corner of the eye for around 1‑2 minutes. This will prevent the drop running through the tear duct into your throat and most of the drop will remain in the eye (Fig 5). If necessary repeat steps 6 to 8 with your other eye.

9. Discard the container after use.


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

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

If you use more Bentifen than you should


There is no danger if you have accidentally taken Bentifen by mouth or if you have used more than one drop in the eye. If you have any doubt contact your doctor for advice.


If you forget to use Bentifen


If you forget to use Bentifen you should treat your eyes as soon as you remember. Then continue with your normal routine. Do not take a double dose to make up for a forgotten dose.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


The following side effects have been reported.


Common (affecting less than 1 in every 10 patients)


Uncommon (affecting less than 1 in every 100 patients)


Reportingof side effects

If you getany side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effectsnot listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.



5. How to store Bentifen


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

Do not store above 25 °C.

After opening a blister/pouch, any unused single-dose containers can be stored for 3 months if in the outer carton or else for 4 weeks.

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

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

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


6. Contents of the pack and other information


What Bentifen contains


The active substance is ketotifen (as fumarate). Each ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen.

The other ingredients are glycerol (E422), sodium hydroxide (E524) and water for injections.


What Bentifen looks like and contents of the pack


Bentifen is a clear, colourless to faint yellow solution. One single-dose container contains 0.4 ml.

Bentifen is available in packs containing 5, 20, 30, 50 and 60 single-dose containers.

Not all pack sizes may be marketed in your country.


Marketing Authorisation Holder and Manufacturer:


Marketing Authorisation Holder:

<[To be completed nationally]>


Manufacturer:

EXCELVISION, 27 rue de la Lombardière, 07100 Annonay, France.


[Or only for Italy]

S.A. Alcon-Couvreur N.V, Rijksweg 14, 2870 Puurs, Belgium


This medicinal product is authorised in the Member States of the EEA under the following names:


Italy

Bentifen 0,25 mg/ml collirio, soluzione in contenitori monodose

Portugal

Bentifen 0,25 mg/ml colírio, solução em unidoses

Sweden

Bentifen 0,25 mg/ml, ögondroppar, lösning i endosbehållare


This leaflet was last revised in 2016-06-10


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