Important information about some of the ingredients of Zaditen

Eye Drops

S1023 LEAFLET Zaditen 20160620

PACKAGE LEAFLET: INFORMATION FOR THE USER ZADITEN® EYE DROPS, SOLUTION (ketotifen fumarate)

Your medicine is known as Zaditen Eye Drops, Solution but will be referred to as “Zaditen Eye Drops” throughout the following patient information leaflet.

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Zaditen Eye Drops are and what they are used for

2.    Before you use Zaditen Eye Drops

3.    How to use Zaditen Eye Drops

4.    Possible side effects

5.    How to store Zaditen Eye Drops

6.    Further information

1. WHAT ZADITEN EYE DROPS ARE AND WHAT THEY ARE USED FOR

Zaditen Eye Drops contain the active substance ketotifen, which is an anti-allergic substance. Zaditen Eye Drops are used to treat eye symptoms of hay fever.

2. BEFORE YOU USE ZADITEN EYE DROPS

Do not use Zaditen Eye Drops

If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Zaditen Eye Drops.

Using other medicines

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important for medicines which are used to treat:

•    depression

•    allergy (e.g. antihistamines)

Using Zaditen Eye Drops with food and drink

Zaditen Eye Drops may increase the effect of alcohol.

Pregnancy and breast-feeding

If you are pregnant or think you might be, ask your doctor or pharmacist for advice before using Zaditen Eye Drops.

Zaditen Eye Drops can be used during breast-feeding.

Driving and using machines

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

Zaditen Eye Drops contains benzalkonium chloride and may cause eye irritation.

If you wear soft contact lenses you should remove them before using Zaditen Eye Drops as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Zaditen Eye Drops before reinserting your contact lenses into your eyes.

3. HOW TO USE ZADITEN EYE DROPS

Always use Zaditen Eye Drops exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not

sure.

The usual 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).

Instructions for use

1.    Wash your hands.

2.    Open the bottle. Do not touch the tip after opening the bottle.

3.    Lean your head back (Fig. 1).

4.    Pull down your lower eyelid with your finger and hold the bottle in your other hand. Squeeze the bottle so that one drop falls into the eye (Fig. 2).

5.    Close your eyes and press the tip of one finger against the 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. 3). If necessary repeat steps 3 to 5 with your other eye.

6.    Close the bottle after use.

Fig. 1    Fig. 2    Fig. 3

If you have any further questions on the use of this product, ask

your doctor or pharmacist.

If you use more Zaditen Eye Drops than you should

There is no danger if you have accidentally taken Zaditen Eye Drops 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 Zaditen Eye Drops

If you forget to use Zaditen Eye Drops 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, Zaditen Eye Drops 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)

• eye irritation or pain

• inflammation in the eye

•    eye pain, blurred vision, abnormal intolerance to light

Uncommon (affecting less than 1 in every 100 patients)

•    blurred vision when putting drops on the eye

•    dry eye

•    eyelid disorder

•    conjunctivitis

•    increased sensitivity of the eyes to light

•    visible bleeding in white of eye

•    headache

•    drowsiness

•    rash (which may also itch)

•    eczema (itchy, red, burning rash)

•    dry mouth

•    allergic reaction (including swelling of the face and eyelids) and increase in severity of existing allergic conditions such as asthma and eczema

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ZADITEN EYE DROPS

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    This medicine must be thrown away four weeks after first opening of the bottle.

•    Do not use after the expiry date printed on the carton or bottle label.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Zaditen Eye Drops contain

•    Each ml of solution contains 0.345mg ketotifen hydrogen fumarate equivalent to 0.25mg ketotifen.

•    Also contains benzalkonium chloride, glycerol, sodium hydroxide and water for injections.

What Zaditen Eye Drops look like and contents of the pack

It is a clear, colourless to faintly yellow solution.

Zaditen Eye Drops are available in bottles of 5ml.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1 Dx.

Manufacturer

This product is manufactured by Excelvision, rue de la Lombardiere, 07100 Annonay, France.

| POM | PL: 19488/1023 Leaflet revision date: 20 June 2016

Zaditen is a registered trade mark of Novartis AG, Switzerland.

S1023 LEAFLET Zaditen 20160620

S1023 LEAFLET Ketotifen 20160620

PACKAGE LEAFLET: INFORMATION FOR THE USER KETOTIFEN 0.25mg/ml EYE DROPS, SOLUTION (ketotifen fumarate)

Your medicine is known as “Ketotifen 0.25mg/ml Eye Drops, Solution” but will be referred to as “Ketotifen Eye Drops” throughout the following patient information leaflet.

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ketotifen Eye Drops are and what they are used for

2.    Before you use Ketotifen Eye Drops

3.    How to use Ketotifen Eye Drops

4.    Possible side effects

5.    How to store Ketotifen Eye Drops

6.    Further information

1. WHAT KETOTIFEN EYE DROPS ARE AND WHAT THEY ARE USED FOR

Ketotifen Eye Drops contain the active substance ketotifen, which is an anti-allergic substance. Ketotifen Eye Drops are used to treat eye symptoms of hay fever.

2. BEFORE YOU USE KETOTIFEN EYE DROPS

Do not use Ketotifen Eye Drops

If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Ketotifen Eye Drops.

Using other medicines

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important for medicines which are used to treat:

•    depression

•    allergy (e.g. antihistamines)

Using Ketotifen Eye Drops with food and drink

Ketotifen Eye Drops may increase the effect of alcohol.

Pregnancy and breast-feeding

If you are pregnant or think you might be, ask your doctor or pharmacist for advice before using Ketotifen Eye Drops.

Ketotifen Eye Drops can be used during breast-feeding.

Driving and using machines

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

Ketotifen Eye Drops contains benzalkonium chloride and may cause eye irritation.

If you wear soft contact lenses you should remove them before using Ketotifen Eye Drops as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Ketotifen Eye Drops before reinserting your contact lenses into your eyes.

3. HOW TO USE KETOTIFEN EYE DROPS

Always use Ketotifen Eye Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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).

Instructions for use

1.    Wash your hands.

2.    Open the bottle. Do not touch the tip after opening the bottle.

3.    Lean your head back (Fig. 1).

4.    Pull down your lower eyelid with your finger and hold the bottle in your other hand. Squeeze the bottle so that one drop falls into the eye (Fig. 2).

5.    Close your eyes and press the tip of one finger against the 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. 3). If necessary repeat steps 3 to 5 with your other eye.

6.    Close the bottle after use.

Fig. 1    Fig. 2    Fig. 3

If you have any further questions on the use of this product, ask

your doctor or pharmacist.

If you use more Ketotifen Eye Drops than you should

There is no danger if you have accidentally taken Ketotifen Eye Drops 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 Ketotifen Eye Drops

If you forget to use Ketotifen Eye Drops 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, Ketotifen Eye Drops 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)

• eye irritation or pain

• inflammation in the eye

•    eye pain, blurred vision, abnormal intolerance to light

Uncommon (affecting less than 1 in every 100 patients)

•    blurred vision when putting drops on the eye

•    dry eye

•    eyelid disorder

•    conjunctivitis

• increased sensitivity of the eyes to light

•    visible bleeding in white of eye

•    headache

•    drowsiness

•    rash (which may also itch)

•    eczema (itchy, red, burning rash)

•    dry mouth

•    allergic reaction (including swelling of the face and eyelids) and increase in severity of existing allergic conditions such as asthma and eczema

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

6. FURTHER INFORMATION

What Ketotifen Eye Drops contain

•    Each ml of solution contains 0.345mg ketotifen hydrogen fumarate equivalent to 0.25mg ketotifen.

•    Also contains benzalkonium chloride, glycerol, sodium hydroxide and water for injections.

What Ketotifen Eye Drops look like and contents of the pack

It is a clear, colourless to faintly yellow solution.

Ketotifen Eye Drops are available in bottles of 5ml.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1 Dx.

Manufacturer

This product is manufactured by Excelvision, rue de la Lombardiere, 07100 Annonay, France.