ZADITEN 0.25MG/ML EYE DROPS SOLUTION
Active substance: KETOTIFEN HYDROGEN FUMARATE
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Zaditen 0.25mg/ml Eye Drops Solution
(ketotifen)
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. Your medicine is called Zaditen 0.25mg/ml Eye Drops Solution but will be referred to as Zaditen throughout the leaflet.
Ref: 0922/170412/1/F
Important information about some of the ingredients of Zaditen Zaditen contains benzalkonium chloride and may cause eye irritation. If you wear soft contact lenses you should remove them before using Zaditen as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Zaditen before reinserting your contact lenses into your eyes. 3
How to use Zaditen
Always use Zaditen 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 12 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.
In this leaflet: 1 What Zaditen is and what it is used for 2 Before you use Zaditen 3 How to use Zaditen 4 Possible side effects 5 How to store Zaditen 6 Further information
1
What Zaditen is and what it is used for
Zaditen contains the active substance ketotifen, which is an anti-allergic substance. Zaditen is used to treat eye symptoms of hay fever.
2
Before you use Zaditen
Do not use Zaditen If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Zaditen. Using other medicines If you need to apply any other medicinal products to your eyes together with Zaditen, wait at least 5 minutes between applying each product. Fig. 1 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 with food and drink Zaditen 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. Zaditen can be used during breast-feeding. Driving and using machines Zaditen may cause blurred vision or drowsiness. If this happens to you, wait until this has cleared before driving or operating machinery.
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 than you should There is no danger if you have accidentally taken Zaditen 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 If you forget to use Zaditen 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.
6
Further Information
What Zaditen contains Each ml of eye drops contains 0.345mg ketotifen hydrogen fumarate corresponding to 0.25mg ketotifen as the active ingredient. The eye drops also contain benzalkonium chloride, glycerol (E422), sodium hydroxide (E524), water for injections. What Zaditen looks like and contents of the pack The eye drops are a clear, colourless to faintly yellow solution. They are available in bottles of 5ml. Manufacturer and Licence Holder Zaditen Eye Drops are manufactured by EXCELVISION, Rue de la Lombardire, 07104 Annonay Cedex, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
4
Possible side effects
Like all medicines, Zaditen 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. 5
POM
PL 15184/0922
Leaflet revision date: 17/04/12
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Ref: 0922/170412/1/B
How to store Zaditen
EXPIRY DATE Do not use this medicine after date shown on the carton label or bottle label. Only keep this medicine if your doctor tells you to. If your eye drops becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. This medicine must be thrown away four weeks after first opening the bottle. HOW TO STORE Do not store above 25C. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Ref: 0922/170412/2/F
Ketotifen 0.25mg/ml Eye Drops Solution
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. Your medicine is called Ketotifen 0.25mg/ml Eye Drops Solution but will be referred to as Ketotifen throughout the leaflet. Important information about some of the ingredients of Ketotifen Ketotifen contains benzalkonium chloride and may cause eye irritation. If you wear soft contact lenses you should remove them before using Ketotifen as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Ketotifen before reinserting your contact lenses into your eyes.
3
How to use Ketotifen
Always use Ketotifen 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 12 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.
In this leaflet: 1 What Ketotifen is and what it is used for 2 Before you use Ketotifen 3 How to use Ketotifen 4 Possible side effects 5 How to store Ketotifen 6 Further information
1
What Ketotifen is and what it is used for
Ketotifen contains the active substance ketotifen, which is an anti-allergic substance. Ketotifen is used to treat eye symptoms of hay fever. 2
Before you use Ketotifen
Do not use Ketotifen If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Ketotifen. Using other medicines If you need to apply any other medicinal products to your eyes together with Ketotifen, 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 with food and drink Ketotifen may increase the effect of alcohol.
Fig. 1
Fig. 2 Pregnancy and breast-feeding If you are pregnant or think you might be, ask your doctor or pharmacist for advice before using Ketotifen. Ketotifen can be used during breast-feeding. Driving and using machines Ketotifen may cause blurred vision or drowsiness. If this happens to you, wait until this has cleared before driving or operating machinery.
Fig. 3 If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you use more Ketotifen than you should There is no danger if you have accidentally taken Ketotifen 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 If you forget to use Ketotifen 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.
6 Further Information What Ketotifen contains Each ml of eye drops contains 0.345mg ketotifen hydrogen fumarate corresponding to 0.25mg ketotifen as the active ingredient. The eye drops also contain benzalkonium chloride, glycerol (E422), sodium hydroxide (E524), water for injections. What Ketotifen looks like and contents of the pack The eye drops are a clear, colourless to faintly yellow solution. They are available in bottles of 5ml. Manufacturer and Licence Holder Ketotifen Eye Drops are manufactured by EXCELVISION, Rue de la Lombardire, 07104 Annonay Cedex, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
4
Possible side effects
Like all medicines, Ketotifen 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.
POM
PL 15184/0922
Leaflet revision date: 17/04/12
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Ref: 0922/170412/2/B
5
How to store Ketotifen
EXPIRY DATE Do not use this medicine after date shown on the carton label or bottle label. Only keep this medicine if your doctor tells you to. If your eye drops becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. This medicine must be thrown away four weeks after first opening the bottle. HOW TO STORE Do not store above 25C. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
(ketotifen)
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. Your medicine is called Zaditen 0.25mg/ml Eye Drops Solution but will be referred to as Zaditen throughout the leaflet.
Ref: 0922/170412/1/F
Important information about some of the ingredients of Zaditen Zaditen contains benzalkonium chloride and may cause eye irritation. If you wear soft contact lenses you should remove them before using Zaditen as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Zaditen before reinserting your contact lenses into your eyes. 3
How to use Zaditen
Always use Zaditen 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 12 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.
In this leaflet: 1 What Zaditen is and what it is used for 2 Before you use Zaditen 3 How to use Zaditen 4 Possible side effects 5 How to store Zaditen 6 Further information
1
What Zaditen is and what it is used for
Zaditen contains the active substance ketotifen, which is an anti-allergic substance. Zaditen is used to treat eye symptoms of hay fever.
2
Before you use Zaditen
Do not use Zaditen If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Zaditen. Using other medicines If you need to apply any other medicinal products to your eyes together with Zaditen, wait at least 5 minutes between applying each product. Fig. 1 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 with food and drink Zaditen 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. Zaditen can be used during breast-feeding. Driving and using machines Zaditen may cause blurred vision or drowsiness. If this happens to you, wait until this has cleared before driving or operating machinery.
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 than you should There is no danger if you have accidentally taken Zaditen 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 If you forget to use Zaditen 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.
6
Further Information
What Zaditen contains Each ml of eye drops contains 0.345mg ketotifen hydrogen fumarate corresponding to 0.25mg ketotifen as the active ingredient. The eye drops also contain benzalkonium chloride, glycerol (E422), sodium hydroxide (E524), water for injections. What Zaditen looks like and contents of the pack The eye drops are a clear, colourless to faintly yellow solution. They are available in bottles of 5ml. Manufacturer and Licence Holder Zaditen Eye Drops are manufactured by EXCELVISION, Rue de la Lombardire, 07104 Annonay Cedex, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
4
Possible side effects
Like all medicines, Zaditen 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. 5
POM
PL 15184/0922
Leaflet revision date: 17/04/12
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Ref: 0922/170412/1/B
How to store Zaditen
EXPIRY DATE Do not use this medicine after date shown on the carton label or bottle label. Only keep this medicine if your doctor tells you to. If your eye drops becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. This medicine must be thrown away four weeks after first opening the bottle. HOW TO STORE Do not store above 25C. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Ref: 0922/170412/2/F
Ketotifen 0.25mg/ml Eye Drops Solution
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. Your medicine is called Ketotifen 0.25mg/ml Eye Drops Solution but will be referred to as Ketotifen throughout the leaflet. Important information about some of the ingredients of Ketotifen Ketotifen contains benzalkonium chloride and may cause eye irritation. If you wear soft contact lenses you should remove them before using Ketotifen as it can discolour your soft contact lenses. You should wait at least 15 minutes after using Ketotifen before reinserting your contact lenses into your eyes.
3
How to use Ketotifen
Always use Ketotifen 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 12 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.
In this leaflet: 1 What Ketotifen is and what it is used for 2 Before you use Ketotifen 3 How to use Ketotifen 4 Possible side effects 5 How to store Ketotifen 6 Further information
1
What Ketotifen is and what it is used for
Ketotifen contains the active substance ketotifen, which is an anti-allergic substance. Ketotifen is used to treat eye symptoms of hay fever. 2
Before you use Ketotifen
Do not use Ketotifen If you are allergic (hypersensitive) to ketotifen or any of the other ingredients of Ketotifen. Using other medicines If you need to apply any other medicinal products to your eyes together with Ketotifen, 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 with food and drink Ketotifen may increase the effect of alcohol.
Fig. 1
Fig. 2 Pregnancy and breast-feeding If you are pregnant or think you might be, ask your doctor or pharmacist for advice before using Ketotifen. Ketotifen can be used during breast-feeding. Driving and using machines Ketotifen may cause blurred vision or drowsiness. If this happens to you, wait until this has cleared before driving or operating machinery.
Fig. 3 If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you use more Ketotifen than you should There is no danger if you have accidentally taken Ketotifen 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 If you forget to use Ketotifen 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.
6 Further Information What Ketotifen contains Each ml of eye drops contains 0.345mg ketotifen hydrogen fumarate corresponding to 0.25mg ketotifen as the active ingredient. The eye drops also contain benzalkonium chloride, glycerol (E422), sodium hydroxide (E524), water for injections. What Ketotifen looks like and contents of the pack The eye drops are a clear, colourless to faintly yellow solution. They are available in bottles of 5ml. Manufacturer and Licence Holder Ketotifen Eye Drops are manufactured by EXCELVISION, Rue de la Lombardire, 07104 Annonay Cedex, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
4
Possible side effects
Like all medicines, Ketotifen 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.
POM
PL 15184/0922
Leaflet revision date: 17/04/12
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Ref: 0922/170412/2/B
5
How to store Ketotifen
EXPIRY DATE Do not use this medicine after date shown on the carton label or bottle label. Only keep this medicine if your doctor tells you to. If your eye drops becomes discoloured or shows any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do. This medicine must be thrown away four weeks after first opening the bottle. HOW TO STORE Do not store above 25C. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
