Geltears
S346 LEAFLET Geltears 20150930
PATIENT INFORMATION LEAFLET GELTEARS (carbomer 980)
Your medicine is called Geltears.
Please read this leaflet before you start to use your medicine. It contains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your pharmacist.
In this leaflet:
1. What is Geltears Eye Gel and what is it used for?
2. Before you use your eye gel
3. How to use your eye gel
4. Possible side effects
5. How to store Geltears
6. Further information
1. WHAT IS GELTEARS EYE GEL AND WHAT IS IT USED FOR?
Geltears belongs to a group of medicines called artificial tears for use as a substitute for natural tears. Geltears is a clear colourless liquid gel and contains a lubricant that is used as a substitute for natural tears. Your eyes will normally produce just enough natural tears to allow them to move easily and comfortably. If your eyes do not produce enough tears they can become dry, red and painful. It can also be used in patients who suffer from sore eyes because their tear film is unstable. Geltears will help keep your eyes comfortable.
3. HOW TO USE YOUR EYE GEL
Unless your doctor has told you differently, the standard dose is to place one drop of gel in the corner of the eye, nearest the nose, 3 to 4 times each day and approximately 30 minutes before going to bed.
Adults including elderly patients, children and adolescents aged to 18 years:
The safety and efficacy of Geltears in children and adolescents at the dosage recommended for adults has been established by clinical experience, but no clinical trial data is available.
The amount of gel used should be enough to cover the eye properly.
Follow these instructions carefully.
1. Wash hands thoroughly.
2. Twist off the cap.
3. Look upwards and gently pull down the lower eyelid.
4. Hold the Geltears tube just above your eye and gently squeeze until some gel falls into the gap between your eyeball and lower eyelid.
5. Release the lower eyelid, and move your eye while open to ensure the gel covers the eye completely.
6. Repeat the process in the other eye if necessary.
4. POSSIBLE SIDE EFFECTS
2. BEFORE YOU USE YOUR EYE GEL
Do not use this gel if you are sensitive to any of the ingredients. These are listed in the section ‘What is in your eye gel?'
If Geltears is used at the same time with other eye drops/eye ointments, there should be an application time interval of approximately 15 minutes between use of such other medications and Geltears should always be the last medication to be applied.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
It is very unlikely that you will suffer an overdose from using this medicine, but if you suddenly feel unwell after using the gel, tell your doctor or eye specialist.
Your eyes may sting a little when the drops are put in. These effects will wear off within a few minutes. A few reports of allergy have been received following use of Geltears eye gel. This is due to one of the ingredients in the formulation. If you develop pain, swelling or redness in or around the eyes, you should stop using your medicine and consult your doctor or pharmacist.
• If you experience any other undesirable effects whilst using this medicine, please talk to your doctor or pharmacist.
If you are pregnant, may be pregnant, or are breastfeeding, tell your doctor before using this product. It is possible that you will still receive it, but it is also possible that an alternative may be used.
Contact lenses
Take special care with Geltears if you wear contact lenses. You should take them out before using Geltears, and then wait for 15 minutes after application before putting them back in.
Benzalkonium chloride is used as a preservative in Geltears, and is known to be absorbed by soft contact lenses. Over time benzalkonium chloride can collect in soft contact lenses, and therefore may cause irritation, or discolour the lenses. Therefore use of Geltears while using soft contact lenses is not recommended. Geltears can, however, be used with daily disposable lenses because a new pair is used each day.
Driving and using machines
As with all eye preparations, you may have blurred vision for a little
while after putting the gel in. Wait until your vision is clear before driving or using machines.
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 GELTEARS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Geltears should not be stored above 25°C. Store in the original package. Discard 28 days after first opening.
• 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.
• Do not use after the expiry date printed on the carton or tube label.
• 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 Geltears contains
• Geltears contains 0.2%w/w of the active ingredient, carbomer 980.
• Geltears also contain the following inactive ingredients: sorbitol, sodium hydroxide, purified water and 0.01%w/w benzalkonium chloride (as a preservative).
• Geltears is available in tubes of 10g in a carton.
What Geltears looks like and
Geltears is a clear colourless gel.
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 1DX, London, United Kingdom.
Tel: +44 (0) 208 799 7600 Manufacturer
This product is manufactured by Laboratoire Chauvin SA, ZI Ripotier Haut, 07200 Aubenas, France.
P PL 19488/0346
Geltears is used for the symptomatic treatment of ‘dry eye', which is a dehydration of the surface of the eye resulting from disturbances in tear secretion or tear quality. The dry eye condition can also be caused when it is not possible to close your eyelids either partly or completely.
This condition is so common that one in five patients who go to see an ophthalmologist suffers from a dry eye condition. There are many causes, such as reduced tear production in old age, air-conditioned rooms, computer work, hormonal changes during menopause, etc. Environmental and climatic effects can also play a role in the development of dry eye conditions.
What do we understand by the term “dry eye”?
During the course of the day we blink 14,000 times on an average. With each blinking motion of the eye, a very thin tear film is distributed over the surface of the eyeball, which keeps it smooth, clean and moist, and protects the eye from pollutants. When the volume or the composition of the tear film is disturbed, desiccation phenomena (drying out) of the cornea and conjunctiva occur and the patient experiences symptoms such as burning, dry eye sensation, gritty feeling, feeling of pressure, and sensitivity to light. Geltears is a soothing gel solution which moistens the eye and provides tear-like lubrication to the eyes and eyelids. The carbomer in Geltears increases the thickness of the gel which assists the gel in remaining in contact with the eye for a longer period of time.
Your ophthalmologist prescribed a tear substitute for the alleviation of your complaints. In addition to using the preparation consistently as directed, you should follow the recommendations below:
• Let fresh air into your apartment or house several times a day
• Take care that you drink sufficiently
• Go out into the fresh air frequently
• Do not direct air vents towards your eyes
• Take breaks when working in front of a computer screen.
It is, however, also important that you consult your ophthalmologist regularly for follow-up examinations, because dry eye conditions may lead to a serious disease if they are treated incorrectly or inadequately.
Leaflet revision date: 30 September 2015
Geltears is a registered trade mark of Bausch & Lomb, France.
S346 LEAFLET Geltears 20150930
PATIENT INFORMATION LEAFLET CARBOMER 0.2% EYE GEL (carbomer 980)
Your medicine is called Carbomer 0.2% Eye Gel but will be referred to Carbomer throughout the remainder of the patient information leaflet.
Please read this leaflet before you start to use your medicine. It contains a summary of the information available on your medicine.
If you have any questions or are not sure about anything, ask your pharmacist.
In this leaflet:
1. What is Carbomer eye gel and what is it used for?
2. Before you use your eye gel
3. How to use your eye gel
4. Possible side effects
5. How to store Carbomer
6. Further information
1. WHAT IS CARBOMER EYE GEL AND WHAT IS IT USED FOR?
Carbomer belongs to a group of medicines called artificial tears for use as a substitute for natural tears. Carbomer is a clear colourless liquid gel and contains a lubricant that is used as a substitute for natural tears. Your eyes will normally produce just enough natural tears to allow them to move easily and comfortably. If your eyes do not produce enough tears they can become dry, red and painful. It can also be used in patients who suffer from sore eyes because their tear film is unstable. Carbomer will help keep your eyes comfortable.
2. BEFORE YOU USE YOUR EYE GEL
Do not use this gel if you are sensitive to any of the ingredients. These are listed in the section ‘What is in your eye gel?'
If Carbomer is used at the same time with other eye drops/eye ointments, there should be an application time interval of approximately 15 minutes between use of such other medications and Carbomer should always be the last medication to be applied.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
If you are pregnant, may be pregnant, or are breastfeeding, tell your doctor before using this product. It is possible that you will still receive it, but it is also possible that an alternative may be used.
Contact lenses
Take special care with Carbomer if you wear contact lenses. You should take them out before using Carbomer, and then wait for 15 minutes after application before putting them back in. Benzalkonium chloride is used as a preservative in Carbomer, and is known to be absorbed by soft contact lenses. Over time benzalkonium chloride can collect in soft contact lenses, and therefore may cause irritation, or discolour the lenses. Therefore use of Carbomer while using soft contact lenses is not recommended. Carbomer can, however, be used with daily disposable lenses because a new pair is used each day.
Driving and using machines
As with all eye preparations, you may have blurred vision for a little
while after putting the gel in. Wait until your vision is clear before driving or using machines.
3. HOW TO USE YOUR EYE GEL
Unless your doctor has told you differently, the standard dose is to place one drop of gel in the corner of the eye, nearest the nose, 3 to 4 times each day and approximately 30 minutes before going to bed.
Adults including elderly patients, children and adolescents aged to 18 years:
The safety and efficacy of Carbomer in children and adolescents at the dosage recommended for adults has been established by clinical experience, but no clinical trial data is available.
The amount of gel used should be enough to cover the eye properly.
Follow these instructions carefully.
1. Wash hands thoroughly.
2. Twist off the cap.
3. Look upwards and gently pull down the lower eyelid.
4. Hold the Carbomer tube just above your eye and gently squeeze until some gel falls into the gap between your eyeball and lower eyelid.
5. Release the lower eyelid, and move your eye while open to ensure the gel covers the eye completely.
6. Repeat the process in the other eye if necessary.
4. POSSIBLE SIDE EFFECTS
It is very unlikely that you will suffer an overdose from using this medicine, but if you suddenly feel unwell after using the gel, tell your doctor or eye specialist.
Your eyes may sting a little when the drops are put in. These effects will wear off within a few minutes. A few reports of allergy have been received following use of Carbomer eye gel. This is due to one of the ingredients in the formulation. If you develop pain, swelling or redness in or around the eyes, you should stop using your medicine and consult your doctor or pharmacist.
• If you experience any other undesirable effects whilst using this medicine, please talk to 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 CARBOMER
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Carbomer should not be stored above 25°C. Store in the original package. Discard 28 days after first opening.
• 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.
• Do not use after the expiry date printed on the carton or tube label.
• 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 Carbomer contains
• Carbomer contains 0.2%w/w of the active ingredient, carbomer 980.
• Carbomer also contain the following inactive ingredients: sorbitol, sodium hydroxide, purified water and 0.01%w/w benzalkonium chloride (as a preservative).
• Carbomer is available in tubes of 10g in a carton.
What Carbomer looks like and Carbomer is a clear colourless gel.
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 1DX, London, United Kingdom.
Tel: +44 (0) 208 799 7600 Manufacturer
This product is manufactured by Laboratoire Chauvin SA, ZI Ripotier Haut, 07200 Aubenas, France.
P PL 19488/0346
Carbomer is used for the symptomatic treatment of ‘dry eye', which is a dehydration of the surface of the eye resulting from disturbances in tear secretion or tear quality. The dry eye condition can also be caused when it is not possible to close your eyelids either partly or completely.
This condition is so common that one in five patients who go to see an ophthalmologist suffers from a dry eye condition. There are many causes, such as reduced tear production in old age, air-conditioned rooms, computer work, hormonal changes during menopause, etc. Environmental and climatic effects can also play a role in the development of dry eye conditions.
What do we understand by the term “dry eye”?
During the course of the day we blink 14,000 times on an average. With each blinking motion of the eye, a very thin tear film is distributed over the surface of the eyeball, which keeps it smooth, clean and moist, and protects the eye from pollutants. When the volume or the composition of the tear film is disturbed, desiccation phenomena (drying out) of the cornea and conjunctiva occur and the patient experiences symptoms such as burning, dry eye sensation, gritty feeling, feeling of pressure, and sensitivity to light. Carbomer is a soothing gel solution which moistens the eye and provides tear-like lubrication to the eyes and eyelids. The carbomer in Carbomer increases the thickness of the gel which assists the gel in remaining in contact with the eye for a longer period of time.
Your ophthalmologist prescribed a tear substitute for the alleviation of your complaints. In addition to using the preparation consistently as directed, you should follow the recommendations below:
• Let fresh air into your apartment or house several times a day
• Take care that you drink sufficiently
• Go out into the fresh air frequently
• Do not direct air vents towards your eyes
• Take breaks when working in front of a computer screen.
It is, however, also important that you consult your ophthalmologist regularly for follow-up examinations, because dry eye conditions may lead to a serious disease if they are treated incorrectly or inadequately.
Leaflet revision date: 30 September 2015
S346 LEAFLET Carbomer 20150930