The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
ALREX 0.2% EYE DROP SUSPENSION
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 questions, please ask your doctor or your pharmacist.
- his 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
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Alrex eye drops is and what it is used for
2. Before you use Alrex eye drops
3. How to use Alrex eye drops
4. Possible side effects
5. How to store Alrex eye drops
6. Further information
WHAT Alrex EYE DROPS IS AND WHAT IT IS USED FOR
Alrex eye drops belong to a group of medicines called corticosteroids (commonly called steroids). It acts by reducing
inflammation and eases the symptoms.
Alrex eye drops are used for the treatment of signs and symptoms of seasonal allergic conjunctivitis. Sometimes the eye may
become inflamed (red and painful) because of irritants such as pollen.
2. BEFORE YOU USE Alrex EYE DROPS
Do not use Alrex eye drops:
- f you are allergic (hypersensitive) to Loteprednol or any of the other ingredients. (see section 6. ‘Further information’ at the end of
- If you are under 18 years of age.
- If you have eye diseases caused by viruses such as herpes simplex, vaccinia, and varicella.
- f you have eye diseases caused by bacteria and fungi.
- If you think you have any other eye infection.
- If you have been allergic to any other corticosteroid (also called “steroids”).
- If you have glaucoma, which is a condition that occurs when the pressure in the eye increases for a period of time.
This can cause damage to the optic nerve and problems with vision. Tell your doctor if you already have glaucoma or have been told
that you have increased pressure in the eye.
Take special care with Alrex eye drops:
- Tell your doctor if pain develops, or if the redness, itching, or inflammation gets worse.
- ee your doctor if your symptoms do not get better within two days. He/she may want to re-evaluate your condition.
- f you use Alrex eye drops for longer than 10 days, you will need to have the pressure in your eyes checked by a doctor.
- ong-term use of Alrex eye drops or other eye drops that contain corticosteroids (steroids) may lower your ability to fight infections
and may increase your chance of getting an eye infection.
- sing eye drops that contain corticosteroids (steroids) may worsen viral diseases of the eye, such as herpes simplex, and make them
- Long term use of Alrex eye drops or other eye drops that contain corticosteroids (steroids) may result in glaucoma
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have taken any other medicines, including herbal remedies and medicines
obtained without a prescription.
Children and adolescents
Children and adolescents under the age of 18 should not be given Alrex eye drops.
Pregnancy and Breast-feeding
If you are pregnant, or intending to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking any
Driving and using machines
Eye drops can cause your vision to be blurred; this usually passes quickly. If you are affected do not drive or use machines until your
vision is clear.
Important information about some of the ingredients of Alrex eye drops
In rare cases, Benzalkonium chloride is reported to cause damage to the surface of the eye, which depending on the extent of the
exposure may be temporary or permanent.
What about contact lenses?
Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait 10 to 15 minutes before reinsertion. This
product contains a preservative Benzalkonium chloride, which is know to discolour soft contact lenses.
3. HOW TO USE Alrex EYE DROPS
Always use Alrex eye drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
If you are using another medicine in the eye, wait at least 10 minutes before applying Alrex.
Shake Alrex eye drops vigorously before using.
The usual dose for adults is:
1 drop of Alrex eye drops applied into the exposed sac between the eyeball and eyelid, 4 times a day or as directed.
f you have been told by your doctor to apply more than 1 drop, wait 30 seconds before applying the next drop to the eye.
- o not allow the tip of the dropper to touch any surface because this may contaminate the medicine.
- Your doctor will tell you how long your treatment with Alrex eye drops will last.
- You will usually only use this medicine for six weeks, unless specifically instructed by your doctor.
If you use Alrex eye drops for longer than 10 days, you will need to have the pressure in your eyes checked by a doctor.
01 DUJhdXNjaCAmIExvbW ILQXNobGV5 IEhh
FnL1 02 0044
If you use more Alrex eye drops than you should
If you use more Alrex eye drops than you should, tell your doctor or a pharmacist.
If you forget to use Alrex eye drops
Do not take a double dose to make up for a forgotten dose. Wait until the next dose and then continue as before.
If you stop using Alrex eye drops
Do not stop treatment without talking to your doctor. You will usually use this medicine for no longer than 6 weeks, unless
specifically instructed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alrex eye drops can cause side effects, although not everybody gets them.
The most common side effects in patients treated with Alrex eye drops are:
• Blurred or abnormal vision
• Burning when putting drops in the eye or at any time during treatment.
• Swelling or discharge from the eyes
• Increased pressure within the eye
• Painful, dry or sticky eyes
• Tearing (i.e., tears running out of the eye)
• Sensation of having an object in your eye
• Itching in the eye or on the eyelid
• Redness in the eye or on the eyelid
• Photophobia (discomfort on exposure to light)
Other unwanted effects might include:
• Headache or migraine, cough or sore throat, runny nose, fatigue, nervousness, nausea, diarrhoea, vomiting, chest
pain, facial swelling, fever, general pain, rash, taste disturbances or urine infection.
If you suffer from any of the side effects and they continue after a couple of days treatment or you are concerned about them, or if
you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Alrex EYE DROPS
Keep out of reach and sight of children.
Store the container in an upright position.
Store upright not above 25ºC.
Do not freeze.
Do not use Alrex after the expiry date, which is stated on the carton and bottle. The expiry date refers to the last day of that month.
Discard any unused contents 28 days after first opening the bottle.
Do not use Alrex if the protective seal is broken.
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.
6. FURTHER INFORMATION
What Alrex contains
- The active substance is Loteprednol etabonate. Each ml contains 2 mg (0.2% w/v) Loteprednol etabonate.
- The other ingredients are edetate disodium dihydrogen, Glycerol, Povidone, Purified Water and Tyloxapol.
Benzalkonium chloride (0.01% w/v) is added as a preservative.
What Alrex looks like and contents of the pack
Alrex eye drops is available in 5ml or 10ml bottles.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch & Lomb GmbH
Brunsbütteler Damm 165-173
Bausch & Lomb Incorporated
8500 Hidden River Parkway
Tampa, Florida 33637
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bausch & Lomb, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN, UK.
Tel: +44 (0) 1748 828864
This leaflet was last approved in October 2007.
Alrex is a registered trademark of Bausch & Lomb Incorporated.
©Bausch & Lomb Incorporated
Prod. No. 353
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.