Exocin 3 Mg/Ml Eye Drops Solution.
Out of date information, search anotherKeep out of the reach and sight of children.
Once you have opened the bottle do not use it longer than 28 days, even if there is solution remaining.
Do not use EXOCIN after the expiry date which is stated on the bottle label and the bottom of the carton after EXP The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use EXOCIN if you notice the tamper-proof seal on the bottle 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 EXOCIN contains
• The active substance is Ofloxacin 0.3% w/v.
• The other ingredients are benzalkonium chloride, sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH) and purified water
What EXOCIN looks like and contents of the pack
EXOCIN is an eye drop solution in a plastic bottle. Each carton contains 1 plastic bottle with a screw cap.
Marketing Authorisation Holder
Allergan Limited Marlow International The Parkway Marlow
Bucks, SL7 1YL United Kingdom
Tel: 01628 494026
Manufacturer
Allergan Pharmaceuticals Ireland
Westport
Co. Mayo
Ireland
This leaflet was last revised in May 2014.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information: Ofloxacin 0.3% reference number PL 00426/0070.
This is a service provided by the Royal National Institute of Blind People.
Package leaflet: Information for the user
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 EXOCIN is and what it is used for
2. Before you use EXOCIN
3. How to use EXOCIN
4. Possible side effects
5. How to store EXOCIN
6. Further information
1. What EXOCIN is and what it is used for
EXOCIN is an eye-drop used to treat external eye infections such as some types of conjunctivitis.
EXOCIN belongs to a group of medicines called 4-quinolone antibacterial agents.
EXOCIN is not recommended for use in infants below the age of one year.
2. Before you use EXOCIN Do not use EXOCIN
• If you are allergic (hypersensitive) to ofloxacin, benzalkonium chloride,
any of the other ingredients, or any other quinolones.
Take special care with EXOCIN
This product should be used with caution in patients sensitive to other quinolone antibacterial agents.
Long term use may result in a new bacterial infection which does not respond to EXOCIN.
This product should be used with caution in patients with a defect or ulceration of the surface of the eye.
EXOCIN potentially increases sensitivity to sunlight. You should avoid exposure to direct sunlight or sun during use of EXOCIN.
Heart problems:
Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Taking other medicines).
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicine, including medicines obtained without a prescription.
The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist.
If you use more EXOCIN than you should
If you have placed too many drops in your eye(s), wash the eye(s) with clean water. Apply your next dose at the normal time.
If, by accident, anyone drinks this medicine, contact your doctor straight away.
If you forget to use EXOCIN
If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then apply your next dose as usual and continue with your normal routine.
You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics
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(e.g. quindine, hydroquindine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials |
Do not use a double dose to make up for a forgotten dose. | ||
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(that belong to the group of macrolides), some antipsychotics. |
If you stop using EXOCIN | ||
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Pregnancy and breast-feeding Tell your doctor before you start using EXOCIN if you are pregnant or if you |
EXOCIN should be used as advised by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. | ||
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are breast-feeding. Your doctor can then decide whether you can use EXOCIN. |
4. Possible side effects | ||
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Ask your doctor or pharmacist for advice before using any medicine. |
Like all medicines, EXOCIN can cause side effects, but not everyone | ||
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Children |
gets them. | ||
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There is limited experience of the use of EXOCIN in children. Talk to your doctor before you start using EXOCIN in children. | |||
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The following side effects are known to occur, but the number of people likely to be affected is unknown. | |||
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Driving and using machines | |||
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Your sight may become blurred for a short time just after using EXOCIN. |
You should see your doctor if any of the following side effects prove | ||
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You should not drive or use machines until your sight is clear again |
troublesome or if they are long-lasting: | ||
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Important information about some of the ingredients of EXOCIN |
Side effects affecting the eye: |
Contact lenses
• Normally you should not wear contact lenses whilst being treated with this product. However, there may be situations where use of contact lenses is unavoidable. In these situations remove the lenses before using EXOCIN. Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
• A preservative in EXOCIN (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.
Visual disturbance Tearing
Mild stinging or burning Irritation
Ocular discomfort Inflammation Redness Itching
Allergic reactions in the eye (including itchiness of the eye and eyelid)
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3. How to use EXOCIN |
• Sensitivity to light | ||
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• A feeling that something is in your eye | |||
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Always use EXOCIN exactly as your doctor has told you. You should |
• Eye swelling | ||
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check with your doctor or pharmacist if you are not sure. The usual dose is |
• Dryness | ||
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1 or 2 drops into the affected eye(s) every 2 to 4 hours for the first 2 days | |||
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and then 4 times a day from then on. |
Side effects affecting the body: | ||
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To be effective EXOCIN must be taken regularly. |
• Dizziness | ||
The length of treatment should not exceed ten days.
Instructions for use
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Apply your eye drops in the following way:
1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket
3. Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds
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• Allergic reactions (including swelling beneath the skin that can occur in areas such as the face, lips or other parts of the body; rash, itching or hives on the skin; swelling of the mouth, tongue or throat that can obstruct the airways which may cause wheezing, difficulty swallowing, breathing or shortness of breath; severe sudden life-threatening allergic reaction)
• Swelling of the face
Heart problems:
Frequency not known: abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG electrical activity of the heart).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
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If a drop misses your eye, try again. |
Yellow Card Scheme | ||
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Website: www.mhra.gov.uk/yellowcard | |||
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To avoid contamination, do not let the tip of the dropper touch your eye | |||
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or anything else. |
By reporting side effects you can help provide more information on the | ||
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Replace and tighten the cap straight after use. |
safety of this medicine. |