5 mg/ml eye drops, solution
levofloxacin
What Oftaquix Is And What Is Oftaquix Used For
Levofloxacin belongs to a type of antibiotic called fluoroquinolones (sometimes abbreviated to quinolones ). It works by killing certain types of bacteria that can cause infection.
Levofloxacin, given in the form of eye drops, is used to treat bacterial infections in the outer part of the eye in children from 1 year of age and adults.
One type of infection in this part of the eye is bacterial conjunctivitis, an infection of the outer membrane of the eye ( conjunctiva or conjunctiva).
Oftaquix is not recommended for children under 1 year.
You must talk to a doctor if you do not feel better or feel worse after 5 days.
Levofloxacin contained in Oftaquix may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before Using Oftaquix
Do Not Use Oftaquix
- If you are allergic to levofloxacin, other quinolones, or any of the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor or pharmacist.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before using Oftaquix
- If you get an allergic reaction after a single dose: Discontinue treatment.
- If eye symptoms worsen during treatment: Contact a doctor as soon as possible.
- If your condition does not improve during the treatment period that you and your doctor have agreed on: Contact a doctor as soon as possible.
- No types of contact lenses should generally be used in case of eye infection.
- Oftaquix contains the preservative benzalkonium chloride, which may cause eye irritation.
Swelling and tendon rupture have occurred in patients taking oral (via the mouth) or intravenous (via injection/infusion) fluoroquinolones, especially in elderly patients and those treated concomitantly with corticosteroids (“cortisone”). Stop taking Oftaquix if you experience pain or swelling in any tendon ( tendinitis ).
Children And Young People
The special warnings and precautions that should be taken when using this medicine apply to adults, adolescents, and children from 1 year of age.
Other Medicines And Oftaquix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor or pharmacist if you are using any other type of eye drops or eye ointment before using Oftaquix.
If you use any other type of eye drops, leave at least 15 minutes between the use of Oftaquix and the other type of eye drops.
Pregnancy, Breastfeeding, And Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Oftaquix eye drops should only be used during pregnancy if the potential benefits outweigh the potential risks to the fetus.
Even if very small amounts of levofloxacin are released into the bloodstream and breast milk when you use the eye drops, it is very unlikely that such small amounts will harm the fetus or breastfed baby.
Your doctor knows the potential risk and will decide whether to use Oftaquix eye drops during pregnancy or breastfeeding.
Your fertility (i.e., the ability to become pregnant or a father) will not be impaired if you use Oftaquix according to the instructions.
Driving And Using Machines
Oftaquix has less effect on the ability to drive and use machines.
If the eye drops cause visual disturbances, wait until they disappear before driving or using machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oftaquix Contains Benzalkonium Chloride
This medicine contains approximately 0.002 mg of benzalkonium chloride per drop, equivalent to 0.05 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.
Benzalkonium chloride can irritate the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How To Use Oftaquix
Oftaquix dosage
- Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Oftaquix eye drops should be used on the outer surface of the eye.
- For patients 1 year of age and older, the following Oftaquix dosage is recommended:
Day 1-2
- 1-2 drops in the infected eye (s) every two hours.
- Dose no more than 8 times a day.
Day 3–5
- 1-2 drops in the infected eye (s).
- Dose no more than 4 times a day.
No adjustment of the recommended dose is needed for elderly patients.
The usual treatment period is five days. Your doctor will tell you how long to use the eye drops.
If you are taking any other type of eye medicine, leave at least 15 minutes between the use of Oftaquix and the other eye medicine.
Use for children and adolescents.
No recommended dose adjustment is needed for children from 1 year of age or adolescents. Oftaquix is not recommended for children under 1 year of age.
Before using the eye drops
If possible, ask someone else to give you the eye drops. In this case, ask the person in question to read the instructions with you before giving the eye drops.
1) Wash your hands.
2) Open the bottle. Ensure that the bottle tip does not come into contact with the eye, the skin around the eye, or the fingers.
6) Wipe off any solution that may have ended up on the skin around the eye.
7) Put the cap back on the bottle and close it tightly.
If you need to take another drop in the eye, or if both eyes need to be treated, repeat steps 3-7.
Oftaquix eye drops must not be injected into the inner parts of the eyeball.
If You Use More Oftaquix Than You Should
If you take more Oftaquix than you should, flush your eye (s) with water and tell your doctor or pharmacist.
If you have ingested too much medicine or if, e.g., a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If You Forget To Use Oftaquix
If you forget to take eye drops, take the next dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you happen to swallow Oftaquix
The amount of levofloxacin in a bottle is too small to cause any side effects. However, if you are concerned, you should consult a doctor or pharmacist for advice on what to do.
If You Stop Using Oftaquix
The recovery process may be delayed if you stop using Oftaquix earlier than directed.
If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.
Possible Oftaquix Eye Drops Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
About one in ten people using Oftaquix experience side effects. Most of these side effects occur locally in the eye and are transient. If you notice any serious or permanent side effects, stop using the eye drops and contact a doctor immediately for help.
In very rare cases, this medicine may cause severe allergic reactions.
The following symptoms may occur after just one dose of Oftaquix:
- Swelling and obstruction of the throat
- Breathing difficulties
In rare cases, other allergic reactions may occur. Symptoms of such reactions are:
- Aggravated red eye and itching of the eyes
- Increased or sudden swelling of the eyelids
Discontinue treatment with Oftaquix and consult a physician immediately if you notice any of these symptoms.
Common side effects (may affect up to 1 in 10 people)
- Burning sensation in the eye
- Impaired vision or secretions in the eye.
Uncommon Oftaquix eye drops side effects (may affect up to 1 in 100 people)
- Burning or irritation of the eye
- Pain in the eye
- Dry or sore eyes
- Swelling or redness (bloodshot eyes) in the conjunctiva (anterior membrane of the eye) or eyelids
- Photosensitivity
- Itching in the eyes
- Sticky eyelids
- Headache
- Rash around the eye
- Stuffy or runny nose.
Rare side effects (may affect up to 1 in 1,000 people)
- Allergic reactions, e.g., rash.
Very rare side effects (may affect up to 1 in 10,000 people)
- Swelling and obstruction of the throat
- Breathing difficulties.
Additional side effects are in children and adolescents
The frequency, type, and severity of adverse reactions are expected to be the same for children and adolescents as adults.
How To Store Oftaquix
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the bottle label and the carton after “EXP.” The expiration date is the last day of the specified month.
- Do not use this medicine if you notice that the plastic seal around the lid and neck of the bottle is missing or broken when you open a new bottle.
- No special storage instructions.
- Keep the bottle tightly closed.
To prevent infection, discard the bottle 28 days after opening it for the first time and start on a new bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Package And Other Information
Content Declaration
- The active substance is levofloxacin.
1 ml contains 5.12 mg levofloxacin hemihydrate corresponding to 5 mg levofloxacin. - The other ingredients are benzalkonium chloride (0.05 mg per ml eye drops; a preservative ), sodium chloride, sodium hydroxide or hydrochloric acid, and water for injections.
What The Medicine Looks Like And The Contents Of The Pack
- Oftaquix is a clear, light yellow to light greenish-yellow solution, free from visible particles.
- Oftaquix is supplied in packs containing 1 white plastic bottle with 5 ml solution. The plastic bottle is closed with a screw cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
FI-33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
FI-33100 Tampere
Finland
This medicinal product is authorized under the European Economic Area (EEA) under the names:
This medicinal product is authorized under the product name Oftaquix in the following EEA Member States:
Denmark, Estonia, Finland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania, Slovakia, the United Kingdom, Sweden, the Czech Republic, Germany, Hungary, and Austria.