5 mg / ml eye drops, solution
levofloxacin
What Levofloxacin Actavis is and what it is 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, which is an infection of the outer membrane ( conjunctiva ) of the eye.
Levofloxacin Actavis is not recommended for use in children under 1 year of age.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
Levofloxacin contained in Levofloxacin Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Levofloxacin Actavis
Do not use Levofloxacin Actavis
- 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 or pharmacist before taking Levofloxacin Actavis.
- If you get an allergic reaction already after a single dose , stop the treatment.
- If eye symptoms worsen during treatment, consult a doctor as soon as possible.
- If your condition does not improve during the treatment period that you and your doctor have agreed upon, contact a doctor as soon as possible.
- As a rule, no types of contact lenses should be used for eye infections .
- Levofloxacin Actavis 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 Levofloxacin Actavis 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 and adolescents as well as to children from 1 year of age.
Other medicines and Levofloxacin Actavis
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 Levofloxacin Actavis.
If you use any other type of eye drops, leave at least 15 minutes between the use of Levofloxacin Actavis 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.
Levofloxacin Actavis eye drops should only be used during pregnancy if the benefits outweigh the 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 these small amounts will harm the fetus or breastfed baby. Your doctor will be informed of the possible risk and will decide whether to use Levofloxacin Actavis eye drops during pregnancy or breastfeeding.
Your fertility (ability to get pregnant or become a father) will not be impaired if you use Levofloxacin Actavis according to the instructions.
Driving and using machines
Levofloxacin Actavis 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 are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/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.
Levofloxacin Actavis contains benzalkonium chloride
This medicine contains 0.05 mg benzalkonium chloride per 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 be irritating to 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 Levofloxacin Actavis
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Levofloxacin Actavis eye drops should be used on the outer surface of the eye.
For patients 1 year of age and older, the following 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 Levofloxacin Actavis and the other eye medicine.
Use for children and adolescents
No adjustment of the recommended dose is needed for children from 1 year of age or adolescents. Levofloxacin Actavis 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.
- Wash your hands.
- Open the bottle. Make sure that the tip of the bottle does not come into contact with the eye, the skin around the eye or the fingers.
- Tilt your head back and hold the bottle upside down above your eye.
- Pull the lower eyelid down and look up. Lightly press on the bottle and squeeze out a drop that you drop into the pocket between the lower eyelid and the eye (Fig. 1).
- Close the eye and press with a finger in the inner corner of the eye and hold it there for about a minute. In this way, the eye drop is prevented from flowing down into the tear duct (Fig. 2).
- Wipe off any solution that may have ended up on the skin around the eye.
- Put the cap back on the bottle and close tightly.
If you need to take another drop in the eye, or if both eyes are to be treated, repeat steps 3 to 7.
Levofloxacin Actavis eye drops must not be injected into the inner parts of the eyeball.
If you use more Levofloxacin Actavis than you should
If you take more Levofloxacin Actavis than you should, flush your eye (s) with water and tell your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
About one in ten people using Levofloxacin Actavis feel 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 (may affect up to 1 in 10,000 people) this medicine may cause severe allergic reactions.
The following symptoms may occur after just one dose of Levofloxacin Actavis:
- 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 Levofloxacin Actavis 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 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
- abnormal 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
Additional side effects in children and adolescents
The frequency, type, and severity of adverse reactions are expected to be the same for children and adolescents as for adults.
How to store Levofloxacin Actavis
Keep this medicine out of the sight and reach of children.
Unopened bottle: No special storage instructions.
Opened bottle: Do not store above 25 ° C. Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is 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.
To prevent infection, discard the bottle 4 weeks after you first open it 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 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 , solution; preservative ), sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
- Levofloxacin Actavis is a clear, light yellow to light green-yellow solution, free from visible particles.
- White LDPE 5 ml bottle with a white LDPE drip tip and a white cap with a sealing ring in white high density polyethylene (HDPE) / LDPE.
- 1 bottle per carton.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
Manufacturer
Balkanpharma-Razgrad AD
68 April Vastanie Blvd., 7200 Razgrad, Bulgaria