Floxal
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How to use Floxal
Package Leaflet: Information for the Patient
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Floxal (Trafloxal), 3 mg/g eye ointment
Ofloxacin
Floxal and Trafloxal are different trade names for the same drug.
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
- You should keep this leaflet, so that you can read it again if you need to.
- In case of any doubts, you should consult a doctor or pharmacist.
- This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
Table of Contents of the Leaflet:
- 1. What is Floxal and what is it used for
- 2. Important information before using Floxal
- 3. How to use Floxal
- 4. Possible side effects
- 5. How to store Floxal
- 6. Contents of the pack and other information
1. What is Floxal and what is it used for
Floxal contains the active substance ofloxacin, which belongs to a group of antibacterial drugs called fluoroquinolones. The drug has antibacterial effects on certain aerobic and anaerobic bacteria.
The drug is used in infections of the anterior segment of the eye, caused by microorganisms sensitive to ofloxacin, such as chronic conjunctivitis, keratitis, corneal ulcer, and chlamydial infection.
2. Important information before using Floxal
When not to use Floxal
Warnings and precautions
Before starting to use Floxal, the patient should discuss it with their doctor or pharmacist, especially in the following situations:
In case of a skin rash or any other allergic reaction to Floxal eye ointment, the patient should stop using the medicine and contact their doctor.
The doctor will then decide on the appropriate treatment.
During the use of Floxal eye ointment, the patient should avoid excessive exposure to sunlight or ultraviolet radiation (e.g., quartz lamps, solarium, etc.) due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to the multiplication of pathogenic microorganisms that are resistant to this medicine. In such a case, the doctor will decide on the appropriate treatment.
Tendonitis and tendon rupture have occurred in patients taking fluoroquinolones orally or intravenously, especially in older patients and those treated with corticosteroids at the same time. The patient should stop using Floxal eye ointment if they experience pain or swelling of the tendon (tendinitis).
Children and adolescents
The use of Floxal is not recommended in children under 1 year of age, as its safety and efficacy in this age group have not been established.
Floxal and other medicines
The patient should tell their doctor or pharmacist about all the medicines they are currently using or have recently used, as well as any medicines they plan to use.
If Floxal eye ointment is used at the same time as other ointments or eye drops, the patient should keep a 15-minute interval between the administration of the medicines. Floxal eye ointment should be used last.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The doctor will decide whether the patient can use Floxal eye ointment.
Ofloxacin has not affected fertility in animals.
Driving and using machines
Immediately after using the ointment, the patient may experience temporary, transient blurred vision. Until this symptom completely disappears, patients should not operate machines or drive vehicles.
Floxal eye ointment contains lanolin
The medicine may cause local skin reactions (e.g., contact dermatitis).
3. How to use Floxal
This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose
On average, 1 cm of squeezed ointment (0.12 mg of ofloxacin) into the conjunctival sac 3 times a day (in the case of chlamydial infection, 5 times a day).
Apply to the conjunctival sac of the infected eye.
Instructions for administering the medicine:
- 1. Wash your hands thoroughly.
- 2. Remove the protective cap.
- 3. Point the tube downwards with the nozzle (with the cannula) and hold it with your thumb and index finger.
- 4. Tilt your head back.
- 5. Gently pull down the lower eyelid with your index finger to create a "pocket" between the eyeball and the eyelid, where the ointment will be inserted.
and then:
- 6. Bring the tip of the tube close to the eye, without touching the tip of the tube to the eye, eyelid, or surrounding areas.
- 7. Gently squeeze the tube to express the ointment.
- 8. Looking up, insert 1 cm of ointment into the eye. If this is not successful, repeat the procedure.
- 9. Several times, gently open and close the eye to spread the ointment over the entire surface of the eye.
- 10. Close the eyelid and press the inner corner of the eye at the base of the nose with your finger. This will help minimize the risk of the medicine entering the entire body.
- 11. If the ointment is to be administered to both eyes, the above steps should be repeated for the second eye.
- 12. Immediately after use, replace the cap and screw the tube tightly.
Having someone else help or using a mirror may make it easier to administer the medicine.
Floxal eye ointment is a sterile medicine. To avoid contamination, do not touch the tip of the tube with your fingers or touch the surface of the eye or any other surface.
Using contaminated eye ointment can lead to serious eye damage, including vision loss.
Duration of treatment
Treatment with Floxal should not last longer than 2 weeks.
In case of worsening of the infection or lack of improvement after a few days, the patient should contact their doctor.
Using more than the recommended dose of Floxal
In case of using a larger dose of the medicine than recommended, the patient should rinse their eye with clean water.
In case of accidental ingestion of the medicine, the patient should immediately contact their doctor.
Missing a dose of Floxal
In case of missing a dose of Floxal, the patient should use the medicine as soon as possible.
However, if it is almost time for the next dose, the patient should skip the missed dose and continue using the medicine according to the doctor's instructions. The patient should not use a double dose to make up for the missed dose. If the patient misses several doses, they should inform their doctor and follow their instructions.
Stopping the use of Floxal
Floxal should be used as directed by the doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.
4. Possible side effects
Like all medicines, Floxal can cause side effects, although not everybody gets them.
If any of the following side effects occur, the patient should stop using the medicine and contact their doctor immediately:
- allergic reaction with swelling localized in the face, lips, mouth, tongue, and/or throat (angioedema). This may cause a feeling of constriction in the throat, difficulty swallowing, and breathing - this side effect has been reported very rarely;
- shortness of breath - this side effect has been reported very rarely;
- allergic reactions affecting the whole body (anaphylactic reaction, including anaphylactic shock) - this side effect has been reported very rarely;
- allergic reactions affecting the eye, including eye itching and eyelid itching - the frequency of this side effect is unknown;
- during the use of Floxal, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as reddish spots or oval patches on the torso, often with blisters in the center - the frequency of this side effect is unknown.
In addition, the following side effects may occur:
Common (may affect up to 1 in 10 people)
- eye irritation;
- feeling of discomfort in the eye.
Frequency not known (cannot be estimated from the available data)
- keratitis;
- conjunctivitis;
- blurred vision;
- photophobia;
- eye swelling;
- eyelid swelling;
- feeling of a foreign body in the eye;
- increased tearing;
- dry eye;
- eye pain;
- eye redness;
- deposits in the cornea (especially in cases of pre-existing corneal disease);
- facial swelling;
- swelling around the eyes (including eyelid swelling);
- nausea.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, it is possible to gather more information on the safety of the medicine.
5. How to store Floxal
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C, in the original packaging.
Any remaining ointment should be discarded 1 month after first opening the tube.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.
6. Contents of the pack and other information
What Floxal contains
The active substance of the medicine is ofloxacin.
1 g of eye ointment contains 3 mg of ofloxacin.
The other ingredients are: light liquid paraffin, lanolin, white petrolatum.
What Floxal looks like and contents of the pack
Floxal is available as an eye ointment.
The available packaging of the medicine is: a tube containing 3 g of ointment, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Belgium, the country of export:
Bausch & Lomb Pharma sa/nv
Bvd. Lambermontlaan 430
1030 Brussels
Belgium
Manufacturer:
Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
D-13581 Berlin (Spandau)
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE156825
Parallel import authorization number: 218/23
Date of leaflet approval: 04.10.2023
[Information about the trademark]
- Country of registration
- Active substance
- Prescription requiredYes
- Marketing authorisation holder (MAH)Bausch & Lomb Pharma sa/nv
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to FloxalDosage form: Ointment, 3 mg/gActive substance: ofloxacinManufacturer: Dr. Gerhard Mann Chem. - Pharm. Fabrik GmbHPrescription requiredDosage form: Drops, 3 mg/ml (0.3%)Active substance: ofloxacinManufacturer: Dr. Gerhard Mann Chem. - Pharm. Fabrik GmbHPrescription required
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