Floxal ointment 3g.
Floxal is an antibacterial medicinal product.
What Floxal is and what it is used for
Floxal is an antibacterial medicinal product.
Floxal is used for:
Anterior eye segment infections caused by ofloxacin-sensitive pathogens:
• chronic conjunctivitis;
• keratitis and root ulcers;
• Chlamydia infections.
2. What you need to know before using Floxal
Do not use Floxal:
- if you are allergic to ofloxacin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Floxal.
If you get an allergic reaction to ofloxacin, stop using the medicine. Use with caution if you are allergic to ofloxacin or other quinolone antibacterial agents.
As with any antibiotic, long-term use of Floxal can lead to other infections.
Use Floxal with caution with regard to the risk of corneal perforation if you have corneal epithelium damage or corneal ulcers.
Avoid sun or UV rays while using Floxal because of the likelihood of photosensitivity.
Do not use soft contact lenses during treatment with Floxal.
Safety and efficacy in children under one year of age have not been established.
Other medicines and Floxal
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
No specific interactions with other medicinal products are known.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Although there is no evidence of any embryotoxic effect (harmful in any way, to embryonic action), do not use Floxal if you are pregnant or breast-feeding unless your doctor deems it necessary.
Driving and using machines
After application of this medicinal product to the conjunctival sac, it may cause transient blurred vision due to streaks. At this time, the patient should not operate machinery, operate in places without secure support, or drive any vehicle on public transport.
Floxal contains anhydrous lanolin, which may cause locally restricted skin reactions (eg contact dermatitis).
3. How to use Floxal
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Unless otherwise directed, place a 1 cm tape (equivalent to 0.12 mg ofloxacin) of ointment three times daily in the conjunctival sac of the affected eye (for chlamydia infections 5 times daily). Treatment with Floxal should not exceed two weeks.
If you use Floxal with other eye drops / eye ointments, there should be an interval of approximately 15 minutes between drug applications, and Floxal should always be the last product administered.
If you use more Floxal than you should
Overdose with Floxal does not pose any known risks. The therapeutic effect will neither improve nor worsen.
If you forget to use Floxal
If you miss a dose, please apply eye ointment as soon as possible to make up for the missed dose. Do not apply a double dose of eye ointment and then follow the same dosing regimen and intervals / rhythm mentioned above or as recommended by your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects after the use of systemic ofloxacin occur rarely and most of the symptoms are reversible. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Floxal, initially appearing to be reddish-like target spots or circular patches on the body, often with blisters in the middle.
Because a small amount of ofloxacin is absorbed systemically after topical administration, side effects reported with systemic use may occur.
The incidence of possible adverse reactions listed below is defined according to
the following criteria:
Very common Affects more than 1 patient in 10
Common Affects 1 to 10 patients in 100
Uncommon Affects 1 to 10 patients in 1,000
Rare It affects 1 to 10 patients in 10,000
Very rare Affects less than 1 patient in 10,000
Frequency unknown: no estimate can be made of the frequency available.
Immune system disorders
Very rare: hypersensitivity (including angioedema, shortness of breath, anaphylactic reactions / shock, oropharyngeal edema and swelling of the tongue).
Nervous system disorders
Of unknown frequency: vertigo
With unknown frequency:
swelling of the eyes;
feeling of a foreign body in the eyes;
pain in the eye;
hypersensitivity (including itching of the eyes and itching of the eyelid);
swelling around the eyes (including swelling of the eyelids).
Not known: nausea
Skin and subcutaneous tissue disorders
Of unknown frequency: periorbital edema, facial edema
How to store Floxal
Keep out of the reach and sight of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Discard any unused amount of eye ointment six weeks after first opening the tube.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Floxal contains
The active substance is ofloxacin.
1 g of eye ointment contains 3.0 mg of ofloxacin.
A single dose (1 cm ointment strip) contains 0.12 mg of ofloxacin.
The other ingredients are: liquid paraffin, anhydrous lanolin, white petrolatum.
What Floxal looks like and contents of the pack
Packing: 1 tube with 3 g ointment.