Oftacilox

Italy
Brand name Oftacilox
Form solution, eye
Active substance / Dosage
CIPROFLOXACIN HYDROCHLORIDE
Prescription type Prescription only
ATC code
S01AE03
Registration number 028476
Manufacturer NTC S.R.L.
Oftacilox solution, eye

OFTACILOX 0.3%
Eye drops,
solutionciprofloxacin
PHARMACOTHERAPEUTIC CATEGORY
Antimicrobial.
THERAPEUTIC INDICATIONS
Adults, neonates (0–27 days), infants (28 days to 23 months), children (2–11 years), and adolescents (12–16 years): OFTACILOX is indicated for the treatment of external ocular infections and ocular adnexal infections caused by bacteria sensitive to ciprofloxacin, and for the treatment of corneal ulcers.
CONTRAINDICATIONS
Hypersensitivity to ciprofloxacin or to any of the excipients. A known hypersensitivity to other quinolones may also constitute a contraindication to the use of ciprofloxacin.

PRECAUTIONS FOR USE
Prolonged use of antimicrobial agents, including ciprofloxacin, may result in overgrowth of non-susceptible microorganisms, including fungi. Repeated use of topical products may lead to sensitization phenomena.
If you are elderly or taking medications called 'corticosteroids' used to treat conditions such as pain and inflammation, asthma, or skin problems, you may have an increased risk of tendon problems during treatment with OFTACILOX. If you experience any inflammation, stop treatment and consult your doctor immediately. If you feel pain, swelling, or inflammation of the tendons during or immediately after using OFTACILOX, discontinue treatment and consult your doctor.
Administration of ciprofloxacin must be discontinued at the first sign of skin reactions or any other hypersensitivity reaction.
Reproduction studies have not shown embryotoxic or teratogenic effects. However, due to the effects of ciprofloxacin on growing cartilage, during pregnancy, lactation, pediatric age, and in adolescents, the product should be used only when considered absolutely essential by the physician.
During breastfeeding, the product should be administered only when clearly necessary and under direct medical supervision.
INTERACTIONS
Ciprofloxacin for ophthalmic use has not been specifically studied for drug interactions. Due to the low systemic concentration of ciprofloxacin following topical ocular administration, drug interactions are unlikely.
If more than one topical ophthalmic medication is used, they should be administered at least 10 minutes apart. Ophthalmic ointments should be administered last.
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
SPECIAL WARNINGS
Use OFTACILOX eye drops, solution only in the eyes.
Clinical experience in children under one year of age, particularly neonates, is very limited.
The use of OFTACILOX eye drops, solution in neonates with gonococcal or chlamydial neonatal ophthalmia is not recommended, as it has not been evaluated in these patients. Neonates affected by neonatal ophthalmia should receive appropriate treatment for their condition.
If you notice a skin reaction, contact your doctor. Skin photosensitivity has been reported with antibiotic use. Such reactions with ciprofloxacin are uncommon.
When using OFTACILOX, consider the risk of nasopharyngeal passage, which may contribute to the emergence and spread of bacterial resistance.
In patients receiving systemic therapy with quinolones, severe and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, sometimes after the first dose. Some reactions were accompanied by cardiocirculatory collapse, loss of consciousness, tingling, pharyngeal or facial swelling, difficulty breathing, urticaria, and pruritus. Only some patients had prior history of hypersensitivity. Severe hypersensitivity reactions require immediate emergency treatment with adrenaline and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, vasopressor amines, and interventions to maintain airway patency.
In patients with corneal ulcers receiving frequent administration of OFTACILOX, white deposits of the drug have been observed, which disappear with continued application of OFTACILOX. The precipitate does not preclude continued use of OFTACILOX nor negatively affect the clinical course of healing.
The medicine contains 0.06 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, OFTACILOX should be used only after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.
Consult your doctor if you suspect you are pregnant or plan to become pregnant.
Effects on ability to drive and use machines
As with any ophthalmic medicine, if vision is temporarily blurred or other visual disturbances occur immediately after instillation, wait until vision clears before driving or operating machinery.
DOSAGE, ADMINISTRATION METHOD, AND DURATION
Adults, neonates (0–27 days), infants (28 days to 23 months), children (2–11 years), and adolescents (12–16 years).
For the first two days, instill 1 or 2 drops into the affected eye every two hours, discontinuing administration during the night. On subsequent days, administer 1 or 2 drops every four hours during daytime hours, until the infection resolves.
In cases of corneal ulcers, administer OFTACILOX at the following intervals, including during the night:
Day 1: 2 drops every 15 minutes for the first 6 hours, then 2 drops every 30 minutes for the remainder of the day;
Day 2: 2 drops every hour;
Day 3 to Day 14: 2 drops every 4 hours.
If treatment beyond 14 days is required, the therapeutic regimen will be determined by the physician.
After removing the cap, if the loose protective ring has loosened, discard it before using the product.
OVERDOSAGE
Excess drug may be removed by rinsing the eye with lukewarm running water. In case of accidental ingestion/ingestion of OFTACILOX, contact your doctor. However, no serious effects are expected.
UNDESIRABLE EFFECTS
Like all medicines, OFTACILOX eye drops may cause undesirable effects, although not everyone experiences them.
The frequency of the possible undesirable effects listed below is defined according to the following convention:
Very common (affects more than 1 in 10 users)
Common (affects 1 to 10 in 100 users)
Uncommon (affects 1 to 10 in 1,000 users)
Rare (affects 1 to 10 in 10,000 users)
Not known (frequency cannot be estimated from available data)
Immune system disorders
Rare: hypersensitivity.
Nervous system disorders
Uncommon: headache.
Rare: dizziness.
Eye disorders
Common: white deposits on the surface of the eye (cornea), ocular discomfort, eye redness.
Uncommon: discomfort, degeneration on the surface of the eye (cornea), corneal staining, photophobia, reduced visual acuity, eyelid swelling, blurred vision, eye pain, dry eye, eye swelling, ocular pruritus, foreign body sensation in the eye, increased lacrimation, ocular discharge, eyelid crusting, eyelid desquamation, conjunctival edema, eyelid erythema.
Rare: ocular toxicity, conjunctivitis, corneal pathology, defect of the eye surface (cornea), double vision, decreased ocular sensitivity, eye fatigue, stye, eye irritation, eye inflammation, eye redness.
Ear and labyrinth disorders
Rare: ear pain.
Respiratory, thoracic and mediastinal disorders
Rare: nasal hypersecretion, nasal inflammation.
Gastrointestinal disorders
Common: taste disturbance.
Uncommon: nausea.
Rare: diarrhea, abdominal pain.
Skin and subcutaneous tissue disorders
Rare: skin inflammation.
Musculoskeletal and connective tissue disorders
Not known: tendon disorders.
General disorders and administration site conditions
Rare: drug intolerance.
Investigations
Rare: laboratory test abnormalities.
With local application of fluoroquinolones, generalized skin eruptions, toxic epidermal necrolysis, exfoliative dermatitis, Stevens-Johnson syndrome, and urticaria occur very rarely.
In isolated cases, with ophthalmic ciprofloxacin, blurred vision, reduced visual acuity, and persistence of drug residues at the ocular site have been observed.
In patients receiving systemic therapy with quinolones, severe and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, sometimes after the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial swelling, difficulty breathing, urticaria, and pruritus.
In patients receiving systemic treatment with fluoroquinolones, ruptures of the shoulder, hand, Achilles tendon, or other tendons have been reported, requiring surgical repair or resulting in prolonged disability.
Clinical studies and post-marketing experience with systemic fluoroquinolones indicate that the risk of such tendon ruptures may increase in patients receiving corticosteroids, especially in elderly patients, and in tendons subjected to high stress, including the Achilles tendon.
Available clinical and post-marketing data have not shown a clear association between OFTACILOX and adverse musculoskeletal and connective tissue reactions.
In cases of hypersensitivity, discontinue treatment at the first symptoms and consult your doctor.
Reporting of undesirable effects
It is important to inform your doctor or pharmacist if any undesirable effect occurs, even if not described in this leaflet.
Undesirable effects can also be reported directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting undesirable effects contributes to providing more information on the safety of this medicine.
Use in children
The safety and efficacy of OFTACILOX have been established in 230 children aged between 0 and 12 years. No serious adverse drug reactions were recorded in this patient group.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
Do not refrigerate or freeze.
Caution: do not use after the expiry date stated on the outer packaging and on the bottle.
The expiry date refers to the product in intact packaging, correctly stored.
The product should not be used more than 28 days after first opening of the container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.
COMPOSITION
1 ml contains:
Active substance: ciprofloxacin hydrochloride monohydrate 3.5 mg, equivalent to 3.0 mg ciprofloxacin base.
Excipients: benzalkonium chloride, sodium acetate, acetic acid, mannitol, edetate disodium, purified water or, alternatively, water for injections.
PHARMACEUTICAL FORM AND CONTENT
Sterile ophthalmic solution; eye drops, solution. 5 ml bottle.
Marketing Authorization Holder:
NTC s.r.l.
Via Luigi Razza 3
20124 Milan
Italy
Manufacturer and Final Controller
SA ALCON - COUVREUR NV, Rijksweg 14, B - 2870 Puurs (Belgium)
Or
SIEGFRIED El Masnou, S.A., Camil Fabra, 58 - 08320 El Masnou Barcelona (Spain)
Or
EXCELVISION S.A., 27, Rue de la Lombardière - 07100 Annonay (France)

OFTACILOX 0.3%
Ophthalmic ointment
ciprofloxacin
PHARMACOTHERAPEUTIC CATEGORY
Antibacterial
THERAPEUTIC INDICATIONS
Adults and children over one year of age.
OFTACILOX is indicated for the treatment of ocular infections such as corneal ulcers (or corneal abscesses), conjunctivitis, and blepharitis caused by strains sensitive to ciprofloxacin.
CONTRAINDICATIONS
Hypersensitivity to ciprofloxacin or to any of the excipients. A known hypersensitivity to other quinolones may also constitute a contraindication to the use of ciprofloxacin.
PRECAUTIONS FOR USE
Prolonged use of antibacterial agents may lead to overgrowth of non-susceptible microorganisms, including fungi. Repeated use of topical products may lead to sensitization phenomena.
If you are elderly or taking medications called 'corticosteroids' used to treat conditions such as pain and inflammation, asthma, or skin problems, you may have an increased risk of tendon problems during treatment with OFTACILOX. If you experience any inflammation, stop treatment and consult your doctor immediately. If you feel pain, swelling, or inflammation of the tendons during or immediately after using OFTACILOX, discontinue treatment and consult your doctor.
Administration of ciprofloxacin must be discontinued at the first sign of skin reactions or any other hypersensitivity reaction.
Reproduction studies have not shown embryotoxic or teratogenic effects.
However, due to the effects of ciprofloxacin on growing cartilage, during pregnancy, lactation, pediatric age, and in adolescents, the product should be used only when considered absolutely essential by the physician.
INTERACTIONS
If you are using other eye medications, wait at least 10 minutes between each application. If you also use an ophthalmic ointment, apply it last.
Ciprofloxacin for ophthalmic use has not been specifically studied for drug interactions. Due to the low systemic concentration of ciprofloxacin following topical ocular administration, drug interactions are unlikely.
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
SPECIAL WARNINGS
Use OFTACILOX ophthalmic ointment only in the eyes.
Clinical experience in children under one year of age, particularly neonates, is very limited.
The use of OFTACILOX ophthalmic ointment in neonates with gonococcal or chlamydial neonatal ophthalmia is not recommended, as it has not been evaluated in these patients. Neonates affected by neonatal ophthalmia should receive appropriate treatment for their condition.
If you notice a skin reaction, contact your doctor. Skin photosensitivity has been reported with antibiotic use. Such reactions with ciprofloxacin are uncommon.
When using OFTACILOX, consider the risk of nasopharyngeal passage, which may contribute to the emergence and spread of bacterial resistance.
In patients receiving systemic therapy with quinolones, severe and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, sometimes after the first dose. Some reactions were accompanied by cardiocirculatory collapse, loss of consciousness, tingling, pharyngeal or facial swelling, difficulty breathing, urticaria, and pruritus. Only some patients had prior history of hypersensitivity. Severe hypersensitivity reactions may require immediate emergency treatment with adrenaline and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, vasopressor amines, and interventions to maintain airway patency.
In patients with corneal ulcers receiving frequent administration of OFTACILOX, white drug residues have been observed, which disappear with continued application of OFTACILOX. The precipitate does not preclude continued use of OFTACILOX nor negatively affect the clinical course of healing.
Do not wear contact lenses (rigid or soft) during treatment with OFTACILOX ophthalmic ointment.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, OFTACILOX should be used only after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.
Consult your doctor if you suspect you are pregnant or plan to become pregnant.
During breastfeeding, the product should be administered only when clearly necessary and under direct medical supervision.
Effects on ability to drive and use machines
As with any ophthalmic medicine, if vision is temporarily blurred or other visual disturbances occur immediately after application, wait until vision clears before driving or operating machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Adults and children over one year of age.
The recommended dosing regimen in adults (including the elderly) and children over one year of age is as follows:

  • Corneal ulcers or abscesses (interchangeable terms): Apply a 1.25 cm strip of ointment into the conjunctival sac, including during the night, at the following intervals: every 1–2 hours for two days, then every 4 hours for an additional 12 days. Treatment may be prolonged at the physician's discretion.
  • Bacterial conjunctivitis (and blepharitis): Apply 1.25 cm of ointment into the conjunctival sac (or on the eyelid margin, respectively) three times daily for two days, then twice daily for an additional five days. Treatment may be prolonged at the physician's discretion.
    Do not touch any surface with the tip of the tube to avoid contamination of the contents.
    Use in the elderly
    Clinical studies have shown that dosage adjustments are not necessary in the elderly.
    OVERDOSAGE
    Excess medicine may be removed by rinsing the eye with lukewarm running water. In case of accidental ingestion or overdose of OFTACILOX, contact your doctor immediately. However, no serious effects are expected.
    UNDESIRABLE EFFECTS
    Like all medicines, OFTACILOX ointment may cause undesirable effects, although not everyone experiences them.
    The frequency of the possible undesirable effects listed below is defined according to the following convention:
    Very common (affects more than 1 in 10 users)
    Common (affects 1 to 10 in 100 users)
    Uncommon (affects 1 to 10 in 1,000 users)
    Rare (affects 1 to 10 in 10,000 users)
    Not known (frequency cannot be estimated from available data).
    Immune system disorders
    Rare: hypersensitivity.
    Nervous system disorders
    Uncommon: headache.
    Rare: dizziness.
    Eye disorders
    Common: white deposits on the surface of the eye (cornea), ocular discomfort, eye redness.
    Uncommon: discomfort, degeneration on the surface of the eye (cornea), corneal staining, photophobia, reduced visual acuity, eyelid swelling, blurred vision, eye pain, dry eye, eye swelling, ocular pruritus, foreign body sensation in the eye, increased lacrimation, ocular discharge, eyelid crusting, eyelid desquamation, conjunctival edema, eyelid erythema.
    Rare: ocular toxicity, conjunctivitis, corneal pathology, defect of the eye surface (cornea), double vision, decreased ocular sensitivity, eye fatigue, stye, eye irritation, eye inflammation, eye redness.
    Ear and labyrinth disorders
    Rare: ear pain.
    Respiratory, thoracic and mediastinal disorders
    Rare: nasal hypersecretion, nasal inflammation.
    Gastrointestinal disorders
    Common: taste disturbance
    Uncommon: nausea.
    Rare: diarrhea, abdominal pain.
    Skin and subcutaneous tissue disorders
    Rare: skin inflammation.
    Musculoskeletal and connective tissue disorders
    Not known: tendon disorders.
    General disorders and administration site conditions
    Rare: drug intolerance.
    Investigations
    Rare: laboratory test abnormalities.
    With local application of fluoroquinolones, generalized skin eruptions, toxic epidermal necrolysis, exfoliative dermatitis, Stevens-Johnson syndrome, and urticaria occur very rarely.
    In patients receiving systemic therapy with quinolones, severe and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, sometimes after the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial swelling, difficulty breathing, urticaria, and pruritus.
    In patients receiving systemic treatment with fluoroquinolones, ruptures of the shoulder, hand, Achilles tendon, or other tendons have been reported, requiring surgical repair or resulting in prolonged disability. Clinical studies and post-marketing experience with systemic fluoroquinolones indicate that the risk of such tendon ruptures may increase in patients receiving corticosteroids, especially in elderly patients, and in tendons subjected to high stress, including the Achilles tendon.
    Available clinical and post-marketing data have not shown a clear association between OFTACILOX and adverse musculoskeletal and connective tissue reactions.
    In cases of hypersensitivity, discontinue treatment at the first symptoms and consult your doctor.
    Reporting of undesirable effects
    It is important to inform your doctor or pharmacist if any undesirable effect occurs, even if not described in this leaflet.
    Undesirable effects can also be reported directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili .
    Reporting undesirable effects contributes to providing more information on the safety of this medicine.
    Use in children
    The safety and efficacy of OFTACILOX have been established in 103 children aged between one and 12 years. No serious adverse events were reported in these patients. These clinical studies have shown that dosage adjustments are not necessary in children.
    EXPIRY DATE AND STORAGE
    Expiry date: see the date on the packaging.
    The expiry date refers to the product in intact packaging, correctly stored.
    Do not store above 25°C.
    Do not refrigerate, do not freeze.
    Caution: do not use the medicine after the expiry date stated on the outer packaging and on the tube.
    The product may be used up to 30 days after first opening of the container: after this period, any remaining product should be discarded.
    Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
    Keep the medicine out of the sight and reach of children.
    COMPOSITION
    1 g of ophthalmic ointment contains:
    Active substance: ciprofloxacin hydrochloride 3.5 mg, equivalent to 3 mg ciprofloxacin.
    Excipients: liquid paraffin, white soft paraffin.
    PHARMACEUTICAL FORM AND CONTENT
    Ophthalmic ointment. 3.5 g tube.
    MARKETING AUTHORIZATION HOLDER
    Novartis Farma S.p.A.
    Largo Umberto Boccioni 1
    21040 Origgio (VA)
    Italy
    MANUFACTURER AND FINAL CONTROLLER
    S.A. ALCON - Couvreur N.V., Rijksweg 14, B-2870 Puurs (Belgium)