Luxabiotic

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Luxabiotic 3 mg/ml + 1 mg/ml eye drops, suspension

Tobramycin Dexamethasone
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Luxabiotic is and what it is used for
2. What you need to know before using Luxabiotic
3. How to use Luxabiotic
4. Possible side effects
5. How to store Luxabiotic
6. Contents of the pack and other information

1. What Luxabiotic is and what it is used for

Luxabiotic contains a combination of two medicines: dexamethasone, which belongs to the class of corticosteroids and has an anti-inflammatory effect, and tobramycin, which belongs to the class of aminoglycoside antibiotics and acts against various bacteria that can cause eye infections.
Luxabiotic is indicated in adults and children from two years of age onwards for the treatment of eye inflammations when a corticosteroid is required and when there is either an existing eye infection or a risk of eye infection.

2. What you need to know before using Luxabiotic

Do not use Luxabiotic:

• If you are allergic to tobramycin, dexamethasone or any of the other ingredients of this medicine (listed in section 6). If you have:
• inflammation of the cornea (the transparent membrane covering the colored part of the eye) caused by the Herpes simplex virus (Herpes simplex keratitis)
• vaccinia, varicella or other viral infections of the cornea and conjunctiva (the transparent membrane covering the white part of the eye and the inside of the eyelids)
• fungal (mycotic) or untreated parasitic eye infections
• eye infections caused by mycobacteria (ocular tuberculosis)
• high pressure in the eye
• eye inflammations with pus formation (acute purulent ophthalmia, purulent conjunctivitis and purulent or herpetic blepharitis), which may be masked or worsened by corticosteroids
• styes.

Warnings and precautions
Talk to your doctor or pharmacist before using Luxabiotic.

• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin administered into the eyes may occur. This allergic reaction may range from localized itching or redness of the skin to severe generalized allergic reactions (anaphylactic reactions) or serious skin reactions. If these symptoms occur while using Luxabiotic eye drops, stop treatment immediately and consult your doctor. Also note that this allergic sensitivity may also occur with other antibiotics belonging to the aminoglycoside class, whether administered into the eyes or systemically (by injection).
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson’s disease. Antibiotics of this type may worsen muscle weakness.
• In patients who have received systemic (by injection) aminoglycoside antibiotics such as tobramycin, serious toxic effects on the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using Luxabiotic together with systemically administered aminoglycoside antibiotics (by injection).
• Long-term use of corticosteroids in the eyes may lead to increased eye pressure (including a condition called glaucoma, with damage to the optic nerve), vision problems, and cataract formation (clouding of the lens inside the eye, called the crystalline lens). If you use Luxabiotic eye drops for a prolonged period, you must have your eye pressure checked regularly and frequently. This is particularly important in children, as the risk of corticosteroid-induced increased eye pressure may be higher in children under six years of age and may appear earlier than in adults. Consult your doctor, especially if you need to use Luxabiotic eye drops in children. The risk of corticosteroid-induced increased eye pressure and/or cataract formation is increased in predisposed patients (e.g., diabetic patients).
• Development of Cushing's syndrome caused by the medicine passing into the bloodstream. Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after stopping prolonged or intensive treatment with Luxabiotic. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat (see section “Other medicines and Luxabiotic”).
• While using Luxabiotic, you may become more susceptible to eye infections caused by bacteria, viruses, fungi, or parasites: if your symptoms worsen or suddenly reappear, consult your doctor.
• If you have a corneal ulcer that does not heal, stop treatment and consult your doctor.
• Consult your doctor before using this medicine if you have conditions causing thinning of the eye tissues, as administration of corticosteroids into the eyes may lead to perforation.
• Corticosteroids applied to the eyes may slow the healing of corneal wounds. It is also known that NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) applied to the eyes may slow or delay healing. Concomitant use of NSAIDs and corticosteroids in the eyes may potentially increase problems with eye wound healing (see section “Other medicines and Luxabiotic”).
• Do not wear contact lenses during treatment for eye inflammation or infection. Also read the section “Luxabiotic eye drops contain benzalkonium chloride”.
• Use Luxabiotic eye drops under the direct supervision of your doctor.
• Use Luxabiotic eye drops only for ocular application.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Luxabiotic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Tell your doctor especially if you are using other eye medications containing NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Concomitant use of NSAIDs and corticosteroids in the eyes may potentially increase problems with corneal wound healing.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase blood levels of dexamethasone.
Incompatibilities
The ingredient tyloxapol contained in Luxabiotic eye drops is incompatible with tetracycline.
Do not use Luxabiotic eye drops together with other eye products containing tetracycline.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Data on the use of tobramycin and dexamethasone in the eyes in pregnant women are lacking or limited. Animal studies have shown reproductive toxicity following systemic (oral or injected) administration of dexamethasone and tobramycin.
Luxabiotic is not recommended during pregnancy. Consult your doctor, who will decide whether you should use Luxabiotic during pregnancy.
Breastfeeding
It is not known whether tobramycin or dexamethasone are excreted in breast milk after ocular administration. Tobramycin is excreted in breast milk after systemic (injected) administration. No data are available on the passage of dexamethasone into human breast milk. Risk to infants cannot be ruled out. Consult your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with Luxabiotic.
Fertility
No studies have been conducted to evaluate the effect of tobramycin on human or animal fertility. Clinical data to assess the effect of dexamethasone on male or female fertility are limited.

Driving and using machines
For a certain period after instillation of Luxabiotic, blurred vision or other visual disturbances may occur, which could impair your ability to drive or operate machinery. If these effects occur, wait until your vision clears before driving or using machinery.

Luxabiotic contains benzalkonium chloride
This medicine contains 73.5 micrograms of benzalkonium chloride per drop, equivalent to 0.1 mg/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.

3. How to use Luxabiotic

Use Luxabiotic only in the eyes.
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Instill 1 or 2 drops 4-5 times a day, as directed by your doctor.
Use the medicine for the length of time prescribed by your doctor.
The following procedure helps reduce the amount of medicine absorbed into the bloodstream after application in the eye: keep the eyelid closed and at the same time apply gentle pressure with a finger at the inner corner of the eye near the nose for at least 2 minutes.
If you are using other eye drops or ophthalmic ointments, wait at least 5 minutes between instillation of each medicine. Ophthalmic ointment should be used last.
Use in children
Do not use Luxabiotic in children under two years of age, as safety and efficacy have not been established in this population and no data are available.
Luxabiotic may be used in children from two years of age onwards at the same doses as recommended for adults.
How to apply Luxabiotic eye drops

1 2

• Wash your hands.
• Take the bottle and shake well before unscrewing the cap.
• If you are opening the bottle for the first time, remove the detached ring from the cap before using the medicine.
• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled into this pouch (Figure 1).
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip to avoid contaminating the remaining drops in the bottle.
• Gently press the base of the bottle to release one drop of Luxabiotic at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is needed (Figure 2).
• If you are instilling drops in both eyes, repeat the same procedure for the other eye.
• Immediately replace the cap after use, screwing it on tightly. If a drop does not enter the eye, try again.

If you use more Luxabiotic than you should
Considering that the medicine is applied in the eyes, overdose is unlikely. However, if this should occur, rinse the eye thoroughly with running water.
Do not use the medicine again until the next scheduled dose.
If you forget to use Luxabiotic
If you forget to use Luxabiotic, do not worry—apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Luxabiotic can cause side effects, although not everyone experiences them. The following side effects have been reported with the use of Luxabiotic.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye effects: increased pressure in the eye(s), eye pain, eye itching, eye discomfort, eye irritation.

Rare side effects (may affect up to 1 in 1,000 people)

• Eye effects: inflammation of the surface of the eye, eye allergy, blurred vision, dry eye, eye redness.
• General side effects: unpleasant taste.

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• Eye effects: swelling of the eyelids, redness of the eyelids, increased pupil size, increased tear production.
• Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or missed menstrual periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).
• General side effects: severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, skin rash, severe skin reactions (erythema multiforme), facial swelling, itching.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luxabiotic

Keep the medicine out of the sight and reach of children.
Do not use the bottle if the anti-counterfeiting seal is broken before first use.
Do not use this medicine after the expiry date stated on the bottle and the outer carton after "Exp.". The expiry date refers to the last day of that month.
Do not use the medicine more than 28 days after first opening the container, even if
some of the solution remains.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Luxabiotic contains

• The active substances are tobramycin and dexamethasone.
• 1 ml of solution contains 3 mg of tobramycin and 1 mg of dexamethasone.

The other ingredients are: benzalkonium chloride as preservative, edetate disodium, hydroxyethylcellulose,
purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide, tyloxapol.
Description of the appearance of Luxabiotic and contents of the pack
Plastic bottle containing 5 ml of a milky white suspension.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
00071 Pomezia (RM), Italy
This medicinal product is authorised in Member States under the following names:
Italy
Luxabiotic 3 mg/ml + 1 mg/ml eye drops, suspension
This leaflet was last approved on