Leviosa

PACKAGE LEAFLET

Package leaflet: Information for the user

Levendex 1 mg/ml + 5 mg/ml
eye drops, solution
dexamethasone / levofloxacin
Please read all of this leaflet carefully before you start using this medicine, as 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Levendex is and what it is used for

What type of medicine it is and how it works
Levendex is an ophthalmic solution containing levofloxacin and dexamethasone.
Levofloxacin is an antibiotic belonging to the fluoroquinolone class (also referred to briefly as quinolones). This antibiotic works by killing certain types of bacteria that may cause infections.
Dexamethasone is a corticosteroid that exerts an anti-inflammatory action (halting symptoms such as pain, heat, swelling, and redness).
What this medicine is used for
Levendex is used to prevent and treat inflammation and to prevent possible eye infections following cataract surgery.

2. What you need to know before using Levendex

Do not use Levendex:

• if you are allergic to levofloxacin (or to other quinolones) or to dexamethasone (or to other corticosteroids) or to any of the other ingredients of this medicine (listed in section 6).
• if you have an eye infection that is not being treated with medication, including viral infections (e.g. herpes simplex, keratitis, or varicella), fungal infections, or tuberculosis of the eye. Your eye may be infected if you have sticky discharge or if it is red and has not been examined by a doctor.

Warnings and precautions
Talk to your doctor before using Levendex:

• If you are using other antibiotics, including oral antibiotics. Like other anti-infective agents, prolonged use may lead to antibiotic resistance and overgrowth of pathogenic microorganisms.
• If you have high intraocular pressure, or have had it in the past after using a steroid eye medicine. Using Levendex may cause this problem to recur. If you have high intraocular pressure, inform your doctor.
• If you have glaucoma.
• If you have visual disturbances or blurred vision.
• If you are using NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), please read section “Other medicines and Levendex”.
• If you have conditions causing thinning of the eye tissues, as prolonged steroid treatment may cause further thinning and possibly lead to perforation.
• If you have diabetes.

Important information if you wear contact lenses
After cataract surgery, you must not wear contact lenses throughout the entire duration of treatment with Levendex.

Children and adolescents
Levendex is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this age group.

Other medicines and Levendex
Tell your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
• if you were already using any other type of eye drops or eye ointment before starting Levendex (see section 3 - How to use Levendex).
• if you are using NSAIDs for the eyes (used to treat pain and inflammation), such as ketorolac, diclofenac, bromfenac, or nepafenac. The concomitant use of NSAIDs and steroid eye medications may increase the risk of poor eye healing.
• if you are taking ritonavir or cobicistat (used in the treatment of HIV), as they may increase the level of dexamethasone in the blood.
• if you are taking probenecid (for the treatment of gout), cimetidine (for the treatment of gastric ulcers), or cyclosporine (to prevent transplant rejection), as they may alter the absorption and metabolism of levofloxacin.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine. Levendex must not be used during pregnancy or breastfeeding.

Driving and using machines
After using this medicine, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until the symptom resolves.

Levendex contains phosphate buffer
This medicine contains 4.01 mg of phosphates per ml, corresponding to 0.12 mg per drop. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment. Inform your doctor, who may recommend a phosphate-free treatment.

Levendex contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per ml, corresponding to 0.0015 mg per drop.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (affecting the eye’s most superficial transparent layer). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Levendex

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop into the affected eye every 6 hours. The maximum dose is 4 drops
per day. The treatment course with Levendex is usually 7 days, followed, if your doctor considers it
necessary, by another 7 days of treatment with a steroid eye drop.
Your doctor will determine the duration of treatment.
If you are using other eye drops or ophthalmic ointments, you must wait at least 15 minutes between
each application. Ophthalmic ointments should be applied last.

Instructions for use:
If possible, ask another person to administer the drops for you. Ask this person to read the
instructions with you before administration.

1. Wash your hands thoroughly (Figure 1).
2. Open the bottle. Remove the security ring, which detaches from the cap upon first opening the
   bottle.
   The dropper tip must not touch the eye, the area around the eye, or your fingers.
3. Unscrew the cap of the bottle. Hold the bottle upside down, gripping it between your thumb and other fingers.
4. Pull down the lower eyelid with one finger to create a "pocket" between the eyelid and the eye. The drop should be instilled into this pocket (Figure 2).
5. Tilt your head backward and bring the tip of the bottle close to the eye. Gently press the center of the bottle until one drop falls into the eye (Figure 3). Note that there may be a delay of several seconds between pressing the bottle and the drop emerging. Do not press too hard.
6. After applying Levendex, press with one finger on the inner corner of the eye near the nose. This will prevent the medicine from spreading throughout the body (Figure 4).

If a drop misses the eye, try again. Immediately after use, tightly replace the cap on the bottle.

If you use more Levendex than you should
If you have applied an excessive amount of medicine, rinse the eye with lukewarm water.

If you forget to use Levendex
If you forget to use this medicine, do not worry—apply it as soon as possible. Do not apply a double
dose to make up for a missed dose.

If you stop using Levendex
If you stop treatment with this medicine earlier than planned, inform your doctor. If you have any
questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most of these are non-serious side effects affecting only the eye.

• Very rarely, this medicine may cause serious allergic reactions (anaphylactic reactions), accompanied by swelling and a feeling of tightness in the throat and breathing difficulties.
• Stop using Levendex and contact your doctor immediately if you experience any of these symptoms.
• Oral or intravenous administration of fluoroquinolones may cause swelling and rupture of tendons, particularly in elderly patients and in those being treated concomitantly with corticosteroids. Stop using Levendex if you experience tendon pain or swelling (tendinitis).

One or more of the following side effects affecting one or both eyes may also occur:
Very common (may affect more than 1 in 10 people):

• increased intraocular pressure.

Common (may affect up to 1 in 10 people):

• eye discomfort, stinging pain or irritation, burning, itching,
• blurred or decreased vision,
• presence of mucus in the eye.
  Uncommon (may affect up to 1 in 100 people):
• delayed healing of corneal wounds
• eye infections
• abnormal sensation in the eye
• increased tearing
• dry and tired eyes
• eye pain
• increased brightness of vision
• swelling or redness (bloodshot eyes) of the outer lining of the eye (conjunctiva)
• swelling or redness of the eyelid
• sensitivity to light
• sticky eyelids.
  Very rare (may affect up to 1 in 10,000 people):
• dilation of the pupil
• drooping of the eyelid
• calcium deposits on the surface of the eye (corneal calcification)
• tearing and sensation of sand in the eye (crystalline keratopathy)
• changes in the thickness of the surface layer of the eye
• ulcer on the surface of the eye
• small holes on the surface of the eye (corneal perforation)
• swelling of the surface of the eye (corneal edema)
• inflammation of the eye causing pain and redness (uveitis).

Side effects affecting other parts of the body may also occur:
Uncommon (may affect up to 1 in 100 people):

• headache
• altered taste
• itching
• stuffy or runny nose.

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

• allergic reactions such as skin rash.
  Very rare (may affect up to 1 in 10,000 people):
• swelling of the face.

Not known

• reduced adrenal gland function, which may present as low blood sugar levels, dehydration, weight loss, and confusion.
• Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called “Cushing's syndrome”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 Levendex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the box after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if, before opening a new bottle, you notice that the plastic film covering the cap and neck of the bottle is damaged or missing.
Keep the bottle tightly closed. To avoid contamination, discard the bottle and use a new one 28 days after first opening.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levendex contains

• The active substances are levofloxacin, as hemihydrate, and dexamethasone, as sodium phosphate. Each millilitre of solution contains 5 mg of levofloxacin and 1 mg of dexamethasone.
• The other components are: monohydrate sodium dihydrogen phosphate, dodecahydrate disodium phosphate, sodium citrate, benzalkonium chloride, sodium hydroxide - hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Levendex and contents of the pack
Levendex is a clear, pale yellowish-green solution, practically free from particles, although the dispensed drop appears transparent and colourless. It is supplied in a pack containing one 5 ml plastic bottle with a white dropper. The plastic bottle is closed with a screw cap.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
NTC S.r.l.
Via Luigi Razza 3
20124 Milan
Italy
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica, 20/22
00040 Pomezia (Rome)
Italy
This medicinal product is authorised in the Member States of the European Economic Area under the following names: