Moxidrop

PACKAGE LEAFLET

Package leaflet: Information for the user

Moxidrop 5 mg/mL eye drops, solution in single-dose container

Moxifloxacin
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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Moxidrop is and what it is used for

Moxidrop eye drops is used to treat eye infections (conjunctivitis) when caused by bacteria. The active substance is moxifloxacin, an ophthalmic anti-infective.

2. What you need to know before using Moxidrop

Do not use Moxidrop

• if you are allergic to moxifloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Moxidrop:

• If you have an allergic reaction to Moxidrop. Allergic reactions occur not commonly, and severe reactions occur rarely. In case of allergic reactions (hypersensitivity) or any adverse effects, refer to section 4.
• If you wear contact lenses – stop wearing them if you experience signs or symptoms of eye infection. Wear glasses instead. Do not resume wearing contact lenses until signs and symptoms of infection have disappeared and until you have stopped using the medicine.
• Tendon swelling and rupture have been reported in people treated with oral or intravenous fluoroquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Discontinue use of Moxidrop if you experience tendon pain or swelling (tendinitis). As with any antibiotic, prolonged use of Moxidrop may lead to other infections.

Other medicines and Moxidrop
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
You may experience blurred vision for a short period immediately after using Moxidrop. Do not drive and do not operate machinery until this sensation has passed.

3. How to use Moxidrop

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults, including the elderly, and children: 1 drop in the affected eye(s), three times a day (in the
morning, in the afternoon and in the evening).
Moxidrop can be used in children, in patients over 65 years of age, and in patients with renal or hepatic impairment. There is only very limited information on the use of the medicine in newborns, and its use in newborns is not recommended.
Method of administration
Use Moxidrop only as an eye drop. Use the medicine in both eyes only if prescribed by your doctor.

Figure 1	Figure 2	Figure 3	Figure 4

1. Wash your hands.
2. Take a strip of single-dose containers from the aluminium pouch and detach one single-dose container (Figure 1).
3. Open the single-dose container by unscrewing the top part (Figure 2).
4. Tilt your head back, look upward, and gently pull down the lower eyelid away from the eye.
5. Instill one drop into the lower conjunctival sac by gently pressing the bottom of the container (Figure 3).
6. Close your eyes slowly and press with one finger at the corner of the eye near the nose for 2–3 minutes. This will prevent the medicine from draining through the tear duct into the throat, and most of the drop will remain in the eye (Figure 4).
7. Discard the single-dose container after use.
8. Return the remaining single-dose containers to the pouch, close it by folding the edge, and place the pouch back into the carton. If any containers remain 3 months after opening the pouch, they must be safely discarded.

The content of the single-dose container is sufficient for one application in both eyes.
Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could
contaminate the eye drops.
If you need to apply the eye drops to both eyes, wash your hands before repeating steps 1–6 for the
other eye. This will help prevent the infection from spreading from one eye to the other.
A new single-dose container must be used for each administration.
If a drop does not enter the eye, try again.
If you use more Moxidrop than you should, immediately rinse the eye with lukewarm water. Do not use the eye drops again until the time of your next scheduled dose.
If you accidentally swallow Moxidrop, consult your doctor or pharmacist.
If you forget to use Moxidrop, continue treatment with the next dose as scheduled. Do not use a double dose to make up for the missed dose.
If you are also using another eye drop at the same time, wait at least 5 minutes between instilling Moxidrop and the other eye drop.

Duration of use
The infection usually improves within 5 days. If no improvement is seen, contact your doctor.
You should continue using the drops for another 2 or 3 days, or as long as your doctor has instructed.

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 everybody gets them.
You can generally continue using the drops, unless the side effects are severe or you experience a serious allergic reaction.
If you have a severe allergic reaction or any of the following side effects occur, stop using Moxidrop immediately and contact your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat causing difficulty in swallowing or breathing, rash or hives, large fluid-filled blisters, sores and ulceration.

Common side effects (may affect up to 1 in 10 people)

• Eye-related effects: eye pain, eye irritation.

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

• Eye-related effects: dry eyes, itchy eyes, eye redness, inflammation or scarring of the eye surface, rupture of ocular blood vessels, abnormal sensation in the eye, eyelid abnormalities, itching, redness or swelling.
• General side effects: headache, bad taste.

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

• Eye-related effects: corneal disorders, blurred or reduced vision, inflammation or infection of the conjunctiva, eye fatigue, eye swelling.
• General side effects: vomiting, nasal discomfort, sensation of a lump in the throat, reduced iron levels in the blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation.

Not known (frequency cannot be estimated from the available data)

• Eye-related effects: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased eye pressure, scratch on the eye surface, eye allergy, eye discharge, increased tearing, light sensitivity.
• General side effects: shortness of breath, irregular heartbeat, dizziness, worsening of allergy symptoms, itching, rash, skin redness, nausea and hives.

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 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 Moxidrop

Keep this medicine out of the sight and reach of children.
Keep the single-dose containers in the aluminium pouch and in the outer carton to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton, bottle, and single-dose container after “Exp.”. The expiry date refers to the last day of that month.
Do not use for more than 3 months after opening the aluminium pouch.
Once opened, the contents of the single-dose container must be used immediately and must not be stored. Discard any remaining solution in the single-dose container after application.
Do not dispose of medicines 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 Moxidrop contains

• The active substance is moxifloxacin. One mL of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride, 5.45 mg). One drop of eye drops contains 160 micrograms of moxifloxacin.
• The other components are sodium chloride, boric acid, sodium hydroxide and, where applicable, hydrochloric acid for pH adjustment, and water for injections.

Description of the appearance of Moxidrop and contents of the pack
The medicine is a liquid (a clear, pale yellow solution).
A single-dose container contains 0.4 mL.
Moxidrop is available in packs containing 10 or 30 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Moxifloxacin Stulln sine 5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
Germany Moxifloxacin Stulln sine 5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
Greece MOFLOTREX UD 5 mg/ml Οφθαλμικές σταγόνες, διάλυμα σε περιέκτη μίας δόσης
Italy Moxidrop 5 mg/mL eye drops, solution
Netherlands Moxifloxacine Stulln zonder conserveermiddel 5 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik
Poland Moxifloxacinum Stulln
Spain Moxifloxacino Stulln PF 5 mg/ml eye drops, solution in single-dose container