Moxifloxacinum stulln

Package leaflet: Information for the user

Moxifloxacinum Stulln, 5 mg/ml, eye drops, solution
Moxifloxacinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Moxifloxacinum Stulln is and what it is used for

Moxifloxacinum Stulln eye drops are used to treat bacterial eye infections (conjunctivitis). The active substance is moxifloxacin, an ophthalmic anti-infective agent.

2. Important information before using Moxifloxacinum Stulln

When not to use Moxifloxacinum Stulln:

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

Warnings and precautions
Before starting treatment with Moxifloxacinum Stulln, consult a doctor or pharmacist if:

• The patient has experienced allergic reactions to moxifloxacin. Allergic reactions occur not frequently, and serious allergic reactions are rare. If any allergic reactions (hypersensitivity reactions) or other adverse effects occur, follow the recommendations given in section 4.
• The patient wears contact lenses – they should discontinue their use when experiencing subjective or objective symptoms of eye infection. Glasses should be used instead. Contact lenses should not be worn until subjective and objective symptoms of eye infection have resolved and treatment with the medicine has been completed.
• Cases of tendon swelling and tendon rupture have been reported in patients receiving oral or intravenous fluoroquinolones, particularly in elderly patients and those concurrently treated with corticosteroids. Treatment with Moxifloxacinum Stulln should be discontinued if the patient experiences tendon pain or swelling.

As with any other antibiotic, prolonged use of Moxifloxacinum Stulln may lead to development of other infections.

Moxifloxacinum Stulln and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Vision may be blurred for a short time after instilling Moxifloxacinum Stulln. Driving vehicles or operating machinery should be avoided until vision returns to normal.

3. How to use Moxifloxacinum Stulln

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults, including elderly individuals, and children: 1 drop into the affected eye or eyes, 3 times
daily (morning, afternoon, and evening).
Moxifloxacinum Stulln may be used in children, in patients over 65 years of age, and in
patients with kidney or liver disease. This medicine is not recommended for newborns,
as there is only very limited information available on its use in this patient group.
Method of administration
Moxifloxacinum Stulln is intended for ocular instillation only. This medicine should be
administered to both eyes only if specifically instructed by a doctor.

Figure 1 Figure 2 Figure 3

• Prepare the Moxifloxacinum Stulln bottle and a mirror.
• Wash your hands.
• Unscrew the cap.
• If the safety collar is loose after removing the cap, remove it before using the medicine.
• Hold the inverted bottle between the thumb and middle finger.
• Tilt the head backward. With a clean finger, gently pull down the lower eyelid to form a “pocket” between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 1).
• Bring the dropper tip close to the eye. A mirror may be used to assist.
• Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This may lead to contamination of the drops.
• Gently squeeze the bottle to release a single drop of medicine at the appropriate moment (Figure 2).
• After instilling Moxifloxacinum Stulln, press with a finger on the inner corner of the eye near the nose for 2–3 minutes (Figure 3). This helps prevent the medicine from draining into the systemic circulation and is particularly important in small children.
• If administering drops to both eyes, wash your hands before repeating the above procedure for the second eye. This helps prevent transferring infection from one eye to the other.
• Immediately after use, recap the bottle tightly.

If the drop misses the eye, repeat the instillation attempt.
Accidental overdose of Moxifloxacinum Stulln: rinse the eyes with warm water. Do not
administer additional drops until the next scheduled dose.
In case of accidental ingestion of Moxifloxacinum Stulln, consult a doctor or pharmacist
for advice.
Missed dose of Moxifloxacinum Stulln: continue using the medicine as scheduled with the
next dose. Do not use a double dose to make up for a missed dose.
If the patient is using other eye drops, an interval of at least 5 minutes should be maintained
between instillation of Moxifloxacinum Stulln and other eye drops. Ointments should be used last.
Duration of treatment
Improvement usually occurs within 5 days. If no improvement is observed, consult a doctor.
Continue using the drops for an additional 2 to 3 days, or as long as directed by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Usually, you may continue using the drops unless the adverse reactions are severe or
the patient experiences serious allergic reactions.
If the patient experiences a severe allergic reaction or any of the symptoms listed below,
stop using Moxifloxacinum Stulln immediately and seek medical help without delay:
swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, rash or hives, large fluid-filled blisters, sores or ulcers.

Common adverse reactions (may occur in less than 1 out of 10 people)

• Eye-related reactions: eye pain, eye irritation

Uncommon adverse reactions (may occur in less than 1 out of 100 people)

• Eye-related reactions: dry eye, itchy eye, red eye, surface eye inflammation or scarring, broken blood vessel in the eye, abnormal sensation in the eye, eyelid disorders, itching, redness or swelling of the eye
• General reactions: headache, unpleasant taste in the mouth

Rare adverse reactions (may occur in less than 1 out of 1,000 people)

• Eye-related reactions: corneal disorder, blurred or limited vision, conjunctivitis or eye infection, eye strain, eye swelling
• General reactions: vomiting, nasal discomfort, sensation of a lump in the throat, decreased blood iron concentration, abnormal liver test results, skin sensation disorders, pain, throat irritation

Frequency not known (frequency cannot be estimated from the available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Moxifloxacinum Stulln

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
bottle after: EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Do not use for more than 4 weeks after first opening the bottle. This is intended to prevent
infections.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the
environment.

6. Contents of the package and other information

What Moxifloxacinum Stulln contains

• The active substance is moxifloxacin. 1 ml of solution contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride 5.45 mg). One drop contains 210 micrograms of moxifloxacin.
• The other ingredients are: sodium chloride, boric acid, sodium hydroxide, and, if necessary, hydrochloric acid, concentrated (to adjust pH), and water for injections.

What Moxifloxacinum Stulln looks like and contents of the pack
Moxifloxacinum Stulln is a liquid (a clear, light yellow solution) supplied in a transparent plastic bottle with a dropper and a screw cap.
Each bottle contains 3 ml or 5 ml of eye drops solution.
Pack sizes: carton containing 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln, Bavaria
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Moxifloxacin Stulln
Germany Moxifloxacin Stulln
Greece MOFLOTREX
Italy Omnimoxa
Netherlands Moxifloxacine Stulln
Poland Moxifloxacinum Stulln
Spain Omnimoxa