Moxifloxacin stulln

Package leaflet: Information for the user

Moxifloxacinum Stulln, 5 mg/ml, eye drops, solution in a single-dose container
Moxifloxacinum
Please read this 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 questions, 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

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 package 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 antibacterial 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 your doctor or
pharmacist if:

• If the patient has experienced allergic reactions to moxifloxacin. Allergic reactions occur not commonly, and serious allergic reactions are rare. If any allergic reactions (hypersensitivity reactions) or other adverse effects occur, follow the recommendations given in section 4.
• If the patient wears contact lenses – they should discontinue their use when experiencing subjective and 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
For a short time after instillation of Moxifloxacinum Stulln, vision may be blurred. Until vision clears, the patient must not drive or operate machinery.

3. How to use Moxifloxacinum Stulln

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

Figure 1	Figure 2	Figure 3	Figure 4

1. Wash your hands.

2. Remove one strip of single-dose containers from the aluminum foil pouch and separate one single-dose container (Figure 1).
3. Open the single-dose container by unscrewing the top part (Figure 2).
4. Tilt your head slightly backward, look upward, and gently pull down the lower eyelid.
5. Place one drop into the lower conjunctival sac by gently squeezing the bottom part of the container (Figure 3).
6. Close your eyes slowly and press with your finger on the inner corner of the eye near the nose for 2–3 minutes. This prevents the drop from draining through the tear duct into the throat, ensuring most of the medication remains in the eye (Figure 4).
7. Dispose of the single-dose container after use.
8. Return the remaining single-dose containers to the pouch and close it by folding the edge. Place the pouch back into the carton. If any containers remain 3 months after opening the pouch, they should be safely discarded.

The contents of one single-dose container are sufficient to administer the medication to both eyes.
Do not touch the eye, eyelid, surrounding areas, or any other surfaces. This may lead to contamination
of the drops.
This may lead to contamination of the drops; you must wash your hands before repeating steps 1–6
for the second eye. This helps prevent the spread of infection from one eye to the other.
Use a new single-dose container for each administration.
If the drop misses the eye, repeat the instillation attempt.
Overdose of Moxifloxacinum Stulln eye drops: 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 physician or pharmacist for advice.
If a dose of Moxifloxacinum Stulln is missed: continue treatment by administering the next dose as scheduled. Do not administer a double dose to make up for the missed dose.
If the patient is using other eye drops, a minimum interval of 5 minutes should be maintained between instillation of Moxifloxacinum Stulln and other eye drops. Eye ointments should be used last.
Duration of treatment
Improvement usually occurs within 5 days. If no improvement is observed, contact your physician. Continue using the drops for an additional 2 to 3 days, or as long as directed by the physician.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Usually, you may continue using the drops unless the adverse reactions are serious or
the patient does not experience severe 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 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 in 10 people)

• Eye-related reactions: eye pain, eye irritation

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

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

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

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

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

• Eye-related reactions: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased intraocular pressure, scratch on the eye surface, eye allergy, eye discharge, increased tear production, photophobia (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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 the 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, sachet, and single-dose container after: EXP. The expiry date refers to the last day of the stated month.
Store single-dose containers in the aluminum sachet and outer box to protect from light.
Do not use more than 3 months after first opening the aluminum sachet.
After opening, the contents of the single-dose container must be used immediately and must not be stored. After administration, any remaining solution in the single-dose container 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.

6. Contents of the pack 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 160 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).
Single-dose container made of LDPE containing 0.4 ml of solution, in a cardboard box.
Moxifloxacinum Stulln 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, Bavaria
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Moxifloxacin Stulln sine
Germany Moxifloxacin Stulln sine
Greece MOFLOTREX UD
Italy Moxivision monodose
Netherlands Moxifloxacine Stulln zonder conserveermiddel
Poland Moxifloxacinum Stulln
Spain Moxifloxacino Stulln PF