Moxifloxacinum Stulln

Package Leaflet: Information for the User

Moxifloxacinum Stulln, 5 mg/ml, Eye Drops, Solution in a Single-Dose Container

Moxifloxacinum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

2. Important information before using Moxifloxacinum Stulln

When not to use Moxifloxacinum Stulln:

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

Warnings and precautions

Before starting to use Moxifloxacinum Stulln, discuss with your doctor or pharmacist if:

• If you have experienced allergic reactions to moxifloxacin. Allergic reactions occur not very often, and serious allergic reactions occur rarely. If you experience any allergic reactions (hypersensitivity) or any other side effects, follow the instructions in section 4.
• If you wear contact lenses- you should stop wearing them when you have symptoms of eye infection. Instead, use glasses. Do not wear contact lenses until the symptoms of eye infection have disappeared and you have finished using the medicine.
• In patients receiving fluoroquinolones orally or intravenously, there have been reports of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids at the same time. You should stop using Moxifloxacinum Stulln if you experience pain or swelling of the tendons. Like any other antibiotic, long-term use of Moxifloxacinum Stulln may lead to the development of other infections.

Moxifloxacinum Stulln and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

For a short time after using Moxifloxacinum Stulln, your vision may be blurred. Do not drive or use machines until your vision is clear.

3. How to use Moxifloxacinum Stulln

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Adults, including the elderly and children: 1 drop into the affected eye(s), 3 times

a day(morning, afternoon, and evening).
Moxifloxacinum Stulln can be used in children, in patients over 65 years of age, and in patients with kidney or liver disease. The use of this medicine is not recommended in newborns, as there is only limited information available on its use in these patients.

Method of administration

Moxifloxacinum Stulln is intended for eye use only. This medicine should be used in both eyes only if your doctor has told you to do so.

Figure 1	Figure 2	Figure 3	Figure 4

1. Wash your hands.

• 2. Remove one strip of single-dose containers from the aluminum sachet and separate one single-dose container (Figure 1).
• 3. Open the single-dose container by twisting off the top (Figure 2).
• 4. Tilt your head back slightly, look up, and pull the lower eyelid down.
• 5. Place one drop in the lower conjunctival sac, gently squeezing the lower part of the container (Figure 3).
• 6. Close your eyes slowly and press the corner of your eye near your nose for 2-3 minutes with your finger. This will prevent the drop from entering the tear duct and most of the drop will remain in the eye (Figure 4).
• 7. Discard the single-dose container after use.
• 8. Put the remaining single-dose containers back and close the sachet, folding the edge. Put the sachet in the carton. If there are any single-dose containers left after 3 months from opening the sachet, they should be discarded in a safe manner.

The contents of the single-dose container are sufficient for administration to both eyes.
Do not touch the eye, eyelid, or surrounding area. This may lead to contamination of the drops.
This may lead to contamination of the drops, wash your hands before repeating steps 1-6
for the second eye. This will help prevent the transfer of infection from one eye to the other.
Use a new single-dose container for each application.
If the drop does not get into the eye, repeat the attempt to administer the drop.
Using more than the recommended dose of Moxifloxacinum Stulln:rinse your eyes with warm water. Do not administer more medicine until the next scheduled dose.
If you accidentally swallow Moxifloxacinum Stulln, consult your doctor or pharmacist for advice.
Missing a dose of Moxifloxacinum Stulln:continue using the medicine, administering the next dose according to the planned dosing schedule. Do notuse a double dose to make up for the missed dose.
If you are using other eye drops, wait at least 5 minutes between administering Moxifloxacinum Stulln and other eye drops. Apply eye ointments last.

Duration of treatment

Improvement usually occurs within 5 days. If there is no improvement, consult your doctor. Continue using the drops for another 2 to 3 days or as long as your doctor has told you to.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue using the drops, unless the side effects are serious or if you experience severe allergic reactions.

If you experience a severe allergic reaction or any of the following symptoms, stop using the medicine immediately and seek medical attention:

Moxifloxacinum Stulln:swelling of hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, rash or hives, large blisters, sores or ulcers.
Common side effects(may affect up to 1 in 10 people)

• Eye disorders:eye pain, eye irritation

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

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

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

• Eye disorders:corneal disease, blurred or impaired vision, conjunctivitis, eye strain, eye swelling
• General disorders:vomiting, discomfort in the nose, feeling of lumps in the throat, decreased iron levels in the blood, abnormal liver test results, skin sensation disorders, pain, throat irritation

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moxifloxacinum Stulln

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, sachet, and single-dose container after: EXP. The expiry date refers to the last day of the month.
Store the single-dose containers in the aluminum sachet and outer carton to protect from light.
Do not use for more than 3 months after opening the aluminum sachet.
After opening, the contents of the single-dose container must be used immediately and cannot be stored. After application, discard the remaining solution in the single-dose container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 applicable, hydrochloric acid (to adjust the pH) and water for injections.

What Moxifloxacinum Stulln looks like and contents of the pack

The medicine is a liquid (clear, pale yellow solution).
A single-dose container made of LDPE containing 0.4 ml of solution, in a carton.
Moxifloxacinum Stulln is available in packs containing 10 or 30 single-dose containers.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharma Stulln GmbH

Werksstrasse 3
92551 Stulln, Bavaria
Germany

This medicine is authorized 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

Date of last revision of the package leaflet: