Moxifloxacinum Stulln

Leaflet attached to the packaging: information for the user

Moxifloxacinum Stulln, 5 mg/ml, eye drops, solution

Moxifloxacinum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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.

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 to use Moxifloxacinum Stulln, the patient should discuss it with their doctor or pharmacist if:

• If the patient has experienced allergic reactions to moxifloxacin. Allergic reactions occur not very often, and serious allergic reactions occur rarely. If any allergic reactions (hypersensitivity) or any other side effects occur, the patient should follow the instructions given in section 4.
• 4.
• If the patient uses contact lenses- they should stop using them when they experience symptoms of eye infection. Instead, they should wear glasses. The patient should not wear contact lenses until the symptoms of the eye infection have resolved and the use of the medicine has been completed.
• In patients receiving fluoroquinolones orally or intravenously, there have been cases of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids at the same time. The patient should stop using Moxifloxacinum Stulln if they 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

For a short time after using Moxifloxacinum Stulln, vision may be blurred. The patient should not drive or operate machinery until their vision has cleared.

3. How to use Moxifloxacinum Stulln

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is unsure, they should ask their 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 for ocular use only. This medicine should be used in both eyes only if the doctor has prescribed it.

Figure 1
Figure 2
Figure 3

• Prepare the Moxifloxacinum Stulln bottle and a mirror.
• Wash your hands.
• Remove the cap.
• If the protective collar is loose after removing the cap, it should be removed before using the medicine.
• Hold the inverted bottle between the thumb and middle finger.
• Tilt the head back. With a clean finger, pull the lower eyelid down to create a "pocket"; the drop should fall into it (Figure 1).
• Bring the tip of the bottle close to the eye. For ease of use, a mirror can be used.
• Do not touch the dropper to the eye or eyelid, or surrounding areas.This may lead to contamination of the drops.
• Gently squeeze the bottle to release a single drop of medicine (Figure 2).
• After using Moxifloxacinum Stulln, press the corner of the eye near the nose for 2-3 minutes (Figure 3). This will help prevent the medicine from entering the entire body, which is especially important in small children.
• If using drops in both eyes, wash your hands before repeating the above steps for the second eye. This will help prevent the transfer of infection from one eye to the other.
• Immediately after use, replace the cap on the bottle.

If the drop does not get into the eye, try again.
If more than the recommended dose of Moxifloxacinum Stulln is used:rinse the eyes with warm water. Do not use more drops until the next normal dose is due.
If Moxifloxacinum Stulln is accidentally ingested, consult a doctor or pharmacist for advice.
If a dose of Moxifloxacinum Stulln is missed:continue using the medicine, giving the next dose at the scheduled time. Do notuse a double dose to make up for a missed dose.
If the patient is using other eye drops, they should leave a 5-minute interval between using Moxifloxacinum Stulln and other drops. Eye ointments should be used last.

Duration of treatment

Improvement usually occurs within 5 days. If there is no improvement, the patient should contact their doctor. The patient should continue using the drops for a further 2 to 3 days or as long as the doctor has advised.

If the patient has any further questions about using this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Moxifloxacinum Stulln can cause side effects, although not everybody gets them.
It is usually possible to continue using the drops, provided the side effects are not serious or if the patient does not experience severe allergic reactions.

If the patient experiences a severe allergic reaction or any of the following symptoms, they should stop using the medicine immediately and seek medical help:

Moxifloxacinum Stulln:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing, rash or urticaria, large blisters, wounds, 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, rupture of a blood vessel in the eye, abnormal sensation in the eye, abnormalities of the eyelids, 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, inflammation or infection of the conjunctiva, eye strain, eye swelling
• General disorders:vomiting, feeling of 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 urticaria

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to 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, more information can be gathered on the safety of the medicine.

5. How to store Moxifloxacinum Stulln

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from light.
Do not use for more than 4 weeks after first opening the bottle. This is to prevent infections.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 210 micrograms of moxifloxacin.
• The other ingredients are: sodium chloride, boric acid, sodium hydroxide, and, if applicable, hydrochloric acid (for pH adjustment) and water for injections.

What Moxifloxacinum Stulln looks like and contents of the pack

The medicine is a liquid (clear, pale yellow solution) supplied in a clear plastic bottle with a dropper and 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Austria
Moxifloxacin Stulln
Germany
Moxifloxacin Stulln
Greece
MOFLOTREX
Italy
Omnimoxa
Netherlands
Moxifloxacine Stulln
Poland
Moxifloxacinum Stulln
Spain
Omnimoxa

Date of last revision of the leaflet: 02/2023