Moxifloxacin misom

Package leaflet: Information for the user

Moxifloxacinum Misom, 5 mg/ml, eye drops, solution
Moxifloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Moxifloxacinum Misom eye drops are used to treat bacterial eye infections (conjunctivitis). The active substance is moxifloxacin, an ophthalmic antibacterial agent.

2. Important information before using the medicine Moxifloxacinum Misom

When not to use the medicine Moxifloxacinum Misom

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

Warnings and precautions
Consult a doctor or pharmacist:

• If the patient experiences allergic reactions to Moxifloxacinum Misom. Allergic reactions occur not commonly, and severe allergic reactions occur rarely. In case of any allergic (hypersensitivity) reactions or any other adverse effects, follow the recommendations given in section 4.
• If the patient wears contact lenses – they should stop using them when objective and subjective symptoms of eye infection occur. Glasses should be used instead. Contact lenses should not be worn until the objective and subjective symptoms of eye infection have resolved and until completion of treatment with the medicine.
• Tendon swelling and tendon rupture have been reported in patients receiving systemic fluoroquinolones orally or intravenously, particularly in elderly patients and in those receiving concomitant corticosteroid therapy. Treatment with Moxifloxacinum Misom should be discontinued if the patient experiences tendon pain or swelling.

As with any other antibiotic, prolonged use of the medicine
Moxifloxacinum Misom may lead to overgrowth of other pathogens causing additional infections.
Moxifloxacinum Misom and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using Moxifloxacinum Misom eye drops.
Driving and operating machinery
Vision may be blurred for a short time after instillation of Moxifloxacinum Misom eye drops. Until vision clears, the patient must not drive or operate machinery.

3. How to use Moxifloxacinum Misom

This medicine should always be used 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, three times
daily (morning, afternoon, and evening).
Moxifloxacinum Misom 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 very limited information available on its use in these patients.
This medicine should be administered to both eyes only if specifically instructed by a doctor.
Moxifloxacinum Misom is intended exclusively for instillation into the eyes.
Infection usually resolves within 5 days. If the patient does not observe improvement, they should contact their doctor. Treatment with eye drops should continue for an additional 2–3 days, or as long as directed by the doctor.

INSTRUCTIONS FOR USE
Using the three-part container for the first time:
Opening the container before first use

1. Before first use of the medicine, ensure that the tamper-evident ring between the container and cap has not been broken (Fig. 1). Do not use the container if the tamper-evident ring on the neck of the container is broken.

2. Before first opening the container, remove the tamper-evident ring to break the seal (Fig. 2).

3. To open the container, unscrew the cap by turning it counterclockwise (Fig. 3).

4. After each use, securely replace the cap on the container (Fig. 4).

Applying eye drops

1. Wash your hands.
2. Tilt your head backward. With a clean finger, gently pull down the lower eyelid to form a "pocket"; the drop should be instilled into this pocket.

3. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may lead to contamination of the drops.

4. Gently squeeze the bottom of the container to release a single drop of the medicine at the appropriate moment.

5. After instilling Moxifloxacinum Misom, press gently with a finger on the inner corner of the eye near the nose for 2–3 minutes. This helps prevent the medicine from being absorbed systemically and is particularly important in young children.

6. If drops are being administered to both eyes, wash your hands before repeating the procedure described above for the second eye. This helps prevent the spread of infection from one eye to the other.
7. Immediately after use, tightly replace the cap on the container. If the drop misses the eye, repeat the instillation attempt.

Use of more than the recommended dose of Moxifloxacinum Misom: rinse the eyes with warm water. Do not administer further drops until the next scheduled dose.
If Moxifloxacinum Misom is accidentally swallowed, consult a doctor or pharmacist for advice.
If a dose of Moxifloxacinum Misom is missed: continue treatment as prescribed, administering the next dose at the scheduled time. 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 Misom and other eye drops.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Usually, you may continue using the drops unless the adverse reactions are severe or
the patient does not experience serious allergic reactions.
If the patient experiences a severe allergic reaction or any of the symptoms listed below,
stop using Moxifloxacinum Misom immediately and inform a doctor 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 affect up to 1 in 10 people)
Eye-related reactions: eye pain, eye irritation

Uncommon adverse reactions
(may affect up to 1 in 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 affect up to 1 in 1,000 people)
Eye-related reactions: corneal disease, blurred or reduced vision, conjunctivitis or eye infection, eye fatigue, eye swelling
General reactions: vomiting, nasal discomfort, sensation of lumps in the throat, decreased iron concentration in blood, abnormal liver test results, skin sensation disturbances, pain, throat irritation

Unknown frequency
(frequency cannot be estimated from available data)
Eye-related reactions: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased intraocular pressure, corneal abrasion, eye allergy, eye discharge, increased tear production, photophobia
General reactions: shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, skin redness, nausea, and urticaria.

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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Moxifloxacinum Misom

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container and carton,
after EXP. The expiry date refers to the last day of the stated month.
Unopened: No special storage precautions required.
After first opening of the container: the medicine should be stored at a temperature below 25°C.
To prevent infections, the container should be discarded 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Moxifloxacinum Misom contains
The active substance is moxifloxacin.
Each 1 ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride).
Each drop of eye drops contains 205 micrograms of moxifloxacin.
The other ingredients are: sodium chloride, boric acid, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment), and water for injections.

What Moxifloxacinum Misom looks like and contents of the pack
A clear, yellowish-green solution. 5 ml in a three-part container with a nominal capacity of 5 ml, consisting of a white, opaque, sterile container made of LDPE, a white, opaque, sterile dropper made of LDPE, and a blue cap made of HDPE, packed in a cardboard box.

Marketing Authorisation Holder
Brown & Burk IR Limited
22 Northumberland Road,
Ballsbridge, Dublin 4, Ireland

Importer
Eurofins Analytical Services Hungary Kft.
Anonymus utca 6
1045 Budapest
Hungary

Misom Labs Limited
Malta Life Sciences Park,
LS2.01.06, Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product has been authorised in the following EU Member States under the following names:
Czech Republic: Moxifloxacin Misom
Poland: Moxifloxacinum Misom
Romania: Moxifloxacină Misom 5 mg/ml eye drops, solution