Moxifloxacinum Misom

Package Leaflet: Information for the User

Moxifloxacinum Misom, 5 mg/ml, Eye Drops, Solution

Moxifloxacinum

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

• Keep this 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.

Contents of the Package Leaflet:

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

Moxifloxacinum Misom 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 Misom

When not to use Moxifloxacinum Misom

Warnings and precautions

Consult your doctor or pharmacist:

• If you have experienced allergic reactions to Moxifloxacinum Misom. 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 signs and symptoms of eye infection. Instead, use glasses. Do not wear contact lenses until the signs and symptoms of eye infection have resolved 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 Misom if you experience pain or swelling of the tendons.

As with any other antibiotic, long-term use of Moxifloxacinum Misom may lead to the development of other infections.

Moxifloxacinum Misom and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using Moxifloxacinum Misom eye drops.

Driving and using machines

For a short time after using Moxifloxacinum Misom, your vision may be blurred. Do not drive or operate machinery until your vision has cleared.

3. How to use Moxifloxacinum Misom

Use this medicine always 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) three times a day (morning, afternoon, and evening).

Moxifloxacinum Misom can be used in children, in patients over 65 years, and in patients with kidney and liver diseases. The use of this medicine is not recommended in newborns, as there is only limited information available on its use in these patients.

This medicine should be used in both eyes only if your doctor has recommended it.

Moxifloxacinum Misom is for ophthalmic use only.

The infection usually clears up within 5 days. If you do not see an improvement, you should contact your doctor. You should continue using the drops for a further 2-3 days or as long as your doctor recommends.

INSTRUCTIONS FOR USE

Using the three-part container for the first time:

Opening the container before first use

• 1. Before using the medicine for the first time, make sure that the protective ring between the container and the cap is not broken (fig. 1). Do not use the container if the protective ring on the neck of the container is cracked.

• 2. Before opening the container for the first time, tear off the protective ring to break the seal (fig. 2).

• 3. To open the container, remove the cap by twisting it counterclockwise (fig. 3).

• 4. After each use, tighten the container cap (fig. 4).

Using the eye drops

• 1. Wash your hands.
• 2. Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket"; the drop should fall into this pocket

• 3. Do not touch the dropper tip to the eye or eyelid, or to any other surface.This may contaminate the drops

• 4. Gently squeeze the bottom of the container to release one drop at the right time

• 5. After using Moxifloxacinum Misom, press the corner of your eye near your nose for 2-3 minutes. This will help prevent the medicine from spreading to the rest of your body, which is especially important in small children.

• 6. If using drops in both eyes, wash your hands before repeating the above steps for the other eye. This will help prevent transferring infection from one eye to the other.
• 7. Immediately after use, tighten the container If the drop does not get into the eye, try again.

If you use more Moxifloxacinum Misom than you should:rinse your eyes with warm water. Do not put in any more drops until it is time for your next dose.

If you accidentally swallow Moxifloxacinum Misom:contact your doctor or pharmacist for advice.

If you forget to use Moxifloxacinum Misom:continue using the medicine as soon as you remember, following the scheduled dosing. Do notuse a double dose to make up for the forgotten dose.

If you are using other eye drops, wait at least 5 minutes between using Moxifloxacinum Misom and other drops.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, Moxifloxacinum Misom can cause side effects, although not everybody gets them.

You can usually continue using the dropsunless 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 Moxifloxacinum Misom and tell your doctor immediately:

Moxifloxacinum Misom and seek medical attention:swelling of hands, feet, ankles, face, lips, tongue, or throat, which may cause difficulty 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, broken blood vessel in the eye, abnormal sensation in the eye, abnormalities of the eyelids, itching, redness, or swelling

General disorders:headache, unpleasant taste

Rare side effects

(may affect up to 1 in 1,000 people)

Eye disorders:corneal disease, blurred or decreased 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

Unknown 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 of side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides,

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

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moxifloxacinum Misom

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 container and carton after EXP. The expiry date refers to the last day of that month.

Store in a cool, dry place.

After first opening: Store below 25°C.

Discard the container 4 weeks after first opening.

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 Misom contains

The active substance ismoxifloxacin.

One ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride).

One drop contains 205 micrograms of moxifloxacin.

The other ingredients are:sodium chloride, boric acid, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Moxifloxacinum Misom looks like and contents of the pack

Clear, greenish-yellow solution.

5 ml in a 3-part container, consisting of a white, opaque, sterile container made of LDPE with a white, opaque, sterile dropper made of LDPE and a blue cap made of HDPE, packed in a cardboard box.

Marketing authorization holder

Misom Labs Limited

Malta Life Sciences Park,

LS2.01.06, Industrial Estate,

San Gwann, SGN 3000, Malta

Tel: +45 40 55 15 65

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 authorized in EU member states under the following names:

Czech Republic: Moxifloxacin Misom

Poland: Moxifloxacinum Misom

Romania: Moxifloxacină Misom 5 mg/ml picături oftalmice, soluţie

Date of revision of the leaflet: MM/YYYY