ABIMOX 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

ABIMOX 5 mg/ml Eye Drops Solution

moxifloxacin

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Abimox and what is it used for
2. What you need to know before using Abimox
3. How to use Abimox
4. Possible side effects
5. Storage of Abimox

Contents of the pack and further information

1. What is Abimox and what is it used for

Abimox eye drops are used to treat eye infections (conjunctivitis) caused by bacteria. The active ingredient is moxifloxacin, an ophthalmic anti-infective.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

2. What you need to know before using Abimox

Do not use Abimox

• if you are allergic (hypersensitive) to moxifloxacin, other quinolones (a type of antibiotic), or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist:

• if you experience an allergic reaction to Abimox. Allergic reactions are rare and severe reactions are very rare. If you experience any allergic reaction (hypersensitivity) or side effect, see section 4.
• if you use contact lenses - if you experience signs or symptoms of an eye infection, stop using contact lenses and wear glasses. Do not use contact lenses until the signs and symptoms of infection have resolved and you have finished using the medicine.
• Tendon inflammation and rupture have been observed in people using oral or intravenous fluoroquinolones, especially in older patients and those treated concomitantly with corticosteroids. Discontinue Abimox treatment if you experience pain or inflammation of the tendons (tendinitis).

As with any antibiotic, long-term use of Abimox may lead to other infections.

Using other medicines with Abimox

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

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

Driving and using machines

You may experience blurred vision immediately after using Abimox. Do not drive or use machines until these effects have disappeared.

3. How to use Abimox

Follow your doctor's or pharmacist's instructions for administering this medicine exactly. If in doubt, consult your doctor or pharmacist again.

Abimox should only be used for applying drops to the eyes.

The recommended dose is:

Adults, including elderly patients and children: 1 dropin the affected eye(s), 3 times a day(morning, afternoon, and evening).

Abimox should only be applied to both eyes if your doctor has recommended it.

Abimox can be used in children, patients over 65 years old, and patients with kidney or liver problems. Information on the use of this medicine in newborns is very limited, and its use is not recommended in these patients.

The infection usually improves within 5 days. If you do not see an improvement, consult your doctor. You should continue using the drops for 2-3 days more or for the entire period indicated by your doctor.

How to use this medicine

• Take the Abimox bottle and stand in front of a mirror.
• Wash your hands.
• Remove the cap.
• Hold the bottle, upside down, between your thumb and index finger.
• Tilt your head back. Gently separate the eyelid from the eye with one finger, forming a pouch where the drop should fall (figure 1).
• Bring the tip of the bottle close to the eye. Use the mirror if it helps.
• Do not touch the eye, eyelid, or surrounding areas with the dropperas the drops may become infected.
• Gently press the base of the bottle to release one drop of medicine at a time (figure 2).
• Do not squeeze the bottle: it is designed so that gentle pressure on the base of the bottle is sufficient (figure 2).
• After using Abimox, press the edge of the eye, next to the nose, with your finger for 2-3 minutes (figure 3). This helps prevent Abimox from entering the rest of the body and is important in small children.
• If you apply drops to both eyes, wash your hands before repeating the above steps for the other eye. This prevents the spread of infection from one eye to the other.
• Close the bottle tightly immediately after use.
• Use one bottle completely before opening the next bottle.

If a drop falls outside the eye, try again.

If you have applied more medicine than you should

You can remove it by rinsing your eyes with warm water. Do not apply more drops until it is time for the next dose.

If you accidentally swallow Abimox

Contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Abimox

Continue with the next scheduled dose. Do notapply a double dose to make up for the missed dose.

If you are using other eye drops

Wait at least 5 minutes between applying Abimox and other eye drops.

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

4. Possible side effects

Like all medicines, Abimox can cause side effects, although not everyone gets them.

Unless the effects are severe or you experience a severe allergic reaction, continue with the treatment as usual.

If you experience a severe allergic reaction and any of the following symptoms appear:swelling of the hands, feet, ankles, face, lips, mouth, or throat that may cause difficulty swallowing or breathing, rash or hives, large fluid-filled blisters, wounds, and ulcers, stop using Abimox immediately and contact your doctor immediately.

Frequent:May affect up to 1 in 10 patients

Eye effects:eye pain, eye irritation

Uncommon:May affect up to 1 in 100 patients

Eye effects:dry eye, eye itching, eye redness, inflammation or scarring of the eye surface, rupture of a blood vessel in the eye, abnormal sensation in the eye, abnormality, itching, redness, or swelling of the eyelid.

General side effects:headache and bad taste

Rare:May affect up to 1 in 1,000 people

Eye effects:corneal disorder, blurred or reduced vision, conjunctival inflammation or infection, eye fatigue, eye swelling

General side effects:vomiting, nose discomfort, sensation of a lump in the throat, decreased iron in the blood, abnormal liver function test values, abnormal sensation on the skin, pain, throat irritation

Frequency not known:cannot be estimated from the available data

Eye effects:eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased pressure in the eye, scratching of the eye surface, eye allergy, eye discharge, increased tear production, sensitivity to light.

General side effects:shortness of breath, irregular heartbeat, dizziness, increased allergic symptoms, itching, rash, redness of the skin, nausea, and hives.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abimox

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the bottle and carton after "EXP.". The expiration date refers to the last day of the month indicated.

This medicine does not require special storage conditions.

To avoid infections, discard the bottle 4 weeks after first opening. Write the opening date of the bottle in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Abimox

• The active ingredient is moxifloxacin.

1 mL of solution contains 5 mg of moxifloxacin (as moxifloxacino hydrochloride 5.45 mg).

One drop of eye drops contains 190 micrograms of moxifloxacin.

• The other ingredients are boric acid, sodium chloride, sodium hydroxide for pH adjustment, and water for injections.

Appearance and packaging of the product

This medicine is a liquid (a clear, yellow-green solution) that comes in a carton containing a 5 mL plastic bottle with a screw cap.

Marketing authorization holder and manufacturer

Marketing authorization holder

TIEDRA FARMACÉUTICA, S.L.

C/ Colón, 7

30510 Yecla (Murcia)

Spain

Manufacturer

PHARMATHEN S.A.

Dervenakion 6

15351 Pallini

Attikis

Greece

FAMAR S.A.

Plant A

Agiou Dimitriou Street 63

174 56 Alimos

Athens

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:Moxifloxacin/Pharmathen 5mg/ml Eye drops, solution

Spain:Abimox 5 mg/ml colirio en solución

Greece:Tamvelier 5mg/ml Eye drops, solution

Date of the last revision of this package leaflet:November2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es