Label: information for the user

ABIMOX 5 mg/ml eye drops in solution

moxifloxacino

Read the entire label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

Contents of the package and additional information

Abimox eye drops are used for the treatment of eye infections (conjunctivitis) caused by bacteria. The active ingredient is moxifloxacino, an ophthalmic antiinfective.

Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

Do not use Abimox

• if you are allergic (hypersensitive) to moxifloxacino, to other quinolonas (a certain type of antibiotics), or to any of the other components of this medication(listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist:

• if you experience an allergic reaction to Abimox. Allergic reactions occur infrequently and severe reactions rarely. If you experience any allergic reaction (hypersensitivity) or any adverse effect, consult section 4.
• if you use contact lenses–if you present signs or symptoms of an eye infection stop using contact lenses anduseglasses. Do not use contact lenses until the signs and symptoms of infection have resolved and the medication has been completed.
• Tendinitis and tendon rupture have been observed in people who use oral or intravenous fluoroquinolones, especially in older patients and those treated concomitantly with corticosteroids. Discontinue Abimox treatment if you experience tendon pain or inflammation.

Like any antibiotic,theuse ofAbimoxfor a long timemay lead to other infections.

Use of other medications with Abimox

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You may experience blurred vision after using Abimox. Do not drive or operate machinery until these effects have resolved.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Abimox should only be used to apply drops in the eyes.

The recommended dose is:

Adults, including elderly patients and children:1 dropin the affected eye or eyes,3 times a day(in the morning, in the afternoon, and at night).

This medication should only be applied in both eyes if your doctor has recommended it.

Abimox can be used in children, in patients over 65 years old, and in patients with kidney or liver problems. The information on the use of this medication in newborns is very limited, and therefore it is not recommended for use in these patients.

Normally, the infection improves in 5 days. If you do not observe improvement, consult your doctor. You should continue using the drops for 2-3 days more or for the entire period of time indicated by your doctor.

Howtousethismedication

• 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 andforefinger.
• Incline your head backward. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall(figure 1).
• Bring the tip of the bottle close to your eye. Use the mirror if it helps.
• Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropperbecause the drops could become infected.
• Press gently the base of the bottle so that a drop of medication falls each time(figure 2).
• Do not squeeze the bottle: it is designed so that a gentle pressure on the base of the bottle is enough (figure 2).
• After using Abimox, press with your finger the edge of your eye, next to your nose for 2-3 minutes(figure 3). This helps to prevent Abimox from passing to the rest of the body, and it is important in young children.
• If drops are applied in both eyes,wash your hands before repeating the above points for the other eyeto prevent the spread of infection from one eye to the other.
• Close the bottle tightly immediately after using the product.
• Use up one bottle completely before opening the next bottle.

If a drop falls outside the eye, try again.

If more medication than necessary has been applied

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 Abimox is accidentallyswallowed

Contact your doctor or pharmacist.

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

If you forgot to use Abimox

Continue with the next dose that was scheduled.Do notapply a double dose to compensate for the missed dose.

If you are using other eye drops

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Unless the side effects are severe or you suffer a severe allergic reaction, continue with the treatment as normal.

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 urticaria, large blisters filled with fluid, wounds, and ulceration,stop using Abimox immediately and contact your doctor immediately.

Frequent:May affect up to 1 in 10 patients

Eye effects:eye pain, eye irritation

Occasional:May affectup 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 in 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, ocular swelling

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

Frequency not known:cannot be estimatedfrom the available data

Eye effects:eye infection, eye surface clouding, corneal edema, deposits on the eye surface, increased eye pressure, scratch on the eye surface, ocular allergy, eye secretion, increased tear production, light sensitivity.

General side effects:shortness of breath, irregular heart rhythm, dizziness, increased allergic symptoms, itching, rash, skin redness, nausea, and urticaria.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD.” The expiration date corresponds to the last day of the month indicated.

This medication does not require special storage conditions.

To prevent infections, discard the bottle 4 weeks after the first opening.Write the opening date of the bottle in the space provided for this purpose in the case.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Abimox

• The active principle is moxifloxacino.

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

One drop of eye drops contains 190 micrograms of moxifloxacino.

• The other components are boric acid, sodium chloride, sodium hydroxide for pH adjustment and water for injection preparations.

Appearance of the product and contents of the packaging

This medicine is a liquid (a transparent, yellowish-green solution) that is presented in a box containing a 5 mL plastic vial with a screw cap.

Holder of the marketing authorization and responsible forthemanufacturing

Holder of the marketing authorization

TIEDRA FARMACÉUTICA, S.L.

C/ Colón, 7

30510 Yecla (Murcia)

Spain

Responsible forthemanufacturing

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 with the following names:

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

Spain:Abimox 5 mg/ml eye drops in solution

Greece:Tamvelier 5mg/ml Eye drops, solution

Date of the last review of this leaflet:November2019

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