Abimox 5 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ABIMOX 5 mg/ml eye drops, solution
moxifloxacin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet
- What Abimox is and what it is used for
- What you need to know before using Abimox
- How to use Abimox
- Possible side effects
- How to store Abimox
Contents of the pack and other information
1. What Abimox is and what it is used for
Abimox eye drops are used to treat bacterial eye infections (conjunctivitis). The active substance is moxifloxacin, an ophthalmic anti-infective.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
2. What you need to know before starting to use Abimox
Do not use Abimox
- if you are allergic (hypersensitive) to moxifloxacin, to other quinolones (a certain type of antibiotics), or to 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 occur infrequently and serious reactions are rare. If you experience any allergic reaction (hypersensitivity) or any adverse effect, refer to section 4.
- if you wear contact lenses – if you develop signs or symptoms of an eye infection, stop using contact lenses and use glasses instead. Do not use contact lenses until signs and symptoms of infection have resolved and you have completed treatment with the medicine.
- Tendon inflammation and tendon rupture have been observed in people taking oral or intravenous fluoroquinolones, especially in elderly patients and in those receiving concomitant corticosteroid therapy. Discontinue treatment with Abimox if you experience tendon pain or inflammation (tendinitis).
As with any antibiotic, prolonged use of Abimox may lead to other infections.
Use of other medicines with Abimox
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and use of machines
You may experience blurred vision shortly after using Abimox. Do not drive or operate machinery until these effects have disappeared.
3. How to use Abimox
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Abimox is intended only for instillation into the eyes as eye drops.
Recommended dose:
Adults, including elderly patients and children: 1 drop in the affected eye(s), 3 times daily (morning, afternoon, and evening).
This medicine should be applied to both eyes only if your doctor has specifically instructed you to do so.
Abimox can be used in children, in patients over 65 years of age, and in patients with kidney or liver problems. Information on the use of this medicine in newborns is very limited, and therefore its use is not recommended in these patients.
The infection usually improves within 5 days. If you do not notice improvement, consult your doctor. You should continue using the drops for an additional 2–3 days or for the entire duration prescribed by your doctor.
How to use this medicine
- Take the Abimox bottle and position yourself in front of a mirror.
- Wash your hands.
- Unscrew the cap.
- Hold the bottle upside down between your thumb and index finger.
- Tilt your head backward. Gently pull down the eyelid of the eye with one finger to form a pouch, into which 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, surrounding areas, or any other surfaces with the dropper tip, as this could contaminate the drops.
- Gently press the base of the bottle so that one drop of medicine is released at a time (figure 2).
- Do not squeeze the bottle—it is designed so that gentle pressure on the base is sufficient (figure 2).
- After using Abimox, press with your finger on the inner corner of the eye, next to the nose, for 2–3 minutes (figure 3). This helps prevent Abimox from passing into the rest of the body and is particularly important in young children.
- If applying drops to both eyes, wash your hands before repeating the above steps for the other eye. This helps prevent the spread of infection from one eye to the other.
- Close the bottle tightly immediately after use.
- Use the entire contents of one bottle before opening the next.
If a drop misses the eye, try again.
If you have used more medicine than you should
You can remove the excess by rinsing the eyes with lukewarm water. Do not apply further drops until it is time for your next scheduled dose.
If Abimox is accidentally swallowed
Contact your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to use Abimox
Continue with your next scheduled dose. Do not apply 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 the other eye drops.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Abimox may cause adverse effects, although not everyone gets them.
Unless the effects are severe or you experience a serious allergic reaction, continue treatment as usual.
If you experience a severe allergic reaction and develop any of the following symptoms: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty swallowing or breathing, rash or hives, large fluid-filled blisters, sores and ulceration, stop using Abimox immediately and contact your doctor immediately.
Frequent: May affect up to 1 in 10 people
Eye effects: eye pain, eye irritation
Uncommon: May affect up to 1 in 100 people
Eye effects: dry eye, itchy eye, red eye, inflammation or scarring of the eye surface, broken blood vessel in the eye, abnormal sensation in the eye, abnormality, itching, redness or swelling of the eyelid.
General adverse effects: headache, bad taste
Rare: May affect up to 1 in 1,000 people
Eye effects: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye fatigue, eye swelling
General adverse effects: vomiting, nasal discomfort, sensation of lump in the throat, decreased iron in blood, abnormal liver function test results, abnormal skin sensation, 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, scratch on the eye surface, eye allergy, eye discharge, increased tear production, light sensitivity.
General adverse effects: shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, skin redness, nausea, and hives.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it concerns possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse reactions, 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 expiry date stated on the bottle and on the outer box, following “EXP.”. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
To prevent infection, discard the bottle 4 weeks after first opening. Write the date of first opening of the bottle in the space provided for this purpose on the carton.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Abimox
- The active substance is moxifloxacin.
One mL of solution contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride 5.45 mg).
One drop of eye drops contains 190 micrograms of moxifloxacin.
- The other components are boric acid, sodium chloride, sodium hydroxide for pH adjustment, and water for injections.
Nature and contents of the container
This medicine is a liquid (a clear, yellowish-green solution) supplied in a box containing one 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 medicinal product 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 eye drops, solution
Greece: Tamvelier 5mg/ml Eye drops, solution
Date of the most recent review of this leaflet: November 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es