PATIENT INFORMATION LEAFLET

Oftalmowell eye drops solution

Polymyxin B sulfate, neomycin sulfate, gramicidin

Read this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1.What Oftalmowell is and what it is used for

2.What you need to know before using Oftalmowell

3.How to use Oftalmowell

4.Possible side effects

5.Storage of Oftalmowell

6.Contents of the pack and additional information

Oftalmowell contains several antibiotics (polymyxin B sulfate, neomycin sulfate, and gramicidina) that act against certain microorganisms that cause bacterial infections in the eyes.

Oftalmowell is indicated for the treatment of bacterial infections such as purulent bacterial conjunctivitis, keratitis, corneal ulcers, and chronic dacryocystitis.

Oftalmowell is also indicated for pre- and postoperative ophthalmological prophylaxis, including surgical procedures and removal of foreign bodies from the eye.

No use Oftalmowell

• If you are allergic to polymyxin B sulfate, neomycin sulfate, gramicidin, or any of the other components of this medication (listed in section 6).
• If you are allergic to other related antibiotics, such as framycetin, kanamycin, or gentamicin.
• There is a possibility that absorption may be increased in very young children, so its use is not recommended in neonates or children under 2 years old. In these populations, absorption may increase through immature skin and renal function may also not be sufficiently developed.

Warnings and precautions

Consult your doctor before starting to use Oftalmowell.

• Use this medication only in your eye(s).
• Prolonged use of Oftalmowell may produce overgrowth of non-susceptible microorganisms, including fungi, and the application should be suspended and the appropriate therapy instituted.
• It is not recommended to use contact lenses during the treatment of an eye infection. See section “Oftalmowell contains benzalkonium chloride”.
• Caution is recommended when used concomitantly with other aminoglycosides or other systemic polypeptide antibiotics.

Use of Oftalmowell with other medications

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

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended during pregnancy.

The active principles/metabolites of this medication are unknown to be excreted in breast milk. It should be decided whether to interrupt breastfeeding or interrupt treatment after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machines

Immediately after applying Oftalmowell, you may notice that your vision becomes blurry. Do not drive or use machines until these effects have disappeared.

Oftalmowell contains benzalkonium chloride

This medication may cause eye irritation due to the presence of benzalkonium chloride. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. It alters the color of soft contact lenses.

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

The recommended dose is:

Adults (18 years and older):

Suppurative bacterial conjunctivitis, Keratitis, Corneal ulcers, and Chronic dacryocystitis

During the first two days, instill one or two drops in the affected eye(s) every 2-4 hours during the day.

Subsequently, instill one or two drops every 4-6 hours until the infection has resolved.

The dosing regimen and treatment duration will be adjusted according to medical evaluation.

Surgical prophylaxis

Your doctor will establish the dose and administration schedule to follow both in the days leading up to the intervention, as well as during the intervention itself, and in the days following the intervention.

The treatment should be continued for at least two days after the problem has been resolved, but should not be prolonged for more than 7 days without medical supervision.

Pediatric population:

Oftalmowell eye drops are suitable for use in children (over 2 years old) at the same adult dose. As there is a probability of increased absorption in the case of very young children, the use is not recommended in neonates and children under 2 years old.

Geriatric population:

Oftalmowell is suitable for use in elderly patients. Special caution should be exercised in cases where there is a decrease in renal function, as there may be significant systemic absorption of neomycin sulfate.

Administration form

Ophthalmic route.

If more than one eye medication is used, the applications of the medications should be spaced at least 5 minutes apart. Ophthalmic ointments should be administered last.

To avoid possible contamination of the dropper tip and solution, be careful not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.

Usage instructions:

1. Wash your hands. Tilt your head back and look up.
2. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and eye, where the drop should fall (figure 1).
3. Bring the dropper tip close to your eye. It may be helpful to use a mirror.
4. Do not touch your eye or eyelid, surrounding areas, or other surfaces with the dropper. The drops could become contaminated.
5. Invert the bottle and gently press to release one drop at a time into the eye that needs treatment (figure 2). Press gently, no need to press hard.

1. Release your lower eyelid and keep your eye closed for 30 seconds (figure 3).
2. After using the eye drops, press the corner of your eye near the nose with your finger. This helps prevent the eye drops from passing into your throat and then into your body (figure 4).
3. If eye drops are applied to both eyes, repeat all previous steps for the other eye. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

IfyouusemoreOftalmowellthanyoushould

If too much has been applied, you can remove it by rinsing your eyes with warm water. Do not apply more drops until the next scheduled dose.

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

IfyouforgottouseOftalmowell

If you forgot to use Oftalmowell, apply a single dose as soon as you remember, and continue with your regular treatment. Do not apply a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following local adverse reactions may appear: burning, irritation, dryness, folliculitis (inflammation of the hair insertion area), hypertrichosis (increased hair growth), eruptions, and striations. These symptoms disappear when application is suspended.

The incidence of neomycin sulfate allergy in the general population is low, but sensitization may occur after use.

Reactions to polymyxin B sulfate and gramicidin topical application are rare.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

You must discard the bottle four weeks after the first opening.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Oftalmowell

The active principles are sulfato de polimixina B, sulfato de neomicina, and gramicidina. Each ml of sterile solution contains (1 ml = 40 drops): 5,000 UI of sulfato de polimixina B, 1,700 UI of sulfato de neomicina, and 25 UI of gramicidina.

The other components are: sodium chloride, ethanol at 96%, propylene glycol, poloxamer 188, benzalkonium chloride, sodium hydroxide or diluted sulfuric acid to adjust the pH, and purified water.

Appearance of the product and contents of the packaging

Oftalmowell is an eye drop solution presented in polypropylene bottles with a dropper included and a screw cap. It contains 5 ml of solution.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Teofarma S.r.l.

Via F.lli Cervi, 8 – 27010

Valle Salimbene (PV) - Italy

Manufacturer:Alcalá Farma S.L.

Avenida de Madrid 82

28802 Alcalá de Henares

Revision date of this leaflet:July 2013

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/