Maxitrol 3.500 ui/ml + 6.000 ui/ml + 1 mg/ml colirio en suspensiÓn

Label: information for the user

MAXITROL 3.500UI/ml + 6.000UI/ml + 1mg/ml eye drop suspension

Neomicin / Polymyxin B / Dexamethasone

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

• Keep this label, as you may need to read it again.
• If you have any questions, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What MAXITROL is and for what it is used

2.What you need to know before starting to use MAXITROL

3.How to use MAXITROL

4.Possible adverse effects

5.Storage of MAXITROL

1. Contents of the package and additional information

It is an eye drop that combines two antibiotics that offer broad-spectrum antibacterial activity together with the anti-inflammatory activity of a corticosteroid (dexamethasone), to treat certain microbial infections of the anterior segment of the eye.

This medication is indicated for the treatment of infectious eye inflammation that requires corticosteroids when antibiotic prophylaxis is necessary.

Do not use Maxitrol

• If you are allergic to neomycin, polymyxin B, dexamethasone, or any of the other components of this medication (listed in section 6).

• If you think you have:

• Herpes simplex keratitis, smallpox, chickenpox/herpes zoster, or any other viral eye infection.
• Eye tuberculosis.
• Fungal eye infections.
• A personal or family history of glaucoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Maxitrol.

• Only use this medication in your eye(s).
• If you experience symptoms of an allergic reaction, discontinue treatment and consult your doctor. Allergic reactions can range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or severe skin reactions. These allergic reactions can occur with other topical or systemic antibiotics of the same family (aminoglycosides).
• The use of this medication may cause discomfort, irritation, and skin redness.

• If you are using another antibiotic treatment at the same time, consult your doctor.
• If you use this medication for a long period of time, you may:

• Become more sensitive to eye infections.
• Experience increased eye pressure. During the use of this medication, you should regularly monitor your eye pressure. This is especially important in pediatric patients, as the risk of corticosteroid-induced ocular hypertension may be higher in children and may occur more quickly than in adults. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is higher in susceptible patients (e.g., diabetes).
• Develop cataracts.

• Develop Cushing's syndrome due to the medication entering the bloodstream. Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of the syndrome. Suppression of adrenal function may occur after interrupting intensive or long-term treatment with Maxitrol. Consult your doctor before discontinuing treatment on your own. These risks are especially important in children and patients treated with medications containing ritonavir or cobicistat.
• Consult your doctor or pharmacist if you have a condition causing thinning of the eye tissues before using this medication.
• If your symptoms worsen or return suddenly, please contact your doctor. With the use of this medication, you may become more sensitive to eye infections.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Topical steroids may delay the healing of eye wounds. It is also known that non-steroidal anti-inflammatory drugs (NSAIDs) may slow down or delay corneal healing. The concomitant use of NSAIDs and topical steroids may increase the risk of healing problems.

• If you wear contact lenses:

• Wearing contact lenses (hard or soft) is not recommended during treatment of an eye inflammation or infection.

Other medications and Maxitrol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are using NSAIDs. The concomitant use of steroids and NSAIDs may increase the risk of corneal healing problems.

Inform your doctor if you are using ritonavir or cobicistat, as it may cause an increase in dexamethasone levels in the blood.

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended during pregnancy or breastfeeding.

Driving and operating machinery

You may notice that your vision becomes blurry for a short time after applying the eye drops. Do not drive or operate machinery until this effect has disappeared.

Maxitrol contains benzalkonium chloride

This medication contains 0.04 mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

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

This medication should only be used as eye drops.

The recommended dose is:

Use in adults (including elderly patients)

Instill 1 or 2 drops in the conjunctival sac 4 or 6 times a day. The dose may be reduced after 3 or 4 days if a satisfactory response has been obtained.

Use in children

No data available.

Usage recommendations:

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1. Wash your hands.
2. Take the bottle (dropper bottle).
3. Shake well before use.
4. After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
5. Hold the bottle, upside down, between your fingers (figure 1).
6. Tilt your head back. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 2).
7. Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
8. Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The drops could become contaminated.
9. Press gently on the base of the bottle with your index finger to allow one drop to fall at a time (figure 3).
10. After using this medication, release your eyelid, close your eye and press gently on the edge of your eye near your nose. This helps prevent this medication from passing into the rest of your body (figure 4).
11. If drops are applied to both eyes, repeat all previous steps for the other eye.
12. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this medication and the other eye medications. Eye ointments should be administered last.

If you use more Maxitrol than you should,you can remove it by washing your eyes with warm water. Do not apply more drops until the next dose.

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 used.

If you forgot to use Maxitrol,apply a single dose as soon as you remember and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen. Do not apply a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects are classified by frequencies, which are defined as: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

The following adverse effects have been reported with this medicine:

Uncommon adverse effects (may affect up to 1 in 100 people):

• Eye effects: conjunctival inflammation, increased eye pressure,eye itching,

eye discomfort, eye irritation,

The following adverse effects have been observed during the post-marketing experience of this medicine. The frequency is unknown(cannot be estimated from available data):

• Eye effects: corneal ulcer, blurred vision, light sensitivity, pupil dilation, eyelid drooping, eye pain, eye swelling, abnormal sensation in the eye, eye redness, increased tear production.
• General effects: allergy, headache, severe skin reactions (Stevens-Johnson syndrome).

Endocrine problems: excessive hair growth (particularly in women), muscle weakness and wasting, purple striae on the body skin, increased blood pressure, irregular or absent menstruation, changes in body protein and calcium levels, delayed growth in children and adolescents, and body and facial swelling and weight gain (Cushing's syndrome) (see section 2, "Warnings and precautions").

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting adverse 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 is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not refrigerate.

To prevent infections, discard the bottle 4weeks after opening it for the first time.

Note the date of opening the bottle in the reserved box on the box.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines that you do not need in the SIGRE collection point of the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medicines that you do not need. By doing so, you will help protect the environment.

Composition of Maxitrol

• The active principles are neomycin sulfate, polymyxin B sulfate, and dexamethasone. One milliliter of suspension contains 3,500 units of neomycin sulfate, 6,000 units of polymyxin B sulfate, and 1 mg of dexamethasone.
• The other components are benzalkonium chloride, sodium chloride, polysorbate 20 (E-432), hypromellose (E 464), concentrated hydrochloric acid and/or sodium hydroxide, and purified water.

Appearance of the product and contents of the container

Maxitrol is a liquid (white or slightly yellowish) that is presented in a container that contains a plastic vial of 5 ml with a screw cap.