MAXITROL 3,500 IU/mL + 6,000 IU/mL + 1 mg/mL EYE DROPS, SUSPENSION

Introduction

Package Leaflet: Information for the User

MAXITROL 3,500 UI/ml + 6,000 UI/ml + 1 mg/ml eye drops, suspension

Neomycin / Polymyxin B / Dexamethasone

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is MAXITROL and what is it used for
2. What you need to know before you use MAXITROL
3. How to use MAXITROL
4. Possible side effects
5. Storage of MAXITROL
   1. Contents of the pack and further information

1. What is MAXITROL and what is it used for

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.

Antibiotics are used to treat bacterial infections and do not work for viral infections.

It is important that you 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 antibiotic left over after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

This medicine is indicated for the treatment of infectious eye inflammations that require corticosteroids when antibiotic prophylaxis is necessary.

2. What you need to know before you use MAXITROL

Do not use Maxitrol

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

• If you think you have:

• Herpes simplex keratitis, smallpox, chickenpox/herpes zoster, or any other viral eye infection.
• Ocular tuberculosis.
• Fungal eye diseases
• Personal or family history of glaucoma.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Maxitrol.

• Only use this medicine in your eye(s).
• If you experience symptoms of an allergic reaction with this medicine, stop 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 medicine may cause discomfort, irritation, and redness of the eye.

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

• become more sensitive to eye infections
• suffer from increased pressure in the eye(s). During the use of this medicine, you should regularly check the eye pressure. This is especially important in pediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur more quickly than in adults. The risk of elevated intraocular pressure and/or cataract formation induced by corticosteroids is greater in prone patients (e.g., diabetes)
• develop cataracts

• Develop Cushing's syndrome due to the medicine entering the bloodstream. Consult your doctor if you suffer from swelling and weight gain around the trunk and face, as these are usually the first manifestations of the syndrome. Adrenal gland function suppression may occur after intensive or long-term treatment with Maxitrol is discontinued. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with medicines containing ritonavir or cobicistat.
• Talk to your doctor or pharmacist if you have a disorder that causes thinning of the eye tissues before using this medicine.
• If your symptoms worsen or return suddenly, please contact your doctor. With the use of this medicine, you may become more sensitive to eye infections.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Corticosteroids applied to the eye can delay the healing of eye wounds. It is also known that topical non-steroidal anti-inflammatory drugs (NSAIDs) slow down or delay wound healing. The concomitant use of NSAIDs and corticosteroid eye drops may increase the potential for healing problems.

• If you use contact lenses:

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

Other medicines and Maxitrol

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are using topical NSAIDs. The concomitant use of corticosteroids and topical NSAIDs may increase corneal healing problems.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

This medicine is not recommended during pregnancy or breastfeeding.

Driving and using machines

You may notice that your vision becomes blurred for a while after applying the eye drops. Do not drive or use machines until this effect has worn off.

Maxitrol contains benzalkonium chloride

This medicine contains 0.04 mg of benzalkonium chloride per ml.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use MAXITROL

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

This medicine is only to be used as eye drops.

The recommended dose is:

Use in adults (including elderly patients)

Instill 1 or 2 drops into 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 are available.

Recommendations for use:

1 2 3 4

1. Wash your hands.
2. Pick up 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 pull your lower eyelid down to form a pocket between your eyelid and your eye, where the drop should fall (figure 2).
7. Bring the tip of the bottle close to your eye. You may find it helpful to look in a mirror.
8. Do not touch your eye or eyelid, or the surrounding areas, or other surfaces with the dropper. The drops could become contaminated.
9. Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 3).
10. After using this medicine, release your eyelid, close your eye, and gently press the edge of your eye next to your nose. This helps prevent the medicine from entering the rest of your body (figure 4).
11. If you are applying drops to both eyes, repeat the above steps for the other eye.
12. Close the bottle tightly immediately after use.

If a drop falls outside the eye, try again.

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

If you use more Maxitrol than you should, you can rinse your eyes with lukewarm 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget 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 make up for missed doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are classified by frequency, which is 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 the available data).

The following side effects have been reported with this medicine:

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

• Eye effects: inflammation of the eye surface, increased pressure in the eye,

itching in the eye, discomfort in the eye, irritation of the eye,

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

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

Hormonal problems: excessive body hair growth (especially in women), weakness and muscle wasting, purple streaks on the skin of the body, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and swelling and weight gain of the body and face (Cushing's syndrome) (see section 2, "Warnings and precautions").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es.By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MAXITROL

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

Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Do not refrigerate.

To avoid infections, you must discard the bottle 4 weeks after first opening.

Write the date of opening on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Place the empty bottle and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the empty bottle and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Maxitrol

• The active substances are neomycin sulfate, polymyxin B sulfate, and dexamethasone. One ml of suspension contains 3,500 IU of neomycin sulfate, 6,000 IU of polymyxin B sulfate, and 1 mg of dexamethasone.
• The other ingredients 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 pack

Maxitrol is a liquid (white or slightly yellowish) that comes in a pack containing a 5 ml plastic bottle with a screw cap.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

Manufacturer

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

or

Novartis Manufacturing NV

Rijsksweg 14

2870 Puurs-Sint-Amands

Belgium

Date of last revision of this package leaflet: January 2019

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