Maxitrol 3,500 IU/mL + 6,000 IU/mL + 1 mg/mL eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MAXITROL 3.500 IU/ml + 6.000 IU/ml + 1 mg/ml eye drops, suspension

Neomycin / Polymyxin B / Dexamethasone

Read all of this leaflet carefully before you start using this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What MAXITROL is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

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, after completing treatment, you have leftover antibiotic, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is indicated for the treatment of infectious ocular inflammations requiring corticosteroids when antibiotic prophylaxis is necessary.

2. What you need to know before using MAXITROL

Do not use Maxitrol

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

• If you think you have:

• Herpes simplex keratitis, smallpox, chickenpox/herpes zoster, or any other eye infection caused by a virus.

• Tuberculosis of the eye.

• Fungal diseases of the eye.

• A personal or family history of glaucoma.

Warnings and precautions

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

• Use this medicine only in your eye(s).

• If you develop symptoms of an allergic reaction while using this medicine, stop treatment and consult your doctor. Allergic reactions may range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic antibiotics of the same class (aminoglycosides).

• Use of this medicine may cause discomfort, irritation, and skin redness.

• If you are simultaneously using another antibiotic treatment, consult your doctor.

• If you use this medicine for a long period of time, you may:

• Become more susceptible to eye infections.

• Experience increased pressure in your eye(s). During treatment with this medicine, eye pressure should be monitored regularly. This is especially important in pediatric patients, as the risk of corticosteroid-induced ocular hypertension may be higher in children and may occur more rapidly than in adults. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is greater in predisposed patients (e.g., diabetes).

• Develop cataracts.

• Develop Cushing's syndrome due to the medicine reaching 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 gland function may occur after discontinuing intensive or long-term treatment with Maxitrol. Consult your doctor before stopping treatment on your own. These risks are particularly significant in children and in patients taking medications containing ritonavir or cobicistat.

• Consult your doctor or pharmacist if you have a condition causing thinning of eye tissues before using this medicine.

• If your symptoms worsen or suddenly return, please contact your doctor. With use of this medicine, you may become more susceptible to ocular infections.

• Contact your doctor if you experience blurred vision or other visual disturbances.

• Ocular steroids may delay healing of eye wounds. It is also known that ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) may slow or delay healing. Concomitant use of NSAIDs and ophthalmic steroids may increase the risk of healing problems.

• If you wear contact lenses:

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

Other medicines and Maxitrol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are using ophthalmic NSAIDs. Concomitant use of steroids and ophthalmic NSAIDs may increase healing problems.

Inform your doctor if you are taking ritonavir or cobicistat, as these 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 become pregnant, consult your doctor or pharmacist 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 short time after instilling the eye drops. Do not drive or operate machinery until this effect has gone away.

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 reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a foreign body sensation, stinging, or pain in the eye after using this medicine.

3. How to use MAXITROL

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is intended for ophthalmic use only.

Recommended dose:

Use in adults (including elderly patients)

Instill 1 or 2 drops into the conjunctival sac 4 to 6 times daily. The dose may be reduced after 3 or 4 days if a satisfactory response has been achieved.

Use in children

No data available.

Instructions for use:

1 2 3 4

1. Wash your hands.
2. Take the bottle (dropper container).
3. Shake well before use.
4. After opening the bottle for the first time, remove the loose plastic seal ring.
5. Hold the bottle upside down between your fingers (figure 1).
6. Tilt your head backwards. Gently pull down the eyelid to form a pouch between the eyelid and your eye, into which the drop should fall (figure 2).
7. Bring the tip of the bottle close to the eye. A mirror may be helpful.
8. Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. 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 the medicine, release the eyelid, close your eye, and gently press your finger against the inner corner of the eye near the nose. This helps prevent the medicine from passing into the rest of the body (figure 4).
11. If drops are to be applied to both eyes, repeat all the previous steps for the other eye.
12. Close the bottle tightly immediately after use.

If a drop misses the eye, try again.

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

If you use more Maxitrol than you should, flush the eyes with lukewarm water. Do not apply further drops until the next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 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 then continue with your next scheduled dose. However, if it is almost time for your next dose, do not take the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are classified by frequency, defined as follows: 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 adverse effects have been reported with this medicine:

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

• Eye effects: inflammation of the surface of the eye, increased pressure in the eye, itching of the eye, eye discomfort, eye irritation.

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

• Eye effects: corneal ulcer, blurred vision, light sensitivity, increase in 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 growth of body hair (particularly in women), muscle weakness and wasting, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual periods, changes in levels of proteins and calcium in the body, growth delay in children and adolescents, and swelling and weight gain in the body and face (Cushing's syndrome) (see section 2, "Warnings and precautions").

Reporting of 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 stated on the bottle and carton after EXP. The expiry date refers to the last day of the month indicated.

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

To avoid infection, the bottle should be discarded 4 weeks after first opening.

Record the date of first opening in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This helps protect the environment.

6. Contents of the package and other 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 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 pack

Maxitrol is a liquid (white or slightly yellowish) supplied 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

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Manufacturing NV

Rijsksweg 14

2870 Puurs-Sint-Amands

Belgium

Date of the most recent review of this 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/