IOPIMAX 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

IOPIMAX 5mg/ml eye drops solution

Apraclonidine hydrochloride

Read all of this leaflet carefullybefore 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is IOPIMAX and what is it used for
2. What you need to know before you use IOPIMAX
3. How to use IOPIMAX
4. Possible side effects
5. Storing IOPIMAX

1. Contents of the pack and further information

1. What is IOPIMAX and what is it used for

IOPIMAX5 mg/ml eye drops solution contains apraclonidine (as hydrochloride) as the active substance.

IOPIMAXbelongs to a group of medicines called alpha-agonists.

It is used for the treatment ofchronic glaucoma in people who are already taking other medicines to treat this disease.

In this group of people, IOPIMAX helps to reduce the pressure of fluids in the eye and to delay surgical intervention to relieve eye pressure.

2. What you need to know before you use IOPIMAX

Do not use IOPIMAX

• if you have a history of severe or unstable heart diseaseor circulation problems.
• if you are allergicto apraclonidine or any of the other ingredients of this medicine (listed in section 6).
• if you are currently taking antidepressants that belong to the class of monoamine oxidase inhibitors or tricyclic antidepressants.
• if you are currently taking medicines of the class of sympathomimetics that are taken orally or by injection.
• in CHILDREN.

If you are unsure, consult your doctor.

Warnings and precautions

Be particularly careful:

• Only use this medicine in your eye(s).
• IOPIMAX may not continue to control the pressure in your eyes after you have used it for a period of time. Your doctor will examine your eyes frequently while you are using IOPIMAX to check that the eye drops are still working.
• Since IOPIMAX reduces the pressure in the eye(s), you should have your eye pressure checked regularly to ensure that the pressure in the eye(s) remains under control.

If you have a history ofor are being treated forany of the following diseases:

• Any heart disease(including angina, infarction, or heart failure)
• High blood pressureor other circulation problems(including embolisms, Raynaud's disease, and fainting)
• Kidney or liver problems
• Depression
• Parkinson's disease
• Diabetes or low blood sugar levels. IOPIMAX may hide the signs and symptoms of a sudden drop in blood sugar, such as rapid heartbeat or tremors
• If you are scheduled for surgery

If you think you are affected by any of the above cases, you may still use IOPIMAX, but consult your doctor first.

Using IOPIMAX with food, drinks, and alcohol

Do not consume alcoholduring treatment with IOPIMAX because it may enhance its effects.

Other medicines and IOPIMAX

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

Do not use IOPIMAXif you are taking antidepressants that belong to the class of monoamine oxidase inhibitors or tricyclic antidepressants. Also, do not use IOPIMAX if you are taking medicines of the class of sympathomimetics that are taken orally or by injection.

IOPIMAX may increase the effectsof other medicines used to treat depression, asthma, high blood pressure, heart medicines that contain digoxin or digitoxin, various types of mental illnesses, and Parkinson's disease. It may interact with some pain-relieving medicines, sedatives, anesthetics, tricyclic antidepressants, cough and cold remedies, glaucoma medications such as timolol or brimonidine, and eye drops used to whiten the eye.

Pregnancy, breastfeeding, and fertility

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

Do not use this medicine during pregnancy or breastfeeding.

Driving and using machines

This type of medication may cause you to feel drowsy and dizzy. If so, do not driveor use machines.

IOPIMAX contains benzalkonium chloride

This medicine contains 0.1 mg of benzalkonium chloride per ml, equivalent to 0.01%.

IOPIMAX contains a preservative (benzalkonium chloride) that can be absorbed by soft contact lenses and may alter the color of the contact lenses. You should remove your contact lenses before using this medicine and wait 15 minutes before putting them back in. Benzalkonium chloride can cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer on 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 IOPIMAX

Recommended dose

The recommended dose is 1 drop in the eye(s) 3 times a day.

1 2 3

Remove the collarthat surrounds the cap when you open the bottle for the first time.

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to use it

• Wash your hands before starting.
• Remove the cap.
• Hold the bottle upside down between your thumb and fingers.
• Tilt your head back.
• Pull your lower eyelid down with one finger until a pocket is formed between the eyelid and your eye, where the drop should fall (figure 1).
• Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
• Do not touch the eye or eyelid, or surrounding areas with the dropper. The drops could become infected.
• Gently squeeze the bottle to release one drop at a time (figure 2).
• Do not squeeze the bottle; gentle pressure is enough.
• After using IOPIMAX, press the edge of your eye, next to your nose, with your finger. This helps prevent IOPIMAX from entering the rest of your body (figure 3).
• If you are applying drops to both eyes, repeat the above steps for the other eye. Close the bottle tightly after use.
• If a drop falls outside the eye, try again.
• In case of ingestion of IOPIMAX, consult your doctor immediately.

If you forget to use IOPIMAX

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 schedule.

Do not apply a double dose to make up for the missed dose.

If you use more IOPIMAX than you should

You can rinse your eyes with warm water. Do not apply more drops until it is time for your next dose. In case of accidental ingestion, the symptoms of overdose may include: low blood pressure, drowsiness, decreased heart rate, shallow breathing (reduced rate and depth of breathing that causes increased carbon dioxide), and convulsions.

If you are using other eye medicines, wait at least 5 minutes between the administration of this eye drop and the other eye medicines. Eye ointments should be applied last.

If you have any further questionsabout 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.

IOPIMAX may cause allergic reactions. If you experienceone or more of the following symptoms in the eye(s): redness, itching, watery eyes, abnormal sensation, or swelling of the eye or eyelid, consult your doctor immediately.

If your vision worsensafter using IOPIMAX, stop using itand consult your doctor immediately.

You may experience some or all of the following reactions in your eye(s):

Very common (may affect more than 1 in 10 people):increased redness, itching, inflammation.

Common (may affect up to 1 in 10 people):discomfort, increased tear production, eyelid swelling, feeling of grit in the eye, dry eye, crusts on the eyelids.

Uncommon (may affect up to 1 in 100 people):swelling under the eyelids, swelling of the eye, abnormal vision, pain, inflammation, and irritation of the eye or eyelids, damage to the corneal surface (the front part of your eye), sensitivity to light, redness of the eyelid, increased or decreased eyelid size, increased pupil size, reduced vision, blurred vision, drooping eyelid, discharge or whitening of the eye.

You may also experience effects in other parts of your body, including:

Common (may affect up to 1 in 10 people):dry mouth, inflammation inside the nose, dermatitis, dry nose, weakness, headache, unusual taste.

Uncommon (may affect up to 1 in 100 people):chest pain, swelling of hands, feet, or limbs, irregular heartbeat, constipation, nausea, feeling of tiredness, throat inflammation, runny nose, muscle pain, abnormal coordination, drowsiness, dizziness, tingling sensation, feeling of nervousness, depression, difficulty sleeping, reduced air exhaled or difficulty breathing, unusual smell sensation, facial swelling, irritability, dilation of blood vessels.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing IOPIMAX

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

• Do not store above 25°C. Do not refrigerate or freeze.

• Keep the bottle tightly closed and store in the outer packaging.

• 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.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of IOPIMAX

• The active substance is apraclonidine 5 mg/ml (as hydrochloride).
• The other ingredients are sodium chloride, sodium acetate (trihydrate), benzalkonium chloride, hydrochloric acid, and/or sodium hydroxide (for pH adjustment) and purified water.

Appearance and packaging

IOPIMAX is a clear, colorless or slightly yellowish solution, presented in a carton containing a 5 ml or 10 ml plastic bottle with a screw cap.

Marketing authorization holder

Essential Pharma Limited,

Vision Exchange Building

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Manufacturer

Essential Pharma Limited,

Vision Exchange Building

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Date of last revision of this leaflet:February 2023.

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