Label: information for the user

IOPIMAX 5mg/ml eye drop solution

Apraclonidine hydrochloride

Read this label carefullybefore starting to use this medication because 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 for 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.

6.Contents of the container and additional information

IOPIMAX5 mg/ml eye drop 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 receiving other medicines to treat this condition.

In this group of people, IOPIMAX helps to reduce the fluid pressure in the eyeand to delay surgical intervention to relieve ocular pressure.

Do not use IOPIMAX

• if you have a history ofserious or unstable heart diseaseorcirculation problems.
• if you areallergicto apraclonidina or to any of the other components of this medication (listed in section 6).
• if you are currently takingmonoamine oxidase inhibitorsortricyclic antidepressants.
• if you are currently takingoral or injectable sympathomimetics.
• inCHILDREN.

If you have any doubts, consult your doctor.

Warnings and precautions

Be especially careful:

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

If you have a history of or are being treated for any of the following conditions:

• Anyheart disease(including angina, heart attack, or heart failure)
• High blood pressureor othercirculation problems(including embolisms, Raynaud's disease, and fainting)
• Problems withkidneys or liver
• Depression
• Disease ofParkinson
• Diabetes or low blood sugar levels. IOPIMAX may mask the signs and symptoms of a sudden drop in blood sugar, such as a rapid heartbeat or tremors
• If you are scheduled for anysurgery

If you think you are affected by any of the above cases, you can still use IOPIMAX, butconsult your doctor first.

Use of IOPIMAX with food, drinks, and alcohol

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

Other medications and IOPIMAX

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

Do not use IOPIMAXif you are taking antidepressants that belong to the class ofmonoamine oxidase inhibitorsortricyclic antidepressants. Do not use IOPIMAX if you are taking medications that belong to the class oforal or injectable sympathomimetics.

IOPIMAX may increase the effectsof other medications used to treat depression, asthma, high blood pressure, heart medications containing digoxin or digitoxin, various types of mental illnesses, and Parkinson's disease. It may interact with some medications for pain relief, sedatives, anesthetics, tricyclic antidepressants, cough and cold remedies, glaucoma medications such as timolol or brimonidina, 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 medication.

Do not use this medication during pregnancy or breastfeeding.

Driving and operating machinery

This type of medication may cause you to feeldrowsiness and dizziness. If sodo not driveor operate machinery.

IOPIMAX contains benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride in each 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 lenses. 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 (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in your eye after using this medication.

Recommended Dose

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

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Remove the Collarthat surrounds the cap when opening the bottle for the first time.

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

How to Use It

• Wash your hands before starting.
• Twist off the cap.
• Hold the bottle upside down between your thumb and fingers.
• Incline your head backward.
• Separate your lower eyelid downward with a finger until a pouch forms between the eyelid and your eye, where a drop should fall (figure 1).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do Not Touch Your Eye or Eyelid, surrounding areas or other surfaces with the dropper. The drops could become infected.
• Press the bottle gently to allow one drop to fall each time (figure 2).
• Do Not Press the Bottle,a gentle pressure is sufficient.
• After usingIOPIMAX, press the edge of your eye, near the nose, with your finger. This helps preventIOPIMAXfrom spreading to the rest of your body (figure 3).
• If drops are applied 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 IOPIMAX Ingestion, 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 regimen.

Do not apply a double dose to compensate for the missed dose.

If You Use More IOPIMAX Than You Should

You can remove it by rinsing your eyes with warm water. Do not apply more drops until it is gone. In case of accidental ingestion, symptoms of overdose may include: decreased blood pressure, drowsiness, decreased heart rate, hypoventilation (reduced breathing rate and depth causing increased carbon dioxide) and convulsion.

If You Are Using Other Ophthalmic Medications, wait at least 5 minutes between the administration of this eye drop and the other ophthalmic medications. Ophthalmic ointments should be administered last.

If You Have Any Other Doubtsabout the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

IOPIMAX may cause allergic reactions.If you experienceone or more of the followingeye symptoms:redness, itching, watery eyes, abnormal sensation or swelling of the eye or eyelid,consult your doctorimmediately.

If your vision worsensafter using IOPIMAX,stop using itandconsult 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, sensation of sand in the eye, dry eye, crusts on the eyelids.

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

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

Common (may affect up to 1 in 10 people): dry mouth, nasal inflammation, dermatitis, nasal dryness, weakness, headache, strange taste.

Uncommon (may affect up to 1 in 100 people): chest pain, hand, foot, or limb swelling, irregular heartbeat, constipation, nausea, feeling of fatigue, throat inflammation, coughing, muscle pain, coordination abnormalities, drowsiness, dizziness, sensation of numbness, nervousness, depression, difficulty sleeping, reduced air exhaled or difficulty breathing, strange odor sensation, facial swelling, irritability, vasodilation.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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 side effects, you can contribute to providing more information on the safety of this medication.

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

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

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

• 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.

• To prevent infections,you must discard the bottle 4weeks after having opened it for the first time.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of IOPIMAX

• The active ingredient isapraclonidina 5mg/ml (as hydrochloride).
• The other componentsarechloride of sodium, acetate of sodium (trihydrate), chloride of benzalkonium, hydrochloric acid and/or sodium hydroxide (to adjust the pH) and purified water.

Appearance of the product and contents of the packaging

IOPIMAX is a transparent and colorless or slightly yellowish solution that is presented in a box containing a plastic bottle of 5ml or 10ml with a screw cap.

Holder of the marketing authorization

Essential Pharma Limited,

Vision Exchange Building

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Responsible for manufacturing

Essential Pharma Limited,

Vision Exchange Building

Triq it-Territorjals, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Last review date of this leaflet:February2023.

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