PROSPECTO : INFORMATION FOR THE USER

IOPIMAX 10 mg/ml eye drops solution

Apraclonidine hydrochloride

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

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

Your doctor will administer IOPIMAX eye drops. This prospect aims to inform you about the medication.

IOPIMAXeye drops contain apraclonidine, which is used to control or prevent an increase in pressure inside the eye after laser surgery

This medication may not be suitable for you. It is essential that you review all the following points, as if any of them affect you, your doctor may decide to prescribe another medication:

You should not administer IOPIMAX in:

• children (this medication is not indicated for minors under 18 years)
• if you areallergicto clonidine, apraclonidine, or any other component of this medication(listed in section 6)
• if you haveuncontrolled and unstableheart diseaseor a severe condition (including chest pain, angina, heart attacks, or heart failure)
• if you are taking monoamine oxidase inhibitors (MAOIs) as antidepressants

If you believe any of the above points affect you or have doubts, consult your doctor before they administer this medication to you.

Be especially careful with IOPIMAX. Consult your doctor if:

•you have or are using medication for:

-heart disease (including chest pain, angina, heart attacks, or heart failure)

-high blood pressure

-circulatory problems (including stroke, Raynaud's disease, or Buerger's disease)

-vasovagal attacks (episodes of fainting)

-reduced liver or kidney function

If any of these points affect you, you may be at a higher risk of heart or circulatory system effects, and your blood pressure and heart rate will be closely monitored.

?Do you suffer from depression?Since clonidine and its derivatives can cause depression

?Do you suffer from diabetes or have low blood sugar levels?Since this medication can mask the signs and symptoms of a sudden drop in blood sugar, such as rapid heartbeats or tremors

?Do you regularly drink alcohol?Since IOPIMAX can increase its effects

?Have you had an exaggerated response to other medications that lower intraocular pressure?In this case, your eye pressure will be closely monitored.

If any of the above points affect you or you have doubts, consult your doctor before they administer this medication to you.

Other medications and IOPIMAX

You should not administer IOPIMAX if:

?you are usingmonoamine oxidase inhibitors (MAOIs) (used to treat depression)such as phenelzine, isocarboxazid, tranylcypromine, moclobemide

?you are usingtricyclic antidepressants (frequently used to treat depression)such as amitriptyline, imipramine, doxepin, mianserin, trazodone, dosulepin, lofepramine

?you are using medications that contain sympathomimeticsused to treat various diseases, including asthma (such as salbutamol, terbutaline, bambuterol), Parkinson's disease, and heart disease, and may also be present in cold and cough medications.

Be especially careful with IOPIMAX

?if you are usingeye drops to treat glaucomathat contain sympathomimetics, such as phenylephrine, brimonidine, dipivefrine, as your blood pressure may increase

?if you are usingsleeping pills, painkillers, or sedatives,as IOPIMAX can increase their effects

?if you are using or have usedneuroleptics(very potent tranquilizers for certain mental illnesses, such as chlorpromazine, flupentixol, haloperidol), as your blood pressure may drop too low.

In case it could affect your blood pressure, it will be closely monitored, along with your heart rate.

Before IOPIMAX is administered to you, inform your doctor if you are using, have used recently, or may need to use any other medication.

Use of IOPIMAX with food and beverages

IOPIMAX should be used with caution if you have recently consumed alcohol or drink it regularly.

Pregnancy, breastfeeding, and fertility

IOPIMAX should not be used if you are or think you may become pregnant or if you are breastfeeding.

Your doctor should have informed you about this. If not, consult your doctor before using any medication.

Driving and operating machinery

This type of medication can cause drowsiness. If this occurs, do not drive or operate tools or machinery.

Adults and Elderly Patients

IOPIMAX is presented in a specially designed single-use container. Your doctor will administer one drop one hour before laser surgery and another drop immediately after surgery.

After IOPIMAX is administered, you will be instructed to press with your finger the edge of your eye, near your nose. This helps to prevent IOPIMAX from passing into the rest of your body.

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

Use in Children

This medication should not be used in children.

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

When used before and after laser surgery,you may experience some or all of the following side effectsin your eyes:

Common(may affect up to 1 in 10 people treated)

- redness in one or both eyes

- enlargement of one pupil

- inability to close the eye

- eye disorder (white appearance of the eye surface)

- unusual or uncomfortable sensation in the eye

- sensation of dry eye

Uncommon(may affect up to 1 in 100 people treated)

- bleeding on the surface of the eye (conjunctival hemorrhage)

- eye inflammation (which may include pain, burning, redness, or swelling of the eye)

- retraction or elevation of the upper eyelid

- extremely low pressure inside the eye (your doctor will notice during eye checks)

- blurry or reduced vision

- hemorrhage on the surface of the eye

- blurred vision

- ocular allergy

- eye itching

- eye irritation

You may also experience side effectsin other areas of the body:

Common(may affect up to 1 in 10 people treated)

• sensation of dryness in the nose
• strange or unpleasant taste

Uncommon(may affect up to 1 in 100 people treated)

- irregular heartbeats

- difficulty sleeping

- altered dreams

- episodes of fainting

- sensations of burning or tingling

- decreased libido

- sensation of irritability

- slow or irregular heartbeats

- sensation of fainting or dizziness when sitting or standing

- diarrhea

- nausea or vomiting

- stomach pain or discomfort

- headaches

- fatigue

Rare(may affect up to 1 in 1,000 people treated)

- reduced sensitivity or numbness (tingling sensation)

- difficulty breathing

- excessive mucus or saliva

- sensation of dryness or burning in the nose

- dry mouth

- increased sweating

- itching skin

- pain in arms or legs

- chest oppression or pain

- sensation of heat or cold

Unknown frequency(cannot be estimated from available data)

- decreased blood pressure

- increased blood pressure

If you experience an allergic reaction,unusual dizziness, or delirium, or have irregular heartbeats, inform your doctor immediately.

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 leaflet. You can also report them directly through the Spanish System for the 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.

Composition of IOPIMAX

• The active ingredient is apraclonidine10 mg/ml (as hydrochloride).
• The other components aresodium acetate, sodium chloride, and purified water. In some cases, very small amounts of hydrochloric acid or sodium hydroxide are added to make the drops more suitable for your eyes.

Appearance of the product and contents of the packaging

IOPIMAX 10 mg/ml eye drops in solutionis pale yellow and is presented in a 0.25ml container.

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:

Alcon Couvreur N.V.

Rijksweg, 14

B-2870 Puurs, Belgium

Date of the last review of this leaflet:April 2018