PATIENT INFORMATION LEAFLET

MYDRIASERT 0.28 mg/5.4 mg Ophthalmic Insert

Tropicamide and Phenylephrine Hydrochloride

1.What MYDRIASERT is and what it is used for

2.What you need to know before you start using MYDRIASERT

3.How to use MYDRIASERT

4.Possible side effects

5Storage of MYDRIASERT

6.Contents of the pack and additional information

MYDRIASERT is an ophthalmic product, which means it is only for ocular treatment.

The use of MYDRIASERT is limited to healthcare professionals.

MYDRIASERT will be placed in the lower eyelid of your eye by medical staff. It is used to obtain mydriasis (pupil dilation) before a surgical procedure or for diagnostic use.

DO NOT USE MYDRIASERTin the following cases:

• If you are allergic to tropicamide or phenylephrine hydrochloride or to any of the other ingredients of this medication (listed in section 6).
• In patients with closed-angle glaucoma or at risk of precipitated glaucoma (increase in intraocular pressure).

-In children under 12 years old.

ADVERTENCIAS AND PRECAUTIONS

• Since this medication causes long-lasting visual disturbances, remember to attend

the consultation (see possible adverse effects).

• In case of discomfort after the insertion of the insert, inform your doctor: it is possible the

displacement or, less frequently, the loss of the insert.

• If you suffer from severe dry eye, your doctor may apply a drop of saline solution in the eye to reduce the risk of eye irritation.
• In case of hypertension (high blood pressure), atherosclerosis (increase in arterial wall thickness), heart disease, hyperthyroidism (increase in thyroid gland activity) or prostate disorders, inform your doctor.
• In certain individuals prone to it, mydriatics (products that dilate the pupil) may trigger an acute glaucoma attack (due to sudden increase in intraocular pressure).
• The use of soft hydrophilic contact lenses is not recommended during treatment.

Children and Adolescents

Mydriasert should not be used in children under 12 years old as children appear to be more susceptible to the risks of severe adverse effects.

The use of Mydriasert in children between 12 and 18 years old is not recommendeddue to lack of adequate clinical experience.

Use of MYDRIASERT with other medications

Inform your doctor if you are using other pupil-dilating medications (mydriatics) different from Mydriasert, so that your doctor knows the total amount of mydriatics to which you are exposed.

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication, including those acquired without a prescription. Although Mydriasert is applied locally, this information may be important because medications may influence each other's action.

Pregnancy and Breastfeeding

There are insufficient data on the use of Mydriasert or its active components in pregnant women. Therefore, Mydriasert should not be used during pregnancy except if necessary.

The use during breastfeeding is not recommended.

Driving and Operating Machines

Do not drive or operate machines because MYDRIASERT may cause bothersome visual disturbances for a few hours (discomfort due to prolonged pupil dilation).

Important Information about some of the components of MYDRIASERT

It should be warned to athletes that this medication contains an active component (phenylephrine hydrochloride) that may produce positive results in substance control tests.

USE LIMITED TO HEALTHCARE PROFESSIONALS.

Mydriasert is intended for use in adults. Mydriasert should not be ingested.

The healthcare professional will place a single insert behind the lower eyelid of the corresponding eye. The healthcare professional will remove the insert once the pupil is sufficiently dilated, before the operation or investigation. The insert should not be left in the eye for more than 2 hours.

If you use more MYDRIASERT than you should

Since the healthcare professional will place a single insert in the eye, the risk of using Mydriasert in excess of the recommended amount is unlikely. Nevertheless, if the healthcare professional needs to use a mydriatic eye drop in addition to Mydriasert, there may be a risk of overdose of the active components of Mydriasert.

Some symptoms of overdoseof the active components of Mydriasert may include extreme fatigue, sweating, dizziness, slow heart rate, coma, headache, rapid heart rate, dry mouth and skin, unusual somnolence, flushing, and sustained dilation of the pupils.

In case of overdose, contact the toxicology information service at the number: 91562 04 20.

If you have any other questions about the use of this product, ask your doctor, pharmacist, or nurse

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Frequent:may affect up to 1 in 10 people:

-itching

-blurred vision

-discomfort due to the perception of the presence or movement of the insert.

Infrequent:may affect up to 1 in 100 people:

-tearing

-irritation

-discomfort due to prolonged pupil dilation

-superficial punctate keratitis (corneal inflammation).

Rare:may affect up to 1 in 1,000 people:

-allergic reactions: blepharitis (inflammation of the eyelids), conjunctivitis (inflammation of the conjunctiva).

Very rare:

may affect up to 1 in 10,000 people:

-seizures.

Corneal ulcer (small erosion of the eye surface) and corneal edema (inflammation of the eye surface) have been observed when the insert has been left accidentally in the eye.

In susceptible individuals, MYDRIASERT may trigger an acute angle-closure glaucoma attack (sudden increase in intraocular pressure): if unusual symptoms occur after administration (redness, pain, and visual disturbances), consult your doctor immediately.

Although unlikely after eye administration, the active components of MYDRIASERT may cause the following adverse effects that should be taken into account:

-elevated blood pressure, tachycardia,

-very rarely, serious events such as cardiac arrhythmia,

-trembling, pallor, headache, dry mouth.

Additional adverse effects in children:

Unknown frequency: cannot be estimated from available data:

• fluid or swelling in the lungs
• paleness around the eyes in premature babies

Reporting Adverse Effects

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

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the package after

“CAD.”.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25?°C.

Use immediately after opening the package.

Do not use MYDRIASERT if you observe any deterioration of the package seal or insert.

Composition ofMYDRIASERT

- The active principles are tropicamide 0.28 mg and phenylephrine hydrochloride 5.4 mg per insert

oftálmico.

- The other components are ammonio methacrylate copolymer (type A), 30% polyacrylate dispersion, dibehenato of glycerol and ethylcellulose.

Aspect of the product and size of the packaging

MYDRIASERT is supplied in a blister pack.

MYDRIASERT has the appearance of a small, white, elongated tablet (4.3 mmx2.3 mm).

Each package contains another blister pack with sterile disposable forceps that are used to place MYDRIASERT in the eye.

Package sizes: 1 insert and 1 forceps, 10 inserts and 10 forceps, 20 inserts and 20 forceps, 50 inserts and 50 forceps, or 100 inserts and 100 forceps.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires THEA

Rue Louis Blériot, 12

F-63017 Clermont-Ferrand Cedex 2, France

Responsible for manufacturing

BENAC

27A, Avenue Paul Langevin

17180 Perigny, France

Local representative:

Laboratorios Thea S.A

C/ Enric Granados, nº 86-88, 2ª planta

08008 Barcelona, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanyMydriasert

AustriaMydriasert

BelgiumMydriasert

DenmarkMydriasert

SpainMydriasert

FinlandMydriasert

FranceMydriasert

ItalyMydriasert

LuxembourgMydriasert

NetherlandsMydriasert

PortugalMydriasert

United KingdomMydriasert

SwedenMydriasert

This leaflet was approved inNovember 2021.

This information is intended solely for medical professionals or healthcare professionals.

Do not ingest.

Before using the product, check the integrity of the blister pack. In case of deterioration of the blister pack seal, sterility will no longer be guaranteed; in such a case, use another insert from an intact package.

POSOLGY

The healthcare professional places a single insert in the inferior conjunctival sac of the eye

corresponding, a maximum of 2 hours before surgery or the research procedure.

Pediatric population

Mydriasert is contraindicated in children under 12 years old.

No data in children from 12 to 18 years old. Mydriasert is not recommended in these patients.

ADMINISTRATION FORM

The sealed edge should be cut along the dotted line, the blister pack is opened and the insert is located. It is thrown

downward of the lower eyelid pinched with the thumb and index finger (A) and the

insert is applied to the inferior conjunctival sac with the help of the sterile disposable forceps included

in the package, which should be discarded immediately after use (B).

INSTRUCTIONS FOR USE

The insert should not be left in the inferior conjunctival sac for more than two hours. The doctor may

remove the insert as soon as he considers that the mydriasis is sufficient to perform the operation or procedure; at most, the insert should be removed 30 minutes after having obtained sufficient pupil dilation. In case of discomfort, ensure that the insert

has been correctly placed in the base of the inferior conjunctival sac.

PRECAUTION: REMOVAL OF THE INSERT

Before a surgical procedure or procedure and as soon as sufficient mydriasis has been obtained, the insert

should be removed from the inferior conjunctival sac with the help of a sterile surgical forceps, a sterile tampon or a sterile irrigation or washing solution, lowering the lower eyelid (C).

Do not reuse the insert for the other eye of the same patient or for another patient.

Discard the insert after use. (See also section 3)