Mydriasert

Package Leaflet: Information for the User

MYDRIASERT 0.28 mg/5.4 mg ophthalmic insert

Tropicamide and Phenylephrine Hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT MYDRIASERT IS AND WHAT IT IS USED FOR

MYDRIASERT is an ophthalmic product, which means it must be used solely as a treatment for the eyes.
The use of MYDRIASERT is restricted exclusively to medical and healthcare professionals.
MYDRIASERT will be placed in the lower eyelid of the eye by medical personnel. It is used to achieve mydriasis (dilation of the pupil) prior to eye surgery or for diagnostic purposes.

2. WHAT YOU NEED TO KNOW BEFORE USING MYDRIASERT

DO NOT USE MYDRIASERT in the following cases:

• If you are allergic to tropicamide or phenylephrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• In patients with closed-angle glaucoma or at risk of glaucoma (increased intraocular pressure).
• In children under 12 years of age.

WARNINGS AND PRECAUTIONS

• Since this medicine causes long-lasting visual disturbances, remember to be accompanied when going to your medical appointment (see possible side effects).
• If you experience discomfort after inserting the ocular insert, inform your doctor: displacement or, more rarely, loss of the insert are possible events.
• If you suffer from severe dry eye, your doctor may administer a drop of saline solution into your eye to reduce the risk of irritation.
• If you have hypertension (high blood pressure), atherosclerosis (arterial wall thickening), heart disease, hyperthyroidism (overactivity of the thyroid gland), or prostate disorders, inform your doctor.
• In some predisposed patients, mydriatics (agents that dilate the pupil) may trigger an acute attack of glaucoma (due to a sudden increase in intraocular pressure).
• The use of soft hydrophilic contact lenses during treatment is not recommended.

Children and adolescents
Mydriasert must not be used in children under 12 years of age, as children appear to be more sensitive to the risk of serious adverse effects.
Mydriasert is not recommended for use in children and adolescents aged between 12 and 18 years, due to lack of adequate clinical experience.

Other medicines and MYDRIASERT
If, in addition to Mydriasert, you are using other medicines that dilate the pupil (mydriatics), inform your doctor so that they can determine the total amount of mydriatic agents to which you are exposed.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This information may be important because, although Mydriasert is applied locally, medicines can influence each other's mechanisms of action.

Pregnancy and breastfeeding
There are insufficient data on the use of MYDRIASERT or its active substances in pregnant women. Therefore, MYDRIASERT must not be used during pregnancy unless clearly necessary.
The use of Mydriasert during breastfeeding is not recommended.

Driving and using machines
Do not drive or operate machinery, as MYDRIASERT may cause bothersome visual disturbances for several hours (glare due to prolonged pupil dilation).

Important information on some components of MYDRIASERT
Athletes should be informed that this medicine contains an active substance (phenylephrine) that may lead to positive results in doping tests.

3. HOW TO USE MYDRIASERT

FOR USE BY HEALTHCARE PROFESSIONALS ONLY
MYDRIASERT must be used only in adults. MYDRIASERT must not be swallowed.
The healthcare professional will place one insert behind the lower eyelid of the eye to be treated and will remove it 30 minutes after the pupil has become sufficiently dilated and before the surgical procedure or diagnostic examination. The insert must not be left in the eye for longer than 2 hours.

If you use more MYDRIASERT than you should
Since a healthcare professional will insert a single insert into the eye, the risk of using more MYDRIASERT than recommended is unlikely. However, if the physician needs to use additional mydriatic drops in addition to MYDRIASERT, there may be a risk of overdose of the active substances in MYDRIASERT.
Symptoms of overdose may include: extreme fatigue, sweating, dizziness, slowed heartbeat, coma, headache, rapid heartbeat, dryness of the mouth and skin, unusual drowsiness, hot flushes, and prolonged pupil dilation.
If you have any doubts about the use of MYDRIASERT, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Common: may affect up to 1 in 10 people:

• stinging pain,
• blurred vision,
• ocular discomfort due to awareness of the presence or movement of the insert.

Uncommon: may affect up to 1 in 100 people:

• tearing,
• irritation,
• glare due to prolonged pupil dilation,
• superficial punctate keratitis (inflammation of the cornea).

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

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

Very rare: may affect up to 1 in 10,000 people:

• seizures.

Cases of corneal ulcer (small erosion of the eye surface) and corneal edema (swelling of the eye surface) have been observed when the insert was accidentally left in the eye.

In predisposed individuals, MYDRIASERT may trigger an acute glaucoma attack (sudden increase in intraocular pressure): if abnormal symptoms occur after administration (redness, pain, and visual disturbances), seek immediate medical advice.

Although unlikely following ocular administration, the active substances contained in MYDRIASERT may cause the following adverse reactions, which should be taken into consideration:

• increased blood pressure, tachycardia
• very rarely, serious events such as cardiac arrhythmia
• tremor, pallor, headache, dry mouth

Additional adverse reactions in children:
Frequency not known (frequency cannot be estimated from the available data):

• Pallor around the eyes in premature infants
• Fluid or swelling in the lungs

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MYDRIASERT

Keep out of the sight and reach of children.
Do not use after the expiry date stated on the sachet following “Exp.”
Do not store above 25 °C.
Use immediately after opening the sachet.
Do not use MYDRIASERT if you notice any deterioration in the closure of the sachet or in the insert.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What MYDRIASERT contains

• The active substances are tropicamide 0.28 mg and phenylephrine hydrochloride 5.4 mg per ocular insert.
• The excipients are: ammonium methacrylate copolymer (type A), polyacrylic dispersion 30%, glyceryl dibehenate, and ethylcellulose.

Description of the appearance of MYDRIASERT and contents of the pack
MYDRIASERT is contained in a pouch.
MYDRIASERT is a small, white, oblong tablet (4.3 mm x 2.3 mm).
Each pack contains another pouch with sterile, disposable forceps for inserting MYDRIASERT into the eye.
Packs containing 1 insert and 1 pair of forceps, 10 inserts and 10 pairs of forceps, 20 inserts and 20 pairs of forceps, 50 inserts and 50 pairs of forceps, or 100 inserts and 100 pairs of forceps.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratoires Théa
12, rue Louis Blériot
Clermont-Ferrand Cedex 2
France

Marketing Authorization Holder in Italy:
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILANO

Manufacturer
BENAC
27 A, avenue Paul Langevin
17180 PÉRIGNY – FRANCE

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Mydriasert
Belgium Mydriasert
Denmark Mydriasert
Finland Mydriasert
France Mydriasert
Germany Mydriasert
Italy Mydriasert
Luxembourg Mydriasert
Netherlands Mydriasert
Portugal Mydriasert
United Kingdom Mydriasert
Spain Mydriasert
Sweden Mydriasert

This leaflet was last approved on:
The following information is intended exclusively for physicians or healthcare professionals.
Do not ingest.
Before using the product, check that the pouch is intact. If the seal of the pouch is damaged, sterility can no longer be guaranteed. In such a case, use another insert from an undamaged package.

DOSAGE
The healthcare professional inserts one ocular insert into the lower conjunctival sac of the eye to be treated, no more than 2 hours before the surgical procedure or diagnostic examination.

Paediatric population
Mydriasert is contraindicated in children under 12 years of age.
No data are available in children aged 12 to 18 years. Mydriasert is not recommended in these patients.

ADMINISTRATION INSTRUCTIONS
Cut along the dotted line on the sealed edge. Open the pouch and locate the insert.
Pull down the lower eyelid by gently pinching it between the thumb and index finger ( A ). Place the ocular insert into the lower conjunctival sac using the sterile, disposable forceps provided in the pack (which must be discarded immediately after use) ( B ).

INSTRUCTIONS FOR USE
The ocular insert must not be left in the lower conjunctival sac for longer than two hours. The physician may remove the ocular insert as soon as sufficient mydriasis has been achieved for the surgical or diagnostic procedure. At the latest, the insert must be removed 30 minutes after adequate pupil dilation has been obtained. If discomfort occurs, ensure that the insert has been correctly placed at the base of the lower conjunctival sac.

WARNING: REMOVAL OF THE OCULAR INSERT
Prior to surgery or diagnostic examination, and as soon as the desired mydriasis has been achieved, the ocular insert must be removed from the lower conjunctival sac using sterile surgical forceps, a sterile swab, or sterile irrigating or washing solution, while pulling down the lower eyelid ( C ).

Do not reuse the insert in the other eye of the same patient or in another patient.
Dispose of the insert after use (refer to section 3).