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PACKAGE LEAFLET : INFORMATION FOR THE USER

MYDRIASERT®

0.28 mg/5.4 mg ophthalmic insert

Tropicamide and phenylephrine hydrochloride

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or your pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

In this leaflet:

1.    What MYDRIASERT is and what it is used for

2.    Before you use MYDRIASERT

3.    How to use MYDRIASERT

4.    Possible side effects

5 How to store MYDRIASERT 6. Further information

1.    WHAT MYDRIASERT IS AND WHAT IT IS USED FOR

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

Use of MYDRIASERT is restricted to health professionals.

MYDRIASERT will be put in the inferior eyelid of your eye by the medical staff. It is used to obtain a mydriasis (dilation of the pupil) before a surgical intervention or for diagnostic purposes.

2.    BEFORE YOU USE MYDRIASERT

DO NOT USE MYDRIASERT in the following cases:

-    If you are allergic (hypersensitive) to tropicamide or phenylephrine hydrochloride or any of the other ingredients of MYDRIASERT,

-    Patients with closed angle glaucoma or at risk of precipitated glaucoma (increase in ocular pressure).

Take SPECIAL CARE with MYDRIASERT

-    Because this medicinal product causes long-lasting visual disturbances, remember to be accompanied when attending the consultation (see possible side effects).

-    In the event of discomfort after the insertion of the insert, inform your doctor: a shifting or, more rarely, a loss of the insert is possible.

-    If you suffer from severe dry eyes, your doctor may put a drop of saline solution in the eye to reduce the risk of irritation of the eye.

-    In case of hypertension (high blood pressure), atherosclerosis (thickening of arterial wall), cardiac disease or hyperthyroidism (increase activity of thyroid gland), prostatic disorders, inform your doctor.

-    In certain predisposed persons, mydriatics (products that dilate pupil) may trigger an attack of acute glaucoma (because of sudden increase in pressure in your eye).

-    The wearing of soft hydrophilic contact lenses is inadvisable during the treatment.

Taking or using other medicines

Please tell your doctor if you are using medicines that dilate the pupils (mydriatics) besides Mydriasert, so that your doctor will know the total amount of mydriatics you are exposed to.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Although Mydriasert is locally applied, such information may be important because medicines can influence each other's actions.

Pregnancy and breast-feeding

Adequate data on the use of Mydriasert or its active ingredients in pregnant women are missing. Therefore, Mydriasert should not be used during pregnancy, unless necessary.

Use during breast-feeding is not recommended.

Driving and using machines

Do not drive or use machines because MYDRIASERT may cause troublesome visual disturbances for a few hours (dazzle due to prolonged dilation of the pupil).

Important information about some of the ingredients of MYDRIASERT

Sportsmen should be warned that this medicinal product contains an active ingredient (phenylephrine hydrochloride) which may produce positive results to tests for prohibited substances.

3. HOW TO USE MYDRIASERT

RESTRICTED USE TO HEALTH PROFESSIONALS.

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

The healthcare professional will place one insert behind the lower eyelid of the concerned eye. The professional will remove the insert within 30 minutes after the pupil is sufficiently dilated, and before the operation or investigation of the eye takes place. The insert should not be left in the eye for more than 2 hours.

If you use more MYDRIASERT than you should

As a single insert will be placed in the eye by the medical or healthcare professional, the risk of using more Mydriasert than recommended is unlikely. However, if the healthcare professional needs to use mydriatics eye drops in addition to Mydriasert, a risk of overdose of the active ingredients of Mydriasert may occur.

Symptoms of overdose of the active ingredients of Mydriasert may include extreme tiredness, sweating, dizziness, a slow heart beat, coma, headache, fast heart beat, dry mouth and skin, unusual drowsiness, flushing and sustained dilation of the pupils.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, MYDRIASERT can have side effects, although not everybody gets them.

The common eye side effects (occurring in more than one in 100 patients in clinical trials) include: stinging, blurred vision, visual discomfort due to perception of the presence or shifting of the insert.

Uncommon eye side effects (occurring in more than one in 1000, but less than 1 in 100 patients in clinical trials) include: tearing, irritation, dazzle due to the prolonged dilation of the pupil, and superficial punctuate keratitis (inflammation of cornea).

In some rare cases (occurring in less than one in 1000 patients), the following side effects were observed: Allergic reactions: inflammation of eyelids (blepharitis), inflammation of the conjunctiva (conjunctivitis).

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

In predisposed subjects, MYDRIASERT may trigger an attack of acute glaucoma (sudden increase in intraocular pressure): in case of abnormal symptoms after administration (redness, pain, and visual troubles), take immediate advice from your doctor.

N2820IN20L02-2/0315

Although unlikely after administration in the eye, the active ingredients contained in MYDRIASERT may cause the following side effects which must be taken into account:

-    elevation of blood pressure, tachycardia,

-    very rarely, major accidents such as cardiac arrhythmia,

-    tremor, pallor, headache, dry mouth.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

Web site: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MYDRIASERT

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the sachet after 'EXP'.

Do not store above 25°C.

Use immediately after sachet opening.

Do not use MYDRIASERT if you notice deterioration of the sachet closure or of the insert.

6. FURTHER INFORMATION

What MYDRIASERT contains

-    The active substances are tropicamide 0.28 mg and phenylephrine hydrochloride 5.4 mg for one ophthalmic insert.

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

What MYDRIASERT looks like and contents of the pack

MYDRIASERT is supplied in a sachet.

MYDRIASERT looks like a white oblong small tablet (4.3 mm x 2.3 mm).

Each pack contains another sachet with disposable sterile forceps used to place MYDRIASERT in the eye.

Packs of 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 pack sizes may be marketed.

Marketing Authorisation Holder Laboratoires Thea

12, rue Louis Bleriot

63017 CLERMONT-FERRAND Cedex 2 - FRANCE

Manufacturer:

BENAC

27A, avenue Paul Langevin 17180 PERIGNY - FRANCE

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria    Mydriasert

Belgium    Mydriasert

Denmark    Mydriasert

Finland    Mydriasert

France    Mydriasert

Germany    Mydriasert

Italy    Mydriasert

Luxembourg    Mydriasert

Netherlands    Mydriasert

Portugal    Mydriasert

Spain    Mydriasert

Sweden    Mydriasert

United Kingdom    Mydriasert

This leaflet was last approved in 03/2015.

The following information is intended for medical or healthcare professionals only.

Do not swallow.

Before using the product, check for the integrity of the sachet. In case of deterioration of the sachet's closing, the sterility is no more ensured; in such case, use another insert from an intact packaging.

POSOLOGY

Mydriasert is reserved to adults.

The health professional places one ophthalmic insert in the lower conjunctival sac of the concerned eye, a maximum of 2 hours before surgery or investigative procedure.

METHOD OF ADMINISTRATION

The sealed edge should be cut along the dotted line, the sachet opened and the insert located. The lower eyelid are pulled down by pinching it between the thumb and index finger (A), and the ophthalmic insert is applied in the lower conjunctival sac, using disposable sterile forceps provided in the packaging, that should be discarded immediately after use (B).

INSTRUCTIONS FOR USE

The ophthalmic insert should not be left for more than two hours in the lower conjunctival sac. The practitioner can remove the ophthalmic insert as soon as mydriasis is deemed sufficient for the operation or procedure to be carried out; at the latest, the insert should be removed 30 minutes after sufficient dilation of the pupil is obtained. In the event of discomfort, ensure that the insert has been placed correctly at the base of the lower conjunctival sac.

CAUTION: REMOVAL OF OPHTHALMIC INSERT

Before an operation or procedure, and as soon as the desired mydriasis has been obtained, the ophthalmic insert should be removed from the lower conjunctival sac using either sterile surgical forceps, or a sterile swab or a sterile irrigation or washing solution, by lowering the lower eyelid (C).