MYDRIASERT 0.28 MG/5.4 MG OPHTHALMIC INSERT

Active substance: TROPICAMIDE

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PACKAGE LEAFLET : INFORMA
TION 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
N2820IN20L01/1111
your doctor.

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.
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 pharmacist.

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’.

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 12/2011.

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 Théa
12, rue Louis Blériot
63017 CLERMONT-FERRAND Cedex 2 - FRANCE
Manufacturer:
BENAC
27A, avenue Paul Langevin
17180 PÉRIGNY - FRANCE
Distributed and marketed by:
Spectrum Thea Pharmaceutical
“Fernbank House”
Springwood Way, Macclesfield
Cheshire.U.K – SK102XA

Do not reuse the insert for the other eye in the same patient, or for another patient.
Discard the insert after use.
(Please also refer to section 3)

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).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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