0.28 mg / 5.4 mg eye
lamellar tropicamide and phenylephrine hydrochloride
What Mydriasert is and what it is used for
Mydriasert is an ophthalmic product, which means that it is only intended for the treatment of eyes.
Mydriasert may only be given by healthcare professionals.
Mydriasert will be placed under your lower eyelid by healthcare professionals. It is used to obtain mydriasis (dilation of the pupil one) before a surgical procedure or examination.
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 any of the other ingredients of this medicine (listed in section 6),
- for patients with a blocked ventricular angle – glaucoma or who are at risk of sudden onset glaucoma (increase in ocular pressure),
- for children under 12 years.
Warnings and cautions
- As this medicine causes long-term visual disturbances, you must remember that someone must accompany you when you go to the doctor’s office (see Possible side effects ).
- if you feel discomfort after placing the lamella, inform your doctor: it is possible that the lamella has moved or, more rarely, is pushed out.
- If you suffer from severely dry eyes, your doctor may drip saline into your eye to reduce the risk of eye irritation.
- Tell your doctor if you suffer from high blood pressure , atherosclerosis (thickening of the artery wall), heart disease, hyperthyroidism (increased activity of the thyroid gland) or prostate problems.
- in some people, mydriatics (products that dilate the pupil ) can trigger an attack of acute glaucoma (due to a sudden increase in pressure in the eye).
- The use of soft hydrophilic contact lenses is not recommended during treatment.
Children and young people
Mydriasert should not be used in children under 12 years of age as children appear to be more susceptible to the risk of serious side effects.
Mydriasert is not recommended for use in children and adolescents aged 12 to 18 years due to a lack of adequate clinical experience.
Other medicines and Mydriasert
Tell your doctor if you are taking other medicines that dilate the pupils (mydriatics) besides Mydriasert so that your doctor knows the total amount of mydriatics you are receiving.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Even if Mydriasert is used topically in the eye, such information can be important as different drugs can affect each other’s effects.
Pregnancy and breastfeeding
There are no data on the use of Mydriasert or its active substances in pregnant women. Therefore, Mydriasert should be used during pregnancy only if needed.
Use during breastfeeding is not recommended.
Driving and using machines
Do not drive or use machines as Mydriasert may cause severe visual disturbances for a few hours (blinded due to prolonged dilation of the pupil ).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mydriasert contains phenylephrine hydrochloride
Athletes should be warned that this medicine contains an active substance (phenylephrine hydrochloride) which may give positive results in tests used in doping control.
How to use Mydriasert
MAY ONLY BE GIVEN BY HEALTHCARE PROFESSIONALS.
Mydriasert is intended for use in adults. Mydriasert must not be swallowed.
The care staff will place a lamella under the lower eyelid of the eye to be treated/examined. The staff will remove the lamella after the pupil has expanded sufficiently, before the operation or examination. The lamella should not be left in the eye for more than 2 hours.
If you use too much Mydriasert
As only one lamella will be placed in the eye of healthcare professionals, the risk of using a larger amount of Mydriasert than recommended is not likely. However, if healthcare professionals need to use pupil dilating eye drops in addition to Mydriasert, there may be a risk of an overdose of the active substances in Mydriasert.
Symptoms of an overdose of the active substances in Mydriasert may include extreme tiredness, sweating, dizziness, slow heartbeat, coma, headache, rapid heartbeat, dry mouth, dry skin, unusual drowsiness, hemorrhage, and prolonged dilation of the pupils.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people:
- sveda,
- dimsyn,
- feeling uncomfortable due to feeling the lamella or that the lamella has moved.
Uncommon: may affect up to 1 in 100 people:
- tear flow,
- irritation,
- blinded due to prolonged dilation of pupil one,
- inflammation of the cornea (superficial punctate keratitis).
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.
A small wound on the surface of the eye (wound on the cornea) and inflammation in the surface of the eye (swelling of the cornea) have been observed when the lamella is inadvertently left in the eye.
In some patients, Mydriasert may trigger an attack of acute glaucoma (sudden increase in pressure in the eye): if abnormal symptoms occur after administration ( redness, pain, and visual disturbances), consult a physician immediately for advice.
Although unlikely, the active substances in Mydriasert may cause the following side effects which need to be considered:
- increased blood pressure , palpitations,
- very rare are serious events such as abnormal heart rhythm ( cardiac arrhythmia ),
- tremors, pallor, headache, dry mouth .
Additional side effects are in children
No known frequency (can not be calculated from the available data)
- fluid or swelling in the lungs
- pallor around the eyes of premature babies
How to store Mydriasert
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet after EXP.
Do not store above 25 ° C.
Use immediately after opening the sachet.
Do not use Mydriasert if you notice that the opening of the sachet or the lamella has been damaged.
Contents of the pack and other information
Content declaration
- The active substances are tropicamide 0.28 mg and phenylephrine hydrochloride 5.4 mg for each eye lamella.
- The other ingredients are ammonio methacrylate copolymer (type A), polyacrylate dispersion 30%, glycerol dibehenate and ethylcellulose.
What the medicine looks like and contents of the pack
Mydriasert is delivered in a sachet.
Mydriasert looks like an oblong, small tablet (4.3 mm x 2.3 mm).
Each pack contains an additional bag of sterile disposable forceps used to place Mydriasert in the eye.
Packaging: 1 slat and 1 tweezer, 10 slats and 10 tweezers, 20 slats and 20 tweezers, 50 slats and 50 tweezers or 100 slats and 100 tweezers.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Laboratories THEA
12, Rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
BENAC
27A, Avenue Paul Langevin
17180 Périgny
France
This medicinal product has been authorized in the EEA Member States under the following names:
| Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Holland, Portugal, Spain, Sweden, England | Mydriasert |