0.2 mg / ml + 3.1 mg / ml + 10 mg / ml solution for injection
tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
What Mydrane is and what it is used for
What Mydrane is
This medicine is a solution that is injected into the eye.
It contains three active substances:
- tropicamide, which belongs to a group of medicines that block the impulse transmission via certain nerves (called anticholinergics)
- phenylephrine (as phenylephrine hydrochloride) which belongs to a group of medicines that mimic the effects of impulses transmitted through certain nerves (called alpha-sympathomimetics)
- lidocaine (as lidocaine hydrochloride) which belongs to a group of medicines called amide-type local anesthetics.
What it is used for
This medicine is for adults only.
Your eye surgeon will give this medicine as an injection into the eye at the beginning of cataract surgery (clouding of the lens) to dilate the pupil ( mydriasis ) and to numb the eye during the operation.
What you need to know before you get Mydrane
You should not be given Mydrane:
- if you are allergic to tropicamide, phenylephrine hydrochloride and / or lidocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to amide-type anesthetics (articles, bupivacaine, mepivacaine, prilocaine, ropivacaine)
- if you are allergic to atropine-like medicines.
Warnings and cautions
Mydrane is not recommended:
- if cataract surgery is performed in combination with a certain other eye surgery (vitrectomy)
- if the front part (front chamber) of your eye is shallow
- if you have previously had a sudden increase in eye pressure ( acute narrow-angle glaucoma ).
Talk to a doctor especially if you have:
- high blood pressure ( hypertension )
- thickening of the artery wall (atherosclerosis)
- any heart disease and especially if it affects the heart rate
- any obstacle ( contraindication ) to the use of antihypertensive drugs (amine-type antihypertensive drugs: adrenaline , noradrenaline , dopamine , dobutamine )
- overactive thyroid gland ( hyperthyroidism )
- disorder of the prostate
- seizures ( epilepsy )
- any liver disease or kidney problem
- breathing problems
- loss of muscle function and weakness ( myasthenia gravis ).
Other medicines and Mydrane
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
This medicine should not be used:
- during pregnancy
- during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Mydrane has a moderate effect on the ability to drive and use machines. Therefore, do not drive or use machines until your vision has returned to normal.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Mydrane contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How Mydrane should be given
You should only receive this medicine if you have received sufficient pupil dilation during the examination before the operation, through treatment with pupil dilating (mydriatic) eye drops.
Dosage and route of administration
- The eye surgeon will inject Mydrane under local anesthesia at the beginning of the cataract surgery.
- The recommended dose is 0.2 ml solution as a single injection . No additional dose should be injected as no additional effect has been demonstrated and as increased loss of endothelial cells (cells covering the back of the cornea) has been observed.
- The same dose is used for both adults and the elderly.
If you get more or less Mydrane
This medicine will be given by an eye surgeon. It is unlikely that you will get an overdose. Too much can increase the loss of corneal endothelial cells (cells that cover the back of the cornea).
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious well-known complications during or after cataract surgery:
Uncommon: may affect up to 1 in 100 people
- damage to the lens of the eye ( rupture of the posterior capsule)
- swelling of the retina (cystic macular edema).
In these cases, you should seek medical attention immediately.
Other side effects:
Uncommon: may affect up to 1 in 100 people
- headache
- corneal swelling ( keratitis ), increased eye pressure, redness of the eye ( ocular hyperemia )
- high blood pressure ( hypertension ).
How to store Mydrane
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 carton, blister, and ampoule. The expiration date is the last day of the specified month.
No special storage instructions.
For single use in one eye. This medicine should be used immediately after opening the ampoule.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances are 0.04 mg tropicamide, 0.62 mg phenylephrine hydrochloride and 2 mg lidocaine hydrochloride per 0.2 ml dose , corresponding to 0.2 mg tropicamide, 3.1 mg phenylephrine hydrochloride and 10 mg lidocaine hydrochloride per 1 ml.
- The other ingredients are sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate disodium edetate and water for injections.
What the medicine looks like and contents of the pack
Mydrane is a clear, slightly brownish-yellow solution for injection that is practically free of visible particles. It comes in a 1 ml brown glass ampoule. Each sterile ampoule contains 0.6 ml of injection liquid and is packaged separately or together with a 5-micrometer filter needle in a paper / PVC blister.
One carton contains 1, 20, or 100 sterile ampoules and the same number of sterile needles with 5-micrometer filters packaged either separately or together in a blister pack. The cannula with a 5-micrometer filter is intended only for drawing up the contents of the ampoule one. All equipment is for single use only.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
The Laboratories
12, Rue Louis Bleriot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
Delpharm Tours
Rue Paul Langevin
37170 Chambray Les Tours
France
or
The Laboratories
12, Rue Louis Bleriot
63017 Clermont-Ferrand Cedex 2
France
This medicinal product is authorized under the European Economic Area under the names:
Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Greece, Iceland, Italy, Croatia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, Czech Republic, Germany, Austria: Mydrane
Ireland, Spain: Fydrane
Norway: Mydane