Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tropicamide, Lidocaine hydrochloride, Phenylephrine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What MYDRANE is This medicine is a solution which is injected into the eye. It contains three active substances:
- tropicamide which belongs to a group of medicines blocking the passage of impulses through particular nerves (known as anticholinergics),
- phenylephrine (as phenylephrine hydrochloride) which belongs to a group of medicines mimicking the effects of impulses conveyed through particular nerves (known as alpha sympathomimetics),
- lidocaine (as lidocaine hydrochloride monohydrate) which belongs to a class of drugs called amide type local anaesthetics. What it is used for This medicine is used in adults only. It will be administered by your ophthalmic surgeon by injection into the eye at the beginning of cataract surgery (cloudiness of the lens), in order to enlarge the pupil of your eye (mydriasis) and to obtain anaesthesia in your eye during the surgical procedure. 2.
What you need to know before you take it
MYDRANE
You should not be given MYDRANE:
- if you are allergic to tropicamide, phenylephrine hydrochloride and/or lidocaine hydrochloride monohydrate or to any of the other ingredients of this medicine (listed in section 6),
- if you are allergic to anaesthetics of the amide type (articaine, bupivacaine, mepivacaine, prilocaine, ropivacaine),
- if you are allergic to atropine derivatives. Warnings and precautions
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MYDRANE is not recommended:
- in combined cataract surgery with a certain type of eye surgery (vitrectomy),
- if the anterior part (anterior chamber) of your eye is shallow,
- if you have a history of acute increase of eye pressure (acute narrow angle glaucoma). You should talk to your doctor in particular if you have:
- high blood pressure (hypertension),
- thickening of the arterial wall (atherosclerosis),
- any heart disease and particularly if it affects the heart rate,
- a contraindication to medicines that increased blood pressure (pressor amines: epinephrine, norepinephrine, dopamine, dobutamine) by general route,
- overactive thyroid gland (hyperthyroidism),
- prostate gland disorders,
- fits (epilepsy),
- any liver diseases or kidney problems,
- any problems with your breathing,
- 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, breast-feeding and fertility This medicine should not be used:
- during pregnancy,
- during breast-feeding. If you are pregnant or breast-feeding, 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 influence on the ability to drive and use machines. Consequently, you should not drive and/or use machines until vision is normal. MYDRANE contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free". 3.
How is administered
You should only be given this medicine if you have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy. Dose and method of administration
- MYDRANE injection will be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataract surgery.
- The recommended dose is 0.2 ml of solution, in only one injection. No additional dose should be injected as no additional effect has been shown and as increased loss of endothelial cells (cells of a layer covering the posterior surface of the cornea) has been observed.
- The same dose is used for both adults and the elderly. If you are given too much, or too little, MYDRANE: Your medication will be given by an ophthalmic surgeon. It is unlikely that you will be given an overdose. Overdosage can cause increased loss of corneal endothelial cells (cells of a layer covering the posterior surface of the cornea). If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most serious well known complications occurring during or after cataract surgery: Uncommon: may affect up to 1 in 100 people
- Injury to the lens (posterior capsule rupture),
- Swelling of the retina (cystoid macular oedema). Please seek urgent medical advice in this case. Other side effects: Uncommon: may affect up to 1 in 100 people
- Headache,
- Swelling of the cornea (keratitis), increased pressure in the eye, redness of the eye (ocular hyperaemia),
- High blood pressure (hypertension).
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
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 expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. For single eye use only. This medicine should be used immediately after first opening of the ampoule. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What MYDRANE contains
- The active substances are tropicamide 0.04 mg, phenylephrine hydrochloride 0.62 mg and lidocaine hydrochloride monohydrate 2 mg for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride monohydrate for 1 ml.
- The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate, disodium edetate and water for injections. What looks like and contents of the pack MYDRANE is a clear, slightly brownish-yellow solution for injection, practically free from visible particles solution for injection and supplied in a 1 ml brown glass ampoule. Each sterile ampoule contains 0.6 ml of solution for injection and is presented alone or together with one sterile 5 micrometers filter needle in a sealed paper/PVC blister.
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Each box contains 1 or 20 or 100 sterile ampoules with 5 micrometers sterile filter needle(s) apart or in the same blister. The 5 micrometers filter needle(s) should be used only for the withdrawal of the vial contents. All components are for single-use only. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder LABORATOIRES THEA 12, RUE LOUIS BLERIOT 63017 CLERMONT-FERRAND CEDEX 2 FRANCE Manufacturer DELPHARM TOURS RUE PAUL LANGEVIN 37170 CHAMBRAY LES TOURS FRANCE or LABORATOIRES THEA 12, RUE LOUIS BLERIOT 63017 CLERMONT-FERRAND CEDEX 2 FRANCE This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Greece, Finland, France, Croatia, Iceland, Italy, Luxembourg, The Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovak Republic, United Kingdom …………………………………………………………………………………………………….. Mydrane Ireland, Spain………………………………………………………………………………………………………………………….Fydrane Norway ………………………………………………………………………………………………………………………………….Mydane This leaflet was last revised in 03/2022
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at THEA Pharmaceuticals Ltd, telephone number 0345 521 1290. —————————————————————————————————————————–
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The following information is intended for medical or healthcare professionals only: Incompatibilities No incompatibility with most commonly used products in cataract surgery was reported in literature with the active ingredients, and during clinical trials. For usual viscoelastics, this was also confirmed by pharmaceutical interaction test. Warning Do not use if the blister is damaged or broken. Open under aseptic conditions only. The content of the unopened blister is guaranteed to be sterile. How to prepare and administer MYDRANE Single-eye use solution for intracameral use only. MYDRANE must be administered by intraocular injection into the anterior chamber of the eye (intracameral injection), by an ophthalmic surgeon, in the recommended aseptic conditions of cataract surgery. Before intracameral injection, the solution should be visually inspected and should only be used if it is clear, slightly brownish-yellow and practically free from visible particles. The recommended dose is 0.2 ml of MYDRANE; no additional dose should be injected as no significant add-on effect has been demonstrated and as increased endothelial cell loss was observed. The product should be used immediately after opening of the ampoule and not be reused for the other eye or any other patient. Only for the presentation in kit (i.e. blister containing an ampoule and a needle) : stick the flag label of the blister on the patient file.
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To prepare MYDRANE for intracameral administration, please adhere to the following instructions:
or 1.
Inspect unopened blister to ensure that it is intact. Peel open blister under aseptic conditions to guarantee the sterility of the content.
2.
Break open the sterile ampoule containing the drug product. The One Point Cut (OPC) ampoule must be opened as follows: Hold the bottom part of the ampoule with the thumb pointing to the coloured point. Grasp the top of the ampoule with the other hand, positioning the thumb at the coloured point and press back to break at the existing cut under the point.
3.
Assemble the 5-micron filter sterile needle (provided) onto a sterile syringe. Remove the 5-micron filter sterile needle protector and withdraw at least 0.2 ml of the solution for injection from the ampoule into the syringe.
4.
Disconnect the needle from the syringe and assemble the syringe with an appropriate anterior chamber cannula.
5.
Carefully expel the air from the syringe. Adjust to 0.2 ml. The syringe is ready for injection.
6.
Inject slowly the 0.2 ml syringe volume into the anterior chamber of the eye, in only one injection, through the side port or principal port.
After use, discard the remaining solution. Do not keep it for subsequent use. Any unused product or waste material should be disposed of in accordance with local requirements. Discard used needles in a sharps container.
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Frequently asked questions about Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection
How do I take Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection?
Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection comes as injection containing 0.2mg/ml / 3.1mg/ml / 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection?
The active substance in Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection is tropicamide, lidocaine hydrochloride, phenylephrine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tropicamide, lidocaine hydrochloride, phenylephrine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Mydrane is indicated for cataract surgery to obtain mydriasis and intraocular anaesthesia during the surgical procedure.
Mydrane is indicated in adults only.
4.2. Posology and method of administration
Intracameral use. One ampoule for single eye use.
Mydrane must be administered by an ophthalmic surgeon.
Posology
Mydrane should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy.
Adults:
Slowly inject, by intracameral route, 0.2 ml of Mydrane in one injection, at the start of the surgical procedure.
Special population
Elderly:
No dose adjustment is necessary.
Paediatric population:
The safety and efficacy of Mydrane in children aged 0 to 18 years have not been established.
Patients with renal impairment:
Considering the low dose and the very low systemic exposure (see section 5.2), no dose adjustment is necessary (see section 4.4).
Patients with hepatic impairment:
Considering the low dose and the very low systemic exposure (see section 5.2), no dose adjustment is necessary.
Method of administration
Intracameral use.
The following procedure should be followed:
1. Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anaesthetic eye drops should be instilled in the eye.
2. At the beginning of surgery, 0.2 ml of Mydrane is slowly injected in only one injection by an ophthalmic surgeon, via intracameral route, through the side port or principal port.
For instructions on handling the medicinal product before administration, see section 6.6.
4.3. Contraindications
- Hypersensitivity to the active substances (tropicamide, phenylephrine hydrochloride and lidocaine hydrochloride monohydrate) or to any of the excipients listed in section 6.1.
- Known hypersensitivity to anaesthetics of the amide type.
- Known hypersensitivity to atropine derivatives.
4.4. Special warnings and precautions for use
Special warnings:
The recommended dose is 0.2 ml of Mydrane; no additional dose should be injected as no significant add-on effect has been demonstrated, and as increased endothelial cell loss was observed (see also section 4.9).
Corneal endothelial toxicity has not been reported at the recommended dose of Mydrane; nevertheless, due to limited data, this risk cannot be excluded.
There is no clinical experience with Mydrane in:
- insulin-dependent or uncontrolled diabetic patients,
- patients with corneal disease, especially those with any coexisting endothelial cell impairment,
- patients with history of uveitis,
- patients with pupillary abnormalities or presenting an ocular traumatism,
- patients with very dark irides,
- cataract surgery when combined with corneal transplantation.
There is no experience in patients at risk of floppy iris syndrome with Mydrane. Such patients should benefit of a step-by-step pupil dilation strategy starting with the administration of mydriatic eye drops.
There is no clinical experience during cataract surgery with Mydrane in patients treated with topical mydriatics and for whom pupil constriction (or even miosis) occurs during surgery.
Mydrane is not recommended to be used in cataract surgery when combined with vitrectomy, due to the vasoconstricting effects of phenylephrine.
Mydrane is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma.
Use of Mydrane in patients with shallow anterior chamber, a history of acute narrow angle glaucoma and/or insufficient pupil dilation can increase the risk of both iridocele and floppy iris syndrome.
Special precautions for use:
Mydrane was shown to produce undetectable or very low systemic concentrations of active substances (see section 5.2). Since systemic effects of phenylephrine and lidocaine are dose dependent, it is unlikely that these effects occur with Mydrane. However, as the risk cannot be excluded, it is reminded that:
- Phenylephrine has sympathomimetic activity that might affect patients in the event of hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders and all subjects presenting with a contraindication to the systemic use of pressor amines;
- Lidocaine should be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Mydrane.
Since the systemic exposure is expected to be very low (see section 5.2), systemic interactions are unlikely.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of phenylephrine and tropicamide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonic/foetal development, parturition and postnatal development.
Although animal studies have revealed no evidence of harm to the foetus, lidocaine crosses the placenta and should not be administered during pregnancy.
Even though a negligible systemic uptake is expected, a low systemic exposure cannot be excluded.
Therefore, Mydrane should not be used during pregnancy.
Breastfeeding
No data are available concerning the secretion of phenylephrine or tropicamide into breast milk. However, phenylephrine is poorly absorbed orally, implying that absorption by the infant would be negligible. On the other hand, infants may be very sensitive to anticholinergics, and despite the expected negligible systemic exposure, tropicamide is therefore not recommended during breast feeding.
Small amounts of lidocaine are secreted into breast milk and there is a possibility of an allergic reaction in the infant.
Therefore, Mydrane should not be used during breast feeding.
Fertility
There is no information on whether Mydrane may affect fertility in human males or females.
4.7. Effects on ability to drive and use machines
Mydrane has a moderate influence on the ability to drive and use machines, due to its mydriatic effect. Consequently, after cataract surgery with one Mydrane injection, the patient should be advised not to drive and/or use machines while the visual disturbances persist.
4.8. Undesirable effects
Adverse reactions were reported with Mydrane during clinical trials (see section 5.1). Most were ocular and of mild to moderate intensity.
Summary of the safety profile:
Posterior capsule rupture and cystoid macular oedema are well known complications occurring during or after cataract surgery. They may occur uncommonly (less than 1 case per 100 patients).
Tabulated list of adverse reactions:
Adverse events are categorised by frequency as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from available data).
Adverse reactions, reported during clinical trials, are presented according to System Organ Class in the table below in order of decreased seriousness within each frequency grouping:
System Organ class
Frequency
Adverse reaction
Nervous system disorders
uncommon
Headache
Eye disorders
uncommon
Keratitis, Cystoid macular oedema, Intraocular pressure increased, Posterior capsule rupture, Ocular hyperaemia
Vascular disorders
uncommon
Hypertension
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
Systemic effects
Due to single administration and low expected systemic passage of Mydrane, the risk of systemic effects due to overdose is considered minimal.
The symptoms of phenylephrine ophthalmic overdose are likely to be effects resulting from systemic absorption, including extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.
Because severe toxic reaction to phenylephrine is of rapid onset and short duration, treatment is primarily supportive. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine (dose 2 to 5 mg in intravenous use) has been recommended.
The symptoms of tropicamide ophthalmic overdose include headache, fast heartbeat, dry mouth and skin, unusual drowsiness, and flushing.
Systemic effects from tropicamide are not expected. Should an overdose occur causing local effects, e.g. sustained mydriasis, pilocarpine or 0.25% w/v physostigmine should be applied.
In the event of excessive absorption of lidocaine into the bloodstream, symptoms may include CNS effects (such as convulsions, unconsciousness and possibly respiratory arrest) and cardiovascular reactions (such as hypotension, myocardial depression, bradycardia and possibly cardiac arrest).
Treatment of a patient suffering from systemic toxicity of lidocaine consists of arresting the convulsions and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (respiration).
Local effects
Overdosage can cause endothelial cell loss (see section 4.4 and 5.1).
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- MYDRANE 0,2 mg/ml+3,1 mg/ml+10 mg/ml prescriptionCOMBINATII (TROPICAMIDUM+PHENYLEPHRINUM+LIDOCAINUM) · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Tropicamide, Lidocaine hydrochloride, Phenylephrine hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Phenylephrine Aguettant partial — not the same combinationPhenylephrinum · injection / infusion
- Biorphen partial — not the same combinationPhenylephrini hydrochloridum · injection / infusion
- Lignocain 2% partial — not the same combinationLidocaini hydrochloridum · injection / infusion
- Xylocaine 2% partial — not the same combinationLidocaini hydrochloridum · injection / infusion
- Xylodont 2% partial — not the same combinationLidocaini hydrochloridum · injection / infusion
- Lidocaine Grindeks partial — not the same combinationLidocaini hydrochloridum · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.