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.
Mydriasert 0.28 mg/5.4 mg ophthalmic insert
⚠ 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 Phenylephrine hydrochloride, Tropicamide 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
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.
What you need to know before you take it
E 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 6.1),
- In patients with closed angle glaucoma or at risk of precipitated glaucoma (increase in ocular pressure).
- In children below the age of 12 years. WARNINGS AND PRECAUTIONS
- 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.
1
–
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.
Children and adolescents Mydriasert should not be used in children below the age of 12 years as children appear more sensitive to the risk of serious side effects. Mydriasert is not recommended to be used in children aged 12 to 18 years as adequate clinical experience is missing. Other medicines and MYDRIASERT 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, have recently taken or might take 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 take it
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 mydriatic 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, pharmacist or nurse.
4.
Possible side effects
2
Like all medicines, this medicine can cause side effects, although not everybody gets them. Common: may affect up to 1 in 10 people:
- stinging,
- blurred vision,
- visual discomfort due to perception of the presence or shifting of the insert. Uncommon: may affect up to 1 in 100 people:
- tearing,
- irritation,
- dazzle due to the prolonged dilation of the pupil,
- superficial punctuate keratitis (inflammation of cornea). Rare: may affect up to 1 in 1,000 people:
- allergic reactions: inflammation of eyelids (blepharitis), inflammation of the conjunctiva (conjunctivitis). Very rare: may affect up to 1 in 10,000 people:
- convulsions. 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. 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. Additional side effects in children: Frequency not known (cannot be estimated from the available data):
- Fluid or swelling in the lungs,
- Paleness around the eyes in preterm babies. 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. Web site: 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
MYDRIASERT
Keep out of the sight and reach of children. Do not use after the expiry date which is stated on the sachet after 'EXP'. Do not store above 25C. Use immediately after sachet opening. Do not use MYDRIASERT if you notice deterioration of the sachet closure or of the insert.
3
6.
Contents of the pack and other 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 and Manufacturer Marketing Authorisation Holder: Laboratoires Théa 12, Rue Louis Blériot 63017 CLERMONT-FERRAND Cedex 2 – FRANCE Manufacturer: BENAC 27A, avenue Paul Langevin 17180 PERIGNY – FRANCE or BENAC 5 rue Albert Turpain 17000 LA ROCHELLE – FRANCE
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.
This leaflet was last revised in 04/2025.
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 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. Paediatric population
4
Mydriasert is contraindicated in children aged below 12 years. There are no data in children aged 12 to 18 years. Mydriasert is not recommended in these patients.
METHOD OF ADMINISTRATION The sealed edge should be cut along the dotted line, the sachet opened and the insert located. The lower eyelid is 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).
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)
5
Frequently asked questions about Mydriasert 0.28 mg/5.4 mg ophthalmic insert
What is the active substance in Mydriasert 0.28 mg/5.4 mg ophthalmic insert?
The active substance in Mydriasert 0.28 mg/5.4 mg ophthalmic insert is phenylephrine hydrochloride, tropicamide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Mydriasert 0.28 mg/5.4 mg ophthalmic insert, 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 Mydriasert 0.28 mg/5.4 mg ophthalmic insert 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: phenylephrine hydrochloride, tropicamide
- 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
Mydriasert is indicated:
- to obtain pre-operative mydriasis,
- or for diagnostic purposes when monotherapy is known to be insufficient.
4.2. Posology and method of administration
Restricted use to health-care professionals.
Posology
One ophthalmic insert per operated eye, a maximum of 2 hours before surgery or the investigative procedure (see also 5.1).
Paediatric population
Mydriasert is contraindicated in children aged below 12 years (see section 4.3).
There are no data in children aged 12 to 18 years. Mydriasert is not recommended in these patients.
Method of administration
Cut the sealed edge along the dotted line, open the sachet and locate the insert.
Hold the insert with disposable sterile forceps with rounded ends provided in the packaging, making sure not to damage it.
Pull down the lower eyelid by pinching it between the thumb and index finger (A), and apply the ophthalmic insert, using the disposable sterile forceps, in the lower conjunctival sac (B).
Instructions for use
Do not leave the ophthalmic insert 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, and at the latest within the next 30 minutes.
In the event of discomfort, ensure that the insert has been placed correctly at the base of the lower conjunctival sac.
Manipulate aseptically. It is recommended to avoid excessive manipulation of eyelids.
CAUTION: Removal of the ophthalmic insert
Before an operation or procedure, and as soon as the required mydriasis has been obtained, the ophthalmic insert should be removed from the lower conjunctival sac (C) by using either sterile surgical forceps, or a sterile swab or a sterile irrigation or washing solution, by lowering the lower eyelid.
Do not reuse the insert. Discard the insert after use immediately.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Risk of angle-closure glaucoma: Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with narrow angle prone to glaucoma precipitated by mydriatics.
Children aged below 12 years (see section 4.4).
4.4. Special warnings and precautions for use
Special warnings:
Because this medicinal product causes long lasting visual disturbances, the patient should be advised to be accompanied when attending the consultation (see section 4.8).
Protect the eye against bright lighting after the end of intervention/consultation.
Ocular hyperemia can increase the absorption of the active ingredients contained in the insert.
Special precautions for use:
The shifting or, more rarely, the expulsion of the insert is possible. In this case, do not re use the removed insert, take a new one (see section 4.2).
Mydriasert should not be left in the conjunctival sac for more than 2 hours. In cases where Mydriasert was forgotten, local adverse reactions were observed (see section 4.8).
Because of uncommon potential irritation on conjunctiva, special care should be taken with patients suffering from severe dry eyes (use of Mydriasert in some patients may necessitate the addition of a drop of saline solution to improve insert tolerance).
All mydriatic agents may trigger an acute attack of glaucoma through the mechanical obstruction of the excretory pathways of aqueous humour in subjects presenting with a narrow iridocorneal angle.
Although not anticipated with Mydriasert due to negligible systemic passage of active ingredients, it is however 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.
Sportsmen and athletes should be warned that this proprietary medicinal product contains an active principle (phenylephrine) which may produce positive results to tests for prohibited substances.
The wearing of soft hydrophilic contact lenses is inadvisable during treatment.
After the insertion of Mydriasert, and if the administration of other mydriatic agents cannot be avoided, account must be taken of the doses in the insert of approximately one drop of a 10% solution of phenylephrine and approximately one drop of a 0.5% solution of tropicamide.
Paediatric population
Use in children aged below 12 years is contraindicated, since serious systemic adverse reactions have been reported with ophthalmic products containing phenylephrine and tropicamide particularly in the paediatric population, such as cardiovascular derangement with severe hypertension, heart rate alterations, and pulmonary oedema.
Compared with adults, children below 12 years appear more sensitive.
Use in children aged 12 to 18 years is not recommended as adequate clinical experience is missing.
4.5. Interaction with other medicinal products and other forms of interaction
No specific studies interaction studies have been performed with Mydriasert.
4.6. 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, embryonal/foetal development, parturition and postnatal development (see section 5.3).
Even though a negligible systemic uptake is expected, a low systemic exposure can not be excluded.
Therefore, Mydriasert should not be used during pregnancy unless necessary.
Lactation
No data are available concerning the passage 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.
Therefore, Mydriasert should not be used during breast feeding.
4.7. Effects on ability to drive and use machines
Mydriasert has major influence on the ability to drive and use machines.
Patients should be warned of the risks related to mydriatic and cycloplegic agents, which may cause visual disturbances like dizziness, drowsiness and impaired concentration: application of the Mydriasert ophthalmic insert causes disabling mydriasis for several hours; consequently, after application, the patient should be advised not to drive and/or use machines while the visual disturbances persist and/or not to perform other hazardous activities.
4.8. Undesirable effects
The following transient effects have been reported during clinical studies and in post-marketing safety data:
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) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
System Organ Class
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
Nervous system disorders
Convulsions
Eye disorders
Stinging;
Blurred vision;
Visual discomfort.
Tearing;
Irritation;
Disabling mydriasis because of prolonged pupil dilation;
Photophobia;
Superficial punctuate keratitis.
Blepharitis;
Conjunctivitis;
Risk of angle-closure glaucoma;
Intraocular hypertension.
Very rare cases of corneal ulcer and corneal oedema were observed due to forgotten insert.
Although administered via the topical route, the mydriatic agents contained in this insert may cause the following systemic effects which must be taken into account:
-elevation of blood pressure, tachycardia,
-very rarely, major accidents such as cardiac arrhythmia,
-tremor, pallor, headaches, dry mouth.
Paediatric population
- Eye disorders:
Periorbital pallor in preterm patients – Frequency not known (cannot be estimated from the available data).
- Respiratory, thoracic and mediastinal disorders:
Pulmonary oedema – Frequency not known (cannot be estimated from the available data).
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
Although unlikely due to single administration of Mydriasert (for either pre-operative or diagnostic purposes), a risk of overdose may nevertheless occur in the event of the additional instillation of mydriatic eyedrops.
Symptoms of a phenylephrine overdose include 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 alphaadrenergic blocking agent such as phentolamine (dose 2 to 5 mg i.v.) has been recommended.
Symptoms of tropicamide ophthalmic overdoses 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Phenylephrine hydrochloride, Tropicamide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- FENEFRIN 100 mg/ml prescription partial — not the same combinationPHENYLEPHRINUM · eye / ear / nose
- BIOFLU NAZAL 2,5 mg/ml over the counter partial — not the same combinationPHENYLEPHRINUM · eye / ear / nose
- BIOFLU NAZAL 5 mg/ml over the counter partial — not the same combinationPHENYLEPHRINUM · eye / ear / nose
- TROPICAMIDA ROMPHARM 5 mg/ml prescription partial — not the same combinationTROPICAMIDUM · eye / ear / nose
- TROPICAMIDA ROMPHARM 10 mg/ml prescription partial — not the same combinationTROPICAMIDUM · eye / ear / nose
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. 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 Phenylephrine hydrochloride, Tropicamide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Neosynephrin-Pos 10% partial — not the same combinationPhenylephrinum · eye / ear / nose
- Tropicamidum WZF 0,5% partial — not the same combinationTropicamidum · eye / ear / nose
- Tropicamidum WZF 1% partial — not the same combinationTropicamidum · eye / ear / nose
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 Mydriasert 0.28 mg/5.4 mg ophthalmic insert. 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.