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.

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Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution

⚠ 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 may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Phenylephrine hydrochloride
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Minims® Phenylephrine Hydrochloride contains a mydriatic agent. It is used to enlarge the pupil of your eye. Your doctor or eye specialist may use it to examine your eye more closely or as part of a treatment program. Minims® Phenylephrine Hydrochloride 2.5% is indicated for children, adults and the elderly. Minims® Phenylephrine Hydrochloride 10% is not indicated for children or the elderly, as this concentration is too strong. The doctor or eye specialist will use an alternative medicine in these patients.

What you need to know before you take it

e Minims® Phenylephrine Hydrochloride eye drops Do not use Minims® Phenylephrine Hydrochloride drops:

  • If you are allergic to the active substance (phenylephrine) or any of the other ingredients of this medicine (listed in section 6).
  • If you have a heart disease.
  • If you have fast heartbeats (tachycardia).
  • If you have high blood pressure.
  • If you have bulges in major blood vessels (aneurysms).
  • If you have an overactive thyroid gland (hyperthyroidism).
  • If you have high blood sugar level (diabetes mellitus).
  • In patients on monoamine oxidase inhibitors, tricyclic antidepressants and anti-hypertensive agents (including beta-blockers).
  • In patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with a narrow angle prone to glaucomaprecipitated by mydriatics.
  • In patients wearing contact lenses. Do not use Minims® Phenylephrine Hydrochloride 10% in children below the age of 12 years. Warnings and precautions Use with caution in the elderly. Minims® Phenylephrine Hydrochloride 10% should not be used in children below the age of 12 years as children appear more sensitive to the risk of serious side effects. Minims® Phenylephrine Hydrochloride 10% is not recommended to be used in children aged 12 to 18years as adequate clinical experience is missing.

Ask yourself the following questions:

  • Do you have narrow arteries in the head (cerebral arteriosclerosis)?
  • Do you have asthma?
  • Do your eyes develop increased internal pressure when the pupil is enlarged? The doctor or eye specialist will have checked to make sure that this problem will not affect you.
  • Are your eyes red or inflamed? If the answer to any of these questions is yes, tell your doctor or eye specialist. The active substance can cause the cornea to become cloudy if the surface of the cornea is damaged. The cornea is the transparent membrane covering the surface of the eye. Your doctor or eye specialist will take this into account before deciding to give you these eye drops. Other medicines and Minims® Phenylephrine Hydrochloride Tell your doctor or eye specialist if you are taking, have recently taken or might take any other medicines.
  • Medicines for depression
  • Any medicines to reduce your blood pressure (including medicines called betablockers)
  • Medicines to treat irregular heartbeats (quinidine or medicines called cardiac glycosides) The active substance can react with several types of anaesthetic (e.g. halothane). Your doctor will know about this. If you are having an operation your doctor will make sure that this problem does not affect you. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or eye specialist for advice before taking this medicine as he/ she may decide to use these drops or to prescribe you an alternative. Contact lenses Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off. Driving and using machines Some people find bright light (such as daylight) uncomfortable for a few hours after receiving Minims® Phenylephrine Hydrochloride. This may make it difficult for you to drive. As with all eye drops, your vision may be blurred after putting the drops in. Wait until your vision is clear before driving or using machines.

How to take it

Minims® Phenylephrine Hydrochloride eye drops Sometimes a drop of local anaesthetic may be used prior to Minims® Phenylephrine Hydrochloride to prevent the stinging effect of phenylephrine eye drops. The drops are for single use only and provided in single use Minims units, to treat both eyes if both eyes are affected. Once opened, use immediately. Discard any unused portion. Dosage The recommended dose is one drop in each eye. If necessary this can be repeated once only at least one hour after the first drop. Phenylephrine 2.5% w/v: For examination of the eye, the normal dose for adults, elderly and children, is one drop in each eye. If necessary this can be repeated once only at least one hour after the first drop. Phenylephrine 10% w/v: For adults the same dose is recommended. However, Minims Phenylephrine 10% w/v should not be used in children below the age of 12 years. Phenylephrine 10% w/v is not recommended for use in children aged 12 to 18 years or elderly patients. If you are

receiving this product as part of a treatment programme your doctor may suggest an additional dose schedule of one drop every 24 hours of the 2.5% w/v product. Method of administration Parents must be careful not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration. The doctor or eye specialist will normally put the drops in your eye for you, but if you are putting the eye drops in yourself, then follow these instructions carefully: 1. Wash your hands. 2. Use a mirror, this will help you to see what you are doing. 3. Carefully dry your eyes using a tissue. Twist and pull cap to separate from the Minims body (Diagram 1). 4. Pull your lower eyelid down gently, and then carefully place 1 drop inside your lower eyelid. 5. Close your eye and blink a few times to make sure your eye is covered by the liquid. 6. Close the eyelids. It is advisable to press gently on the inner corner of your eyelid for 3 minutes. This will help stop the solution draining into your nose and throat. 7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw away the Minims unit, even if some solution remains.

If you use more Minims® Phenylephrine Hydrochloride than you should, an overdose is very unlikely to occur. If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately. If you forget to use Minims® Phenylephrine Hydrochloride, you should take the missed dose as soon as you remember, unless it is nearly time for the next dose, but you should not take a double dose to make up for a missed dose.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Minims® Phenylephrine Hydrochloride may sting when the drops are first put in and your vision may become blurred. This will gradually wear off. Serious side effects

  • Rarely, more serious reactions, including spasm of the artery of the heart, heart irregularities and heart attacks, have been reported after using phenylephrine solutions. These have usually occurred in patients using some 10 % phenylephrine and already suffering from heart disease. Other side effects Not known: frequency cannot be estimated from the available data.
  • In some cases bright light can be uncomfortable for a few hours after receiving the drops.
  • Occasionally allergic reactions or conjunctival sensitivity (abnormal sensitivity of the conjunctiva (thin, clear, moist membrane that coats the white outer surface of the eye) to various substances with discomfort upon instillation) can occur.
  • The active substance can sometimes affect your circulatory system, causing increased blood pressure and palpitations (a sensation in which a person is aware of an irregular, hard, or rapid heartbeat), tachycardia (fast heartbeats) and other heart irregularities (extrasystoles and cardiac arrythmias).
  • Paleness around the eyes in preborn babies (this is relevant to the 2.5% formulation). Additional side effects in children: Not known: frequency cannot be estimated from the available data
  • Fluid or swelling in the lungs (this is relevant to the 10% formulation). Reporting of side effects If you or your child get any side effects, talk to your doctor, the doctor treating your child or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: The Yellow Card Scheme at: 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.

How to store it

your eye drops Keep this medicine out of the sight and reach of children. Do not use the eye drops after the expiry date which is stated on the overwrap of each unit and on the carton after the letters "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light. The drops are for single use only and provided in single use Minims units, to treat both eyes if both eyes are affected. Once opened, use immediately. Discard any unused portion. 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

What do your eye drops contain

  • The active ingredient is phenylephrine hydrochloride. Each Minims unit contains approximately 0.5 ml eye drops solution of Phenylephrine hydrochloride 2.5% w/v (12.5 mg) or 10% w/v (50 mg).
  • The other ingredients are sodium metabisulphite (E223), disodium edetate and purified water. This medicine does not contain a preservative as it is a sterile single use unit. Contents of the pack Each carton contains 20 units. Marketing Authorisation Holders: UK Bausch & Lomb UK Ltd. 106 London Road – Kingston-upon-Thames – KT2 6TN – UK Manufacturer: Laboratoire Chauvin Zone Industrielle de Ripotier 50 Avenue Jean Monnet 07200 Aubenas France This leaflet was last revised in: November 2023

Frequently asked questions about Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution

How do I take Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution?

Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution comes as eye drops containing 2.5%. 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 Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution?

The active substance in Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution is phenylephrine hydrochloride.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution, 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 Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Phenylephrine hydrochloride (60 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. It may be indicated to dilate the pupil for diagnostic or therapeutic procedures.

4.2. Posology and method of administration

Posology

Adults, including the elderly population

Apply one drop topically to each eye. If necessary, this dose may be repeated once only, at least one hour after the first drop.

Paediatric population

Apply one drop topically to the eye. It is not usually necessary to exceed this dose.

Phenylephrine 2.5%w/v eye drops may be combined with other mydriatics/cycloplegics to produce adequate mydriasis/cycloplegia. Heavily pigmented irides may require larger doses and caution should be exercised to avoid overdosage.

The use in preterm and newborn infants is not recommended unless clearly necessary and only with caution because of safety concerns associated with the risk of systemic adverse reactions including transient increases in blood pressure. If treatment is medically justified the lowest possible concentration and dose should be used and instillation of more than one drop per eye must be avoided (see section 4.4).

Method of administration

The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.

Especially in infants, children and the elderly, it is advised to minimise systemic absorption and the risk for systemic adverse reactions by compressing the lacrimal sac at the medial canthus or gently closing the eye for a few minutes after instillation. To minimise cutaneous absorption, excess fluid should be wiped away from the periocular area (see also section 4.4).

4.3. Contraindications

Patients with cardiac disease, hypertension, aneurysms, thyrotoxicosis, long-standing insulin dependent diabetes mellitus and tachycardia.

Patients on monoamine oxidase inhibitors, tricyclic antidepressants and anti-hypertensive agents (including beta-blockers).

Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with a narrow angle prone to glaucoma precipitated by mydriatics.

Newborns and infants with cardio- and cerebrovascular disease.

Elderly adults with severe arteriosclerotic, cardiovascular or cerebrovascular disease.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Use with caution in elderly or in patients with sympathetic denervation (e.g. patients with insulin dependent diabetes), orthostatic hypotension, hypertension, hyperthyroidism.

Use with caution in patients with cerebral arteriosclerosis or long-standing bronchial asthma.

To reduce the risk of precipitating an attack of narrow angle glaucoma, evaluate the anterior chamber angle before use.

Ocular hyperaemia can increase the absorption of phenylephrine given topically.

Corneal clouding may occur if phenylephrine 10% is instilled when the corneal epithelium has been denuded or damaged.

Use of a drop of topical anaesthetic a few minutes before the instillation of phenylephrine is recommended to avoid eye pain.

Systemic absorption may be minimised by compressing the lacrimal sac at the medial canthus for one minute during and after the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in infants, children and the elderly).

Paediatric population

Use with caution in children. The lowest dose necessary to produce the desired effect should always be used (see section 4.2).

Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration.

Both full-term, but especially low birth weight and premature infants may be at an increased risk for systemic adverse reactions including transient increases in blood pressure which potentially increases the risk of intraventricular haemorrhage. The infant should be monitored after instillation and routines to adequately deal with emergency situations should be in place.

4.5. Interaction with other medicinal products and other forms of interaction

Anti-hypertensive Agents

Topical phenylephrine should not be used as it may reverse the action of many anti-hypertensive agents with possibly fatal consequences.

Monoamine Oxidase Inhibitors

There is an increased risk of adrenergic reactions when used simultaneously

with, or up to three weeks after, the administration of MAOIs.

Tricyclic Antidepressants

The pressor response to adrenergic agents and the risk of cardiac arrythmia may be potentiated in patients receiving tricyclic antidepressants (or within several days of their discontinuation).

Halothane

Because of the increased risk of ventricular fibrillation, phenylephrine should be used with caution during general anaesthesia with anaesthetic agents which sensitise the myocardium to sympathomimetics.

Cardiac Glycosides or Quinidine

There is an increased risk of arrythmias.

4.6. Fertility, pregnancy and lactation

Safety for use during pregnancy and lactation has not been established. This product should only be used during pregnancy if it is considered by the physician to be essential.

4.7. Effects on ability to drive and use machines

May cause stinging and temporarily blurred vision. Warn patients not to drive or operate hazardous machinery until vision is clear.

4.8. Undesirable effects

The frequency of the undesirable effects are not known (cannot be estimated from the available data).

Immune System Disorders

Hypersensitivity

Eye Disorders

Eye pain, eye irritation, blurred vision, photophobia, conjunctivitis allergic.

Cardiac disorders

Palpitations, tachycardia, extrasystoles, arrythmias.

Vascular disorders

Hypertension

Serious cardiovascular reactions including arteriospasm coronary, ventricular arrhythmia and myocardial infarction have occurred following topical use of 10% phenylephrine. These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease.

Paediatric population

Periorbital pallor in preterm patients

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 at www.mhra.gov.uk/yellowcard

4.9. Overdose

Because a 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 5mg iv) has been recommended.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • FENEFRIN 100 mg/ml prescriptionPHENYLEPHRINUM · eye / ear / nose
  • BIOFLU NAZAL 2,5 mg/ml over the counterPHENYLEPHRINUM · eye / ear / nose
  • BIOFLU NAZAL 5 mg/ml over the counterPHENYLEPHRINUM · eye / ear / nose

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

  • Neosynephrin-Pos 10%Phenylephrinum · eye / ear / nose

Same active substance. 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 Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution. 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.

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