Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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.
e Minims® Phenylephrine Hydrochloride eye drops Do not use Minims® Phenylephrine Hydrochloride drops:
Ask yourself the following questions:
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.
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
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.
What do your eye drops contain
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.
The active substance in Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution is phenylephrine hydrochloride.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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).
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.
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.
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.
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.
May cause stinging and temporarily blurred vision. Warn patients not to drive or operate hazardous machinery until vision is clear.
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
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
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 →
Medicines sold in Poland with the same active substance: W Polsce znany jako
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 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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