Consumer medicine information

Minims Phenylephrine Eye Drops

Phenylephrine hydrochloride

BRAND INFORMATION

Brand name

Minims Phenylephrine Hydrochloride Eye Drops

Active ingredient

Phenylephrine hydrochloride

Schedule

S4 | S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Phenylephrine Eye Drops.

What is in this leaflet

This leaflet answers some common questions about Minims Phenylephrine Eye Drops, including how to use the eye drops.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Phenylephrine Eye Drops against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Minims Phenylephrine Eye Drops is used for

Minims Phenylephrine Eye Drops belongs to a class of medicines called sympathomimetic agents. It is used to dilate (enlarge) the pupil of the eye so that your doctor can examine your eye(s). It is usually used at the beginning of an eye examination.

Ask your doctor if you have any questions about why this medicine has been prescribed to you. Your doctor may have prescribed it for another reason.

Before you use Minims Phenylephrine Eye Drops

When you must not use it

Do not use Minims Phenylephrine Eye Drops if you have an allergy to:

  • Any medicine containing Phenylephrine
  • Any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Rash, itching or hives on the skin

Do not use the 10% strength of Minims Phenylephrine Eye Drops in children or the elderly. Children and the elderly may be more susceptible to the effects of phenylephrine.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have had an allergy to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • Glaucoma (high pressure in the eye)
  • Asthma
  • Diabetes
  • High blood pressure
  • Fast heart beat
  • Hyperthyroidism (overactive thyroid gland)
  • Arteriosclerosis
  • Heart disease

Tell your doctor if you are pregnant or are breast-feeding. Your doctor will discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using Minims Phenylephrine Eye Drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Phenylephrine Eye Drops may interfere with each other. These include:

  • Medicines to lower blood pressure
  • Medicines to treat depression
  • Medicines to treat heart disease

These medicines may be affected by Minims Phenylephrine Eye Drops or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor and pharmacist will have more information on medicines to be careful with or avoid while using Minims Phenylephrine Eye Drops.

How to use Minims Phenylephrine Eye Drops

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor for help.

How much to use

Use Minims Phenylephrine Eye Drops only when prescribed by your doctor. Your doctor will tell you how often to use the eye drops and how many drops to use each time.

Adults: The usual dose is one drop instilled into the eye(s). This may be repeated once if necessary, at least one hour after the first drop.

Children and Elderly: The usual dose is one drop of the 2.5% solution to the eye(s).

Sometimes a drop of local anaesthetic may be used before using Minims Phenylephrine Eye Drops. This is to help prevent the stinging effect of phenylephrine eye drops.

How to use it

Your doctor will normally instil the drops into your eyes for you. If you are instilling your own drops, then follow the directions below.

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing contact lenses, remove them before putting the drops in your eye.

If you are instilling your own drops, then follow these steps to use the eye drops.

  1. Wash your hands well with soap and water.
  2. Shake the container.
  3. Break the seal.
  4. Hold the container upside down in one hand between your thumb and forefinger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch/pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the container close to your lower eyelid. Do not let it touch your eye.
  8. Release the required number of drops into the pouch/pocket formed between your eye and eyelid by gently squeezing the container.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This is very important when administering to children. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body.
  11. Repeat steps 4-10 for the other eye if needed.
  12. Throw away any eye drops left in the container.
  13. Wait 15 minutes before replacing your contact lenses.

If you use too much (overdose)

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of Phenylephrine. If you think that an infant or young child may have swallowed any or all of the contents of the container of Minims Phenylephrine Eye Drops, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

While you are using Minims Phenylephrine Eye Drops

Things you must do

If you have any irritation, pain, swelling, excessive tear production or light-sensitivity occur while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes.

Stop using the eye drops and contact your doctor if these symptoms persist.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if you think they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Minims Phenylephrine Eye Drops affects you.

This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause stinging and transient blurred vision at the time of application and sufficient time should be allowed to regain clear vision before driving or operating hazardous machinery.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Phenylephrine Eye Drops.

This medicine helps most people but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Local irritation or stinging or feeling of having something in the eye on instillation
  • Blurred vision and/or problems seeing clearly
  • Sensitivity to light
  • Headache or brow ache
  • Red eyes

The above list includes the more common side effects of your medicine.

Tell your doctor immediately or visit Accident and Emergency at your nearest hospital if you notice any of the following:

  • Fast or irregular heart beat
  • Whitening of the skin
  • Trembling or tremors
  • Increased sweating

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Minims Phenylephrine Eye Drops

Storage

Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Disposal

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining containers.

Product description

What it looks like

Minims Phenylephrine Eye Drops comes in single dose units containing 0.5mL of a clear, colourless solution. Each carton contains 20 single dose units.

Ingredients

Minims Phenylephrine Eye Drops contains 2.5%w/v or 10%w/v of phenylephrine hydrochloride as the active ingredient.

It also contains:

  • Sodium metabisulphite
  • Disodium edetate
  • Water - Purified

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia Minims Phenylephrine Eye Drops is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Chatswood, NSW 2067
Phone: 1800 251 150

Minims Phenylephrine Eye Drops 2.5% AUST R 46174

Minims Phenylephrine Eye Drops 10% AUST R 32276

In New Zealand Minims Phenylephrine Eye Drops is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Toll free number: 0508375394

Date of preparation

This leaflet was prepared in February 2018

Published by MIMS May 2018

BRAND INFORMATION

Brand name

Minims Phenylephrine Hydrochloride Eye Drops

Active ingredient

Phenylephrine hydrochloride

Schedule

S4 | S2

 

1 Name of Medicine

Phenylephrine hydrochloride.

2 Qualitative and Quantitative Composition

Minims Phenylephrine Eye Drops containing phenylephrine hydrochloride 2.5% w/v (25 mg/mL) or 10% w/v (100 mg/mL). No preservatives are contained in the formulation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A single-use eye drops, solution.
Minims Phenylephrine Eye Drops are clear, colourless sterile solutions, reasonable free from visible particulate matter.

4 Clinical Particulars

4.1 Therapeutic Indications

Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. Minims Phenylephrine Hydrochloride Eye Drops are indicated to dilate the pupil for diagnostic or therapeutic procedures.

4.2 Dose and Method of Administration

The use of a drop of topical anaesthetic a few minutes before instillation of Minims Phenylephrine Eye Drops is recommended to prevent stinging.

Adults.

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

Children and the elderly.

Instil one drop of the 2.5% solution topically to the eye. It is not usually necessary to exceed this dose. The use of phenylephrine 10% is contraindicated in children (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use) and the elderly because of the increased risks of systemic toxicity.
Systemic absorption of phenylephrine may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Each Minims Phenylephrine Eye Drops unit should be discarded after a single use.

4.3 Contraindications

Minims Phenylephrine Eye Drops are contraindicated in:
Patients with hypersensitivity to any of the components of the preparation.
Children and the elderly with Minims Phenylephrine Hydrochloride Eye Drops 10% because of the increased risk of systemic toxicity.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Minims Phenylephrine Eye Drops are for topical ophthalmic use only. The solution should not be injected.
Caution must be exercised when using Minims Phenylephrine Hydrochloride Eye Drops in the following patient groups:
Patients with cardiac disease, hypertension, aneurysms, long-standing insulin dependent diabetes mellitus and tachycardia.
Patients on monoamine oxidase inhibitors, tricyclic antidepressants and antihypertensive 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.
The use of phenylephrine 10% solution is contraindicated in children and the elderly because of the increased risks of systemic toxicity (see Paediatric use).
Patients treated with:

Antihypertensive agents.

Topical phenylephrine may reverse the action of many antihypertensive 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 arrhythmia 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 arrhythmias if phenylephrine is used in patient taking cardiac glycosides or quinidine.
There have been rare reports associating the use of phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions with the development of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions. These episodes, some ending fatally, have usually occurred in elderly patients with pre-existing cardiovascular diseases.
A significant elevation in blood pressure is rare but has been reported following conjunctival instillation of recommended doses of phenylephrine hydrochloride 10% ophthalmic solutions. Caution should be exercised in children, the elderly, and patients with diabetes, hypertension, hyperthyroidism, generalised arteriosclerosis or cardiovascular disease.
Minims Phenylephrine Eye Drops should be used with caution in the presence of long standing bronchial asthma.
To reduce the risk of precipitating an attack of narrow angle glaucoma the anterior chamber angle should be evaluated 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.
Due to a strong action of the drug on the dilator muscle, older individuals may also develop transient pigment floaters in the aqueous humor 30 to 45 minutes following the administration of the eye drops. The appearances may be confused with anterior uveitis or to a microscopic hyphema.
Systemic absorption of phenylephrine may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa.)

Use in the elderly.

The use of phenylephrine 10% is contraindicated in the elderly because of the increased risks of systemic toxicity. Where phenylephrine eye drops are indicated for use in this group, the 2.5% solution should be used.

Paediatric use.

Use of phenylephrine 10% solution is contraindicated in children. Serious systemic adverse reactions have been reported with ophthalmic products containing phenylephrine in children below 12 years of age.
There is inadequate clinical experience in children aged 12 to 18 years. Where phenylephrine eye drops are indicated for use in this group, the 2.5% solution should be used.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although negligible phenylephrine passes into the bloodstream after ocular instillation, drug interactions are nevertheless possible. The interactions observed with phenylephrine administered by any route should therefore be taken into account (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been performed in either animals or humans to evaluate the potential for phenylephrine to impair fertility.
(Category B2)
Safety for use in pregnancy has not been established. Minims Phenylephrine Eye Drops should only be used during pregnancy if it is considered by the physician to be essential.
 Safety for use in lactation has not been established. Minims Phenylephrine Eye Drops should only be used during lactation if it is considered by the physician to be essential.

4.7 Effects on Ability to Drive and Use Machines

Minims Phenylephrine Eye Drops may cause stinging and transient blurring of vision. Patients should be advised not to drive or operate hazardous machinery until vision is clear.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

Local.

Eye pain and stinging on instillation, temporary blurred vision, photophobia, conjunctival allergy, reactive hyperaemia and transient punctuate keratitis may occur. Other local adverse effects reported include: lacrimation, corneal oedema, pigmented aqueous floaters, rebound miosis, and rebound conjunctival vasoconstriction.

Systemic.

Palpitations, tachycardia, extrasystoles, cardiac arrhythmias and hypertension, headache, subarachnoid haemorrhage, reflex bradycardia, blanching of the skin, trembling or tremors, and increased perspiration.
Serious cardiovascular reactions including significant hypertension, aneurisms, coronary artery spasm, ventricular arrhythmias and myocardial infarctions have occurred following topical use of 2.5% and 10% phenylephrine. These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease.

Undesirable effects.

Paediatric population.

Phenylephrine 2.5% eye drops.

Periorbital pallor in preterm patients: frequency not known (cannot be estimated from the available data).

Phenylephrine 10% eye drops.

Respiratory, thoracic and mediastinal disorders. Pulmonary oedema: frequency not known (cannot be estimated from the available data).

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
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 IV) has been recommended.
Reversal of mydriasis is possible with 0.1% thymoxamine.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Phenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the stimulation of alpha-adrenergic receptors. There is almost no cycloplegic effect.
Phenylephrine is an alpha-agonist, with both alpha-1A and alpha-1B effects.
Alpha-adrenergic receptors are unimportant in the aqueous humour outflow response, hence there is no effect on intraocular pressure in open angle glaucoma.
The phenylephrine molecule differs from adrenaline only by the substitution of a hydrogen atom for a hydroxyl group on position 4 of the benzene ring.
Maximal mydriasis occurs in 10-90 minutes with recovery after 5-7 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Phenylephrine is a weak base at physiological pH. The extent of ocular penetration is determined by the condition of the cornea. A healthy cornea presents a physical barrier, in addition to which, some metabolic activity may occur. Where the corneal epithelium is damaged, the effect of the barrier and the extent of metabolism are reduced, leading to greater absorption.

5.3 Preclinical Safety Data

Genotoxicity.

Phenylephrine was negative in tests for bacterial mutagenicity and did not cause chromosomal aberrations in Chinese hamster ovary cells.

Carcinogenicity.

There are no studies on the carcinogenicity of phenylephrine by the topical ocular route. No carcinogenic activity was noted in mice or rats receiving oral doses of up to 270 and 50 mg/kg/day, respectively, for 2 years.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium metabisulphite, disodium edetate and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.) Do not expose to strong light.

6.5 Nature and Contents of Container

Minims Phenylephrine Eye Drops are supplied in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units. Each unit contains approximately 0.5 mL solution.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: (1R)-1-(3-hydroxyphenyl)-2-(methylamino) ethanol hydrochloride.
Molecular formula: C9H13NO2.HCl.
Molecular weight: 203.7.

CAS number.

61-76-7.

7 Medicine Schedule (Poisons Standard)

Minims Phenylephrine Eye Drops 2.5% - S2 - Pharmacy Medicine.
Minims Phenylephrine Eye Drops 10% - S4 - Prescription Only Medicine.

Summary Table of Changes