Minims Phenylephrine HCl

Phenylephrine hydrochloride

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).
Excipients/Inactive Ingredients: 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.

Minims Phenylephrine Hydrochloride contains a mydriatic agent. It is used to enlarge the pupil of the eye. It may be used to examine the 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. An alternative medicine will be used in these patients.

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 the patient is receiving this product as part of a treatment programme the 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 the eye for the patient, but if the patient is the one putting the eye drops, follow these instructions carefully: 1. Wash hands.
2. Use a mirror, this will help to see what is being done.
3. Carefully dry the eyes using a tissue. Twist and pull cap to separate from the Minims body.
4. Pull the lower eyelid down gently, and then carefully place 1 drop inside the lower eyelid.
5. Close the eye and blink a few times to make sure the eye is covered by the liquid.
6. Close the eyelids. It is advisable to press gently on the inner corner of the eyelid for 3 minutes. This will help stop the solution draining into the 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 the patient forgets to use Minims Phenylephrine Hydrochloride, he/she should take the missed dose as soon as remembered, unless it is nearly time for the next dose, but the patient should not take a double dose to make up for a missed dose.

If the patient uses more Minims Phenylephrine Hydrochloride than prescribed, an overdose is very unlikely to occur. If the patient suddenly feels unwell after receiving the drops, tell the doctor or eye specialist or contact the nearest emergency department immediately.

Do not use Minims Phenylephrine Hydrochloride drops: If the patient is allergic to the active substance (phenylephrine) or any of the other ingredients of this medicine (listed in Description); If the patient has a heart disease; If the patient has fast heartbeats (tachycardia); If the patient has high blood pressure; If the patient has bulges in major blood vessels (aneurysms); If the patient has an overactive thyroid gland (hyperthyroidism); If the patient has 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 glaucoma precipitated by mydriatics; In patients wearing contact lenses.
Do not use Minims Phenylephrine Hydrochloride 10% in children below the age of 12 years.

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 18 years as adequate clinical experience is missing.
Tell the doctor or eye specialist if the patient has any of the following: narrow arteries in the head (cerebral arteriosclerosis); asthma; the 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 the patient); red or inflamed eyes.
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. The doctor or eye specialist will take this into account before deciding to give these eye drops.
Contact lenses: The doctor will ask the patient to remove the 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 the 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 the patient to drive. As with all eye drops, the vision may be blurred after putting the drops in. Wait until the vision is clear before driving or using machines.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or eye specialist for advice before taking this medicine as he/she may decide to use these drops or to prescribe an alternative.

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 the 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 the 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: In case of any side effects, talk to the doctor or pharmacist. This includes any side effects not listed in the monograph.

Tell the doctor or eye specialist if the patient is taking, has recently taken or might take any other medicines: Medicines for depression; Any medicines to reduce your blood pressure (including medicines called beta blockers); Medicines to treat irregular heartbeats (quinidine or medicines called cardiac glycosides).
The active substance can react with several types of anaesthetic (e.g. halothane). The doctor will know about this. If the patient is having an operation the doctor will make sure that this problem does not affect the patient.

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 the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light.

Mydriatic Drugs

S01FB01 - phenylephrine ; Belongs to the class of sympathomimetics used as mydriatics and cycloplegics.

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