PATIENT INFORMATION LEAFLET

Minims* Phenylephrine Hydrochloride

2.5% and 10% w/v Phenylephrine Hydrochloride

About Minims Phenylephrine

The name of this product is Minims Phenylephrine Hydrochloride. Each Minims unit contains 2.5% or 10% w/v phenylephrine hydrochloride solution. It also contains sodium metabisulphite, disodium edetate and purified water. Each Minims unit is a sterile, single use eyedrop containing approximately 0.5ml of solution. Each carton contains 20 units. Phenylephrine is a mydriatic drug. These drugs are used to enlarge the pupil of the eye.

Who makes it?

Minims Phenylephrine Hydrochloride 2.5% and 10% are manufactured by

The Marketing Authorisations for Minims Phenylephrine Hydrochloride 2.5% (PL 0033/0117 and PA 118/16/2) and Minims Phenylephrine Hydrochloride 10% (PL 0033/5021R and PA 118/16/1) are held by

What is it for?

Minims Phenylephrine is used to enlarge the pupil of your eye. This might be so that a doctor or eye specialist can examine your eye closely, or it might be part of a treatment programme.

Before using Minims Phenylephrine

Do you suffer from any of these problems?

• Heart disease?
• Tachycardia (fast heartbeats)?
• High blood pressure?
• Aneurysms (bulges in major blood vessels)?
• Thyrotoxicosis (an overactive thyroid gland)?
• Sugar diabetes?
• Cerebral arteriosclerosis (narrow arteries in the head)?
• Asthma?

Are you allergic to any of the ingredients listed in the section “About Minims Phenylephrine” above?

Do you wear contact lenses?

Are you taking, or have you recently taken, drugs for depression?

Are you taking any drugs to reduce your blood pressure (including beta-blockers)?

Are you taking quinidine or drugs called cardiac glycosides (these drugs help to steady your heartbeats)?

Are your eyes red and inflamed?

If the answer to any of these questions is YES, tell your doctor or eye specialist who may decide to use an alternative drug.

Phenylephrine should not be used if you suffer from closed angle glaucoma or if your eyes are likely to 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.

Phenylephrine can react with several types of general anaesthetic (for instance 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.

Phenylephrine can cause the cornea to become cloudy if the surface of the cornea is damaged. Your doctor or eye specialist will take this into account before deciding to give you Minims Phenylephrine.

If you are (or think you might be) pregnant, or if you are breast feeding a baby, tell your doctor or eye specialist. It is still possible that you will be given Minims Phenylephrine, but an alternative may be used instead.

The 10% strength of Minims Phenylephrine should not be used in children or in elderly patients. The doctor or eye specialist will use an alternative drug in these patients.

Minims Phenylephrine may sting when the drops are first put in and your sight may become blurred. This will gradually wear off. Do not drive or use machinery until your sight has returned to normal.

Using Minims Phenylephrine

The normal adult dose is one drop in each eye. If necessary this can be repeated once only at least one hour after the first drop.

The doctor or eye specialist will normally put the drops in your eye for you but if you are putting in your own drops then follow these instructions carefully:

• 1. Peel the overwrap apart and take out the Minims unit.
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• 2. Twist off the cap.
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• 3. Look upwards and gently pull down the lower eyelid.
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• 4. Hold the Minims unit just above your eye and gently squeeze until a drop of liquid falls into the gap between your eyeball and lower eyelid.
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• 5. Release the lower eyelid.

Remember to throw away the Minims unit when you have finished. It is advisable to press on the inner corner of your eye for a minute during and after addition of the solution. This helps to prevent loss of drug through drainage into the passages in the nose.

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

It is very unlikely that you will suffer an overdose if you follow these instructions carefully, but if you suddenly feel unwell after using Minims Phenylephrine, tell your doctor or eye specialist or contact your nearest casualty department immediately.

After using Minims Phenylephrine

You may have some eye pain and blurred vision when the eye drops are first put in. Sometimes bright light can be uncomfortable for a few hours after receiving the drops. Occasionally conjunctival sensitivity or allergic reactions can occur. Phenylephrine can sometimes affect your circulatory system, causing increased blood pressure, palpitations, fast heartbeats (tachycardia) and other heart irregularities (extrasystoles and cardiac arrythmias).

More serious reactions, including spasm of the coronary artery, irregular contraction of the ventricles and heart attacks, have been reported after using some 10% phenylephrine solutions. These have usually occurred in patients already suffering from heart disease and have not been reported with Minims Phenylephrine.

If you experience any unpleasant effects after using Minims Phenylephrine, tell your doctor or eye specialist.

Storing Minims Phenylephrine

• Minims Phenylephrine should be stored below 25°C and protected from strong light. Do not allow to freeze.
• The expiry date is printed on each Minims unit overwrap and on the carton label. Do not use it after this date.

This leaflet applies only to Minims Phenylephrine, but it does not contain all the information known about it. If you have any questions or are not sure about anything, ask your doctor or eye specialist.

Date of Partial Revision: August 2002

* Trade Mark