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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Minims® Phenylephrine Hydrochloride eye drops are and what they are used for
2. What you need to know before you use Minims® Phenylephrine Hydrochloride eye drops
3. How to use Minims® Phenylephrine Hydrochloride eye drops
4. Possible side effects
5. How to store Minims® Phenylephrine Hydrochloride eye drops
6. Contents of the pack and other information

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.

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.

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.

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.

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.

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.

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.

• 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.

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).

Not known: frequency cannot be estimated from the available data

• Fluid or swelling in the lungs (this is relevant to the 10% formulation).

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:

United Kingdom

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

Each carton contains 20 units.

UK

Ireland