Phenylephrine Eye Drops Bpc 10% W/V
PACKAGE LEAFLET: INFORMATION FOR THE USER D00270
Phenylephrine Hydrochloride
(Referred to as Phenylephrine Eye Drops in this leaflet)
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Phenylephrine Eye Drops are and what they are used for
2. Before you are given Phenylephrine Eye Drops
3. How Phenylephrine Eye Drops will be given
4. Possible side effects
5. How to store Phenylephrine Eye Drops
6. Further information
1. What Phenylephrine Eye Drops are and what they are used for
Phenylephrine Hydrochloride belongs to groups of medicines called mydriatics. These are medicines that widen the pupil.
Phenylephrine Hydrochloride is used to diagnose and treat eye problems.
2. Before you are given Phenylephrine Eye Drops
You should not be given Phenylephrine Eye Drops if:
• you are allergic (hypersensitive) to Phenylephrine Hydrochloride or to any of the other ingredients present in
this product (see Further Information, Section 6)
• you suffer from increased pressure in the eye (closed angle glaucoma)
• you suffer from heart disease
• you have high blood pressure
• you currently have an unusually fast heart beat (tachycardia)
• you suffer from diabetes
• you suffer from problems with your thyroid
• you are taking medicines used to treat depression (monoamine oxidase inhibitors or tricyclic antidepressants)
• you are taking medicines used to treat high blood pressure (e.g. beta-blockers)
Take special care with Phenylephrine Eye Drops if:
• you normally wear contact lenses.
Soft contact lenses must not be worn whilst using this medicine (see Important information about one of the ingredients)
• you have had an injury to your eye
• your doctor has told you that you have a problem with the blood vessels in your brain known as cerebral arteriosclerosis
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine including medicines obtained without prescription.
Medicines that you should not use with Phenylephrine Eye Drops include:
• a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs). You must not use Phenylephrine Eye Drops if you are currently taking MAOIs or have taken them in the last 4 weeks.
• medicines used to treat depression known as tricyclic antidepressants. You must not use Phenylephrine Eye Drops if you are currently taking tricyclic antidepressants or have taken them within the last week.
• medicines used to treat high blood pressure
• cyclopropane and halothane, medicines used as general anaesthetics
• medicines used to treat heart problems e.g. cardiac glycosides and quinidine
Pregnancy and breast-feeding:
This medicine should be avoided if you are pregnant, trying to become pregnant or you are breast-feeding, unless your doctor has recommended it.
Driving and using machines:
This medicine can cause temporary stinging and blurred vision. If affected, do not drive or use machines until your vision is clear.
Important information about one of the ingredients:
Phenylephrine Eye Drops contain benzalkonium chloride which may:
• cause eye irritation
• discolour soft contact lenses.
You should not wear soft contact lenses when using these eye drops. If you are using hard contact lenses, remove before using the eye drops and wait at least 15 minutes after using the drops before reinserting them.
6. Further information
What Phenylephrine Eye Drops contain:
The active ingredient is phenylephrine hydrochloride BP 100mg/ml
Adults:
The usual dose is 1 drop in each eye. If needed, this may be repeated after an hour
Children and the elderly:
Not recommended
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Phenylephrine Eye Drops can cause side effects, although not everybody gets them.
Possible side effects include:
• eye pain and stinging
• redness, itching and watering of the eye
• increased sensitivity to light (photophobia). Eyes should be protected from bright light, particularly when pupils are widened
• water on the lungs
• irregular heartbeat
• increased blood pressure
• an allergic reaction, symptoms of which include a red, itchy rash, shortness of breath and fainting
If any of these side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Other ingredients are sodium metabisulphite, sodium citrate, purified water and benzalkonium chloride solution (see Important information about one of the ingredients, section 2). Phenylephrine Eye Drops may also contain sodium hydroxide or hydrochloric acid.
What Phenylephrine Eye Drops look like and contents of the pack:
Phenylephrine Eye Drops are a clear, colourless solution supplied in 10ml plastic dropper bottles with a tamper proof cap.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals Ltd. Bampton Road, Romford, RM3 8UG,
Product Licence Number:
Phenylephrine Eye drops BPC 10% w/v 00156/0075
Date of approval: 03/2011
© Martindale Pharmaceuticals
MARTINDALE
Pharmaoeul
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom
5. How to store Phenylephrine Eye Drops
Keep out of the reach and sight of children.
Phenylephrine Eye Drops should be stored between 2°C and 8°C (in a fridge).
You should not be given this medicine once it has passed the expiry date which is stated on the bottle label. The doctor will check this before Phenylephrine Eye Drops are given to you. The expiry date refers to the last day of that month.
Once the bottle is opened it should be disposed of after 4 weeks.