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PHENYLEPHRINE EYE DROPS BPC 10% W/V

Active substance(s): PHENYLEPHRINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

D00270

Phenylephrine Eye Drops BPC 10%w/v
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.

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.

100mm Measurement Verification Bar

In this leaflet:

3. How Phenylephrine Eye Drops
will be given
Your doctor will give Phenylephrine Eye
Drops to you
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.

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.

6. Further information
What Phenylephrine Eye Drops contain:
The active ingredient is phenylephrine
hydrochloride BP 100mg/ml
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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