Phenylephrine 10% eye drops

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Phenylephrine hydrochloride

Διαθέσιμο από:

A A H Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

S01FB01

INN (Διεθνής Όνομα):

Phenylephrine hydrochloride

Δοσολογία:

100mg/1ml

Φαρμακοτεχνική μορφή:

Eye drops

Οδός χορήγησης:

Ocular

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 11050000

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
D00270
Phenylephrine Hydrochloride
(Referred to as Phenylephrine Eye Drops in this leaflet)
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 t

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenylephrine Eye Drops BPC 10%w/v
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine Hydrochloride BP 100mg/ml
3
PHARMACEUTICAL FORM
Eye Drops
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A mydriatic agent to dilate the pupil for diagnosis and treatment.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For topical ocular use only.
Adults
Administer 1 drop in each eye. If necessary repeat once after 1 hour.
Children and the elderly
Not recommended
4.3.
CONTRA-INDICATIONS
Patients with closed angle glaucoma, cardiac disease, hypertension,
diabetes,
tachycardia, thyrotoxicosis and hypersensitivity to any component of
the
preparation. Also patients taking MAOI’s, tricyclic antidepressants
and anti-
hypertensive agents including beta blockers.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Corneal clouding may occur with phenylephrine if corneal epithelium
has
been denuded or damaged. Use with caution in patients with cerebral
arteriosclerosis. Not to be used by patients who continue to wear soft
contact
lenses.
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
Do not use in conjunction with the following:
Monoamine oxidase inhibitors (where interactions may occur within 4
weeks
of stopping treatment), due to an increased risk of adrenergic
reactions.
Tricyclic antidepressants (where interactions may occur within several
days of
stopping treatment), due to the risk of raised blood pressure and
cardiac
arrhythmia.
Anti-hypertensives due to potential reversal of action by using
topical
phenylephrine with possible fatal consequences
Cyclopropane and halothane due to the increased risk of ventricular
fibrillation
Cardiac glycosides and quinidine due to an increased risk of
arrhythmias
4.6.
PREGNANCY AND LACTATION
Safety has not been established and therefore it should only be used
in
pregnancy if considered essential by the physician.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause stinging and transient blurring o