MINIMS PHENYLEPHRINE HYDROCHLORIDE

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

PHENYLEPHRINE HYDROCHLORIDE

Διαθέσιμο από:

Bausch & Lomb UK Limited

Φαρμακολογική κατηγορία (ATC):

S01GA05

INN (Διεθνής Όνομα):

PHENYLEPHRINE HYDROCHLORIDE

Δοσολογία:

10 %w/v

Φαρμακοτεχνική μορφή:

Eye Drops Solution

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

phenylephrine

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1979-04-01

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
MINIMS® PHENYLEPHRINE HYDROCHLORIDE 2.5% W/V
MINIMS® PHENYLEPHRINE HYDROCHLORIDE 10% W/V
EYE DROPS, SOLUTION
PHENYLEPHRINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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.
WHAT IS IN THIS LEAFLET:
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
1. WHAT MINIMS® PHENYLEPHRINE HYDROCHLORIDE EYE DROPS ARE AND WHAT
ARE THEY USED FOR
Minims® Phenylephrine Hydrochloride contains a mydriatic agent. It is
used to enlarge the pupil of your eye. Your doctor or eye specialist
may use it to examine your eye more closely or as part of a treatment
program.
Minims® Phenylephrine Hydrochloride 2.5% is indicated for children,
adults and the elderly.
Minims® Phenylephrine Hydrochloride 10% is not indicated for children
or the elderly, as this concentration is too strong. The doctor or
eye specialist will use an alternative medicine in these patients.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MINIMS® PHENYLEPHRINE
HYDROCHLORIDE EYE DROPS
Do not use Minims® Phenylephrine Hydrochloride drops if:
•
you are allergic to the active substance (phenylephrine) or any of the
other ingredients of this medicine (listed in section 6)
•
you have a heart disease
•
you have fast heartbeats (tachycardia)
•
you have high blood pressure
•
you have bulges in major blood vessels (aneurysms)
•
you have an overactive thyroid gland (hyperthyroidism)
•
you hav

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Phenylephrine Hydrochloride 10% w/v Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine Hydrochloride 10% w/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops, solution
Single-use, clear, colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phenylephrine is a directly acting sympathomimetic agent used
topically in the eye as a mydriatic.
It may be indicated
to dilate the pupil in diagnostic or therapeutic procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
Apply one drop to each eye. If necessary, this dose may be repeated
once only, at least one hour after the first drop.
Paediatric and the Elderly population
The use of phenylephrine 10% solution is contraindicated in these
groups because of the increased risks of systemic
toxicity (SEE SECTION 4.3)
Method of administration
The use of a drop of topical anaesthetic a few minutes before
instillation of phenylephrine is recommended to prevent
stinging.
4.3 CONTRAINDICATIONS
Hypersensitivity to phenylephrine or to any of the excipients listed
in section 6.1.
Patients with cardiac disease, hypertension, aneurysms,
thyrotoxicosis, long-standing insulin dependent diabetes
mellitus and tachycardia.
Patients on monoamine oxidase inhibitors, tricyclic antidepressants
and anti-hypertensive agents (including beta-
blockers).
Children and the elderly, because of increased risk of systemic
toxicity.
Patients with closed angle glaucoma and patients with a narrow angle
prone to glaucoma precipitated by mydriatics.
Use in patients wearing contact lenses.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__