Minims Phenylephrine Hydrochloride 2.5% w/v eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylephrine hydrochloride

Available from:

Bausch & Lomb UK Limited

ATC code:

S01GA; S01GA05

INN (International Name):

Phenylephrine hydrochloride

Dosage:

2.5 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Sympathomimetics used as decongestants; phenylephrine

Authorization status:

Marketed

Authorization date:

1990-04-19

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Phenylephrine Hydrochloride 2.5% w/v eye drops, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine Hydrochloride 2.5% w/v.
Each unit (0.5ml) contains 12.5mg phenylephrine hydrochloride.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless, aqueous, 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, including the elderly population
Apply one drop topically to each eye. If necessary, this dose may be
repeated 3-4 hourly.
Paediatric population
Apply one drop topically to the eye. It is not usually necessary to
exceed this dose.
Phenylephrine 2.5%w/v eye drops may be combined with other
mydriatics/cycloplegics to produce adequate
mydriasis/cycloplegia. Heavily pigmented irides may require larger
doses and caution should be exercised to avoid
overdosage.
The use in preterm and newborn infants is not recommended unless
clearly necessary and only with caution because of
safety concerns associated with the risk of systemic adverse reactions
including transient increases in blood pressure. If
treatment is medically justified the lowest possible concentration and
dose should be used and instillation of more than
one drop per eye must be avoided (see section 4.4).
Method of administration
The use of a drop of topical anaesthetic a few minutes before
instillation of phenylephrine is recommended to prevent
stinging.
Especially in infants, children and the elderly, it is advised to
minimise systemic absorption and the risk for systemic
adverse reactions by compressing the lacrimal sac at the medial
canthus or gently closing the eye for a few minutes
after instillation. To minimise cutaneous absorption, excess fluid
should be wiped aw