Minims phenylephrine hydrochloride 2.5% eye drops 0.5ml unit dose

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenylephrine hydrochloride

Available from:

Bausch & Lomb UK Ltd

ATC code:

S01FB01

INN (International Name):

Phenylephrine hydrochloride

Dosage:

25mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11050000; GTIN: 5027519001804

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

OBJECT 1
MINIMS PHENYLEPHRINE HYDROCHLORIDE 2.5% W/V,
EYE DROPS SOLUTION
Summary of Product Characteristics Updated 09-Aug-2016 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Phenylephrine Hydrochloride 2.5%w/v Eye Drops, Solution
2. Qualitative and quantitative composition
Clear, colourless, sterile eye drops containing Phenylephrine
Hydrochloride Ph. Eur. 2.5% w/v.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile, single-use eye drop 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 for 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 once only, at least one hour
after the first drop.
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 cant