Minims phenylephrine hydrochloride 10% 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:

100mg/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: 5027519001903

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 10% 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 10%w/v Eye drops, solution
2. Qualitative and quantitative composition
Clear, colourless, sterile eye drops containing Phenylephrine
Hydrochloride Ph. Eur. 10% 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 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 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
Patients with cardiac disease, hypertension, aneurysms,
thyrotoxicosis, long-standing insulin dependent
diabetes mellitus and tachycardia.
Children and elderly, because of the increased risk of systemic
toxicity.
Patients on monoamine oxidase inhibitors, tricyclic anti-depressants
and anti-hypertensive agents
(including beta-blockers).
Patients with closed angle glaucoma (unless previously treated with
iridectomy) and patients with a
narrow angle prone to glaucoma precipitated by mydriatics.
Hypersensitivity to phenylephrine or to any of the excipients listed
in section 6.1.
4.4 Special warnings and precautions for use
Use with caution in the presence of diabetes, cerebral
arteriosclerosis or long standing bronchial asthma.
To reduce the risk of precipitating an attack of narro