Pilocarpine hydrochloride 1% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pilocarpine hydrochloride

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

S01EB01

INN (International Name):

Pilocarpine hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5014124374263

Patient Information leaflet

PILOCARPINE EYE DROPS 1%, 2% AND 4% W/V
WHAT IS IN THIS LEAFLET:
1.
What Pilocarpine Eye Drops are and what are
they used for
2.
What you need to know before you use
Pilocarpine Eye Drops
3.
How to use Pilocarpine Eye Drops
4.
Possible side effects
5.
How to store Pilocarpine Eye Drops
6.
Contents of the pack and other information
1. WHAT PILOCARPINE EYE DROPS ARE
AND WHAT ARE THEY USED FOR
Pilocarpine Hydrochloride belongs to a group of
medicines called miotics, these medicines affect
muscles in the eye causing the pupil of the eye
to get smaller.
Pilocarpine Eye Drops are used to treat certain
forms of glaucoma (an increase in the pressure
within the eye) and to reverse the effect of drugs
that cause the pupil of the eye to get bigger.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE PILOCARPINE EYE DROPS
Do not use Pilocarpine Eye Drops if:
• you are allergic (hypersensitive) to Pilocarpine
or any of the other ingredients in this
medicine, which are listed in section 6 of this
leaflet
• you are suffering from inflammation of the
coloured part of the eye (acute iritis or anterior
uveitis)
• you are suffering from eye disorders such
as narrow angle glaucoma or secondary
glaucoma.
• you are wearing soft contact lenses. WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacists before taking
Pilocarpine eye drops if
• you are suffering from any heart problems.
• you have asthma.
• you have Parkinson’s disease.
• you have problems in passing urine.
• you have high blood pressure.
• you have a stomach ulcer.
• you are pregnant or are breast-feeding.
If you are unsure about how to use Pilocarpine
Eye Drops talk to your doctor or pharmacist.
CHILDREN
Pilocarpine should be given at the lowest
available dose at the start of the treatment for
children under 18 years of age.
EYE TESTS
Your doctor may want to check your eyes before
and during your therapy particularly if you have
had any eye disorders. If you have not had your
eyes checked recently, tell your doctor.
OTHER MEDICINES AND PILOCARPINE
Please

Summary of Product characteristics

OBJECT 1
PILOCARPINE EYE DROPS BP 1.0% W/V
Summary of Product Characteristics Updated 04-May-2016 | Martindale
Pharma
1. Name of the medicinal product
Pilocarpine Eye Drops 1.0% w/v
2. Qualitative and quantitative composition
Excipient(s) with known effect
Pilocarpine Hydrochloride 10 mg/ml also contains Benzalkonium
Chloride.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye Drops.
4. Clinical particulars
4.1 Therapeutic indications
• Pilocarpine is a direct acting miotic indicated for:
• chronic simple glaucoma
• acute (closed angle) glaucoma alone, or in conjunction with other
agents to decrease intra-ocular
pressure prior to surgical treatment
• miosis - to counteract the effects of cycloplegic or mydriatic eye
drops
4.2 Posology and method of administration
POSOLOGY
ADULTS AND THE ELDERLY
a) In the treatment of open angle glaucoma, the dosage is one or two
drops every six hours or as
prescribed by the physician.
The strength of the preparation and the frequency of use are
determined by the severity of the condition
and the response to treatment.
b) When used prior to surgery for acute attacks of closed-angle
glaucoma, the dosage is one drop every
five minutes until miosis is obtained or as directed by the physician.
c) To overcome weaker mydriatics, the normal dosage is one drop every
five minutes until the effect is
counteracted or as directed by the physician.
Paediatric population
Based on the infrequency of reports of adverse events in children, and
the extensive experience of use of
pilocarpine in childhood glaucoma, concentrations of up to 2% may be
safely used in children. Currently
available data are described in section 5.1 but no recommendation on a
posology can be made.
Treatment should be started with the lowest available dose and
concentration in patients under 18 years of
age. Depending on clinical response and tolerability, the dose may be
increased up to the maximum
recommended adult dosage of the 2% pilocarpine eye drop solution.
Directly after administration