Pilocarpine 4 % w/v Eye Drops, solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Pilocarpine hydrochloride

Boleh didapati daripada:

Martindale Pharmaceuticals Ltd

Kod ATC:

S01EB; S01EB01

INN (Nama Antarabangsa):

Pilocarpine hydrochloride

Dos:

4 percent weight/volume

Borang farmaseutikal:

Eye drops, solution

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Parasympathomimetics; pilocarpine

Status kebenaran:

Not marketed

Tarikh kebenaran:

1988-09-01

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
PILOCARPINE 2% W/V EYE DROPS, SOLUTION
PILOCARPINE 4% W/V EYE DROPS, SOLUTION
Pilocarpine Hydrochloride
(Referred to as Pilocarpine Eye Drops in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINES BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or
pharmacist.
•
This medicine has been prescribed for you. Do not pass it onto others.
It may harm them,
even if their signs of illness are the same as yours.
•
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4. .
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

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pilocarpine 4 % w/v Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipient(s) with known effect
Pilocarpine Hydrochloride 40 mg/ml. Also contains Benzalkonium
Chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (Eye Drops)
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a direct acting miotic in: Chronic simple glaucoma.
Acute (closed angle) glaucoma alone, in conjunction with other agents,
to decrease intraocular pressure prior to
surgical treatment.
Miosis to counter the effects of cycloplegic and mydriatic eye drops.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly
The usual dose is 2 drops three times daily.
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 of any dose, the lacrimal punctum should
be occluded for one minute with a finger to limit systemic exposure.
Method of administration
Eye drops for topical administration into the conjunctival sac.
4.3 CONTRAINDICATIONS
• Miotics where constriction of the pupil is undesirable such as in
acute iritis or anterior uveitis
• Narrow angle glaucoma and some forms of secondary glaucoma
• Hypersensitivity to Pilocarpine or any of the excipients listed in
section 6.1
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