Minims Atropine Sulphate 1% Eye Drops, solution

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Prieinama:

Bausch + Lomb Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT, Ireland

ATC kodas:

S01FA01

INN (Tarptautinis Pavadinimas):

ATROPINE SULFATE 1 % (W/V)

Vaisto forma:

EYE DROPS, SOLUTION

Sudėtis:

ATROPINE SULFATE 1 % (W/V)

Recepto tipas:

POM

Gydymo sritis:

OPHTHALMOLOGICALS

Autorizacija statusas:

Authorised

Leidimo data:

2005-10-04

Pakuotės lapelis

MINIMS® ATROPINE SULPHATE 1%
EYE DROPS, SOLUTION
ATROPINE SULPHATE
Read all this leaflet carefully BEFORE you start using your medicine.
It contains a summary of the
information available on your medicine.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1.
What Minims® Atropine Sulphate eye drops are and what they are used
for
2.
Before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Further information
1. WHAT MINIMS
®
ATROPINE SULPHATE EYE DROPS ARE AND WHAT THEY ARE USED FOR
Minims® Atropine Sulphate contains a mydriatic and cycloplegic 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.
This medicine is indicated for children, adults and the elderly.
2. BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
.
you are allergic to the active substance (atropine sulphate) or any of
the ingredients (refer to
the end of this leaflet).
.
you have history of closed angle glaucoma (with your eyes likely to
develop sudden increased
internal pressure when the pupil is enlarged).
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
Tell your doctor or eye specialist, he/she may decide to use these
drops or to prescribe you an
alternative.
CONTACT LENSES
Your doctor will ask you to remove your contact lenses prior to the
administration of the drops.
Do not wear your contact lenses until the effects of the drops have
completely worn off.
DRIVING AND USING MACHINES
As with all eye drops, your vision may be blurred after putting the
drops in. Wait until your vision is
clear before driving or using machines.
3. HOW TO USE YOUR EYE DROPS
The drops are for single use only and provided in single use Minims
units, to treat both eyes if
necessary. Once opened, use immediately. Discard any unused portion.
DOSAGE
The normal dose

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minims Atropine Sulphate 1% Eye Drops, solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atropine Sulphate 1% w/v
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution
Single use, clear, colourless, sterile solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minims Atropine Sulphate is indicated:
As a mydriatic and cycloplegic agent.
For pre-operative use in ophthalmic surgery.
For treatment of uveitis and refraction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly)_
_ _
_ _
Uveitis:
1 drop 2-3 times a day.
Refraction:
1 drop twice a day prior to examination.
4.3
CONTRAINDICATIONS
Use in patients with a known hypersensitivity to atropine.
Due to the risk of precipitating an acute attack, do not use in cases
of confirmed narrow-angle glaucoma or where latent
narrow angle glaucoma is suspected. If in doubt it is recommended that
an alternative preparation is used.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used with caution in an inflamed eye, as
hyperaemia greatly increases the rate of systematic
absorption through the conjunctiva.
Systemic absorption may be reduced by compressing the lacrimal sac at
the medial canthus for a minute during and
following the instillation of the drops. (This blocks the passage of
the drops via the naso-lacrimal duct to the wide
absorptive area of the nasal and pharyngeal mucosa. It is especially
advisable in children.)
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
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None known
4.6
FERTILITY, PREGNANCY AND LACTATION
The safety for use in pregnancy and lactation has not been
established, therefore, use only when directed by a
physician.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause transient blurring of vision on instillation. Warn patients
not to drive or operate hazardous machinery until
vision is clear.
4.8
UNDESIRABLE EFFECTS
Transient stinging may occur o