Atropine 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atropine sulfate

Available from:

Waymade Healthcare Plc

ATC code:

S01FA01

INN (International Name):

Atropine sulfate

Dosage:

5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11050000

Patient Information leaflet

ATROPINE EYE DROPS 0.5% & 1.0 %W/V
WHAT IS IN THIS LEAFLET:
1. What Atropine Eye Drops are and what they
are used for
2. What you need to know before you use
Atropine Eye Drops
3. How to use Atropine Eye Drops
4. Possible side effects
5. How to store Atropine Eye Drops
6. Contents of the pack and other information
1. WHAT ATROPINE EYE DROPS ARE AND
WHAT THEY ARE USED FOR
Atropine Eye Drops contain atropine sulfate
which belongs to groups of medicines called
mydriatics (medicines that widen the pupil) and
cycloplegics (medicines used to relax the muscles
which enable the eyes to focus).
Atropine Eye Drops are used to treat
inflammation in the eye (uveitis or iritis) and
beforecertain eye examinations.
This medicine is also used to diagnose eye
problems such as blurred vision (refraction) in
children below 6 years and children with cross
eyes or squint (convergent strabismus).
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE ATROPINE EYE DROPS
DO NOT USE ATROPINE EYE DROPS IF:
• you are allergic to atropine sulfate or to any of
the other ingredients of this medicine (listed in
section 6).
• you suffer from increased pressure in the eye
(closed angle or narrow angle glaucoma).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
USING ATROPINE EYE DROPS IF:
• you normally wear contact lenses, soft contact
lenses must not be worn whilst using this
medicine (see Important information about
one of the ingredients).
• you are pregnant, trying to become pregnant
or you are breast-feeding.
• you have a high temperature (fever).
• you have dark coloured eyes, as it is more
difficult to widen the pupils. (Care should be
taken to avoid using more eye drops than you
should).
• you suffer from any heart problems such as
faster heart beat (tachycardia).
If the weather is very warm consult your doctor
or pharmacist before using Atropine Eye Drops
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atropine Eye Drops 0.5% w/v
Vistatropine Eye Drops 0.5% w/v
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atropine sulfate 0.5% w/v
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops.
Clear, colourless solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atropine sulfate is an antimuscarinic agent used as a cycloplegic and
mydriatic. The
eye drops are used in the treatment of iritis and uveitis to
immobilise the iris and
ciliary muscle and to prevent or break down adhesions.
Since it is a powerful cycloplegic it is used in the determination of
refraction in
children below six years and children with convergent strabismus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical ocular use.
The depth of the angle of the anterior chamber should be assessed
before the
product is used.
Adults
Refraction:-
One or two drops to be instilled into the eye(s) one hour
before refracting.
Uveitis / iritis:-
One or two drops to
be instilled into the eye(s) to
a
maximum of 4 times daily.
Elderly
Mydriatics and cycloplegics should only be used with caution in the
elderly
and others who may have raised intra ocular pressure.
Children
Refraction:-
One drop to be instilled into each eye twice daily for 1 3
days prior to the examination.
Uveitis / iritis:-
One drop to be instilled into each eye to a maximum of 3
times daily.
4.3
CONTRAINDICATIONS
Hypersensitivity to Atropine Sulfate or to any of the excipients
listed in section 6.1.
The product should not be used in patients with closed angle glaucoma.
It is also contraindicated in patients with narrow angle between the
iris and the cornea
since it may raise intra-ocular pressure and precipitate an acute
attack of closed angle
glaucoma.
It should not be used by patients with known hypersensitivity to any
component of
the preparation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It should only be used with caution in patients who may have raised
intra ocular
pressure.
The product conta