Atropine 1% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atropine sulfate

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

S01FA01

INN (International Name):

Atropine sulfate

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: 11050000; GTIN: 5014124374058

Patient Information leaflet

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 before certain 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 recently, tell your doctor.
OTHER MED

Summary of Product characteristics

OBJECT 1
ATROPINE EYE DROPS BP 1.0% W/V VISTATROPINE
EYE DROPS 1.0% W/V
Summary of Product Characteristics Updated 08-Nov-2016 | Martindale
Pharma
1. Name of the medicinal product
Atropine Eye Drops 1.0% w/v
Vistatropine Eye Drops 1.0% w/v
2. Qualitative and quantitative composition
Atropine sulfate 1.0% 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 the active substance 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 precau