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ATROPINE EYE DROPS BP 1.0% W/V

Active substance(s): ATROPINE SULPHATE

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Package leaflet: information for the user

D02423

Vistatropine Eye Drops 0.5% & 1.0 %w/v
atropine sulphate

(Referred to as Vistatropine Eye Drops in this leaflet)
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.
Taking other medicines:
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicine
including medicines obtained without prescription.
Other medicines may interfere with the actions of
Vistatropine Eye Drops. Tell your doctor if you are
using any of the following medicines:
In this leaflet:
• any other eye medicines, as they may delay the
absorption of Vistatropine Eye Drops.
1. What Vistatropine Eye Drops are and what they
• muscle relaxants such as hyoscyamine as these
are used for
may increase the effect of Vistatropine Eye
2. Before you use Vistatropine Eye Drops
Drops.
3. How to use Vistatropine Eye Drops
4. Possible side effects
Pregnancy and breast-feeding:
5. How to store Vistatropine Eye Drops
This medicine should be avoided if you are
6. Further information
pregnant, trying to become pregnant or you
are breast-feeding, unless your doctor has
1. What Vistatropine Eye Drops are
recommended it.
and what they are used for
Driving and using machines:
Vistatropine Eye Drops contain atropine sulphate This medicine is used to widen pupils and can
which belongs to groups of medicines called
cause blurred vision. You should not drive or
mydriatics (medicines that widen the pupil) and
operate machinery until the effects of the drops
cycloplegics (medicines used to relax the muscles have worn off.
which enable the eyes to focus).
Important information about one of the
Vistatropine Eye Drops are used to treat
ingredients:
inflammation in the eye (uveitis or iritis) and
Vistatropine Eye Drops contain benzalkonium
before certain eye examinations.
chloride which may cause eye irritation. Avoid
contact with soft contact lenses. Remove hard
This medicine is also used to diagnose eye
contact lenses prior to application and wait at
problems such as blurred vision (refraction) in
least 15 minutes before reinsertion.
children below 6 years and children with crossKnown to discolour soft contact lenses.
eyes or squint (convergent strabismus).
Read all of this leaflet carefully before you
start using this medicine.
• 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 on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

2. Before you use Vistatropine Eye
Drops
Do not use Vistatropine Eye Drops if:
• you are allergic (hypersensitive) to atropine
sulphate or to any of the other ingredients
present in this product (see Further Information,
Section 6).
• you suffer from increased pressure in the eye
(closed angle or narrow angle glaucoma).
Take special care with Vistatropine Eye Drops
Tell your doctor 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 Vistatropine Eye Drops

3. How to use Vistatropine Eye Drops
Always use Vistatropine Eye Drops exactly as your
doctor or pharmacist has told you. You should
check with your doctor or pharmacist if you are
not sure.
How much to use
Adults:
Inflammation of the eye (uveitis/iritis):
1 or 2 drops to be dropped into the eye(s), up to a
maximum of 4 times daily.
Eye disorder which may cause blurred vision
(refraction):
1 or 2 drops to be dropped into the eye(s), one
hour before examination.
Elderly and patients with increased pressure in
the eyes:
Discuss your treatment with your doctor or
pharmacist.
Children:
Inflammation of the eye (uveitis/iritis):
1 drop to be dropped into each eye, up to a
maximum of 3 times daily.
Eye disorder which may cause blurred vision
(refraction):
1 drop to be dropped into each eye, twice daily for
1-3 days before examination.
Continued overleaf

Instructions for use
Vistatropine Eye Drops are only to be used in
the eyes:
• gently pull the lower eyelid downwards and
outwards.
• place one or two drops into the gap between
the lid and the eye.
• blink a few times.
• take care not to touch the dropper nozzle on
the eye lid or any other surface.
• if applying the drops to your own eyes you are
advised to use a mirror.
Precautions for use of Vistatropine Eye drops:
• Vistatropine Eye Drops are for external use only.
Do not swallow. If you swallow Vistatropine
Eye Drops tell your doctor or nearest hospital
casualty unit immediately.
• do not wear soft contact lenses when
using these drops. Remove hard contact lenses
prior to application and wait at least 15 minutes
before reinsertion.
Known to discolour soft contact lenses.
• you should protect the eyes from bright light,
particularly when pupils are widened (dilated).
• you should wash your hands after using the eye
drops and care should be taken to avoid getting
the product into the mouth.
• Vistatropine Eye Drops should be discarded 4
weeks after first opening.
If you use more Vistatropine Eye Drops than
you should:
If you feel you may have used too much of your
medicine contact your doctor or your nearest
hospital casualty unit.
If you forget to use Vistatropine Eye Drops:
Do not use a double dose to make up for the
forgotten dose. Use the next dose at usual time.
If you stop using Vistatropine Eye Drops:
Please speak to your doctor or pharmacist before
stopping any medicine.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Vistatropine Eye Drops can
cause side effects, although not everybody gets
them.
Possible side effects include:
• an allergic reaction, the symptoms of which
include skin rashes and red, swollen or
watery eyes (pink eye, conjunctivitis). If
these side effects occur you should stop
using Vistatropine Eye Drops and speak to
your doctor or pharmacist.
• increased sensitivity to light (photophobia).
Eyes should be protected from bright light,
particularly when pupils are widened (dilated).
• dry mouth.
• difficulty in swallowing and talking.
• flushing and a dry skin .
• slower heart beat (bradycardia) followed by
faster heart beat (tachycardia).
• feeling your heart beat (palpitations).
• irregular heart beat (arrhythmia).
• reduced lung fluids.
• urgent desire to pass urine.
• inability to pass urine.
• constipation.
• confusion (particularly in the elderly).
• feeling sick (nausea).

• being sick (vomiting).
• giddiness.
If Vistatropine eye drops are absorbed into
your blood stream the following side effects
may occur:
• difficulty in controlling movements (ataxia).
• restlessness.
• excitement.
• seeing or hearing things that are not real
(hallucinations).
If you use Vistatropine Eye Drops for a long
period of time you may experience:
• local irritation (itching around the eye).
• temporary stinging.
• blood shot eyes (hyperaemia).
• swelling of eye lids (oedema).
• redness of eye (conjunctivitis).
• increase in pressure in eyes (glaucoma).
If any of these side effects gets serious, or you
notice any other side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store Vistatropine Eye
Drops
Keep this medicine out of the sight and reach of
children.
Store upright below 25oC, in a dry place, away
from strong light.
Do not use Vistatropine Eye Drops after the expiry
date which is stated on the bottle label. The expiry
date refers to the last day of that month.
Once you have opened the bottle it should be
disposed of after four weeks.
Medicines should not be disposed of via
wastewater or household water. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help protect
the environment.

6. Further information
What Vistatropine Eye Drops contain:
The active ingredient is atropine sulphate
0.5%w/v or 1% w/v.
Other ingredients are purified water and
benzalkonium chloride solution.
What Vistatropine Eye Drops look like and
contents of the pack:
Vistatropine Eye Drops are a sterile solution of
atropine sulphate 0.5% w/v or 1% w/v.
The product is a clear, colourless solution supplied
in bottles containing 10ml of the eye drops.
Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd. Bampton Road,
Romford, RM3 8UG, United Kingdom
Manufacturers:
Martindale Pharmaceuticals Ltd. Bampton Road,
Romford, RM3 8UG, United Kingdom and
Famigea S.p.A, Via G.B. Oliva, 6/8 - 56121, Pisa, Italy
Product Licence Numbers:
Vistatropine Eye Drops 0.5% w/v; PL 00156/0043
& HK - 22076
Vistatropine Eye Drops 1.0% w/v; PL 00156/0044
& HK - 09066
This leaflet was last updated November 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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