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VISTATROPINE EYE DROPS 0.5% W/V

Active substance(s): ATROPINE SULFATE / ATROPINE SULFATE / ATROPINE SULFATE

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Package leaflet: Information for the user
Vistatropine Eye Drops 0.5% & 1.0 %w/v
Atropine sulfate
(Referred to as Vistatropine Eye Drops in this leaflet)
Read all of this leaflet carefully before you start using this medicine 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 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. See section 4.
What is in this leaflet:
1. What Vistatropine Eye Drops are and what they are used for
2. What you need to know before you use Vistatropine Eye Drops
3. How to use Vistatropine Eye Drops
4. Possible side effects
5. How to store Vistatropine Eye Drops
6. Contents of the pack and other information

1. What Vistatropine Eye Drops are and what they are used for
Vistatropine 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).
Vistatropine 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 Vistatropine Eye Drops
Do not use Vistatropine 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 Vistatropine 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 medicines and Atropine Eye Drops:
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:
• any other eye medicines, as they may delay the absorption of Vistatropine Eye Drops.
• muscle relaxants such as hyoscyamine as these may increase the effect of Vistatropine Eye Drops.
Pregnancy, breast‐feeding and fertility:
If you are pregnant or breast‐feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist before taking this medicine.
Driving and using machines:
This medicine is used to widen pupils and can cause blurred vision. You should not drive or operate
machinery until the effects of the drops have worn off.
Important information about one of the ingredients:
Vistatropine Eye Drops contain benzalkonium chloride which may cause eye irritation. Avoid contact
with soft contact lenses. Remove hard contact lenses prior to application and wait at least 15
minutes before reinsertion.
Known to discolour soft contact lenses.
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.
The recommended dose for:
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.

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 this medicine 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Vistatropine Eye Drops
Keep this medicine out of the sight and reach of children.
Store upright below 25°C, in a dry place, away from 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. Contents of the pack and other information
What Vistatropine Eye Drops contain:
The active substance is atropine sulfate 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 sulfate 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
or
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 revised in September 2016

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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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