Atropine Eye Drops Bp 1.0% W/V
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PACKAGE LEAFLET: INFORMATION FORTHE USER D02423
Vistatropine Eye Drops 0.5% & 1.0 %w/v
atropine sulphate
(Referred to as Vistatropine Eye Drops in this leaflet)
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.
In this leaflet:
1. What Vistatropine Eye Drops are and what they are used for
2. Before you use Vistatropine Eye Drops
3. Elowto use Vistatropine Eye Drops
4. Possible side effects
5. Howto store Vistatropine Eye Drops
6. Further information
1. What Vistatropine Eye Drops are and what they are used for
Vistatropine Eye Drops contain atropine sulphate 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. 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
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:
• 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 ofVistatropine Eye Drops.
Pregnancy and breast-feeding:
This medicine should be avoided if you are pregnant, trying to become pregnant or you are breast-feeding, unless your doctor has recommended it.
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. Howto 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 25°C, 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
MARTINDALE PHARMA
Bampton Road, Harold Hill, Romford, RM3 8UG, UK