The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: atropine sulfateOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Atropine sulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Atropine sulfate

Equivalent medicines (same active substance, strength and form)

→ Minims Atropine Sulphate 1%, Eye drops solution brand

→ Atropine 1% w/v eye drops, solution

→ Atropine 1.0 % w/v eye drops, solution

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

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).

What you need to know before you take it

e 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 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 Atropine 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 Atropine Eye Drops.
muscle relaxants such as hyoscyamine as these may increase the effect of Atropine 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: Atropine 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 discolor soft contact lenses.

How to take it

Atropine Eye Drops Always use Atropine 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 Continued overleaf

examination. Instructions for use Atropine 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 Atropine Eye drops
Atropine Eye Drops are for external use only. Do not swallow. If you swallow Atropine Eye Drops tell your doctor or nearest hospital casualty unit immediately.
Do not wear soft contact lenses when using these drops. Remove hard 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
Atropine Eye Drops should be discarded 4 weeks after first opening. If you use more Atropine 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 Atropine 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 Atropine 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 Atropine 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 Atropine 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 atropine 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 Atropine 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.

How to store it

Atropine 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 Atropine 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.

Contents of the pack and other information

What Atropine Eye Drops contain: The active substance is atropine sulfate 1% w/v. Other ingredients are purified water and benzalkonium chloride solution. What Atropine Eye Drops look like and contents of the pack: Atropine Eye Drops are a sterile solution of atropine sulfate 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 Tubilux Pharma S.p.A., Via Costarica 20/22 00071 Pomezia (RM) ITALY Product Licence Number: Atropine Eye Drops 1.0%w/v; PL 00156/0044 & HK – 09066 This leaflet was last revised in December 2016

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PACKAGE LEAFLET: INFORMATION FOR THE USER

100mm Measurement Verification Bar

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Frequently asked questions about Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v

How do I take Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v?

Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v?

The active substance in Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v is atropine sulfate.

Are there equivalent medicines to Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v?

Medicines with the same active substance, strength and form include: Minims Atropine Sulphate 1%, Eye drops solution, Atropine 1% w/v eye drops, solution, Atropine 1.0 % w/v eye drops, solution. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: atropine sulfate
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Atropine sulfate (8 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

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 precautions for use

It should only be used with caution in patients who may have raised intra ocular pressure.

The product contains benzalkonium chloride solution and soft contact lenses must not be worn during the period of use.

Patients should be warned that antimuscarinic eye drops will temporarily impair vision.

Patients should wash hands after using the eye drops and great care should be taken to avoid getting the product into the mouth.

Due to the risk of provoking hyperpyrexia, atropine should only be used with great caution when the ambient temperature is high or the patient has a fever.

Care is also required in patients with conditions characterised by tachycardia.

Darkly pigmented iris is more resistant to pupillary dilation and caution should be exercised to avoid overdosage.

The eye drops should be discarded 4 weeks after first opening.

During use, care should be taken not to touch the dropper nozzle on to the eyelid or any other surface.

The product is for external use only and should be stored out of the sight and reach of children.

4.5. Interaction with other medicinal products and other forms of interaction

The effects of atropine may be enhanced by the concomitant use of other drugs with antimuscarinic properties. Studies have indicated that the absorption of atropine sulphate appears to be delayed by solutions of higher osmolarity.

4.6. Fertility, pregnancy and lactation

The safety for use in pregnancy and lactation has not been established, therefore, use only when directed by a physician.

4.7. Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.

4.8. Undesirable effects

Patients may experience photophobia and eyes should be protected from bright light while the pupils are dilated.

Prolonged use of atropine eye drops may lead to local irritation, transient stinging, hyperaemia, oedema and conjunctivitis. An increase in intra-ocular pressure may occur, especially in patients with closed angle glaucoma.

Hypersensitivity to atropine is not uncommon and may appear as a skin rash or conjunctivitis.

Systemic toxicity may be produced by the instillation of the eye drops especially in infants and the elderly. Reported symptoms include severe ataxia, restlessness, excitement and hallucinations.

Other adverse effects may include a dry mouth with difficulty in swallowing and talking, flushing and a dry skin, transient bradycardia followed by tachycardia, palpitations and arrhythmias, reduced bronchial secretions, urinary urgency and retention and constipation.

Side effects that occur occasionally include confusion (particularly in the elderly), nausea, vomiting and giddiness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Symptoms

Systemic reactions to topical atropine are unlikely at normal doses. Symptoms which can occur following an overdose, however, include anticholinergic effects (as listed in section 4.8 above), cardiovascular changes (tachycardia, atrial arrhythmias, atrio-ventricular dissociation) and central nervous system effects (confusion, ataxia, restlessness, hallucination, convulsions).

Treatment

Supportive therapy should be given as required.

💬 Ask about this leaflet

Ask anything about Atropine Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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