Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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).
E ATROPINE EYE DROPS Do not use Atropine eye drops:
ATROPINE EYE DROPS Always use this medicine exactly as your doctor or pharmacist has told you. 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 Atropine eye drops are only to be used in the eyes
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 medicine, 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:
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
ATROPINE EYE DROPS Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton label after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light. Do not use the eye drops more than four weeks after first opening the bottle. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Atropine eye drops contain
Atropine 1.0 % w/v eye drops, solution comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Atropine 1.0 % w/v eye drops, solution is atropine sulfate.
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 Eye Drops BP 1.0% w/v Vistatropine Eye Drops 1.0% w/v. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Atropine 1.0 % w/v eye drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
The depth of the angle of the anterior chamber should be assessed before the product is used.
Posology
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.
Paediatric population
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.
Method of administration
For topical ocular use.
Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
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 only be used with caution in patients who may have raised intra ocular pressure.
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.
This medicinal product contains benzalkonium chloride
As with other ophthalmic solutions containing benzalkonium chloride, soft contact lenses should not be worn during treatment period.
From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use.
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.
Pregnancy
There are no or limited amount of data from the use of atropine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Atropine 1.0 % w/v eye drops, solution during pregnancy.
Breast-feeding
It is unknown whether atropine or its metabolites are excreted in human milk. A risk to newborns / infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Atropine 1.0 % w/v eye drops, solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no human data on the effect of atropine sulfate on male or female fertility.
Atropine 1.0 % w/v eye drops, solution may have a minor influence on the 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.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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, atrioventricular dissociation) and central nervous system effects (confusion, ataxia, restlessness, hallucination, convulsions).
Treatment
Supportive therapy should be given as required.
Ask anything about Atropine 1.0 % w/v eye drops, solution. 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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