- Approval Id
- e3f17c791344dc9a
- Drug Approval Emc Name
- Atropine 1.0 % w/v eye drops, solution
- Drug Name
- Atropine 1.0 % w/v eye drops, solution
- Company Name
- Neon Healthcare Ltd
- Company Address
- 8 The Chase, John Tate Road, Foxholes Business Park, Hertford, Hertfordshire, SG13 7NN, UK
- Company Website
- http://www.neonhealthcare.com
- Company Telephone
- +44 (0)1992 926 330
- Company Medical Info Direct Line
- +44 (0)1992 926 330
- Company Medical Info Email
- medinfo@neonhealthcare.com
- Company Customer Care Direct Line
- +44 (0)1992 926 330
- Company Stock Availability
- +44 (0)1992 926 330
- Atc Code
- S01FA01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Neon Healthcare Limited
8 The Chase, John Tate Road,
Hertford
SG13 7NN
United Kingdom
- Authorisation Number
- PL 45043/0132
- Authorisation Date
- 06/11/2023
- Instruction Authorisation Holder
- Neon Healthcare Limited
8 The Chase, John Tate Road,
Hertford
SG13 7NN
United Kingdom
- Instruction Authorisation Number
- PL 45043/0132
- Instruction Authorisation Date
- 06/11/2023
- Instruction Composition
- Each ml of eye drops contains 10 mg of atropine sulfate.
\*\*Excipient with known effect\*\*
0.10 mg of benzalkonium chloride per ml of eye drops.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Eye drops, solution.
Clear, colourless solution.
- Instruction Clinical Particulars
- 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
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.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.4.4 Special warnings and precautions for use
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.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
\*\*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.4.7 Effects on ability to drive and use machines
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.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 or search for MHRA Yellow Card in the Google Play or Apple App Store.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, atrioventricular dissociation) and central nervous system effects (confusion, ataxia, restlessness, hallucination, convulsions).
\*\*Treatment\*\*
Supportive therapy should be given as required.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anticholinergic agents ATC code: S01FA01
Dilation of the pupil normally occurs within half an hour following local application and lasts for seven days or longer. Paralysis of accommodation in one to three hours with recovery in three to seven days.5.2 Pharmacokinetic properties
Atropine is readily absorbed from the gastro-intestinal tract and mucous membranes, it is also absorbed from the eye.
It is incompletely metabolised in the liver and is excreted in the urine as unchanged drug and metabolites.5.3 Preclinical safety data
No additional pre-clinical data of relevance to the prescriber.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Benzalkonium chloride
Hydrochloric acid, concentrated (for pH adjustment)
Water for injections6.2 Incompatibilities
None known relevant to topical ocular use.6.3 Shelf life
Unopened: 3 years.
Once opened: use within 4 weeks.6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.6.5 Nature and contents of container
Low Density Polyethylene (LDPE) bottle with a nozzle and a tamper evident high- density polyethylene (HDPE) and LDPE screw cap. Each bottle contains 10 ml of the medicinal product.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Each ml of eye drops contains 10 mg of atropine sulfate.
\*\*Excipient with known effect\*\*
0.10 mg of benzalkonium chloride per ml of eye drops.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Eye drops, solution.
Clear, colourless solution.
## Clinical Particulars
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
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.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.4.4 Special warnings and precautions for use
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.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
\*\*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.4.7 Effects on ability to drive and use machines
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.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 or search for MHRA Yellow Card in the Google Play or Apple App Store.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, atrioventricular dissociation) and central nervous system effects (confusion, ataxia, restlessness, hallucination, convulsions).
\*\*Treatment\*\*
Supportive therapy should be given as required.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anticholinergic agents ATC code: S01FA01
Dilation of the pupil normally occurs within half an hour following local application and lasts for seven days or longer. Paralysis of accommodation in one to three hours with recovery in three to seven days.5.2 Pharmacokinetic properties
Atropine is readily absorbed from the gastro-intestinal tract and mucous membranes, it is also absorbed from the eye.
It is incompletely metabolised in the liver and is excreted in the urine as unchanged drug and metabolites.5.3 Preclinical safety data
No additional pre-clinical data of relevance to the prescriber.
## Pharmaceutical Particulars
6.1 List of excipients
Benzalkonium chloride
Hydrochloric acid, concentrated (for pH adjustment)
Water for injections6.2 Incompatibilities
None known relevant to topical ocular use.6.3 Shelf life
Unopened: 3 years.
Once opened: use within 4 weeks.6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.6.5 Nature and contents of container
Low Density Polyethylene (LDPE) bottle with a nozzle and a tamper evident high- density polyethylene (HDPE) and LDPE screw cap. Each bottle contains 10 ml of the medicinal product.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
