- Approval Id
- 50e7dc6001512999
- Drug Approval Emc Name
- Artelac 0.32%w/v Single dose unit, Eye drops solution
- Drug Name
- Artelac 0.32%w/v Single dose unit, Eye drops solution
- Company Name
- Bausch & Lomb U.K Limited
- Company Address
- Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
- Company Telephone
- +44 (0)208 781 2900
- Company Medical Info Email
- ukmedinformation@bausch.com
- Company Customer Care Direct Line
- Tel: +44 (0)208 781 2991 Fax: +44 (0)208 781 295
- Atc Code
- S01XA20
- Legal Category
- Pharmacy
- Authorisation Holder
- Bausch & Lomb (UK) LtdBausch &Lomb House106 London RoadKingston-Upon-ThamesSurrey KT2 6TNUK
- Authorisation Number
- PL 03468/0033
- Authorisation Date
- 16/09/2010
- Instruction Authorisation Holder
- Bausch & Lomb (UK) LtdBausch &Lomb House106 London RoadKingston-Upon-ThamesSurrey KT2 6TNUK
- Instruction Authorisation Number
- PL 03468/0033
- Instruction Authorisation Date
- 16/09/2010
- Instruction Composition
- Hypromellose, 0.32% w/vFor full list of excipients, see 6.1.
- Instruction Dosage Form
- Eye drops, solution in single-dose container.Sterile clear solution
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
This medicinal product acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure.Artelac 0.32% w/v Eye Drops Single Dose Unit is indicated in adults and children.4.2 Posology and method of administration
\*\*Posology\*\*
Suitable for use in adults and children.Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication.Therapy of dry eye syndrome requires an individual dosage regimen.Leave an interval of at least 5 minutes before instilling another ophthalmic medication
\*\*Method of administration\*\*
For ocular use only4.3 Contraindications
Hypersensitivity to the active substance (hypromellose) or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop. Wearers of soft contact lenses should remove their lenses before Artelac 0.32% w/v Eye Drops Single Dose Unit is administered and should wait for at least 15 minutes before they insert them again.4.5 Interaction with other medicinal products and other forms of interaction
None4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
Artelac 0.32% w/v Eye Drops Single Dose Unit can be used during pregnancy
\*\*Breast-feeding\*\*
Artelac 0.32% w/v Eye Drops Single Dose Unit can be used in lactation.
\*\*Fertility\*\*
Artelac 0.32% w/v Eye Drops Single Dose Unit is not expected to have any effect on fertility.4.7 Effects on ability to drive and use machines
Artelac 0.32% w/v Eye Drops Single Dose Unit on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery.4.8 Undesirable effects
The following adverse reactions have been reported following administration of Artelac 0.32% w/v Eye Drops Single Dose Unit.
\*\*Eye disorder:\*\*
Very rare (<1/10,000):Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
\*\*Not known:\*\*
Brief blurred vision or a slight stinging sensation on instilling Artelac 0.32% w/v Eye Drops Single Dose Unit.Reporting of 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 Yellow Card Scheme Website: \*\*www.mhra.gov.uk/yellowcard\*\*4.9 Overdose
No case of overdose has been reported.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group:Ophthalmologicals: other ophthalmologicalsATC code: S01X A20Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.5.2 Pharmacokinetic properties
Hypromellose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.5.3 Preclinical safety data
There is no preclinical data of relevance to the prescriber.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Disodium phosphate dodecahydrateSodium dihydrogen phosphate dihydrateSorbitolPurified water6.2 Incompatibilities
Not applicable6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 25° C.6.5 Nature and contents of container
0.5 ml single dose unit, composed of LDPE.30, 60 and 120 single dose units6.6 Special precautions for disposal and other handling
Avoid contamination during use. Artelac SDU eye drops are sterile until first opened.For single use only. Each carton contains a patient insert with instructions for use.
- Instruction Content
- ## Composition
Hypromellose, 0.32% w/vFor full list of excipients, see 6.1.
## Pharmaceutical Form
Eye drops, solution in single-dose container.Sterile clear solution
## Clinical Particulars
4.1 Therapeutic indications
This medicinal product acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure.Artelac 0.32% w/v Eye Drops Single Dose Unit is indicated in adults and children.4.2 Posology and method of administration
\*\*Posology\*\*
Suitable for use in adults and children.Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication.Therapy of dry eye syndrome requires an individual dosage regimen.Leave an interval of at least 5 minutes before instilling another ophthalmic medication
\*\*Method of administration\*\*
For ocular use only4.3 Contraindications
Hypersensitivity to the active substance (hypromellose) or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop. Wearers of soft contact lenses should remove their lenses before Artelac 0.32% w/v Eye Drops Single Dose Unit is administered and should wait for at least 15 minutes before they insert them again.4.5 Interaction with other medicinal products and other forms of interaction
None4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
Artelac 0.32% w/v Eye Drops Single Dose Unit can be used during pregnancy
\*\*Breast-feeding\*\*
Artelac 0.32% w/v Eye Drops Single Dose Unit can be used in lactation.
\*\*Fertility\*\*
Artelac 0.32% w/v Eye Drops Single Dose Unit is not expected to have any effect on fertility.4.7 Effects on ability to drive and use machines
Artelac 0.32% w/v Eye Drops Single Dose Unit on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery.4.8 Undesirable effects
The following adverse reactions have been reported following administration of Artelac 0.32% w/v Eye Drops Single Dose Unit.
\*\*Eye disorder:\*\*
Very rare (<1/10,000):Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
\*\*Not known:\*\*
Brief blurred vision or a slight stinging sensation on instilling Artelac 0.32% w/v Eye Drops Single Dose Unit.Reporting of 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 Yellow Card Scheme Website: \*\*www.mhra.gov.uk/yellowcard\*\*4.9 Overdose
No case of overdose has been reported.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group:Ophthalmologicals: other ophthalmologicalsATC code: S01X A20Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.5.2 Pharmacokinetic properties
Hypromellose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.5.3 Preclinical safety data
There is no preclinical data of relevance to the prescriber.
## Pharmaceutical Particulars
6.1 List of excipients
Disodium phosphate dodecahydrateSodium dihydrogen phosphate dihydrateSorbitolPurified water6.2 Incompatibilities
Not applicable6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 25° C.6.5 Nature and contents of container
0.5 ml single dose unit, composed of LDPE.30, 60 and 120 single dose units6.6 Special precautions for disposal and other handling
Avoid contamination during use. Artelac SDU eye drops are sterile until first opened.For single use only. Each carton contains a patient insert with instructions for use.
