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- Artelac 10ml hypromellose 0.32% with preservative, Eye drops solution
Artelac 3.2 mg/ml Eye Drops Solution
Summary of product characteristics
1. Name of the medicinal product
Artelac 3.2 mg/ml Eye Drops Solution
2. Qualitative and quantitative composition
Each ml of solution contains 3.2mg of hypromellose equivalent to Hypromellose 3.2 mg/ml. For full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution. Sterile clear solution
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 3.2 mg/ml Eye Drops Solution is indicated in adults and children.
4.2. Posology and method of administration
Posology
Suitable for use in adults and children. Unless otherwise directed, instil 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.
Method of administration
For ocular use only.
4.3. 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 3.2 mg/ml Eye Drops Solution is administered and should wait for at least 15 minutes before they insert them again. Ensure the dropper tip does not touch any surface including the eye surface.
4.5. Interaction with other medicinal products and other forms of interaction
None.
4.6. Fertility, pregnancy and lactation
Pregnancy
Artelac 3.2 mg/ml Eye Drops Solution can be used during pregnancy.
Breast-feeding
Artelac 3.2 mg/ml Eye Drops Solution can be used during and lactation.
Fertility
Artelac 3.2 mg/ml Eye Drops Solution is not expected to have any effect on fertility.
4.7. Effects on ability to drive and use machines
Artelac 3.2 mg/ml Eye Drops Solution 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 3.2 mg/ml Eye Drops Solution.
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 3.2 mg/ml Eye Drops Solution.
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 Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
No case of overdose has been reported.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals ATC code: S01X A20 Hypromellose 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
Hypromellose has proved to be very well tolerated in local toxicity studies.
6.1. List of excipients
CetrimideDisodium Phosphate DodecahydrateSodium Dihydrogen Phosphate DihydrateDisodium EdetateSorbitolWater for Injections in Bulk
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Discard within 28 days of first opening.
6.4. Special precautions for storage
Protect from light. Store below 25°C. Sterile until opened. Avoid contamination during use.
6.5. Nature and contents of container
10 ml round transparent white bottle (LDPE) with white dropper plug (LDPE) and white cap (HDPE).
6.6. Special precautions for disposal and other handling
Avoid contamination during use. Hypromellose SDU eye drops are sterile until first opened. For single use only. Each carton contains a patient insert with instructions for use.
7. Marketing authorisation holder
Bausch & Lomb (UK) LtdBausch &Lomb House106 London RoadKingston-Upon-ThamesSurrey KT2 6TNUK
8. Marketing authorisation number(s)
PL 03468/0032
9. Date of first authorisation/renewal of the authorisation
02/09/2009
10. Date of revision of the text
15/05/2015
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 3.2 mg/ml Eye Drops Solution is indicated in adults and children.
4.2 Posology and method of administration
Posology
Suitable for use in adults and children. Unless otherwise directed, instil 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.
Method of administration
For ocular use only.
4.3 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 3.2 mg/ml Eye Drops Solution is administered and should wait for at least 15 minutes before they insert them again. Ensure the dropper tip does not touch any surface including the eye surface.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
Pregnancy
Artelac 3.2 mg/ml Eye Drops Solution can be used during pregnancy.
Breast-feeding
Artelac 3.2 mg/ml Eye Drops Solution can be used during and lactation.
Fertility
Artelac 3.2 mg/ml Eye Drops Solution is not expected to have any effect on fertility.
4.7 Effects on ability to drive and use machines
Artelac 3.2 mg/ml Eye Drops Solution 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 3.2 mg/ml Eye Drops Solution.
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 3.2 mg/ml Eye Drops Solution.
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 Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard.
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Disclaimer
The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.
Medthority will not be held liable for explicit or implicit errors, or missing data.
Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).