Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Artelac 0.32%w/v Single dose unit, Eye drops solution
⚠ 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 Hypromellose may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Artelac SDU Preservative Free contains hypromellose as the active ingredient, which is a form of cellulose. Your drops are used as a tear substitute and lubricant when applied to the eye. The hypromellose in these drops increases the thickness of the solution which has a moisturising effect and helps the solution to stay in contact with the eye for a longer period of time. These drops work by soothing the eye and giving tear-like lubrication to the eyes and eye lids. They are used to treat the symptoms of "dry eye", which is a dehydration of the surface of the eye because no natural tears are being produced. Dry eye can also be caused if it is not possible to close your eyelids partly or completely. You must talk to a doctor if you do not feel better or if you feel worse.
What you need to know before you take it
E ARTELAC SDU PRESERVATIVE FREE Do not use Artelac SDU Preservative Free if you are allergic to hypromellose or any of the ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Artelac SDU Preservative Free if you wear soft contact lenses – take out your lenses before using Artelac SDU Preservative Free and then wait for at least 15 minutes after using these drops before putting your lenses back in. Other medicines and Artelac SDU Preservative Free Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines. You should wait 5 minutes before using any other eye medication. 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 for advice before taking this medicine. Driving and using machines All eye drops can cause a short term blurring of vision when first used so you should wait until your eyes are clear before driving or using machines.
How to take it
ARTELAC SDU PRESERVATIVE FREE Always use your drops exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure. The medicine is to be used only as drops applied into one or both eye(s). The recommended dose is Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The usual dose is to apply one drop in the corner of the eye, nearest the nose, 3 to 5 times each day or as required to give enough lubrication. Dry eye is a condition that varies from person to person. Use the drops as often as you think necessary. continued overleaf
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Graphics&Packing Technology Section ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu Product Name
Artelac 0.32% w/v DRP Single Dose Unit
Kolor nadruku Colours
Kraj Country (ISO)
United Kingdom (UK)
Nr wykrojnika Spec No
93037
Kod Wytwórcy Manufacturer code
40898PB276/6-UK
Kod farmaceutyczny
329
P9UKIE01
Inny kod Other code
–
minimum 8 pt
Wymiar ulotki PIL size
148 x 210 mm
Black
Opracowane przez Designed by Nr korekty Proof No Kod wersji Valeant version code Rozmiar czcionki Font size Krój czcionki Font used
7
Data Date
15.10.2015
Helvatica font Family
Gramatura papieru Paper weight
Komentarze Comments (Reason for the change) safety update to include phosphate warning and qrd update PMR_ICN-15-0625-A Packing site: DMP Berlin – [email protected] Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
- g/m2
Directions for use — sit down in front of a mirror so that you can see what you are doing — wipe your eyes to clear any residual wateriness or discharge — holding the unit by the label end, remove a single-dose unit from the pack — twist the cap off the single-dose unit — pull your lower eyelid gently down, and then carefully place one drop inside the lower eyelid, in the corner nearest the nose — release the lower eyelid, and blink a few times to make sure the eye is covered by the liquid — repeat the procedure for your other eye — when you have finished, throw away the single-dose unit Always read the label before using this medicine. If you use more Artelac SDU Preservative Free than you should If you accidentally use a larger dose than recommended, this may cause some blurring of vision, which will soon pass. Make sure you know how and when to use your medicine. If you are not sure about using your drops, ask your pharmacist. If you forget to take Artelac SDU Preservative Free Do not take a double dose to make up for a forgotten dose
Possible side effects
Like all medicines, Artelac SDU Preservative Free can cause some side effects, although not everybody gets them. If you experience any difficulty stop using your drops and talk to your doctor or pharmacist. In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment. Like all eye drops you may briefly have blurred vision or a slight stinging feeling after using your drops. There is also a slight possibility that irritation or itching of the eye may occur in a very small number of people. (frequency cannot be estimated from the available data) If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 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
ARTELAC SDU PRESERVATIVE FREE Keep out of the reach and sight of children. Do not use this medicine after its expiry date which is stated on the label. The expiry date refers to the last day of that month. If the expiry date has passed, take the medicine back to your pharmacist. Keep the eye drops at normal room temperature (do not store above 25oC). Protect from light. Your eye drops are sterile until first opened. It is important to keep the drops as clean as possible during use. Your drops come in single-dose, single-use units, which should be thrown away immediately after use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Artelac SDU Preservative Free contains The active ingredient is Hypromellose 0.32% w/v. The other ingredients are Sorbitol, Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate and Purified Water. What Artelac SDU Preservative Free looks like and contents of the pack Your eye drops are artificial tears and are supplied in plastic single-dose units in pack sizes of 30, 60 and 120. Each single dose unit has a volume of 0.5 ml. Your drops contain no preservative, therefore each unit is for single-use only. These eye drops are a clear solution. Your drops do not contain a preservative and can be used by patients who are hypersensitive to preservatives or who wear contact lenses. This medicine is for you, never give it to anyone else, even if they appear to have the same symptoms as you. Return any unused medicine to your pharmacist. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is: The manufacturer is: Bausch & Lomb UK Ltd., Dr Gerhard Mann Chem-pharm 106 London Road,
Fabrik GmbH Kingston-Upon-Thames, Surrey, 13581 Berlin PL 03468/0033 Germany P9UKIE01 This leaflet was last approved in 07/2015. 40898PB276/6-UK
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Frequently asked questions about Artelac 0.32%w/v Single dose unit, Eye drops solution
How do I take Artelac 0.32%w/v Single dose unit, Eye drops solution?
Artelac 0.32%w/v Single dose unit, Eye drops solution comes as eye drops containing 0.32%. 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 Artelac 0.32%w/v Single dose unit, Eye drops solution?
The active substance in Artelac 0.32%w/v Single dose unit, Eye drops solution is hypromellose.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Artelac 0.32%w/v Single dose unit, 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.
Can I get Artelac 0.32%w/v Single dose unit, Eye drops solution 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: hypromellose
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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 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 0.32% w/v Eye Drops Single Dose Unit is administered and should wait for at least 15 minutes before they insert them again.
4.6. 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.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- ArtelacHypromellosum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Artelac 0.32%w/v Single dose unit, 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.