Artelac 0.32 % W/V Eye Drops Single Dose Unit
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Artelac® 0.32% w/v eye drops single dose unit (hypromellose)
Please read all of this leaflet carefully because it contains important
information for you.
• This medicine is available without prescription, as an over the counter item only in a pharmacy. However, you still need to use Artelac 0.32% w/v eye drops single dose unit carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Artelac® 0.32% w/v eye drops single dose unit but will be referred to as Artelac SDU throughout the remainder of this leaflet.
In this leaflet:
1) What Artelac SDU is and what it is used for
2) Before you use Artelac SDU
3) How to use Artelac SDU
4) Possible side effects
5) How to store Artelac SDU
6) Further information
1) WHAT ARTELAC SDU IS AND WHAT IT IS USED FOR
Your drops contain 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.
2) BEFORE YOU USE ARTELAC SDU Do not use these drops
• if you have been told, or know, that you are allergic (hypersensitive) to any of its ingredients (see section 6).
Take special care with these drops
• if you wear soft contact lenses - take out your lenses before using Artelac SDU and then wait for at least 15 minutes after using these drops before putting your lenses back in.
Using other medicines
• You should wait 5 minutes before using any other eye medication. Pregnancy and breast-feeding
• These drops can be used if you are pregnant or breast-feeding. 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.
3) HOW TO USE ARTELAC SDU
Always use your drops exactly as your doctor or pharmacist has told you to. You should 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).
Dosage
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.
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 singledose unit
Always read the label before using this medicine.
If you use more Artelac SDU 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.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Artelac SDU 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.
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.
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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5) HOW TO STORE ARTELAC SDU
• Keep out of the sight and reach of children.
• Do not use this medicine after its expiry date.
Check the expiry date on the label before you begin to use your medicine.
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.
• If your medicine becomes discoloured or shows any sign of deterioration, return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Artelac SDU contains
The active ingredient is hypromellose 0.32% w/v.
The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sorbitol and water for injections.
What Artelac SDU looks like and contents of the pack
Artelac SDU is a clear colourless sterile solution and is supplied in singledose containers. Each single dose unit has a volume of 0.5ml.
Artelac SDU come in packs of 30 and 60 single dose units.
Product Licence Holder
Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
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Repackaged by xxxxxxxxxxx
Manufacturer: Dr. Gerhard Mann Chem-Pharm. Fabrik GmbH, 13581 Berlin, Germany
Artelac® 0.32% w/v eye drops single dose unit PL: 33532/0364
Leaflet dated 5th February 2015 Leaflet coded xxxxxx
Artelac® is a trademark of
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