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Artelac 3.2mg/Ml Eye Drops Solution

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac® 3.2mg/ml Eye Drops, Solution

(hypromellose)

This product is available using the above name but will be referred to as Artelac throughout the following leaflet.

Please read all of this entire 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 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.

In this leaflet:

1.    What Artelac is and what it is used for

2.    Before you use Artelac

3.    How to use Artelac

4.    Possible side effects

5.    How to store Artelac

6.    Further information

1. What Artelac is and what it is used foi

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 Artelag


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 and then wait for at least 15 minutes after using these drops before putting your lenses back in.

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

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 HgraagffffiEyEfiHc u 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

•    unscrew the cap from the bottle and check the dropper is clean

•    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, replace the protective cap tightly to avoid spillage or spoilage

Always read the label before using this medicine.

If you use more Artelac 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 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

•    Keep out of the sight and reach of children.

•    Do not use this medicine after its expiry date.

•    If the expiry date has passed, take the medicine back to your pharmacist.

•    Do not store above 25°C.

•    Your eye drops are sterile until first opened. It is important to keep the drops as clean as possible during use. Do not touch the dropper tip on the eye or any other surface.

•    Your drops come in a bottle, which should be use within 28 days after first opening.

• 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.

•    If the solution becomes discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist.

6. Further information

What Artelac contains

The active ingredient is Hypromellose 3.2 mg/ml equivalent to 0.32% w/v.

The other ingredients are Sorbitol, Sodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate, Disodium Edetate, Cetrimide and Water for Injections in Bulk. The preservative in your eye drops is cetrimide. Artelac is therefore suitable for patients who are hypersensitive to benzalkonium chloride.

What Artelac looks like and contents of the pack

Your eye drops are artificial tears and are supplied in 10 ml plastic eye drop bottles. These eye drops are a clear solution. 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.

Manufacturer

Artelac is manufacturer by Dr Gerhard Mann Chem-pharm Fabrik GmbH, Brunsbutteler Damm 165, 13581 Berlin. Procured from within the EU by the Product license Holder Pharma-XL Limited, Unit 5-7 Colonial Way, Watford, Herts WD24 4PR and repackaged by OPD Laboratories Ltd, Colonial Way, Watford, Herts wD24 4PR.

|POM|

PL No: 29510/0059 Artelac 3.2mg/ml Eye Drops, Solution

Leaflet revision and issue date (Ref) 29.11.2013.

Artelac is a registered Trade Mark of Dr Gerhard Mann Chem-pharm Fabrik GmbH., Germany.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.