eye drops, solution 
eye drops , solution, single-dose container

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if you do not feel better or if you feel worse.

In this leaflet: 
1. What Artelac is and what it is used for 
2. What you need to know before you use Artelac 
3. How to use Artelac 
4. Possible side effects 
5. How to store Artelac 
6. Contents of the packaging and other information 

1. What Artelac is and what it is used for

Artelac is a tear substitute that acts as the natural tear fluid and lubricates and moisturizes the eye. Artelac eye drops relieve symptoms of dry eyes.

2. What you need to know before using Artelac

Do not use Artelac eye drops

  • if you are allergic to any of the ingredients of this medicine (listed in section 6).

Other medicines and Artelac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you use another eye preparation, wait at least 5 minutes between the different preparations; drop Artelac at the end.

Pregnancy and breastfeeding

Artelac can be used during pregnancy and lactation.

Driving and using machines

The eye drops can cause temporary blurred vision immediately after dripping. You should avoid driving and using machines until this effect has disappeared.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Contact lenses

If you wear contact lenses, remove the lenses before dropping Artelac and replace them after 15 minutes at the earliest.

Artelac eye drops in single-dose containers do not contain preservatives. Therefore, they can be used with contact lenses.

Artelac contains phosphate buffer

Artelac eye drops solution contains 0.051 mg phosphate per drop equivalent to 1.84 mg / ml.

Artelac eye drops, solution, the single-dose container contains 0.068 mg phosphate per drop corresponding to 1.84 mg/ml.

If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.

3. How to use Artelac

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one drop in each eye if needed. Your doctor may also decide on another dosage.

Before use:

  • wash your hands
  • choose the position that feels most natural to you (you can, for example, sit down, lie on your back, stand in front of the mirror)

Single-dose container: 
A single-dose container is sufficient for both eyes. After use, the single-dose container should be discarded with any remaining solution.

Application:

Single-dose containers: The 
instructions for use for single-dose containers are printed on the packaging.

Eye drop bottle:

1.Open the bottle. Avoid touching anything with the tip of the bottle so that the contents are not contaminated.
2. Tilt your head back and hold the bottle above your eye.
3. Pull the lower eyelid down, look up and squeeze a drop into the eye.
4. Blink a few times so that the drop spreads. Close the bottle.

Wait at least 5 minutes between each application if you are using multiple medicines in the same eye.

If you use more Artelac than you should

There are no known reactions.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Artelac may cause temporary blurred vision or a burning sensation in the eye.

If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.

Contact your doctor if you feel great discomfort or have other problems with the use of the eye drops.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Artelac

Keep this medicine out of the sight and reach of children.

An opened bottle should be used within 4 weeks.

The single-dose containers and unopened bottles should not be stored above 25 ° C.

The single-dose container should be discarded immediately after use.

Do not use this medicine after the expiry date which is stated on the label / single-dose container and carton.

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. Contents of the packaging and other information

Content declaration

Artelac bottle drops : Hypromellose 3.2 mg / ml, cetrimide 0.10 mg / ml, disodium phosphate, sodium dihydrogen phosphate, disodium edetate, sorbitol and water for injections.

Artelac single-dose eye drops Hypromellose 3.2 mg/ml, disodium phosphate, sodium dihydrogen phosphate, sorbitol, and water for injections.

Marketing Authorisation Holder

BAUSCH HEALTH IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24 – D24PPT3 – Ireland

Manufacturer:

Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH 
13581 Berlin 
Germany

For further information on this medicinal product, please contact the representative of the Marketing Authorization Holder: 

Muhammad Nadeem

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