In this leaflet:

1. What Lipolac gel oftálmico is and what it is used for
2. Before you use Lipolac gel oftálmico
3. How to use Lipolac gel oftálmico
4. Possible side effects
5. Storing Lipolac gel oftálmico

Lipolac gel oftálmico

The active substance of Lipolac gel oftálmico is 0.2% carbomer w/w.
The other ingredients of Lipolac gel oftálmico are: cetrimide, sorbitol, medium-chain triglycerides, sodium hydroxide (to adjust pH) and purified water.

Marketing authorisation holder
FARMA-LEPORI, S.A.
C. Osi, 7 - 08034 Barcelona (Spain)

Manufacturer:
Dr. Mann Pharma
Brunsbütteler Damm 173
13581 Berlin (Germany)

1. WHAT Lipolac gel oftálmico IS AND WHAT IT IS USED FOR
Lipolac is an ophthalmic gel, white, turbid, highly viscous, with dripping capacity.
There are two presentations: one of 5 g and another of 10 g.
Lipolac gel oftálmico is used in the symptomatic treatment of dry eye syndrome.

2. BEFORE YOU USE Lipolac gel oftálmico
Do not use Lipolac gel oftálmico:
- If you know or suspect you have a reaction to any of its ingredients. Check this by reading the aforementioned list of ingredients.

Be particularly careful with Lipolac gel oftálmico:
- Lipolac gel oftálmico is sterile until the first opening, whereby it is important to keep the tube as clean as possible during use.
- If you wear contact lens, remove them before using Lipolac gel oftálmico, and wait for 30 minutes after application before putting them back in.

Pregnancy
Due to the absence of clinical data on Lipolac gel oftálmico during pregnancy, you should see your doctor or pharmacist before using this medicine.

Lactation
Due to the absence of clinical data on Lipolac gel oftálmico during lactation, you should see your doctor or pharmacist before using this medicine.

Use in children
No specific studies with Lipolac gel oftálmico have been carried out in children. Your doctor will tell you which dose to take.

Driving and using machines:
Following application, all eyedrops may cause blurred vision for a short period of time. You should therefore wait for a few minutes until you see clearly again before driving or using machinery. This will only take five minutes.

Use of other medicines
Please inform your doctor or pharmacist if you are using or have recently used any other medicines, even those not prescribed.
Lipolac gel oftálmico may prolong the contact time of topically applied ophthalmologic products.
If Lipolac gel oftálmico is used at the same time as other eyedrops/ointments, 15 minutes should be allowed to apply between the application of both medications. Lipolac gel oftálmico should always be applied last.
Always read the label before using a medicine.

3. HOW TO USE Lipolac gel oftálmico
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
The standard dose is as follows: apply one drop in the angle of the eye next to the nose, 3-5 times a day, and approximately 30 minutes before going to bed (otherwise there is a risk of the eyelids sticking together).
The proper drop size is achieved when the tube is held upright above the eye during application.

Instructions for use:
Tilt the head backwards and gently pull down the lower eyelid with your index finger. Hold the tube upright with your other hand, without touching the eye, and apply a drop to the conjunctival sac, which is the part of the eye that is closest to the nose. Try to keep your eye open and move it around so that the gel is spread equally over the eye.
If you have impression that the effect of Lipolac gel oftálmico is too strong or weak, talk to your doctor or pharmacist.
Make sure you know how and when to use your medicine. If you are not sure how to use Lipolac gel oftálmico contact your pharmacist.
This medicine should be used only for the eye.
If you accidentally apply a greater dose than the one recommended, you may get blurred vision, although it will go away in a very short period of time.
If you have used more Lipolac gel oftálmico than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service on 91 562 04 20.
Do not take a double dose to make up for the doses you forgot to take.

4. POSSIBLE SIDE EFFECTS
As occurs with all medicines, Lipolac gel oftálmico may have adverse effects.
Generally speaking, Lipolac gel oftálmico does not cause adverse effects, although occasionally some people may get a burning sensation, redness of the eyes, sticky eyelids, conjunctivitis, corneal spots, inflammation of the eyeball, blurred vision, stinging feeling, discomfort.

As occurs with any other eye preparation, you may have blurred vision or a slight sensation of itch following the application of Lipolac gel oftálmico, for a short period of time.

There is a possibility that a very small number of people may notice irritation and itch in the eyes. If this irritation is serious, or if the gel causes your symptoms to get worse, please see your doctor or pharmacist.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING Lipolac gel oftálmico
- Do not store Lipolac gel oftálmico above 25ºC.
- Keep the tube as clean as possible, Lipolac gel oftálmico is sterile until opened.
- The contents of the tube should be consumed within 28 days following its first opening. For this purpose, it may be useful to write down the date you opened it on the tube.

Keep Lipolac gel oftálmico out of the sight and reach of children.

This leaflet was approved in April 2003.

Licensed by Dr. Mann Pharma, subsidiary of BAUSCH & LOMB.

FARMA-LEPORI
C. Osi, 7 - 08034 Barcelona

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