In this leaflet:

1. What Ciprofloxacino-lepori is and what it is used for
2. Before you use Ciprofloxacino-lepori
3. How to use Ciprofloxacino-lepori
4. Possible side effects
5. Storing Ciprofloxacino-lepori

Ciprofloxacino-lepori 0,3% colirio en solución
Ciprofloxacin

The active substance is ciprofloxacin (INN), present in the solution in the form of hydrochloride. Each ml of eyedrop in solution contains 3 mg of this active substance.
The other ingredients are benzalkonium chloride (preservative), edetate disodium, mannitol, acetic acid, sodium acetate, sodium hydroxide, hydrochloric acid, bidistilled water.

Marketing authorisation holder:
FARMA-LEPORI, S.A.
C. Osi, 7 - 08034 Barcelona

Manufacturer:
Laboratorio Edol - Productos Farmacéuticos, S.A.
Av. 25 de Abril, 6. 2796-902 Linda-a-Velha (Portugal)

1. WHAT Ciprofloxacino-lepori IS AND WHAT IT IS USED FOR

These eyedrops are presented in a container with 5 ml. It is included in the group of anti-infectious agents for eye administration (excluding the antivirals).
This medicine is indicated in the treatment of corneal ulcers and superficial infections of the eye and eyelids caused by susceptible bacteria.

2. BEFORE YOU USE Ciprofloxacino-lepori

Do not use Ciprofloxacino-lepori:
- If you are allergic to the quinolones
- If you are allergic to any ingredient of the product
- If you are using alkaline solutions
- In children under the age of 1 year

Be particularly careful with Ciprofloxacino-lepori:
- When using it in children aged above 1 year, since experience in children is limited.
- When using it for prolonged periods, since, like any antibacterial preparation, it may give rise to the appearance of bacterial resistance.
- If skin rash or any other sign of allergic reaction appears, treatment should be suspended.

Pregnancy:
Ask your doctor or pharmacist for advice before using any medicine.
Since no controlled studies have been conducted in pregnant women, this medicine should only be used during pregnancy if the benefits outweigh the possible risks for the fetus.

Lactation:
Ask your doctor or pharmacist for advice before using any medicine.
It is not known whether ciprofloxacin applied topically to the eye is excreted in human milk, and for this reason you should ask your doctor before using Ciprofloxacino-lepori during lactation.

Driving and using machines:
There is no known effect that prevents the use of the product before or while driving vehicles or using machines.

Important information on some of the ingredients of Ciprofloxacino-lepori:
This medicine, as it contains benzalkonium chloride as excipient, may decolour soft contact lenses.

Use of other medicines:
Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those not prescribed.
No specific interaction studies have been carried out with Ciprofloxacino-lepori.

3. HOW TO USE Ciprofloxacino-lepori

Follow these instructions unless told to do otherwise by your doctor:
- Wash your hands before opening the bottle, making sure that you do not touch the dropper with your hands, eye or any other surface to avoid possible contamination.
- Hold the bottle with the thumb and middle finger.
- Tilt your head backwards, draw your lower eyelid downwards, and tap the bottom of the container with your index finger to apply one or two drops in the cavity formed (the conjunctival sac), as you look upwards.
- Blink gently several times with your head still tilted backwards.
- Close the bottle tightly after using it.

Remember to use your medicine.
Always follow the posology recommended by your doctor.
The standard dose for the cases indicated below are:

Adults and children over 1 year:
Corneal ulcers: Ciprofloxacino-lepori must be applied to each affected eye, even at night, at the following intervals:
1st day of treatment: 2 drops every 15 minutes for the first 6 hours, continuing with 2 drops every 30 minutes for the rest of the day.
2nd day of treatment: 2 drops every hour.
Days 3-14 of treatment: 2 drops every 4 hours.
If necessary, treatment can be prolonged beyond a fortnight, with the frequency of administration indicated by the physician.
Other eye infections: Ciprofloxacino-lepori must be applied to each affected eye, even at night, at the following intervals:
1st and 2nd day of treatment: apply 1 or 2 drops to the conjunctival sac of the affected eye every 2 hours.
3rd day of treatment: 1 or 2 drops every 4 hours until the bacterial infection has disappeared.

If you have impression that the effect of Ciprofloxacino-lepori is too strong or weak, talk to your doctor or pharmacist.
Your doctor will tell you the duration of your treatment with Ciprofloxacino-lepori. Do not interrupt the treatment before that, since it may eliminate the effect expected.
Do not use Ciprofloxacino-lepori for more than 21 days unless told to do otherwise by your doctor.
Ciprofloxacino-lepori must be applied to the eye.

If you use more Ciprofloxacino-lepori than you should:
If you have used more eye solution than you should, see your doctor or pharmacist immediately.
In the event of a topical overdose of Ciprofloxacino-lepori it may be eliminated from the eye with lukewarm water.
In case of overdose or accidental intake, go to a medical centre or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Ciprofloxacino-lepori:
Do not use a double dose to make up for the doses you forgot to use.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ciprofloxacino-lepori may have adverse effects.
After using the product you may notice a sensation of burning and discomfort in your eye, such as itch, the sensation of a foreign body, desquamation in the eyelids, eye redness and a bad taste in your mouth.
Sometimes there may be corneal staining or inflammation, allergical reactions, swelling of the eyelid, tearing, sensitivity to the light, particles in the cornea, nausea and reduced vision.
Allergical reactions may appear.
In some patients with corneal ulcer, white precipitates were observed in the eye following administration between 24 h and the first 7 days of treatment, which will disappear after the continuous application of Ciprofloxacino-lepori.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING Ciprofloxacino-lepori

Keep Ciprofloxacino-lepori out of the reach and sight of children.

- No special storage conditions are required.
- Keep the container closed tight.

Expiry
Do not use Ciprofloxacino-lepori after the expiry date indicated on the box or label.
After opening the container, the eyedrops in solution must not be used after one month.

This leaflet was approved in 2001.

Farma-Lepori
C. Osi, 7 - 08034 Barcelona

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