In this leaflet:

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

Diclofenaco-lepori colirio 5 ml
Diclofenac sodium

The active substance is diclofenac (DOE) sodium. Each ml of eyedrop in solution contains 1 mg of this active substance.
The other ingredients are L-lysin monohydrate, boric acid (E-284), sodium borate, sodium chloride, polyoxyethylenated castor oil, benzalkonium chloride, sodium edetate, water for injectable solutions.

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

Manufacturer: ACRAF, SpA. Via Vecchia del Pinocchio, 22. 60131 Ancona (Italy)

1. WHAT Diclofenaco-lepori colirio 5 ml IS AND WHAT IT IS USED FOR
It is an ophthalmic preparation of 0.1% diclofenac sodium presented in a container of 5 ml. This medicine is included in the group of topical ophthalmological medicines.
It is indicated for:
• Postoperative treatment of the inflammation of the anterior segment of the eye
• Treatment of inhibition of peri- and postoperative cataract miosis
• Symptomatic treatment of non-infectious chronic conjunctivitis
• Treatment of eye inflammation, eye pain and post-refractive surgery photophobia

2. BEFORE YOU USE Diclofenaco-lepori colirio 5 ml
Do not use Diclofenaco-lepori colirio 5 ml:
• If you know you are allergic to any of the ingredients of the product.
• In children aged under 3 years.

Be particularly careful with Diclofenaco-lepori colirio 5 ml, since:
• In case of infection or risk of infection, check with your doctor, who may prescribe Diclofenaco-lepori colirio 5 ml together with another appropriate treatment (for example, antibiotics)
• The NSAIDs (non-steroidal antiinflammatories) may mask an acute infectious process.
• If you use soft contact lenses, apply the eyedrops in the container only when you are not wearing them.

Pregnancy:
Ask your doctor or pharmacist for advice before using any medicine. Although no development fetal anomalies have been detected it is advisable to use the product only in case of absolute need and under strict medical control.

Lactation:
Ask your doctor or pharmacist for advice before using any medicine. Although no effects have been described following application, use of the product is not recommended.

Driving and using machines:
The product should be avoided when driving or using machines.

Important information on some of the ingredients of Diclofenaco-lepori colirio 5 ml:
As it contains boric acid and sodium borate as excipients, it is contraindicated in children aged under 3 years.
Similarly, as it contains benzalkonium chloride as ingredient, it may decolour soft contact lenses.

Use of other medicines:
In intraocular application, no interactions with other drugs have been described to date.
Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those not prescribed.

3. HOW TO USE Diclofenaco-lepori colirio 5 ml
Follow these instructions unless told to do otherwise by your doctor:
Tilt your head backwards, draw your lower eyelid downwards, and apply the drop to the conjunctival sac (the space between the eye and the eyelid), as you look upwards. Close your eyes gently and keep them closed for a few instants. Wait at least 5 minutes before you use other ophthalmic medicines. If you forget a dose, apply it as soon as possible, unless it is already time for the next one; then go back to your usual dosage system. If you forget several doses see your doctor.
Being a sterile medicine, the following instructions should be followed:
• Each patient will use their own container.
• The eyedrop must be performed with the utmost pulchritude, avoiding as far as possible any contact with the dropper.
• After each application close the container tightly.
• On completion of the treatment dispose of the medicine, even if you have not used it all.
Remember to use your medicine.
Your doctor will tell you the duration of your treatment with Diclofenaco-lepori colirio 5 ml. Do not interrupt the treatment before you are told.
The correct dose for the cases indicated below are:
- Before surgery: 1 drop of Diclofenaco-lepori colirio 5 ml 3-5 times over the 3 hours before the operation, which means a maximum of 5 drops.
- After surgery: 3 drops of Diclofenaco-lepori colirio 5 ml applied at regular time intervals, beginning immediately after the operation, followed by 1-2 drops of Diclofenaco-lepori colirio 5 ml 3-5 times a day for the time required, which means a maximum daily amount of 10 drops.
- Other indications: 1-2 drops of Diclofenaco-lepori colirio 5 ml 3-4 times a day, according to the seriousness of the case, which means a maximum daily amount of 8 drops.
If you have impression that the effect of Diclofenaco-lepori colirio 5 ml is too strong or weak, talk to your doctor or pharmacist.

Diclofenaco-lepori colirio 5 ml must be applied to the eye.

If you use more Diclofenaco-lepori colirio 5 ml than you should:
Consult your doctor or pharmacist immediately.
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 taken.

If you forget to use Diclofenaco-lepori colirio 5 ml:
Do not use a double dose to make up for the doses you forgot to use.

4. POSSIBLE SIDE EFFECTS
As occurs with all medicines, Diclofenaco-lepori colirio 5 ml may have adverse effects.
Occasionally, as with other eyedrops in solution of the same therapeutic class, you may feel a mild or moderate sensation of passing stinging just after you apply the eyedrops in solution. Rarely, hypersensitivity reactions with pruritus, redness and photosensitivity may occur.
Stop using the medicine if you notice any adverse effect. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING DICLOFENACO-LEPORI COLIRIO 5 ML
Keep Diclofenaco-lepori colirio 5 ml out of the reach and sight of children.
- Do not store above 30ºC.
- Store in the original container.
Once the container has been opened, the eyedrops prepared for use, stored in normal environmental conditions, may be used for a period of no more than one month.

Expiry
Do not use Diclofenaco-lepori colirio 5 ml after the expiry date indicated on the box or label.

This leaflet was approved in April 2006.

Farma-Lepori
C. Osi, 7 - 08034 Barcelona

top