Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have further questions, please see your doctor or pharmacist.
• This medicine has been prescribed to you personally and you should not give it to anyone else. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

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

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 polyoxyethylenated castor oil 35, L-lysin monohydrate, boric acid (E-284), borax (E-285), sodium chloride, disodium edetate, water for injectable solutions.

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

Manufacturer: SIFI Pharmaceuticals. Via Ercole Patti, 36. 95020 Aci S. Antonio (CT) (Italy)

1. WHAT Diclofenaco-lepori colirio en solución monodosis IS AND WHAT IT IS USED FOR

These eyedrops are presented in cases containing 30 single-dose containers with 0.3 ml of eyedrops in solution. 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 en solución monodosis

Do not use Diclofenaco-lepori colirio en solución monodosis:
• 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 en solución monodosis, since:
• In case of infection or risk of infection, check with your doctor, who may prescribe Diclofenaco-lepori colirio en solución monodosis together with another appropriate treatment (for example, antibiotics).
• The NSAIDs (non-steroidal antiinflammatories) may mask an acute infectious process.

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 en solución monodosis:
As it contains boric acid and sodium borate as excipients, it is contraindicated in children aged under 3 years.

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 en solución monodosis

Follow these instructions unless told to do otherwise by your doctor:

1. Detach a single-dose container by levering it up and down.
2. Tap the base of the single-dose container lightly with the tip of your finger for the eyedrop to move down towards the opening.
3. Turn the stopper gently. The eyedrops are open.
4. Apply the eyedrops in solution to the eye and press the base to help the liquid down, as it may sometimes by blocked by air bubbles.

Remember to use your medicine.

Your doctor will tell you the duration of your treatment with Diclofenaco-lepori colirio en solución monodosis. 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 en solución monodosis 3-5 times over the 5 hours before the operation, which means a maximum of 5 drops.
- After surgery: 3 drops of Diclofenaco-lepori colirio en solución monodosis applied at regular time intervals, beginning immediately after the operation, followed by 1-2 drops of Diclofenaco-lepori colirio en solución monodosis 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 en solución monodosis 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 en solución monodosis is too strong or weak, talk to your doctor or pharmacist.

Diclofenaco-lepori colirio en solución monodosis must be applied to the eye.

If you use more Diclofenaco-lepori colirio en solución monodosis 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 en solución monodosis:
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 en solución monodosis 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 en solución monodosis

Keep Diclofenaco-lepori colirio en solución monodosis out of the reach and sight of children.

- No special storage conditions are required.
- Store in the original container.

This medicine does not contain preservatives. After use, dispose of the product even if you have not used it all.

Expiry
Do not use Diclofenaco-lepori colirio en solución monodosis after the expiry date indicated on the box or label.

This leaflet was approved in December 2004.

FARMA-LEPORI
C. Osi, 7 - 08034 Barcelona

 

 

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