In this leaflet:

1. What Corifina 0.5 mg/ml, colirio en solución is and what it is used for
2. Before you use Corifina 0.5 mg/ml, colirio en solución
3. How to use Corifina 0.5 mg/ml, colirio en solución
4. Possible side effects
5. Storing Corifina 0.5 mg/ml, colirio en solución

Corifina 0,5 mg/ml, colirio en solución
Azelastine hydrochloride

One ml of Corifina 0.5 mg/ml colirio en solución contains 0.5 mg of azelastine hydrochloride (0.05% w/v) as active substance. The other ingredients are: hypromellose, disodium edetate, benzalkonium chloride, sorbitol, sodium hydroxide, water for injection.
Each drop contains 0.015 mg of azelastine hydrochloride.

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

Manufacturer:
MEDA Pharma GmbH & Co. KG, Bad Homburg (Germany)

1. WHAT Corifina 0.5 mg/ml, colirio en solución IS AND WHAT IT IS USED FOR
Corifina colirio is presented in a bottle of 6 ml with dropper containing eyedrops in sterile solution for ophthalmic use.
Corifina colirio are potent long-acting anti-allergic eyedrops that prevent the effects of histamine (antihistamine) and other substances the body produces as part of an allergic reaction, which originate symptoms of redness, itch and/or tearing, together with sneezing, runny nose, itch or nose obstruction. Corifina colirio also has an additional antiinflammatory effect.
Corifina colirio is used for the treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children aged above 4 years.
Corifina colirio is also used for the treatment of symptoms of non-seasonal allergic conjunctivitis (perennial) in adults and children aged above 12 years.

2. BEFORE YOU USE Corifina 0,5 mg/ml, colirio en solución
Do not use Corifina colirio:
If you have ever had an allergic reaction to azelastine hydrochloride or to any of its ingredients.

Be particularly careful with Corifina colirio:
These eyedrops are not to be used for the treatment of eye infections

Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Due to the route of administration (eye) and at the low doses given, the absorption of this medicine may be expected to be minimal. Your doctor will decide whether or not to give you Corifina colirio.

Driving and using machines:
No effects on the capacity to drive or use machines by the use of Corifina colirio have been described.

Important information about some of the ingredients of Corifina colirio:
This medicine, as it contains benzalkonium chloride as ingredient, may decolour soft contact lenses. As occurs with other ophthalmic solutions, you should not use these eyedrops while you wear contact lens.

Taking other medicines
No specific interactions of Corifina colirio with other medicines have been described.
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine or products, even non-prescription drugs.

3. HOW TO USE Corifina 0,5 mg/ml, colirio en solución
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
Corifina colirio are drops for eye administration.
Normally, you should apply one drop of Corifina colirio to each eye, twice daily (0.06 mg of azelastine hydrochloride a day), for example first thing in the morning and at the same time in the evening. This dose may be increased, if necessary, to one drop in each eye four times a day (0.12 mg of azelastine hydrochloride a day), for example, every 6 hours.
If you expect to be exposed to the allergen (the substance that causes your symptoms of conjunctivitis, such as redness, itch and/or tearing), you should take Corifina colirio before any such exposure as a preventive measure.

Adults: The normal dose is one drop in each eye, twice daily (0.06 mg of azelastine hydrochloride a day). If necessary, this dose may be increased to four times a day (0.12 mg of azelastine hydrochloride a day).

The elderly: The same dose as in adults.

Children:
In case of seasonal allergic conjunctivitis, for children aged above 4 years, the same dose as for adults.
In case of non-seasonal allergic conjunctivitis (perennial), for children aged above 12 years, the same dose as for adults.

If you have the impression that the effect of Corifina colirio is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will tell you the duration of your treatment with Corifina colirio. Since safety and efficacy has been demonstrated for a period of six weeks, in the case of non-seasonal allergic conjunctivitis (perennial) the duration of treatment will be limited to a maximum of six weeks.

Instructions for the proper use of Corifina colirio:
1. Gently clean the area around the eyes to eliminate any humidity.
2. Draw your lower eyelid carefully downwards, making sure that the dropper does not touch the eyelids,
and place a drop in the middle area of the lower eyelid.
3. Release your lower eyelid and gently press on the inner side of your eye.
4. Then blink slowly a few times to spread the drop over the eye surface.

If you use more Corifina colirio than you should:
If you have applied more Corifina colirio than you should, see your doctor or pharmacist immediately.
No specific reactions caused by eye overdose are known and no effects of overdose are expected after application to the eye.
In case of overdose or accidental intake, call the Toxicology Information Service on 91562 04 20.

If you forget to use Corifina colirio:
If you forgot to take your medicine, use it as soon as possible and take the next dose 12 or 6 hours later, if necessary.
Do not take a double dose to make up for the doses you forgot to take.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Corifina colirio may have adverse effects.
Occasionally, it may produce mild transient irritation of the eye after the application of the eyedrops. Less frequently, a bitter taste.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING Corifina 0,5 mg/ml, colirio en solución
Keep Corifina colirio out of the reach and sight of children.
No special storage conditions are required. Store in the original container.

Expiry
Do not use Corfinia colirio after the expiry date indicated on the container.
Do not use one month after the first opening.

Other presentations
Corifina nasal spray.

This leaflet was revised in May 2006

Farma-Lepori
C. Osi, 7 - 08034 Barcelona

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